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Konig Surgical Instruments Recommended Cleaning and

1. Cycle Type Parameter Minimum Set Point Exposure Temp 270 F 132 C Prevacuum Exposure Time 4 minutes Dry Time 20 minutes Cycle Type Parameter Minimum Set Point Exposure Temp 250 F 121 C Gravity Displacement Exposure Time 30 minutes Dry Time 15 minutes Gas Sterilization Gas sterilization by ethylene oxide may be used up to a maximum temperature of 65 C and 8p s i This method is preferred if sterilization is to be performed regularly Steam Sterilization Steam sterilization can also be performed autoclave pouch Insert device inappropriate Note do not exceed a temperature of 135 C and a pressure of 28p s i WARNING Flash autoclaving and hot air sterilization should be avoided as these processes will damage the instrument Blade and Handle Test Procedure Laryngoscope blades and handles should always be tested after cleaning disinfection sterilization and prior to use To test connect the laryngoscope blade to the handle and pull it to the ON position as shown in Figure 1 If the unit fails to light or flickers check the lamp batteries and the electrical 12 contacts Be sure adequate supplies of spare lamps batteries and replacement parts are readily available NOTE THE ABOVE LISTED STERILIZATION GUIDELINES PROVIDED BY MEDLINE INDUSTRIES INC ARE INTENDED AS PROCEDURES COMPATIBLE WITH SPECIFIC MATERIALS STERILIZATION MUST BE PERFORMED TO APPROVED HOSPITAL PROTOCOL ME
2. Rongeurs Recommended Cleaning Sterilization and Instructions for Use K nig rongeurs are devices intended to access cut and bite soft tissue and bone during surgery Caution Federal U S laws restrict this device to sale distribution and use by or on the order of a physician WARNING If this device is was used in a patient with or suspected of having Creutzfeldt Jakob Disease CJD the device cannot be reused and must be destroyed due to the inability to reprocess or sterilize to eliminate the risk of cross contamination Instructions for Use Warning Remove all protective caps and sheaths carefully Prior to surgical use rongeur must be cleaned lubricated decontaminated sterilized and inspected Instruments are reusable and supplied as non sterile Attention Risk of damage The rongeur is a precision device Careful handling is important for accurate functioning of the product Improper external handling e g bending banging dropping etc can cause product malfunction Control function before use Before using the general functioning and preparation of the rongeur and accessories must be controlled Please confirm prior to use Operation Neurosurgical procedures should be performed only by persons having adequate training and familiarity with neurosurgical techniques In addition consult medical literature relative to techniques complications and hazards prior to performing any neurosurgical proced
3. Operation Cardiovascular procedures should be performed only by persons having adequate training and familiarity with cardiovascular techniques In addition consult medical literature relative to techniques complications and hazards prior to performance of any cardiovascular procedure Before using the product all instructions regarding its safety features as well as surgical techniques must be read carefully The sterile instrument is inserted into the body The instrument must be operated only by trained personnel Please observe general operating room technique Decontamination and Cleaning Decontamination Take the device with the adapter s and accessories to the decontamination area Clean decontaminate and sterilize the device adapter s and accessories following the instructions in the IFUs Warning Risk of infection Before use the entire device including its accessories must be decontaminated Inadequate incorrect or superficial decontamination can create a serious risk of infection in patients and or users Cleaning Follow the General Instruments cleaning guide found on page 2 16 Sterilization Autoclave sterilization o Use steam autoclave sterilization only Steam sterilize at 270 F for fifteen 15 minutes Other time and steam temperature cycles may also be used However user must validate any deviation from the recommended time and temperature Note Contact the manufacturer of your steam autocl
4. electrosurgical generator for additional information on contraindications Caution Please refer to the labelling and user manual on electrosurgical or laparoscopic use Cautions amp Warnings Avoid touching or grounding electrosurgical instruments to non insulated instruments scopes trocar sleeves etc All persons using such devices should be knowledgeable in the use and handling of laparoscopic instruments laparoscopes coagulation equipment their accessories and other related equipment Test all instruments accessories and equipment prior to each use Written standard operating procedures for cleaning sterilization storage inspection and maintenance of the instruments accessories and equipment are recommended Caution Do not use electrosurgical instruments on patients with pacemakers Caution Do not use in presence of flammable liquids or anesthetics Electrosurgical generators used with these devices are designed to cause destruction of tissue and are inherently dangerous if operated improperly Follow all safety precautions and instructions supplied by the manufacturer of the electrosurgical generator The electrode tip must always be in full view before activating power Apply power only when electrode tip is in full contact with the tissue selected for coagulation Electrode tip must not come in contact with the laparoscope or other metal instruments during use Failure to observe these cautions and contraindica
5. l aiia Locking Screw J H g Fig 1 sak The integrated fiber optic blades are built with an integrated fiber optic bundle with no cavities thus allowing for easy decontamination Integrated fiber optic blades are maintenance free and may be sterilized via autoclave up to 134 C 5 min approximately 4 000 times Operating Instructions 1 Engage the blade by aligning the slot of the blade on to the hook pin of the handle and apply a sufficient force 1Ib as shown in Figure 2 2 Apply force upward to bring the blade into operating position as shown in Figure 3 3 To bring the blade into standby position apply force downward as shown in Figure Operating Position Stand By Position Fig 2 g Fig 3 Light Guide Replacement Procedure 1 Remove locking screw with a screw driver as shown in Figure 1 2 Pull out the green block and slide out the light guide 3 Fix new light guide of similar size and replace the locking screw 4 Be sure the screw is properly tightened Caution Great care should be taken while performing this procedure to avoid structural damage to the fiber blade Lamp Replacement Procedure for Xenon F O Handle 1 Unscrew the head from the barrel counter clock wise as shown in Figure 5 2 Remove the lamp from the head Replace the new lamp Screw the head clock wise to the barrel Attention Always try to keep the lens of the lamp clean for better performance NOTE LED handles do
6. 4 Cleaning Instruments Choose a cleaning solution appropriate for surgical instruments and follow manufacturer s instructions for use e The use of neutral pH detergents is recommended to avoid corrosion pitting and breakage e Using a small clean hand held brush remove soil from all surfaces of instrument while fully immersed in solution e Never use steel wool wire brushes scalpel blades or highly abrasive detergent or cleansers to remove soil as these will damage the instruments protective surface and lead to corrosion e Use a clean soft bristled brush to clean instruments with an accessible channel e Remove soil from jaws tips and hinge mechanism Vigorously flush channels with distilled water 5 Rinse Thoroughly rinse instruments with distilled water and wipe with a clean soft cloth Onis Surgical Instruments MEDLINE 6 Ultrasonic Cleaning and Rinsing Follow recommendations of ultrasonic manufacturer regarding cycle times detergents proper placement of instrument tray and conditioning de gassing of cleaning solution e Use an ultrasonic cleaner to remove soil from hard to reach surfaces such as grooves crevices and moving parts after gross soil has been removed e Open or disassemble instruments as appropriate e Keep different metal types separated i e separate stainless steel from non anodized aluminum brass copper and chrome plating to avoid possible transfer of one metal platin
7. FROM THE INSTRUCTIONS PROVIDED MUST BE PROPERLY EVALUATED FOR EFFECTIVENESS AND POTENTIAL ADVERSE CONSEQUENCES 2014 2015 Medline Industries Inc All rights reserved MEDLINE K nig and Medline are registered trademarks of Medline Industries Inc Mundelein IL 60060 USA 1 800 MEDLINE www medline com Onis Surgical Instruments MEDLINE Vessel Dilators Recommended Cleaning Sterilization and Instructions for Use K nig Vessel Dilators are devices used to enlarge or calibrate vessels during coronary artery bypass or angioplasty procedures They are designed to locate orifices to trace the course of abnormal vessels and to perform various maneuvers of dilation and measurement of annulus and lumen diameters Caution Federal U S laws restrict this device to sale distribution and use by or on the order of a physician Caution Surgical instruments should not be used by individuals who are not fully trained in proper cardiovascular surgical techniques Consult relevant medical literature for the appropriate indications techniques and risks applicable to the corresponding cardiovascular procedure Read the instructions for Use prior to using this device WARNING If this device is was used in a patient with or suspected of having Creutzfeldt Jakob Disease CJD the device cannot be reused and must be destroyed due to the inability to reprocess or sterilize to eliminate the risk of cross contamination Inst
