Howard Instruments, Inc.





LASERMATE
KERATOME SYSTEM

Howard Instruments, Inc.
4749 Appletree
Tuscaloosa, AL 35405-5747
Phone: (205) 553-4453
Fax: (205) 556-9267
Email: howard@howardinstruments.com
http://www.howardinstruments.com

1.0 DESCRIPTION

• The Keratome System is designed to produce a corneal flap.
  It features a high speed, low torque nitrogen turbine motor which drives a reciprocating surgical blade.
• The Keratome head is preset to produce a corneal resection approximately 160 microns in depth with the corresponding blade insertion and a flap diameter of approximately 10.0 mm can be achieved.
  Due to varying factors inherent to refractive procedures, such as intraocular pressure, corneal tissue, tissue hydration and other surgical bias, tissue thickness should be determined by practice.
• It is also recommended that Physicians and Technicians be trained on the proper use, care and set up of the instruments.

TRAINING:
• Training is available from the distributor or the manufacturer of this equipment, do not hesitate to call if any questions should arise.
• Proper training on the equipment and practice with animal eyes and donor eyes is highly recommended for the surgeon.

2.0 COMPONENTS

Each basic system includes the following:
• One Power Unit
• One Suction Tubing with Quick disconnect fitting and filter
• One Nitrogen Tubing with Quick disconnect fitting
• Two foot switches (Nitrogen & Vacuum)
• One 12 Volt battery charger
• One Turbine motor with hose and Quick disconnect fitting
• One Sterilization tray
• One Keratome head
• One Drive assembly
• One 9.5 mm suction ring
• One Suction ring Handle
• One 9.5 mm Applanator
• One Flap stop Ring
• One Nitrogen tank pressure regulator
• One Shipping Case

3.0 TECHNICAL SPECIFICATIONS

• PNEUMATIC CHARACTERISTICS
  • Powered by pressurized Nitrogen Gas
  • Recommended Tank Regulator Pressure: Minimum 500 PSI
  • Recommended tank output pressure: Maximum 65 PSI
    
    TURBINE
  • 14000 rpm
  • Autoclave Sterilization
  
  
• ACCESSORIES
  
  BLADES:     Single use sterile, disposable
  
  FIXATION RING     10.0 mm Autoclave Sterilization
  
  APPLANATOR     10.0 mm Cold Soak Sterilization
  
  
• ELECTRICAL CHARACTERISTICS
  • Built-in 12 volt battery
  • Charger: 110 volts AC 60 Hz/12 volts DC
  • Options:
    • 220 volts AC 50 Hz/12 volts DC
    • 100 volts AC 60 Hz/12 volts DC

4.0 POWER UNIT

1. Providing suction
2. Providing Power for cutting

• SUCTION
  The suction is indicated by the ?VACUUM? dial gauge located on the front of the Power Unit. The Vacuum quick disconnect hose fitting is located on the front panel.
• NITROGEN PRESSURE
  Nitrogen pressure is indicated by the ?NITROGEN? dial gauge located on the front of the Power Unit.
  This gauge shows the regulated nitrogen flowing through the Power Unit available to the turbine.
  The ?NITROGEN? quick disconnect hose fitting is located on the front panel.
• FITTINGS
  • There are two (2) quick disconnect hose fittings on the front of the Power Unit.
  • The fitting on the left is the ?TURBINE? hose fitting.
  • The fitting on the right is the ?VACUUM? hose fitting.
• FOOT SWITCH
  The foot switch receptacle, is located on the front Panel of the Power Unit.
• POWER SWITCH
  The power switch is located on the front of the Power Unit. This switch activates all of the internal components required to operate this Keratome Unit.

• PRESSURE ADJUSTMENT KNOB
  The pressure adjustment knob, labeled PSI CONTROL is to fine tune the ?NITROGEN? gauge located on the front of the Power Unit.
• NITROGEN INTAKE FITTING
  This fitting accepts the nitrogen tubing fitting coming from the nitrogen tank regulator.
• BATTERY CHARGER
  This receptacle will accept the charger connector.
• FUSE HOLDER
  Under the twist cap is a 3.15 amp slow blow fuse.

