Instruction For Use
Contents
1. Dilator holder can be connected to the table clamp to avoid surgeon hand exposure during X rays Figure 3 Step 3 Slide down carefully the smallest dilator containing the probe into the wound Step 4 Remove the probe from the dilator once nerve monitoring is completed and slide carefully the largest dilator on top of the smallest dilator Nerve monitoring can be performed at this stage using the groove located in the dilator Step 5 Once the largest dilator is in position it will provide the surgeon with the desired diameter where the retractor blades will fit tightly around it for the insertion of the device Removing advice First remove the probe then the dilator Dispose the probe after use Retractor Kit LLPRO2 A USER MANUAL 1 3 4 Retractor blades and wrench The retractor blades and wrench are reusable devices Choose the blades size using the graduation on the dilators blades length depending on the thickness of the patient on the selected access for the surgery or on the surgeon s needs Fix the 3 selected blades on the retractor body they slide vertically either from the top or from beneath until a click can be heard e Place a right blade R marked on the right arm R marked see figure 4 e Place a left blade L marked on the left arm L marked e Place a central blade C marked on the middle arm Before inserting the retractor in the wound check that the retractor is well cl2. Screwing and unscrewing the black knob will Slide the lateral blades and the retractor body forwards or backwards Figure 12 Retractor Kit LLPRO2 A USER MANUAL 1 3 6 Disposable light mats and extension cords The light mats are sterile single use products Check the expiry date and the packaging before use Dispose after use The extension cords are reusable The light mat and its optic fiber cable are employed to light up the bottom of the wound WARNING Read the Instruction For Use of the light mats and the extension cords before any use of the product Innovasis Inc can t be responsible for any misuse of the light mats or the extension cords Those Instructions for Use are included inside the packaging Q m Plug the extension cord to the light mat Plug the extension cord to a suitable light source following the instructions for use of the light mats Slide carefully the mat through the dedicated slot inside the blade until the appropriate depth see figure 13 Removing advice To remove the disposable light mat slide carefully the light mat out of the blade Dispose after use Figure 13 Retractor Kit LLPRO2 A USER MANUAL 1 3 7 Light cable and light holder The light cable and the light holder are reusable The light cable helps to light up the wound WARNING Read the Instruction For Use of the dual light cable before any use of the product Innovasis Inc can
3. t be responsible for any misuse of the dual light cable This Instruction for Use is included inside the packaging These lights are inserted into the light holder The light holders are placed in their corresponding holes e Spot 1 on the retractor body see figure 14 e Spot 2 on the optional 4th blade support see figure 15 In that case the 4th blade support uses the same holes as the light cables spot 1 both plastic connectors of the 4th blade support are inserted in the retractor body as shown in the chapter 1 3 9 Optional 4th blade and its support Figure 14 Figure 15 Adjust the position of the lightning system by orienting the light support to the suitable direction After several uses the light holder can lose its fitting Use a common flat screwdriver to give back to the light holder its appropriate fitting Retractor Kit LLPRO2 A USER MANUAL 1 3 8 Shim broach and shim broach holder Shim broach and shim broach holder are reusable products Clip the shim or broach lug in the shim broach holder dedicated claw on the top end of the holder see picture 16 The laser marking on the shim or broach provides you with the correct orientation Make sure the lug is well tightened by the holder claw see figure 17 before locking the Shim or broach by pushing the firing pin with the thumb see picture 18 Figure 17 Figure 18 Figure 16 Insert the shim or broach i