8. IS THE RESPONSIBILITY OF THE REPROCESSOR TO ENSURE THAT THE REPROCESSING IS ACTUALLY PERFORMED USING EQUIPMENT MATERIALS AND PERSONNEL IN THE REPROCESSING FACILITY ACHIEVE THE DESIRED RESULT THIS REQUIRES VALIDATION AND ROUTINE MONITORING OF THE PROCESS LIKEWISE ANY DEVIATION BY THE REPROCESSOR FROM THE INSTRUCTIONS PROVIDED MUST BE PROPERLY EVALUATED FOR EFFECTIVENESS AND POTENTIAL ADVERSE CONSEQUENCES 2014 2015 Medline Industries Inc All rights reserved K nig and Medline are registered trademarks of Medline Industries Inc Mundelein IL 60060 USA 1 800 MEDLINE www medline com MEDLINE nig Surgical Instruments MEDLINE Laparoscopes and Accessories Recommended Cleaning Sterilization and Instructions for Use K nig Laparoscopes and Accessories are intended to be used by qualified physicians to provide access illumination and visualization of internal structures and for manipulating soft tissue grasping cutting coagulating dissecting and suturing in a wide variety of diagnostic and therapeutic laparoscopic urologic closed and minimally invasive procedures Instructions for Use Caution Federal U S laws restrict this device to sale by or on the order of a physician only Special safety precautions should be observed when using electrosurgical instruments Electrosurgical instruments can pose a significant shock burn or explosion hazard if used improperly incorrectly or carelessly for the
9. clean soft cloth Ultrasonic cleaning The cavitation action of ultrasonic cleaners can remove particles of debris from areas of the instrument inaccessible to a brush and is recommended as part of the reprocessing procedure With the jaws in the open position place the instrument in a mesh bottom instrument basket Place the basket in the ultrasonic cleaner Follow the recommendations of the ultrasonic cleaner manufacturer as to cycle times cleaning solutions suspension of the basket e g the basket should not sit on the bottom of the ultrasonic cleaner conditioning of the water etc Ensure that all instruments are fully submerged in the ultrasonic cleaner Do NOT place dissimilar metals stainless copper chrome plated etc in the same cleaning cycle Rinse After removing from the ultrasonic cleaner rinse all of the instrument s components thoroughly with lukewarm neutral pH 7 or lower water which is controlled for bacterial endotoxins to remove any remaining debris or ultrasonic detergent residue that could interfere with the sterilization process Flush the instruments internal channels with the jaws open to remove dislodged gross soil and remaining debris or ultrasonic detergent residue from inside the shaft Wipe the instrument with a clean soft cloth Dry Instruments must be thoroughly dried with a clean soft cloth The use of pressurized air is recommended to aid in drying especially in the crevices of the instrume
10. e Follow manufacturer s specifications when using automatic washers to process general surgical instrumentation Recommended automatic washer parameters to remove gross amounts of soil Phase Time mmi ss Temperature Presoak 02 00 15 20 C 59 60 F Enzymatic Wash 04 00 60 C 140 F Wash Cleaning 02 00 50 C 122 F Rinse 02 00 70 C 158 F Dry 15 00 80 C 176 F Remove instruments from automatic washer eFollow Steps 7 10 of Manual Decontamination cleaning instructions to perform instrument final rinse visual inspection lubrication and drying before terminal sterilization Sterilization Autoclave Sterilization Use steam autoclave sterilization only Steam sterilize at 270 F for four 4 minutes and thirty 30 minutes dry time Other time and steam temperature cycles may also be used However user must validate any deviation from the recommended time and temperature Note Contact the manufacturer of your steam autoclave to confirm appropriate temperatures and sterilization times The rongeurs can be sterilized in an open or closed position Caution Autoclave temperatures should not exceed 280 F handles insulation or other nonmetallic parts may be damaged Make certain that the instrument container is sealed in appropriate packaging for sterilization Sterilize in compliance with the local guidelines for hospital hygiene K nig surgical instruments are re usable and meet AAMI stan
11. not require replacement Fig 5 Onis Surgical Instruments MEDLINE Battery Replacement Procedure C Type lt Batteries rg N li a s i Re Chargeable Z NiMH Battery 2 5V f ra Cap for Barrel 2 5V Xenon amp LED handles can be used with dry batteries as well as rechargeable batteries NOTE In accordance with local regulations rechargeable batteries should be disposed of as an electronic device separately Cleaning Procedure Attention Remove batteries before cleaning high level disinfection or sterilization of the laryngoscope system Blades and Handles Cleaning 1 Immediately after use the laryngoscope system should be rinsed under cool running tap water until all visible soil is removed Ensure that all hard to reach areas are flushed with the running tap water 2 Immerse the sealed laryngoscope system in a presoak enzymatic cleaner solution prepared in accordance to the manufacturer s recommendations for a minimum of two 2 minutes 3 Remove device from enzymatic cleaner solution and rinse with lukewarm running tap water for a minimum of one 1 minute to remove all residues and visible soils 4 Immerse the device in enzymatic detergent Remove bottom cap and brush items thoroughly using a soft bristle brush ensuring all visible soils are removed 5 Rinse under running reverse osmosis deionized RO DI water to remove detergent
12. use It is especially essential to check areas such as blades points ends stops and snaps as well as all movable parts Do not use damaged instruments Never attempt to make repairs yourself Service and repairs should be referred to trained qualified persons only Cleaning and Maintenance Every surgical instrument should be disinfected and thoroughly cleaned after each use Proper cleaning inspection and maintenance will help ensure correct function of the surgical instrument Clean inspect and test each instrument carefully Sterilize all instruments before surgery A good cleaning and maintenance procedure will extend the useful life of the instrument Special attention must be paid to slots stops ends hollow tubes and other highly inaccessible areas Check insulation cables and connectors for cuts voids cracks tears abrasions etc Do not use damaged instruments Cleaning and rinsing must take place immediately after each use for best results Failure to clean promptly may result in adherent particles or dried secretions that may resist cleaning and complicate or resist future sterilization Instruments must be completely cleaned and rinsed of all foreign body matter Use warm water and a commercially available instrument pre soak or cleaning agent Enzymatic cleaners must be used to remove protein deposits Follow the enzymatic cleaner s instructions and rinse thoroughly NOTE Do not use corrosive cleaning agents i e blea
13. 5 Medline Industries Inc All rights reserved K nig and Medline are registered trademarks of Medline Industries Inc Mundelein IL 60060 USA 1 800 MEDLINE www medline com Kos Surgical Instruments MEDLINE Standard Laryngoscopes Recommended Cleaning Sterilization and Instructions for Use Standard Laryngoscope Features These operating instructions pertain to Konig brand standard laryngoscope systems These instructions should be followed to ensure the longevity and durability of this product Please inspect all components before use to confirm all items are present and in perfect working condition Medline standard laryngoscope blades are manufactured from high quality AISI 303 304 stainless steel which is highly resistant to corrosion and conforms to ISO 7376 Operating Instructions 1 Engage the blade by aligning the slot of the blade on to the hook pin of the handle and apply a sufficient force 1lb as shown in Figure 1 2 Apply force upward to bring the blade in operating position as in Figure 2 3 To bring the blade to standby position apply force downward as in Figure 2 Operating Position Stand By Position Fig 3 Bulb Replacement Procedure 1 Unscrew the bulb counter clock wise direction until free as shown in Figure 3 2 Replace the bulb and verify that the bulb is sufficiently tight before use 11 Battery Replacement Procedure Nickle Metalhydrid insert Sis Way On
14. All of our products are designed and manufactured to meet the highest quality standards We cannot accept liability for failure of products which have been modified in any way from their originals NOTE IT IS THE RESPONSIBILITY OF THE REPROCESSOR TO ENSURE THAT THE REPROCESSING IS ACTUALLY PERFORMED USING EQUIPMENT MATERIALS AND PERSONNEL IN THE REPROCESSING FACILITY ACHIEVE THE DESIRED RESULT THIS REQUIRES VALIDATION AND ROUTINE MONITORING OF THE PROCESS LIKEWISE ANY DEVIATION BY THE REPROCESSOR FROM THE INSTRUCTIONS PROVIDED MUST BE PROPERLY EVALUATED FOR EFFECTIVENESS AND POTENTIAL ADVERSE CONSEQUENCES MEDLINE 2014 2015 Medline Industries Inc All rights reserved K nig and Medline are registered trademarks of Medline Industries Inc Mundelein IL 60060 USA 1 800 MEDLINE www medline com Onis Surgical Instruments MEDLINE Retractors Recommended Cleaning Sterilization and Instructions for Use K nig Surgical retractors are manual orthopedic devices intended to provide minimally invasive access to the surgical site by ensuring the placement and positioning of the retractor with its attachment to a flexible arm to provide a self locking method of access to the site through which tubes Endoscopes and surgical instruments can be manipulated Caution Federal U S laws restrict these devices to sale distribution and use by or on the order of a physician Instructions for Use Warning Remove al