5.0 SUCTION AND TESTING

• The suction is indicated by a dial gauge located on the right side of the Power Unit, labeled ?VACUUM?.
• Inside the Power Unit a high-quality suction pump that provides a constant vacuum.
• The maximum suction that can be achieved is 30 in Hg.
• It is recommended to operate this unit between 22 - 30 in Hg.
• The suction pump is a 12 volt unit and is Powered by an internal battery pack that is rechargeable utilizing an external charger.
• It is recommended that this Power unit be recharged for a minimum of (8) hours before use.
• The Unit will also operate when the charger is plugged to the wall socket.
• When the battery is fully discharged the full charging time is 16 to 20 hours, and will not be harmed by over-discharge.
• Suction is activated by depressing the foot switch labeled VACUUM.
• When the foot switch is depressed the suction pump will activate.
• The sound produced could vary depending on the suction achieved or if the vacuum is occluded.
• The surgeon and the technician should always verify proper vacuum with the ?VACUUM? gauge on the front panel of the Power Unit.

TESTING VACUUM.
• Depress the foot switch labeled ?VACUUM? and obstruct the suction hose.
• The ?VACUUM? gauge on the front panel of the Power unit should read between 22 In Hg and 30In Hg.
• If the vacuum level does not rise to the proper level, check for external leaks, possible hose perforation, check fittings for possible leaks.
• If no leaks are found, plug the charger in the proper electrical wall outlet and re-test.
• If suction does not rise to the proper levels after this testing, an internal leak may be present.
• In this event, the Power Unit should not be used; and it should be and returned to the manufacturer for repair.

6.0 NITROGEN REQUIREMENTS AND TESTING

7.0 SYSTEM COMPONENTS

• 7.1 TURBINE MOTOR
  • The Turbine motor is a high speed motor to Power the Keratome with low torque for safety.
  • The motor can be sterilized by autoclave or wiped cleaned with alcohol.
  • The turbine is to be lubricated with 3 drops of oil (provided with your unit).
    The drops of oil are administered in the smaller of the two (2) holes at the hose connection and care should be use to insure that the oil only goes in the smaller of the 2 holes.
    The shaft tip requires NO lubricant.
  • The turbine motor should be operated at 55 psi when running.
    This will be approximately 14,000 revolutions per minutes.
• 7.2 VACUUM FIXATION HANDLE
  • Attaches to the suction hose from the Power Unit.
  • The vacuum fixation ring screws on to the fixation handle and is placed upon the eye.
  • After use, the vacuum fixation handle must be flushed with distilled water and dried with air.
• 7.3 VACUUM FIXATION RING
  • A complete unit comes with only one 9.5 mm fixation ring.
  • After use, the vacuum fixation ring should be flushed with distilled water and dried with air.
• 7.4 STOP RING
  • One stop ring is supplied with your Keratome system.
  • The stop ring will provide the correct hinge.
  • The stop ring is a slip fit onto the drive assembly.
  • After use, the stop ring should be rinsed with distilled water and dried with air.
• 7.5 Keratome HEAD
  • Attaches to the turbine motor and fits into the double dovetails of the vacuum fixation ring.
  • The Keratome head contains a reciprocating blade which is driven by the turbine motor.
  • The translation across the cornea is accomplished by the surgeon sliding the Keratome within the double dovetails until the stop ring contacts the vacuum fixation ring, limiting the travel.
  • After use, the Keratome head should be rinsed and brushed with a soft bristle tooth brush with distilled water and dried with air.
  • The Keratome houses a small precision bearing.
  • This cleaning method will not harm this precision bearing.
    
  
      DO NOT ULTRASONICLY CLEAN THIS KERATOME.
  
  
• 7.6 APPLANATOR
  • One 10.0 mm Applanator is supplied with your Keratome system.
  • The applanator lens confirms the diameter of exposed cornea through the fixation ring.
  • The applanator lens fits between the double dovetail of the vacuum fixation ring with the handle of the applanator lens 90 degrees from the vacuum fixation handle.
  • After use, the applanator lens should be brushed with a soft bristle tooth brush.
  
  Do not Autoclave or use alcohol. This will severely damage the Applanator lens.
  
  
• 7.7 STERILIZATION TRAY
  • After use, the tray should be flushed with distilled water and dried with air.
• 7.8 DISPOSABLE VACUUM TUBING SET
  • This filter, installed on the suction tubing six to eight inches from the Power Unit, is important for trapping any moisture entering the suction tubing during the surgical procedure.
  • Absence of moisture insures maximum efficiency of the vacuum pump located inside the Power Unit.