4. the products during the handling and the storage Regarding the probe the light mats the extension cords the light cables and the table clamp refer to the corresponding Instruction For Use IFU Be aware that the storage dwell time of sterile products is limited by the sterilization expiry date Retractor Kit LLPRO2 A Instructions for cleaning sterilization and maintenance 2 5 Maintenance Use surgery lubricant before each use Apply only where it is recommended in the following pictures red circles WARNING DO NOT lubricate any part which will be in contact with the patient 2 5 1 Retractor 2 threads 1 slide 3 guillotines Figure 36 2 5 2 Table clamp connector q Figure 37 Retractor Kit LLPRO2 A Instructions for cleaning sterilization and maintenance 2 5 3 4 blade support Thread Figure 38 2 5 4 Shim holder 2 pins Trigger Figure 39 Retractor Kit LLPRO2 A Instructions for cleaning sterilization and maintenance 2 6 Complaints Any Health Care Professional who has any complaint or who has experienced any dissatisfaction in the quality identity reliability safety effectiveness and or performance of surgical instruments should notify Innovasis Inc Innovasis Inc must be notified immediately by telephone fax or written correspondence of any serious accident or if there has been a risk of a serious accident which may or has caus
5. Retractor Kit LLPRO2 A Instruction For Use Retractor system IN TECH MEDICAL pol ais INNOV SIS INNOVATE INVOLVE INVENT Retractor Kit LLPRO2 A Summary SSCP Mana sac cewerauscexeoassscear DOU NaS asda DE ET Sa Isca GOA Cana EUR Dona pic CPR DE Naga 3 i PRECIO aa Te ee ee ee ee ee er eee ee er ee tica 3 1 1 1 DESNICI Re cpa ues AO E E r 3 1 1 2 Surgical CONTO sau ice ccesacactinnes ste das ATA neta de inha asa sn tu ade unido penais Sacada ns sis dai 3 Ll3 DE CED O aaa A E E O 4 Bogs COMVEMICNCe KIL CONMLCMC 2 aia atan date A dA TA TUA AA e AA ATTAC A Aa dieta 4 Lo Andina MoE U ON ssa reset cano d idas acao ch and Casados seca casa organ E aaa regis adaga 4 1 3 1 GON Cl al EE E T E E T RR E 4 1 3 2 K wire and K wire handle s sssssssssssnusssnnunannunanunnannnnnsnnnnnusnnnnnusnnnnnannnnnnnnnann 5 1 569 Dilators dilator holder and probe assansiisadsssadisdassasssca bs sad nadas Lados SEG dd fla 5 1 3 4 Retractor blades and wrench cccccccceeeeeeeeeeeeeeeeeeeeeeeeecgeeeeeeeeeeeeeteseegggueeeeneeeeenngs 7 1 325 Table clamp use for mobile and static position ccc cece cece cece eee eeeeeeeee 10 1 3 6 Disposable light Mats and extension COIS s sssssssssnsnsnnnnssennnnnnnnnannnsennnnannnnnnn 12 1 3 7 Light cable and light holder 2 aa oa a aa aa aa a a aa a ea Ea Ea ERA ERA ERA ADA E errar nene 13 1 3 8 Shim broach and shim broach holder e eesea oa ea aa aa aa a a
6. a aa aa aa aa Ea Ea aa aa aa aa aa aa aa aa aa nana Dada 14 1 3 9 Optional blade Extensi iriiria e ta add dg o ata da 15 1 3 10 Optional 4 blade and its SUPPOFt ceceecececeeeeeeeeeeeeeeeeseeeeeeeaeeneaeeneaenneenanness 16 1 3 11 COMUGINGE sarrerara r E DG ns ADE dO OL ADS sateen odds anne 17 2 Instructions for cleaning sterilization and MAINTENANCE cece cece e eee Ea aa ea a anada 18 ZA Manding Prior LO CICAMINA sc ctecesgrecstsatsidetessecianoidecdetesgrees acted deeatecbarsdeadateaniecseadeauc 18 Zi dvds Disassembling OF the FECFACUON cc ncecccdentathaneeceucemianesansexneesecesteadacenmndenesareceeeesieadas 18 2 1 2 Shim broach holder disassembling ssssssssssssnsssssnsssssrssrssrsssnsnssessnsnessnsnessnenne 20 2 1 3 4 blade support special handling care ceececceceeeeceeeeceeeueeeeueeeaueeeeeeueeeeevenaueenaes 20 2 1 4 Dilators holder special handling CALE cece cece eee e eee seen EDAR aa eeeaeeeeeee nes 21 2 1 5 Table clamp base special handling Care sssssssssnsnnsnnrnnrnnrnrrnnrnnrnnennennennennrnnns 21 2 2 Cleanind GecontaminaOnl sicsacccrestncoxsentueaatesiudessescseoctesedaaniaetdeecdesteaasianadieccecmsenss 22 PATA E Preparation for CIGANI O yvis man trenrd aia acae E AONE 22 2 2 2 Manual Cean o e Re RR ERR RR PR 2 2 Likud Automatic CICAMING s cncocecscestaecccenscnaedaat n n aa EEE a ai 23 Ed Oo E E ia A Acade 24 24 O e ee ee ee ee er 24 2 5 WIGWIWCMANGCynondciadtanattuetandesncssua
7. able products Be careful K wire is very sharp Wearing gloves is recommended Using the K wire handle is recommended to insert the K wire Insert the K wire in the handle see figure 1 Beware the insertion direction sharp tip should stay outside of the K wire handle Screw and unscrew the chuck to secure and release the K wire K wire is used to locate the center of the channel and to guide the dilators see next chapter OS S o Figure 1 1 3 3 Dilators dilator holder and probe Dilators and dilators holder are reusable The disposable probe is a sterile single use roduct Check the expiry date and the packaging before use Dispose after use WARNING Read the own Instruction For Use of the probe before any use of the product Innovasis Inc can t be responsible for any misuse of the disposable probe This Instruction for Use is included inside the packaging Q m Step 1 Plug the probe to a suitable electrical source via DIN 42802 touch proof connectors Insert carefully the probe in the smallest dilator tube groove The detection ball located at the end of the probe will be exposed at the end of the dilator see figure 2 The ball probe should never stick out from the distal end of the dilator probe Do not overstrain nor press too hard while inserting the probe Retractor Kit LLPRO2 A USER MANUAL ca Figure 2 Step 2 Use the dilator holder to handle the dilators see figure 3