15. DLINE INDUSTRIES INC CAN NOT GUARANTEE STERILITY THIS WILL BE VALIDATED BY THE HOSPITAL AND OR STERILIZATION EQUIPMENT MANUFACTURERS ee E 2014 2015 Medline Industries Inc All rights reserved 7422 4 Konig and Medline are registered trademarks of Medline Industries Inc Mundelein IL 60060 USA 1 800 MEDLINE www medline com Onis Surgical Instruments MEDLINE Gynecological Forceps Recommended Cleaning Sterilization and Instructions for Use K nig Surgical gynecological forceps are surgical instruments with two blades and handles used to seize tissue by compression or traction during gynecological surgery Caution Federal U S laws restrict this device to sale distribution and use by or on the order of a physician Caution Surgical forceps should not be used by individuals who are not fully trained in proper gynecological surgical techniques Consult relevant medical literature for the appropriate indications techniques and risks applicable to the corresponding gynecological procedure Read the instructions for Use prior to using this device WARNING If this device is was used in a patient with or suspected of having Creutzfeldt Jakob Disease CJD the device cannot be reused and must be destroyed due to the inability to reprocess or sterilize to eliminate the risk of cross contamination Instructions for Use Warning Remove all protective caps and sheaths carefully Prior to surgical us
16. INE MONITORING OF THE PROCESS LIKEWISE ANY DEVIATION BY THE REPROCESSOR FROM THE INSTRUCTIONS PROVIDED MUST BE PROPERLY EVALUATED FOR EFFECTIVENESS AND POTENTIAL ADVERSE CONSEQUENCES 2014 2015 Medline Industries Inc All rights reserved MEDLINE K nig and Medline are registered trademarks of Medline Industries Inc Mundelein IL 60060 USA 1 800 MEDLINE www medline com Kois Surgical Instruments MEDLINE Lead Hands Recommended Cleaning Sterilization and Instructions for Use K nig Lead Hands are made from malleable lead and used to position and immobilize a patient s hand during surgical procedures Instructions for Use 1 Place the lead hand on the surgical table and place the patient s hand on top of the device 2 To immobilize bend the wrist tabs over the patient s wrist and bend the immobilizer finger tabs over the applicable fingers as needed It is recommended to place a barrier or drape between the patient s hand and the lead hand to avoid direct contact 3 After the procedure carefully straighten the lead hand s finger and wrist tabs NOTE Due to the malleability of the material continual bending of the tabs in the same location will cause the material to weaken and may crease or break 4 Reprocess according to the cleaning and sterilization instructions below Caution The Lead Hand must not come in direct contact with open wounds or mucous membrane Decontamination and Cleani
17. Kos pe Surgical Instruments K nig Surgical Instruments Instructions for Use Cleaning Sterilization and Maintenance Guidelines Contents General Instrumentation Recommended Cleaning and Sterilization Instructions ccccccccccecessesscseceeeeeeeesessaeeeeeesseesees 2 Retractors Recommended Cleaning Sterilization and Instructions for USC ceceessssccececeseeseneeeceeecessessaaeseeeesesssessnaeess 4 Open Up Kerrison Rongeurs Recommended Cleaning Sterilization and Instructions for US cc cccccccecesesssssceeeeeens 5 Rongeurs Recommended Cleaning Sterilization and Instructions for USe cccceesssscceeeceseessceceeeeecessessaeseeeeecessesaaeess 7 Fiber Optic Laryngoscopes Recommended Cleaning Sterilization and Instructions for USC ccccccesssssssceeeeesessessaeees 9 Standard Laryngoscopes Recommended Cleaning Sterilization and Instructions for USe cccceesssseceeeceseesssseeeeeeeens 11 Gynecological Forceps Recommended Cleaning Sterilization and Instructions for USC cccccecesssssseceeecessesssseseeeeeens 13 Obstetrical Forceps Recommended Cleaning Sterilization and Instructions for USE ccccccccccesesssssseeeeeecessessnteseeeeeens 14 Vascular Clamps Recommended Cleaning Sterilization and Instructions fOr USC cccccccssesssceceeecesessssaeeeeeeseessesssaeees 16 Vessel Dilators Recommended Cleaning Sterilizati
18. M THE INSTRUCTIONS PROVIDED MUST BE PROPERLY EVALUATED FOR EFFECTIVENESS AND POTENTIAL ADVERSE CONSEQUENCES _L 2014 2015 Medline Industries Inc All rights reserved 1 78 8 K nig and Medline are registered trademarks of Medline Industries Inc Mundelein IL 60060 USA 1 800 MEDLINE www medline com nig Surgical Instruments MEDLINE Obstetrical Forceps Recommended Cleaning Sterilization and Instructions for Use K nig Obstetrical Forceps are intended to grasp and apply traction to the fetal head to facilitate delivery in cases of prolonged second stage suspicion of immediate or potential fetal compromise or shortening of the second stage for maternal benefit provided that the cervix is fully dilated and the fetal head is positioned appropriately in the vagina Caution Federal U S laws restrict this device to sale distribution and use by or on the order of a physician Caution Obstetrical forceps should not be used by individuals who are not fully trained in proper use of forceps and the potential complications associated with their use Consult relevant medical literature for the appropriate obstetric indications prerequisites techniques and risks of operative vaginal delivery prior to the performance of any forceps delivery Read the Instructions for Use prior to using this device Caution Obstetrical forceps should only be used in settings in which personnel are readily available to
19. Note Contact the manufacturer of your steam autoclave to confirm appropriate temperatures and sterilization times The rongeurs can be sterilized in an open or closed position Caution Autoclave temperatures should not exceed 280 F handles insulation or other nonmetallic parts may be damaged Make certain that the instrument container is sealed in appropriate packaging for sterilization Sterilize in compliance with the local guidelines for hospital hygiene K nig surgical instruments are re usable and meet AAMI standards for sterilization We guarantee our products to withstand a minimum of twenty 20 sterilization cycles when sterilized according to the criteria listed Maintenance Attention Apply lubricant only on the connecting elements locking mechanism and moving parts Repair To ensure that all repairs are completed according to the manufacturer s specifications the precision rongeur should be repaired by Medline or by an authorized service agency only Warranty All K nig surgical products are guaranteed to be free from defects in material and workmanship at the time of shipping All of our products are designed and manufactured to meet the highest quality standards We cannot accept liability for failure of products which have been modified in any way from their original design NOTE IT IS THE RESPONSIBILITY OF THE REPROCESSOR TO ENSURE THAT THE REPROCESSING IS ACTUALLY PERFORMED USING EQUIPMENT MATERIALS AND
20. PERSONNEL IN THE REPROCESSING FACILITY TO ACHIEVE THE DESIRED RESULT THIS REQUIRES VALIDATION AND ROUTINE MONITORING OF THE PROCESS LIKEWISE ANY DEVIATION BY THE REPROCESSOR FROM THE INSTRUCTIONS PROVIDED MUST BE PROPERLY EVALUATED FOR EFFECTIVENESS AND POTENTIAL ADVERSE CONSEQUENCE be lis 2014 2015 Medline Industries Inc All rights reserved MEDLINE K nig and Medline are registered trademarks of Medline Industries Inc Mundelein IL 60060 USA 1 800 MEDLINE www medline com Kos Surgical Instruments MEDLINE Fiber Optic Laryngoscopes Recommended Cleaning Sterilization and Instructions for Use Fiber Optic Features These operating instructions pertain to both K nig brand integrated and non integrated Green System Fiber Optic Laryngoscopes These instructions should be followed to ensure the longevity and durability of this product Please inspect all components before use to confirm all items are present and in perfect working condition Medline fiber optic laryngoscope blades are manufactured from a high quality AISI 303 304 stainless steel which is highly resistant to corrosion and conforms to ISO 7376 Green System fiber optic laryngoscope blades are removable and interchangeable with other blades of the same size By unscrewing the locking side screw as shown in Figure 1 the light guide can be disengaged and removed for cleaning repairs or replacement Light Guide gt h met I gt