8.0 ASSEMBLY OF BLADE

• Open pre-sterilized blade package and carefully remove the blade assembly.
• Holding it by the side of the blade but away from the cutting edge
  - insert the blade into the side of the Keratome Head matching the cutting edge of the blade with the front of the Keratome Head.
  (Care should be taken not to damage the blade during insertion).
• Holding the Keratome Head between your index finger and thumb, covering the opening of the blade insertion slot, will ensure the blade is centrally located inside the Keratome Head.
• (Blade should be fully embodied within the Keratome Head and not exposed on either side of the Keratome Head)

9.0 ASSEMBLY KERATOME TO TURBINE MOTOR

• You must first insert the stop ring onto the drive assembly.
• Then screw (clockwise) the Keratome head onto the drive assembly, (one revolution) finger tight only.
• Then using the special black hand drive tool that has a double slot cut on one end, insert into the drive assembly giving a twist 360 degrees.
• This will engage the blade holder into the drive shaft, make sure the blade is isolating inside the Keratome head.

10.0 PRACTICAL GUIDE FOR MAKING A FLAP

• Apply suction.
• Check IOP with optical tonometer.
• Dry the eye and carefully measure the exposed cornea with applanator lens.
• Wet the blade and the top of the suction ring with the appropriate solution suited for the procedure.
• Insert the Keratome into the dovetails of the vacuum fixation ring.
• Activate the turbine motor.
• Gently slide the Keratome away from the cornea for a short distance to check for smooth translation within the dovetails.
• Move the Keratome forward across the cornea in a smooth, uninterrupted motion until the stop ring contacts the vacuum fixation ring.
  
  STOPPING OF THE KERATOME MOVEMENT OR TURBINE MOTOR MAY RESULT IN IRREGULAR CORNEAL RESECTIONS AND DAMAGE.
  
• When the Stop ring contacts the fixation ring immediately stop the Turbine motor while maintaining suction.
• Gently back the Keratome out of the vacuum fixation ring to allow the corneal flap to be withdrawn through the Keratome.
• Stop suction.
• Remove fixation ring from the eye.

11.0 FLAP AND HINGE POSITION

• There are factors that can influence the diameter of a flap and the position of the hinge.
  IOP, proper measurements, proper suction and surgical technique can all provide variables.
  The variables can be minimized by practice and surgical experience.
• The effects of Stop Ring, Vacuum Fixation ring and Applanator lens on the production of a corneal flap.
  • Applanator lens - measures the diameter of exposed cornea and provides a reference for the hinge position.
    There is (1) applanator lens provided with the Keratome System.
    The diameter of exposed cornea through the center of the suction ring is confirmed with the applanator lens.
  • Vacuum / Fixation ring - controls the diameter of cornea that is exposed above the ring.
    The ring allows a small diameter of cornea to be exposed and serves as a fixation device.
  • Stop ring - The Stop ring limits the travel of the Keratome through the vacuum fixation ring.

12.0 BLADES AND FILTERS

• Only use blades manufactured by Howard Instruments, Inc.
• The use of any other blade may cause damage to the eye or Keratome.
• Blades are provided sterile and are disposable, for single use only.
• Blades should be inspected prior to use for damage.
• Use only In-line suction filters available from Howard Instruments, Inc. which have been engineered to work with the Keratome System.
• Filters should be changed every 25 cases.

13.0 BREAK-IN PERIOD

• The physician should practice with the Keratome before use in surgery.
• The physician and technical staff should become thoroughly familiar with the proper operation and cleaning of the Keratome and related instruments.
• During this practice period, the Turbine should be lubricated before being used to actually cut animal eyes.
• The blades should be changed frequently, and the keratome cleaned according to cleaning procedure in chapter 18.0 with every blade change.
• Special care should be taken to clean the recessed area of the Keratome.

14.0 STERILIZATION

15.0 PRIOR TO PERFORMING SURGERY

For optimum performance, before performing surgery and with every blade change the Keratome must be prepared for use as follows:
1. Do not assemble head and stop ring before sterilizing.
2. Sterilize components.
3. Lubricate turbine motor.
4. Insert blade into Keratome then assemble the keratome to the drive assembly and to the Turbine.
5. Dry-run the Keratome for 5 seconds.
6. Immerse Keratome head in sterile distilled water and run for 5 seconds while immersed.
7. Perform surgery

16.0 TAKING APART THE Keratome HEAD

• Simply hold firmly between your fingers and twist one revolution counter clockwise.
• Care must be taken when removing to ensure that the stop ring and the Keratome head is not dropped.
• This would prevent damage to either or both components.