8. cal procedure on the disk in a lateral anterior or posterior approach The retractor comes with a set of blades of various lengths a set of dilators and some additional instruments like a dilator holder a nerve monitoring probe light mats etc WARNING Read the following handling instructions before use Failure to follow these instructions could render the device unusable and void any warranty 1 2 Convenience kit content Refer to the Retractor Kit Cue Card included in the packaging 1 3 Handling instructions 1 3 1 General Before the surgery Check that every instrument including single use ones mentioned in the cue card is present Check that no instrument is used or deficient If anything is missing or doesn t seem right call your local agent as soon as possible and discard the kit Be aware that any failure in cleaning maintenance or usage can lead to an unusable corroded broken instrument that could be dangerous to the patient and the medical staff Take required precautions to handle that instrumentation Small parts can be lost Some instruments are sterile probe and light mat check the packaging is unharmed Check the expiry date on the sterile products Some parts are sharp and require to be handled with care in order not to harm the patient and the medical staff Retractor Kit LLPRO2 A USER MANUAL 1 3 2 K wire and K wire handle The K wire and the K wire handle are reus
9. corresponding blade see figure 10 Push buttons to release the blades Figure 10 Retractor Kit LLPRO2 A USER MANUAL 1 3 5 Table clamp use for mobile and static position The table clamp is a reusable device It s a flexible arm which is used to fasten the retractor to the surgery table WARNING Read the Instruction For Use of the table clamp before any use of the product Innovasis Inc can t be responsible for any misuse of the table clamp This Instruction for Use Is included inside the packaging To fix the flexible arm to the surgery table refer to the specific Instruction For Use of the table clamp Use knob 1 to fasten the table clamp base to the surgical table rail See figure 11 Use knob 2 to set the height of the arm Use knob 3 to lock the three articulations Use knob 4 to fasten the retractor with the arm a Figure 11 Retractor Kit LLPRO2 A USER MANUAL Use the black connector to fix the table clamp to the retractor see figure 12 To fix the retractor on the table clamp depending on the surgeon choice there are 2 different options e Central blade is mobile amp lateral blades are fixed Use the steel lock to lock the retractor body and lateral blades Only the central blade will slide forwards and backwards when screwing and unscrewing the black knob e Central blade is fixed and lateral blades are mobile Use the black lock to immobilize the central arm
10. cseetanssentdevetaasandesucssacsutanssiee tenets E E 25 pane rd RELACI N coscsuauravacesvergee Rs RS ada DEI setter a TADO AU aa AA PATAS SAN cesses 25 2 5 2 Table clamp connector ssssssssssssssnssnsnnsnnesnennennrenennrsnennrsnesnrsnennsenennesnennrenee 25 253 A Blade SE coia E E E 26 2 5 4 SM NOOT miraa a EE E T A E A E E E 26 Boe COE rra ne E EE EET 27 Zits CONO E A e ATA ATAN DAS E EE Tea Aa aa TAN 27 3 Chart of medical device symbols used ccccccccceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeuauaeeeaenaneaaaaags 27 Retractor Kit LLPRO2 A USER MANUAL 1 User manual 1 1 Presentation 1 1 1 Destination This kit is composed of several instruments which will be used by a trained orthopedic Surgeon or neuro surgeon to create a lateral or posterior access to the spine This kit is used to provide a spinal access channel through the tissue The retractor will move apart the flesh to allow the surgeon access to the disk or at the wound bottom 1 1 2 Surgical context Probes and light mats are sterile single use products Other instruments of the kit are reusable se er SE sa E ee l T ee USE Probe STERILE K063729 AO SINGLE USE Light mats STERILE E exempt Retractor Kit LLPRO2 A USER MANUAL 1 1 3 Description This instrumentation is designed for spinal surgery Its main purpose is to keep away the flesh of the wound from the working area where the surgeon will perform a surgi