21. ave to confirm appropriate temperatures and sterilization times o Caution Autoclave temperatures should not exceed 280 F Make certain that the instrument container is sealed in appropriate packaging for sterilization Sterilize in compliance with the local guidelines for hospital hygiene K nig surgical instruments are reusable and meet AAMI standards for sterilization We guarantee our products to withstand a minimum of twenty 20 sterilization cycles when sterilized according to the criteria listed Maintenance Attention Apply lubricant only on the connecting elements locking mechanism and moving parts Repair To ensure that all repairs are completed according to the manufacturer s specifications the precision device should be repaired by Medline or by an authorized service agency only Warranty All K nig products are guaranteed to be free from defects in material and workmanship at the time of shipping All of our products are designed and manufactured to meet the highest quality standards We cannot accept liability for failure of products which have been modified in any way from their original design NOTE IT IS THE RESPONSIBILITY OF THE REPROCESSOR TO ENSURE THAT THE REPROCESSING IS ACTUALLY PERFORMED USING EQUIPMENT MATERIALS AND PERSONNEL IN THE REPROCESSING FACILITY TO ACHIEVE THE DESIRED RESULT THIS REQUIRES VALIDATION AND ROUTINE MONITORING OF THE PROCESS LIKEWISE ANY DEVIATION BY THE REPROCESSOR FRO
22. ave to confirm appropriate temperatures and sterilization times o Caution Autoclave temperatures should not exceed 280 F Make certain that the instrument container is sealed in appropriate packaging for sterilization Sterilize in compliance with the local guidelines for hospital hygiene K nig Surgical instruments are reusable and meet AAMI standards for sterilization We guarantee our products to withstand a minimum of twenty 20 sterilization cycles when sterilized according to the criteria listed Maintenance Attention Apply lubricant only on the connecting elements locking mechanism and moving parts Repair To ensure that all repairs are completed according to the manufacturer s specifications the precision device should repaired by Medline or by an authorized service agency only Warranty All K nig Surgical products are guaranteed to be free from defects in material and workmanship at the time of shipping All of our products are designed and manufactured to meet the highest quality standards We cannot accept liability for failure of products which have been modified in any way from their original design NOTE IT IS THE RESPONSIBILITY OF THE REPROCESSOR TO ENSURE THAT THE REPROCESSING IS ACTUALLY PERFORMED USING EQUIPMENT MATERIALS AND PERSONNEL IN THE REPROCESSING FACILITY TO ACHIEVE THE DESIRED RESULT THIS REQUIRES VALIDATION AND ROUTINE MONITORING OF THE PROCESS LIKEWISE ANY DEVIATION BY THE REPROCESSOR
23. ay container with a towel moistened with the solution Enzymatic detergents soak Prior to manual cleaning soak the instrument in an approved neutral pH 7 or lower enzymatic detergent solution Use only low foaming non ionizing cleaning agents and detergents Always follow the manufacturer s instructions for use warnings concentrations and recommended cycles Be sure that the solution is at the correct temperature as per the detergent manufacturer s recommendations Completely immerse the instrument with the jaws open into the solution for a minimum of 5 minutes or longer if called for on the detergent manufacturer s label Manual cleaning Flush the instrument s internal channels with enzymatic detergent with the jaws open to remove gross soil and debris from inside the shaft clean each of the instrument s components jaws hinges handles and shaft with a clean appropriately sized soft bristle brush to remove all organic debris Pay particular attention to the hinges crevices and other hard to clean areas Do NOT remove any screws and do NOT attempt to disassemble the instrument Rinse Prior to sonication in an ultrasonic cleaning unit rinse the instrument s components thoroughly with lukewarm water for a minimum of 1 minute to remove dislodged debris and the detergent solution Flush the instruments internal channels with the jaws open to remove dislodged gross soil and debris from inside the shaft Wipe the instrument with a
24. ch Cleaning solutions and rinses at or near a neutral pH 7 0 are best Do not use abrasive cleaners Only a soft bristle brush should be used Immerse the entire device in detergent and clean while soaking 2 Use a minimum of six strokes out with an instrument brush for all inside channels 3 Rinse with sterile deionized water Repeat this procedure Instrument may be disinfected in an automated washer up to 203 F 5 Rinse thoroughly with distilled water 6 Prepare for storage and or sterilization Onis Surgical Instruments MEDLINE After cleaning and rinsing dry instruments completely and carefully with compressed air including inside channels and highly inaccessible areas NOTE After cleaning and before sterilization treat all instruments with oil which is considered as being physiologically safe especially their blades ends stops snaps and all movable parts Sterilization Thoroughly clean instruments of all debris tissue and foreign matter prior to sterilization Follow the sterilizer manufacturer s instructions for operation and loading of steam autoclaves There must be direct steam exposure to all surfaces of the instruments being sterilized including the internal surface and tube channels Allow instrument to air cool to room temperature before use Use steam autoclave sterilization only Steam sterilize at 270 F for fifteen 15 minutes Other time and steam temperature cycles may also be use
25. d However user must validate any deviation from the recommended time and temperature Note Contact the manufacturer of your steam autoclave to confirm appropriate temperatures and sterilization times Caution Autoclave temperatures should not exceed 280 F as handles insulation or other non metallic parts may be damaged Storage Instruments must be stored in a clean dry moisture free area The instruments should be stored individually in their shipping carton or in a protective tray with partitions Protect tips with cloth gauze or tubing if stored in drawers Handling All surgical instruments must be handled with the greatest care when being transported cleaned treated sterilized and stored This is especially true for blades fine points and other sensitive areas Surgical instruments corrode and their functions are impaired if they come into contact with aggressive materials The instruments must not be exposed to acids or other aggressive cleaning agents NOTE IT IS THE RESPONSIBILITY OF THE REPROCESSOR TO ENSURE THAT THE REPROCESSING IS ACTUALLY PERFORMED USING EQUIPMENT MATERIALS AND PERSONNEL IN THE REPROCESSING FACILITY TO ACHIEVE THE DESIRED RESULT THIS REQUIRES VALIDATION AND ROUTINE MONITORING OF THE PROCESS LIKEWISE ANY DEVIATION BY THE REPROCESSOR FROM THE INSTRUCTIONS PROVIDED MUST BE PROPERLY EVALUATED FOR EFFECTIVENESS AND POTENTIAL ADVERSE CONSEQUENCES 20 2014 2015 Medline Industries Inc Al
26. dards for sterilization We guarantee our products to withstand a minimum of twenty 20 sterilization cycles when sterilized according to the criteria listed Maintenance Attention Apply lubricant only on the connecting elements locking mechanism and moving parts Repair To ensure that all repairs are completed according to the manufacturer s specifications the precision rongeur should be repaired by Medline or by an authorized service agency only Warranty All K nig surgical products are guaranteed to be free from defects in material and workmanship at the time of shipping All of our products are designed and manufactured to meet the highest quality standards We cannot accept liability for failure of products which have been modified in any way from their original design NOTE IT IS THE RESPONSIBILITY OF THE REPROCESSOR TO ENSURE THAT THE REPROCESSING IS ACTUALLY PERFORMED USING EQUIPMENT MATERIALS AND PERSONNEL IN THE REPROCESSING FACILITY TO ACHIEVE THE DESIRED RESULT THIS REQUIRES VALIDATION AND ROUTINE MONITORING OF THE PROCESS LIKEWISE ANY DEVIATION BY THE REPROCESSOR FROM THE INSTRUCTIONS PROVIDED MUST BE PROPERLY EVALUATED FOR EFFECTIVENESS AND POTENTIAL ADVERSE CONSEQUENCE 2014 2015 Medline Industries Inc All rights reserved MEDLINE K nig and Medline are registered trademarks of Medline Industries Inc Mundelein IL 60060 USA 1 800 MEDLINE www medline com nig Surgical Instruments MEDLINE
27. delivery closely inspect the cervix vagina and perineum for lacerations 9 Inform neonatal care providers of the use of forceps during the delivery References American College of Obstetricians and Gynecologists Operative vaginal delivery ACOG practice bulletin no 17 Washington DC American College of Obstetricians and Gynecologists 2000 Decontamination and Cleaning Decontamination Take the device with the adapter s and accessories to the decontamination area Clean decontaminate and sterilize the device adapter s and accessories following the instructions in the IFUs Warning Risk of infection Before use the entire device including its accessories must be decontaminated Inadequate incorrect or superficial decontamination can create a serious risk of infection in patients and or users Cleaning Follow the General Instruments cleaning guide found on page 2 Onis Surgical Instruments MEDLINE Sterilization Autoclave Sterilization o Use steam autoclave sterilization only Steam sterilize at 270 F for fifteen 15 minutes Other time and steam temperature cycles may also be used However user must validate any deviation from the recommended time and temperature Note Contact the manufacturer of your steam autoclave to confirm appropriate temperatures and sterilization times o Caution Autoclave temperatures should not exceed 280 F Make certain that the instrument container is seal