17.0 PROPER STORAGE

• The Keratome should be cleaned according to the cleaning procedure outlined in chapter 18.0 of this manual before it can be placed in it's proper storage place to insure protection from damages.
• Turn off the nitrogen at the shut-off valve located on the top of the nitrogen tank.
• Disconnect the ?NITROGEN? hose (black) from the back of the Power Unit.
• Disconnect the Foot Switch, Vacuum hose and the Turbine hose from the Power Units' front panel, storing them in a proper place to prevent damages.

18.0 CLEANING INSTRUCTIONS

1. THE BODY: WITH THE DOVE TAILS BUT WITHOUT THE BLADE HOUSING.
   • Clean with soft bristle tooth brush and mild soap. Rinse in clean, clear water. Use compressed
   • air to blow excess water off the blade housing (this prevents rust) then dip the holder in alcohol
   • and blow excess off . (Again this process eliminates unwanted moisture to prevent rust).
2. THE BLADE HOUSING: THIS IS WHAT HOUSES THE BLADE HOLDER WITH THE BLADE ATTACHED.
   • Please remove the blade. Clean in ultrasonic cleaning tank for 5 minutes
   • immediately after use, before it has a chance to dry out. Use compressed
   • air to blow excess water off the blade housing (this prevents rust) then dip
   • the holder in alcohol and blow excess off again (this process eliminates
   • unwanted moisture to prevent rust.
3. TURBINE MOTOR: THIS IS THE MOTOR WITHOUT THE GREY HOSE.
   • The turbine can be autoclaved inside of a pouch.
   • After the autoclave cycle you must lubricate the turbine through the smaller of the two (2) holes in back of the turbine.
   • Apply only the lubricant supplied by the Manufacturer.
   • Apply only 2 drops before using the turbine again.
   • Always run the Turbine for 15 seconds after applying the lubricant.
   • This will lubricate all of the internal parts that have been dried out by the Autoclave.
   • The turbine can also be wiped with rubbing alcohol.
4. TURBINE HOSE: THIS IS THE GREY HOSE
   • This GREY hose connects the back of the turbine to the Power Unit, this hose can only be wiped clean with alcohol.
5. VACUUM HOSE: THIS IS THE CLEAR HOSE
   • This hose is intended for a single use and disposable.
   • The hose comes with a filter and a quick disconnect hose fitting.
   • These components will melt if place in an autoclave.
6. VACUUM RING:
   • This Vacuum ring also known as a (Suction ring) is stainless steel and should be cleaned in an ultrasonic cleaning tank for 5 minutes immediately after use.
   • Rinse in clean clear distilled water.
   • Use compressed air (can be purchase in electronic or computer stores) to blow excess water off.
   • The vacuum ring should be dipped in alcohol (this process eliminates unwanted moisture preventing rusting).
7. APPLANATOR:
   • The applanator is Acrylic.
   • To clean simply brush Clean with soft bristle tooth brush and mild soap.
   • Rinse in clean clear distilled water.
   • Use compressed air to blow off excess water.
   • Let air dry before storing.
8. BLADE PUSHER:- THIS IS THE BLACK INSTRUMENT
   • This has a dual purpose one is to extract the blade and the other is to test if the blade holder is engaged with the motor assembly of the turbine.
   • To clean simply brush Clean with soft bristle toot brush and mild soap.
   • Rinse in clean clear distilled water. Use compressed air to blow off excess water, let air dry before storing.

19.0 WARRANTY :

20.0 REPAIRS:

HOWARD INSTRUMENTS, INC. provides repair services for all of it's instruments.
When an instrument needs repair please use the following procedure:
1. Make sure the instrument(s) are cleaned properly before shipping to HOWARD INSTRUMENTS, INC..
2. To ship the instrument, use the proper shipping case that was supplied when you received it.
   Use the same method of packaging to insure the instrument(s) arrive to HOWARD INSTRUMENTS, INC. undamaged.
3. Include all necessary paperwork, return address, telephone number, special instruction and the return authorization number or your purchase order.
4. Ship to:
   Howard Instruments, Inc.
   4749 Appletree
   Tuscaloosa, Alabama 35405-5747
   Attention: Instrument repair
5. Any telephone inquiries regarding instrument repairs should be made to HOWARD INSTRUMENTS, INC. Customer Service at (205) 553-4453.

21.0 LIMITATION OF CLAIM

Presented by Howard Instruments Inc.
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