11. e disassembled prior to cleaning some should be handled specifically prior to cleaning as described below 2 1 1 Disassembling of the retractor Hold the tips away from each other screwing the lateral nut and turn the black knob until the central arm is totally out Both handles have to be removed from the retractor body Push the left and right buttons to release both handles see figure 27 Figure 27 Retractor Kit LLPRO2 A Instructions for cleaning sterilization and maintenance PAGE TO BE REMOVED FROM FINAL CUSTOMER INSTRUCTIONS FOR USE With the retractor body in its opened position see figure 28 remove the screws on the bottom side of the retractor body the central screw will release the central arm see figure 29 left and right screws release left and right arms see figure 30 BEWARE NOT TO LOSE ANY PART SCREWS SPRINGS ETC THIS DISASSEMBLING IS NOT RECOMMENDED FOR MEDICAL HEALTHCARE FACILITIES jo lt P o 4 Es v O po o O q ba o a 1 aaa Wim Figure 30 Figure 28 Figure 29 Retractor Kit LLPRO2 A Instructions for cleaning sterilization and maintenance 2 1 2 Shim broach holder disassembling Disassemble the shim broach holder for cleaning take off the pin see figure 31 then pull the firing pin and hold up the rod see figure 32 Figure 31 Figure 32 2 1 3 4 blade support special handling care The support must be completely
12. ed the death or serious deterioration in health of a patient or user When filling a complaint please provide the name s serial numbers s number s of the lot of the component s in question the name and address of the person making the complaint the nature of the complaint with as many details as possible and notification of whether an answer is requested 2 Contact Innovasis Inc 614 East 3900 South Salt Lake City UT 84107 USA 801 261 2236 5 801 261 0573 www innovasis com Retractor Kit LLPRO2 A Instructions for cleaning sterilization and maintenance 3 Chart of medical device symbols used Manufacturer Date of manufacture YYYYMM or YYYY Caution consult accompanying documents Caution Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner Keep product dry Batch code lot number Consult Instructions for Use B o Retractor Kit LLPRO2 A Instructions for cleaning sterilization and maintenance Sterile EO Catalog reorder or reference number Do not use if package is damaged Single use only Expiry date
13. l has been removed Do not use metallic brush Particular attention must be given to crevices lumens mated surfaces connectors and other hard to clean areas Thoroughly flush lumens holes and other hard to clean areas with the enzyme solution Aniosyme DD1 0 5 at room temperature 20 25 C Rinse device in running water for at least 1 minute Thoroughly flush lumens holes and other hard to clean areas Repeat the rinse step twice to achieve 3 rinsing The 3 rinsing should be in purified water Visually inspect the device for remaining soil and repeat the steps above if necessary Remove excess moisture from the instrument with a clean absorbent and non shedding wipe or using compressed air Retractor Kit LLPRO2 A Instructions for cleaning sterilization and maintenance 2 2 3 Automatic Cleaning Completely submerge the device in an enzyme solution Aniosyme DD1 0 5 and allow to soak for 5 minutes at room temperature 20 25 C with ultrasonic vibrations Use a soft bristled nylon brush to gently scrub the device for 2 minutes at room temperature 20 25 C and until all visible soil has been removed Do not use metallic brush Particular attention must be given to crevices lumens mated surfaces connectors and other hard to clean areas Thoroughly flush lumens holes and other hard to clean areas with the enzyme solution Aniosyme DD1 0 5 Rinse device in purified water for at lea