28. devices shall be positioned to allow steam contact of all surfaces e All instruments with concave surfaces shall be placed so that the surfaces will drain water Always verify parameters with sterilizer manufacturer s written instructions e The use of flash sterilization is not recommended as it may shorten the life of instruments Cycle Type Parameter Minimum Set Point Exposure Temp 270 F 132 C Prevacuum Exposure Time 4 minutes Dry Time 30 minutes Cycle Type Parameter Minimum Set Point Exposure Temp 275 F 135 C Prevacuum Exposure Time 3 minutes Dry Time 30 minutes Cycle Type Parameter Minimum Set Point Exposure Temp 270 F 132 C Gravity Displacement Exposure Time 15 minutes Dry Time 30 minutes Storage After sterilization instruments should remain in sterilization wrap and be stored in a clean and dry environment The devices are manufactured from non degradable materials When stored under the recommended conditions the shelf life of this product is not limited Maintenance Attention Apply lubricant only on the connecting elements locking mechanism and moving parts Repair To ensure that all repairs are completed according to the manufacturer s specifications the precision instrument should only be repaired by an authorized service agent only All products are guaranteed to be free from defects in material and workmanship at the time of shipping
29. e the retractor and accessory instruments must be cleaned lubricated decontaminated sterilized and inspected Instruments are reusable and supplied as non sterile Attention Risk of damage The forceps is a precision device Careful handling is important for the accurate functioning of the product Improper external handling e g bending dropping malfunction banging etc can cause product Control function before use Before using the general functioning and preparation of the instrument and accessories must be controlled Please confirm prior to use Decontamination and Cleaning Decontamination Take the device with the adapter s and accessories to the decontamination area Clean decontaminate and sterilize the device adapter s and accessories following the instructions in the IFUs Warning Risk of infection Before use the entire device including its accessories must be decontaminated Inadequate incorrect or superficial decontamination can create a serious risk of infection in patients and or users Cleaning Follow the General Instruments cleaning guide found on page 2 13 Sterilization Autoclave Sterilization o Use steam autoclave sterilization only Steam sterilize at 270 F for fifteen 15 minutes Other time and steam temperature cycles may also be used However user must validate any deviation from the recommended time and temperature Note Contact the manufacturer of your steam autocl
30. e are registered trademarks of Medline Industries Inc Mundelein IL 60060 USA 1 800 MEDLINE www medline com Onis Surgical Instruments MEDLINE Open Up Kerrison Rongeurs Recommended Cleaning Sterilization and Instructions for Use K nig Surgical Kerrison rongeurs are devices intended to access cut and bite soft tissue and bone during surgery Caution Federal U S laws restrict these devices to sale distribution and use by or on the order of a physician WARNING If this device is was used in a patient with or suspected of having Creutzfeldt Jakob Disease CJD the device cannot be reused and must be destroyed due to the inability to reprocess or sterilize to eliminate the risk of cross contamination Instructions for Use Warning Remove all protective caps and sheaths carefully Prior to surgical use rongeur must be cleaned lubricated decontaminated sterilized and inspected Instruments are re usable and supplied as non sterile Attention Risk of damage The rongeur is a precision device Careful handling is important for accurate functioning of the product Improper external handling e g bending banging dropping etc can cause product malfunction Control function before use Before using the general functioning and preparation of the rongeur and accessories must be controlled Please confirm prior to use Operation Neurosurgical procedures should be performed only by persons having adeq
31. ed in appropriate packaging for sterilization Sterilize in compliance with the local guidelines for hospital hygiene K nig surgical instruments are reusable and meet AAMI standards for sterilization We guarantee our products to withstand a minimum of twenty 20 sterilization cycles when sterilized according to the criteria listed Maintenance Attention Apply lubricant only on the connecting elements locking mechanism and moving parts Repair To ensure that all repairs are completed according to the manufacturer s specifications the precision device should be repaired by Medline or by an authorized service agency only Warranty All K nig products are guaranteed to be free from defects in material and workmanship at the time of shipping All of our products are designed and manufactured to meet the highest quality standards We cannot accept liability for failure of products which have been modified in any way from their original design NOTE IT IS THE RESPONSIBILITY OF THE REPROCESSOR TO ENSURE THAT THE REPROCESSING IS ACTUALLY PERFORMED USING EQUIPMENT MATERIALS AND PERSONNEL IN THE REPROCESSING FACILITY TO ACHIEVE THE DESIRED RESULT THIS REQUIRES VALIDATION AND ROUTINE MONITORING OF THE PROCESS LIKEWISE ANY DEVIATION BY THE REPROCESSOR FROM THE INSTRUCTIONS PROVIDED MUST BE PROPERLY EVALUATED FOR EFFECTIVENESS AND POTENTIAL ADVERSE CONSEQUENCES 15 poe Ee MEDLINE 2014 2015 Medline Industries Inc All
32. g Decontamination Take the device with the adapter s and accessories to the decontamination area Clean decontaminate and sterilize the device adapter s and accessories following the instructions in the IFUs WARNING Risk of infection Before use the entire device including adapter s and accessories must be decontaminated Inadequate incorrect or superficial decontamination can create a serious risk of infection in patients and or users Cleaning Clean the instrument externally with a soft sponge and a soft brush See General Instruments Pre Cleaning Unscrew the retractor adapter s before decontamination Perform Manual or Automated cleaning per the General Instruments IFU Do not clean in an ultrasonic bath to avoid risk of damage Screw the adapter s on only immediately before the next usage of the retractor Be sure that the threading is completely dry Sterilization Autoclave sterilization Use steam autoclave sterilization only Standard autoclave cycle Steam sterilize at 270 F for fifteen 15 minutes Other time and steam temperature cycles may also be used However user must validate any deviation from the recommended time and temperature Note Contact the manufacturer of your steam autoclave to confirm appropriate temperatures and sterilization times Caution Autoclave temperatures should not exceed 280 F or handles insulation or other nonmetallic parts may be damaged Make certain that the i
33. g to another e Place instruments in a mesh bottom stainless steel instrument tray Place tray into ultrasonic cleaner 7 FINALRINSE with distilled pyrogen free water preferred 8 Visual Inspection and Instrument Set Assembly Visually inspect instrument for cleanliness and ensure all parts are in proper working order 9 Lubricate The use of a water soluble instrument lubricant that is compatible with pre vacuum steam sterilization is recommended before instruments are sterilized e After thoroughly cleaning instruments proper application of lubricants to all joints and movable mating surfaces will keep them moving freely and aid in protecting surface from mineral deposits e Proper lubrication is required for all instruments regardless of surface coatings e NOTE Ultrasonic cleaners remove all lubrication therefore this maintenance procedure should be done routinely after ultrasonic cleaning and before sterilization 10 Drying Before instruments are wrapped for sterilization they must be thoroughly dry Prepare instrument sets for sterilization using a wrapper such as polypropylene wrap or cotton muslin which is appropriate for pre vacuum steam sterilization Mechanical Decontamination Before using automatic washer e Perform Pre Cleaning instructions e Follow Steps 1 3 of Manual Decontamination cleaning instructions to maintain moisture perform enzymatic soak and rinse e Open or disassemble instruments as appropriate
34. l protective caps and sheaths carefully Prior to surgical use the retractor and accessory instruments must be cleaned lubricated decontaminated sterilized and inspected Instruments are reusable and supplied as non sterile Attention Risk of damage The retractor is a precision device Careful handling is important for the accurate functioning of the product Improper external handling e g bending banging dropping etc can cause product malfunction Control function before use Before using the general functioning and preparation of the retractor and accessories must be controlled Please confirm prior to use Final preparation for use Place the retractor in the compatible position and secure the locking mechanism respectively Confirm once again to ensure that the device is secure and ready for use according to indication Operation Neurosurgical procedures should be performed only by persons having adequate training and familiarity with neurosurgical techniques In addition consult medical literature relative to techniques complications and hazards prior to performance of any neurosurgical procedure Before using the product all instructions regarding its safety features as well as surgical techniques must be read carefully The sterile retractor with the shaft is inserted into the body The retractor must be operated only by trained personnel Please observe general operating room technique Decontamination and Cleanin
35. l rights reserved MEDLINE K nig and Medline are registered trademarks of Medline Industries Inc Mundelein IL 60060 USA 1 800 MEDLINE www medline com
36. nd temperature Note Contact the manufacturer of your steam autoclave to confirm appropriate temperatures and sterilization times o Caution Autoclave temperatures should not exceed 280 F Make certain that the instrument container is sealed in appropriate packaging for sterilization Sterilize in compliance with the local guidelines for hospital hygiene K nig Surgical instruments are reusable and meet AAMI standards for sterilization We guarantee our products to withstand a minimum of twenty 20 sterilization cycles when sterilized according to the criteria listed Maintenance Attention Apply lubricant only on the connecting elements locking mechanism and moving parts Repair To ensure that all repairs are completed according to the manufacturer s specifications the precision device should be repaired by Medline or by an authorized service agency only Warranty All K nig Surgical products are guaranteed to be free from defects in material and workmanship at the time of shipping All of our products are designed and manufactured to meet the highest quality standards We cannot accept liability for failure of products which have been modified in any way from their original design NOTE IT IS THE RESPONSIBILITY OF THE REPROCESSOR TO ENSURE THAT THE REPROCESSING IS ACTUALLY PERFORMED USING EQUIPMENT MATERIALS AND PERSONNEL IN THE REPROCESSING FACILITY TO ACHIEVE THE DESIRED RESULT THIS REQUIRES VALIDATION AND ROUT
37. ng Clean the lead hand immediately after each use using an automatic washer with integrated electronic controls It is not recommended to clean the lead hand manually 1 Prepare an alkaline or neutral cleaning solution in accordance with the manufacturer s instructions 2 If necessary soak soiled lead hand in cleaning solution for 10 minutes to loosen or remove soil 3 Rinse the lead hand with tap water 4 Drain water and rinse for a second time with tap water 5 Wash per automatic washing procedure on page 2 6 Dry for 30 minutes under hot air at 100 C 212 F 7 Allow lead hand to cool at room temperature for 30 minutes 8 Visually inspect the lead hand before sterilization or storage to ensure the complete removal of soil Sterilization The K nig Lead Hand is provided non sterile Chemical sterilization is not recommended due to danger of corrosion Cycle Type Parameter Minimum Set Point Exposure Temp 270 F 132 C Prevacuum Exposure Time 4 minutes Dry Time 20 minutes 18 NOTE Due to the nature of the material oxidation will occur leaving a film coating on the lead hand that can be wiped away The film coating does not affect the performance of the hand immobilizer Storage Store all devices in a clean and dry environment The devices are manufactured from non degradable materials When stored under the recommended conditions the shelf life of this product is not limited NOTE IT
38. nstrument container is sealed in appropriate packaging for sterilization Sterilize in compliance with the local guidelines for hospital hygiene K nig Surgical instruments are reusable and meet AAMI standards for sterilization Please clean the retractor individually and separately from other instruments Maintenance Attention Apply lubricant only on the connecting elements locking mechanism and moving parts Repair To ensure that all repairs are completed according to the manufacturer s specifications the precision retractor should be repaired by Medline or by an authorized service agency only Warranty All K nig Surgical products are guaranteed to be free from defects in material and workmanship at the time of shipping All of our products are designed and manufactured to meet the highest quality standards We cannot accept liability for failure of products which have been modified in any way from their original design NOTE IT IS THE RESPONSIBILITY OF THE REPROCESSOR TO ENSURE THAT THE REPROCESSING IS ACTUALLY PERFORMED USING EQUIPMENT MATERIALS AND PERSONNEL IN THE REPROCESSING FACILITY TO ACHIEVE THE DESIRED RESULT THIS REQUIRES VALIDATION AND ROUTINE MONITORING OF THE PROCESS LIKEWISE ANY DEVIATION BY THE REPROCESSOR FROM THE INSTRUCTIONS PROVIDED MUST BE PROPERLY EVALUATED FOR EFFECTIVENESS AND POTENTIAL ADVERSE CONSEQUENCES 1 78 4 2014 2015 Medline Industries Inc All rights reserved K nig and Medlin
39. nt Residual moisture Onis Surgical Instruments MEDLINE may contain waterborne pathogens and must be removed prior to sterilization Additionally any remaining moisture especially in the internal areas may result in corrosion that can cause the instrument to bind up and shorten the life of the instrument 8 Visual Inspection Visually inspect the instrument for cleanliness and clean off any remaining debris Visually inspect the instrument for damage Open and close the jaws to ensure proper operation of the instrument 9 Lubrication Use a hospital approved instrument lubricant instrument milk on all of the instrument s moving parts to ensure that they move freely and will not bind up during use Flush the instrument s internal channels with the instrument lubricant with the jaws open Ultrasonic cleaners remove all of the lubrication from the instrument therefore proper lubrication during every reprocessing cycle before sterilization will extend the useful life of the instrument If the instrument is to be stored or if it is to be sterilized by ethylene oxide EtO gas be sure it is thoroughly dried after lubrication Sterilization Autoclave Sterilization Use steam autoclave sterilization only Steam sterilize at 270 F for four 4 minutes and thirty 30 minutes dry time Other time and steam temperature cycles may also be used However user must validate any deviation from the recommended time and temperature
40. nutes and aggressively flush lumens with a syringe until water exiting instrument is clear of detergent Dry with a disposable lint free cloth Visually inspect for cleanliness Repeat cleaning process as necessary until visually clean Automated Washer Neutral pH Detergent 1 Follow Pre Cleaning steps outlined above 2 Load instruments into automatic washer per manufacturer s recommended orientation 3 Wash instruments per Mechanical Washer Parameters in Table 1 Table 1 Phase Time Description Detergent Pre Wash 1 2 min Pre wash with cold tap None water Enzyme Wash 1 min Enzyme spray and soak Enzymatic with hot tap water Detergent Cold Tap 15sec Cold tap water rinse 2x None Water Rinse Wash 1 2 min Detergent wash with hot Neutral pH tap water Cleaner Rinse 1 Hot 15 sec Hot tap water rinse None Tap Water Pure Rinse 10 sec Hot purified water None Drying 7 min Hot air dry None 4 Visually inspect for cleanliness Repeat cleaning process as necessary until visually clean Automated Washer Low Impingement High pH Detergent 1 Follow Pre Cleaning steps outlined above 2 Load instruments into automatic washer per manufacturer s recommended orientation 3 Wash instruments per Mechanical Washer Parameters in Table 1 Low motor setting low impingement requires Neutral pH Cleaner to be replaced with Alkaline Detergent with pH above 11 in Wash 1 Phase 5 Visually inspect f
41. on and Instructions fOr USC c cccccccesesssssceeeeecessessseeeeeessessesseaees 17 Lead Hands Recommended Cleaning Sterilization and Instructions fOr USC cccccssssececeeeceesesseaeceeeceseeseseaeeeeeesseesens 18 Laparoscopes and Accessories Recommended Cleaning Sterilization and Instructions for US cccceessseeeeeeeeeeeeees 19 nig Surgical Instruments MEDLINE General Instrumentation Recommended Cleaning and Sterilization Instructions Pre Cleaning 1 All devices should be cleaned in the open position to allow solution to contact all surfaces Contaminated instruments should be cleaned as soon as possible Rinse off device to remove any excess gross soil Submerge instruments in an enzymatic neutral pH detergent bath and allow soaking between 5 and 10 minutes Use a soft bristled brush and gently remove any visible soil still remaining on the device Be sure to clean hinges crevices and other difficult to reach areas Lumens should be cleaned with a soft bristled pipe cleaner of corresponding width and length to ensure the entire lumen has been scrubbed Rinse instruments in purified water for a minimum of 2 minutes Flush lumens hinges crevices and other difficult to reach areas until the water exiting the device is clear of soil and detergent If soil still remains repeat the steps above Manual Cleaning 10 11 Rinse under cool running tap water to remove gross
42. or cleanliness Repeat cleaning process as necessary until visually clean Note Ensure instruments are lubricated prior to sterilization and after last rinse cycle using a water soluble product intended for surgical instruments Sterilization Sterilization should be performed in a medical grade instrument tray or disposable paper or plastic pouch Make certain that the instrument container is sealed in an appropriate packaging for sterilization Sterilize in compliance with the local guidelines for hospital hygiene Sterilization of instruments may be accomplished by Autoclave or Ethylene Oxide Time and temperature parameters required for sterilization vary according to type of sterilizer cycle design and packaging material Autoclave Sterilization Testing should be conducted by each healthcare facility to ensure that the specific configuration of instrument sets is acceptable for the sterilization process e Do not sterilize instruments at temperatures over 141 C 285 F e All ring handled instruments must be autoclaved in the fully open position to prevent cracking of the box lock e All instruments must be sterilized in the completely open and disassembled i e taken apart configuration Note that Onis Surgical Instruments MEDLINE applicable instrument disassembly should not require any mechanical tooling i e screwdriver pliers etc All flush ports shall remain in the fully open position e All
43. perform cesarean delivery in the event that operative delivery is unsuccessful Warnings 1 K nig Obstetrical Forceps are not approved for use for gt 45 degree rotation of the fetal head 2 Use of forceps may result in maternal complications to include lacerations of the vagina and cervix pelvic hematoma episiotomy extension hemorrhage resulting from these events and possibly injury to the pelvic floor 3 Use of forceps may result in fetal complications to include minor lacerations forceps marks rare facial and brachial plexus palsies cephalhematoma skull fracture and intracranial hemorrhage 4 Use caution in attempting multiple efforts at vaginal delivery with different instruments i e forceps and vacuum 5 Use caution in performance of operative vaginal delivery in cases of presumed macrosomia 6 Adhering to established obstetric guidelines for the use of forceps and careful placement of forceps helps minimize the risks of forcep assisted delivery 7 If this device is was used in a patient with or suspected of having Creutzfeldt Jakob Disease CJD the device cannot be reused and must be destroyed due to the inability to reprocess or sterilize to eliminate the risk of cross contamination Obstetrical forceps should not be used in the following situations 1 If a live fetus is known to have a bone demineralization condition or bleeding disorder 2 The fetal head is unengaged 3 The position of the fetal head i
44. residuals 6 Dry with a lint free cloth or filtered pressurized air WARNING Ultrasonic cleaning is strictly prohibited Disinfection Soaking in solutions or thermo chemically in a washer sterilizer up to 65 C max may be used to perform disinfection Manufacturer s instructions regarding duration and concentration of solutions should be strictly adhered After disinfection rinse thoroughly in RO DI water and dry with a lint free cloth Cold Soak Solution To achieve a high level disinfection Cidex OPA or 2 4 Glutaraldehyde solution may be used according to the manufacturer s instructions Dry with 10 lint free clean cloth or filtered pressurized air Reassemble all parts load handle with batteries and test the system for proper function If not functional review the battery lamp testing instructions below WARNING Hydroxide solutions instruments Avoid metal to metal contact during and after soaking Do not immerse blades in Bleach Betadine or Potassium Doing so will cause severe damage to the Xenon and LED Handles Xenon and LED handles may withstand the same cold soak solution outlined in the blade section The batteries and lamp must be removed prior to disinfection sterilization Battery handles may withstand exposure to ethylene oxide The Lamp may be cleaned with a cotton ball dampened in alcohol IPA Note The LED handles may be autoclaved sterilized without removing the LEDs Attention Do no
45. rights reserved K nig and Medline are registered trademarks of Medline Industries Inc Mundelein IL 60060 USA 1 800 MEDLINE www medline com Onis Surgical Instruments MEDLINE Vascular Clamps Recommended Cleaning Sterilization and Instructions for Use K nig Vascular Clamps are devices intended for temporary occlusion of blood vessels during open vascular or minimally invasive coronary surgical procedures Caution Federal U S laws restrict this device to sale distribution and use by or on the order of a physician WARNING If this device is was used in a patient with or suspected of having Creutzfeldt Jakob Disease CJD the device cannot be reused and must be destroyed due to the inability to reprocess or sterilize to eliminate the risk of cross contamination Instructions for Use Warning Remove all protective caps and sheaths carefully Prior to surgical use the instrument must be cleaned lubricated decontaminated sterilized and inspected Instruments are reusable and supplied as non sterile Attention Risk of damage The vascular clamp is a precision device Careful handling is important for the accurate functioning of the product Improper external handling e g bending banging dropping etc can cause product malfunction Control function before use Before using the general functioning and preparation of the instrument and accessories must be controlled Please confirm prior to use
46. ructions for Use Warning Remove all protective caps and sheaths carefully Prior to surgical use the instrument must be cleaned lubricated decontaminated sterilized and inspected Instruments are reusable and supplied as non sterile Attention Risk of damage The instrument is a precision device Careful handling is important for accurate functioning of the product Improper external handling e g bending banging dropping etc can cause product malfunction Control function before use Before using the general functioning and preparation of the instrument and accessories must be controlled Please confirm prior to use Decontamination and Cleaning Decontamination Take the device with the adapter s and accessories to the decontamination area Clean decontaminate and sterilize the device adapter s and accessories following the instructions in the IFUs Warning Risk of infection Before use the entire device including its accessories must be decontaminated Inadequate incorrect or superficial decontamination can create a serious risk of infection in patients and or users Cleaning Follow the General Instruments cleaning guide found on page 2 17 Sterilization Autoclave sterilization o Use steam autoclave sterilization only Steam sterilize at 270 F for fifteen 15 minutes Other time and steam temperature cycles may also be used However user must validate any deviation from the recommended time a
47. s unknown 14 Instructions for Use Warning Remove all protective caps and sheaths carefully Prior to surgical use the instrument must be cleaned lubricated decontaminated sterilized and inspected Instruments are reusable and supplied as non sterile Attention Risk of damage The forceps is a precision device Careful handling is important for accurate functioning of the product Improper external handling e g bending banging dropping etc can cause product malfunction Control function before use Before using the general functioning and preparation of the instrument and accessories must be controlled Please confirm prior to use Instructions for Placing the Forceps 1 Ensure that all prerequisites for operative vaginal delivery are met prior to performing forceps assisted delivery 2 Insert the forceps one blade at a time The blades should lie evenly against the sides of the head reaching to and beyond the malar eminences symmetrically covering the space between the orbits and the ears 3 Lock the forceps and check their position to ensure even and symmetric placement 4 Apply traction in a downward and outward direction to accomplish delivery of the fetal head 5 Anaxis traction device may be used to assist with the initial downward force Episiotomy may be performed at the discretion of the physician The forceps blades may be disarticulated during crowning or after delivery of the fetal head 8 After
48. soil Bathe in enzymatic detergent per manufacturer s recommendation using lukewarm tap water for 1 minute Scrub thoroughly with a soft bristled brush to remove soil Pass a stylet through lumens a minimum of 3 times and using a syringe aggressively flush lumens with enzymatic detergent to remove soil Rinse under cool running tap water and aggressively flush lumens with a syringe to remove detergent residuals Bathe in a neutral detergent per manufacturer s recommendation using warm tap water for 3 minutes Scrub thoroughly with a soft bristled brush to remove soil Pass a stylet through lumens a minimum of 3 times and using a syringe aggressively flush lumens with neutral detergent to remove soil Rinse under running reverse osmosis deionized RO DI water to remove detergent residuals Sonicate in enzymatic detergent per manufacturer s recommendation for 10 minutes Rinse under running RO DI water and aggressively flush lumens with a syringe Dry with a disposable lint free cloth Visually inspect for cleanliness Repeat cleaning process as necessary until visually clean Ultrasonic Cleaning 1 2 Follow Pre Cleaning steps outlined above Submerge instruments fully opened in Ultrasonic Washer with cold distilled water and the minimum effective concentration of enzymatic cleaner per manufacturer s recommendation Ultrasonically clean instruments at 45kHz for 10 minutes Rinse under cool running RO DI water for 2 mi
49. t allow excess fluid to seep into electrical contact batteries must be removed before cleaning and sterilization Sterilization Before performing any of the procedures described below the blade and handle should be cleaned as described in the cleaning procedure Note It is recommended to remove the fiber optic light guide from Green System blades before sterilization as it may adversely affect the polishing of the fiber and decrease light output Gas Sterilization Gas sterilization by ethylene oxide may be used up to a maximum temperature of 65 C and 8p s i Steam Sterilization Cycle Type Parameter Minimum Set Point Exposure Temp 270 F 132 C Prevacuum Exposure Time 4 minutes Dry Time 20 minutes Cycle Type Parameter Minimum Set Point Exposure Temp 250 F 121 C Gravity Displacement Exposure Time 30 minutes Dry Time 15 minutes Note do not exceed a temperature of 135 C and a pressure of 28p s i WARNING Flash autoclaving and hot air sterilization should be avoided as these processes will damage the instrument NOTE THE ABOVE LISTED STERILIZATION GUIDELINES PROVIDED BY MEDLINE INDUSTRIES INC ARE INTENDED AS PROCEDURES COMPATIBLE WITH SPECIFIC MATERIALS STERILIZATION MUST BE PERFORMED TO APPROVED HOSPITAL PROTOCOL MEDLINE INDUSTRIES INC CAN NOT GUARANTEE STERILITY THIS WILL BE VALIDATED BY THE HOSPITAL AND OR STERILIZATION EQUIPMENT MANUFACTURERS 7 224 VA 2014 201
50. the guide of the lower handle runner Step 2 Align the arrows in the same position Step 3 Move the handle trigger upwards until the locking system is engaged Squeeze the handle to ensure normal operation Pre Cleaning Remove gross debris from surgical instruments with a lap sponge and sterile water routinely during procedure to prevent drying of blood and body fluids Follow Pre Cleaning Instructions used for General Instruments NOTE Perform Manual Decontamination or Mechanical Decontamination Manual Decontamination CLEANING To prevent formation of biofilm cleaning should occur as soon as possible after instrumentation is used 1 Maintain moisture Immediately after surgical procedure place instruments in an instrument tray container and cover with a towel moistened with sterile water Foam spray or gel products specifically intended for use with surgical instruments are available to keep soil moist Rinse foam spray or gel products from instruments with distilled water prior to enzymatic soak 2 Enzymatic Soak Immerse fully opened and or disassembled instruments in an enzymatic solution specific for use with surgical instruments Prepare solution and use per enzyme manufacturer s recommendations instructions for correct dilution temperature and soak time 3 Rinse Remove from enzymatic soak after time period recommended by enzymatic manufacturer and rinse thoroughly with lukewarm distilled water
51. tions may result in injury malfunction or other unanticipated occurrences or events for the operator staff and or the patient Contraindications Contraindications to endoscopic procedures not necessarily monopolar coagulation include Not intended for contraceptive coagulation of the fallopian tube but may be used to achieve hemostasis following transection of the tube 19 As identified in the Manual of Endoscopy available from the American Association of Gynecologic Laparoscopists The presence of large pelvic or pelvic abdominal masses hypovolemic shock and severe cardiac decompensation Also intestinal obstruction and marked bowel distention increase of possibility of pelvic and abdominal adhesions A significantly elevated diaphragm contra indicates the use of insufflation which may be necessary for proper surgical visualization and may increase the chance of inadvertent bowel injury Pelvic abscess chronic pulmonary disease diaphragmatic hernia obesity and septic peritonitis may exclude some patients from surgical consideration depending on severity of these conditions Decontamination and Cleaning Initial use of new instruments Every instrument must be cleaned and sterilized before it is used for the first time These instruments were developed for sterilization by autoclave Inspection and functional check It is very important to carefully examine each surgical instrument scope for breaks cracks or malfunction before
52. uate training and familiarity with neurosurgical techniques In addition consult medical literature relative to techniques complications and hazards prior to performing any neurosurgical procedure Before using the product all instructions regarding its safety features as well as surgical techniques must be read carefully The sterile shafted rongeur is inserted into the body The rongeur must be operated only by trained personnel Please observe general operating room technique Squeeze handle to cut bite bone Medline K nig Open Up Kerrison Rongeur shaft should operate smoothly When attached shaft should be perfectly aligned Caution For Open Up Kerrison Rongeurs avoid engaging the gold button while operating the rongeur Decontamination and Cleaning Decontamination Take the device with the adapter s and accessories to the decontamination area Clean decontaminate and sterilize the device adapter s and accessories following the instructions in the IFUs WARNING Risk of infection Before use the entire device including adapter s and accessories must be decontaminated Inadequate incorrect or superficial decontamination can create a serious risk of infection in patients and or users Open Up Kerrison Rongeurs Unlocking Step 1 Press the gold PUSH button and hold it Step 2 Pull the handle trigger downwards Step 3 Open up the instrument at the higher runner Locking Step 1 Insert the higher runner into
53. ure Before using the product all instructions regarding its safety features as well as surgical techniques must be read carefully The sterile shafted rongeur is inserted into the body The rongeur must be operated only by trained personnel Please observe general operating room technique Decontamination and Cleaning Take the device with the adapter s and accessories to the decontamination area Clean decontaminate and sterilize the device adapter s and accessories following the instructions below Warning Risk of infection Before use the entire device including its accessories must be decontaminated Inadequate incorrect or superficial decontamination can create serious risk of infection in patients and or users Cleaning Clean the instrument externally with a soft sponge and a soft brush If appropriate take the instrument apart prior to decontamination 1 Immediately after use For best results and to prolong the life of the instrument reprocess immediately after use Place the soiled instrument in an instrument tray container that contains sterile distilled water or an enzymatic cleaning solution to moisten the soil and prevent blood mucus and other debris from drying on the instrument Do NOT use a saline solution as it might damage or corrode the instrument Flush the instrument s internal channels to remove gross soil and debris from inside the shaft Place the instrument back into the solution and cover the tr
54. urgical Instruments MEDLINE Disinfection Soaking in solutions or thermo chemically in a washer sterilizer up to 65 C max may be used to perform disinfection Manufacturer s instructions regarding duration and concentration of solutions should be strictly adhered After disinfection rinse thoroughly in RO DI water and dry with a lint free cloth Cold Soak Solution To achieve a high level disinfection Cidex OPA or 2 4 Glutaraldehyde solution may be used according to the manufacturer s instructions Dry with lint free clean cloth or filtered pressurized air Reassemble all parts load handle with batteries and test the system for proper function If not functional review the battery lamp testing instructions below WARNING Hydroxide solutions Doing so will cause severe damage to the instruments Avoid metal to metal contact during and after soaking Do not immerse blades in Bleach Betadine or Potassium Standard Handles Standard handles may withstand the same cold soak solution outlined in the blade disinfection sterilization section The batteries must be removed prior to Battery handles may withstand exposure to ethylene oxide Attention Do not allow excess fluid to seep into electrical contact batteries must be removed before cleaning and sterilization Sterilization Before performing any of the procedures described below the blade and handle should be cleaned as described in the cleaning procedure
55. y Re Chargable battery Cap for Barrel gt 2 5V battery handles can be used with dry batteries as well as rechargeable batteries NOTE In accordance with local regulations rechargeable batteries should be disposed of as an electronic device separately Cleaning Procedure Attention Remove batteries before cleaning high level disinfection or sterilization of the laryngoscope system Blades and Handles Cleaning 1 Immediately after use the laryngoscope system should be rinsed under cool running tap water until all visible soil is removed Ensure that all hard to reach areas are flushed with the running tap water 2 Immerse the sealed laryngoscope system in a presoak enzymatic cleaner solution prepared in accordance to the manufacturer s recommendations for a minimum of two 2 minutes 3 Remove device from enzymatic cleaner solution and rinse with lukewarm running tap water for a minimum of one 1 minute to remove all residues and visible soils 4 Immerse the device in enzymatic detergent Remove bottom cap and brush items thoroughly using a soft bristle brush ensuring all visible soils are removed 5 Rinse under running reverse osmosis deionized RO DI water to remove detergent residuals Dry with a lint free cloth or filtered pressurized air 7 The bulb may be cleaned with a cotton ball dampened in alcohol IPA WARNING Ultrasonic cleaning is strictly prohibited Onis S

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