14. nto the blade dedicated slot until the suitable depth see figures 19 amp 20 Release the shim or broach by pushing the trigger with the forefinger Figure 19 Figure 20 Retractor Kit LLPRO2 A USER MANUAL 1 3 9 Optional blade extension The blade extension is reusable Handling of the blade extension see figure 24 is similar as the shim broach procedure see precedent chapter 1 3 8 Shim broach and shim broach holder Clip the blade extension lug in the shim broach holder dedicated claw on the top end of the holder see picture 16 Make sure the lug is well tightened by the holder claw see figure 17 before locking the blade extension by pushing the firing pin with the thumb see picture 18 SN Figure 21 Insert the blade extension into the blade dedicated slot until the suitable depth see figure 25 Figure 22 Retractor Kit LLPRO2 A USER MANUAL 1 3 10 Optional 4 blade and its support The 4 blade and its support are reusable Clip of the 4 blade support connectors to the retractor spots see figure 21 they are the same spots used to plug the light cables in chapter 1 3 7 Light cable and light holder Figure 23 Select the suitable 4th blade depending on the required length and width Insert the 4 blade in the dedicated groove inside the support At this point the 4th blade is still mobile it can be moved up and down through the groove suppor
15. opened maximum wingspan to maximize the access for cleaning Screw must be totally loosened Figure 33 Retractor Kit LLPRO2 A Instructions for cleaning sterilization and maintenance 2 1 4 Dilators holder special handling care Open the holder to its maximum to let appear the cog see figure 34 AS Figure 34 2 1 5 Table clamp base special handling care The thumb screw which fastens the tube to the base see figure 35 has to be loosened to free up the washer to allow for a more efficient cleaning and sterilization Figure 35 Retractor Kit LLPRO2 A Instructions for cleaning sterilization and maintenance 2 2 Cleaning decontamination Regarding the extension cords the light cables and the table clamp refer to the corresponding Instruction For Use IFU 2 2 1 Preparation for cleaning Disassemble any device that can be disassembled before cleaning Open devices when possible See instructions provided to that intend in the precedent chapter Cleaning agents must be prepared as recommended by manufacturer Do not use fixation agents or hot water gt 40 C 2 2 2 Manual Cleaning Completely submerge the device in an enzyme solution Aniosyme DD1 0 5 and allow to soak for 10 minutes at room temperature 20 25 C with ultrasonic vibrations Use a soft bristled nylon brush to gently scrub the device for 5 minutes at room temperature 20 25 C and until all visible soi
16. osed blades shall make a closed circle see figure 4 If necessary use the right and left screws to reduce the angle of the blades refer to figure 6 for more details Then slide down the retractor body with its blades in the wound around the largest dilator see figure 5 Figure 5 Figure 4 Retractor Kit LLPRO2 A USER MANUAL Spreading is obtained via 3 different movements see figure 6 e a Spreading of the lateral blades Squeezing the handle and screw the knob to maintain spreading as needed see figure 7 e b Tilting movement of the lateral blades to enlarge the well on the bottom use the screws on the left and right arms screwing opens angularly the blades unscrewing closes the blades see figure 8 e c Lateral movement of the selected blades Screwing the big black knob will enlarge the opening either the central blade will slide posterior or the 2 lateral blades will slide anterior depending on where the retractor clamp is fixed to the table see figure 9 c Knob for central blade a Knob for spreading the lateral blades Lateral movement of the selected blades b Knob for tilting the lateral blades Figure 6 Retractor Kit LLPRO2 A USER MANUAL Figure 7 Figure 8 Figure 9 Tip The wrench can be used to screw and unscrew every knob of the retractor Removing advice To remove the blades from the retractor use the push button on each arm of the retractor and pull the
17. st 1 minute Thoroughly flush lumens holes and other hard to clean areas Place the devices in a suitable washer disinfector basket and process through a standard washer disinfector cleaning cycle Visually inspect the device for remaining soil and repeat the steps above if necessary Example of Vario TD cleaning cycle HAMO ECOLINE LM 25 Cycle Vario TD liquide NEODISHER FLA Pre cleaning lt 45 C 2 minutes Rinsing Tap water 2 minutes cold water Thermal 90 C 5 minutes Disinfection Demineralized water DO NOT CLEAN THE SINGLE USE PRODUCTS Retractor Kit LLPRO2 A Instructions for cleaning sterilization and maintenance 2 3 Sterilization Please refer to chapter 2 1 5 Table clamp base special handling care to free up the washer of the table clamp base before sterilization Regarding the extension cords the light cables and the table clamp refer to the corresponding Instruction For Use IFU Sterilization should be done following the following procedure e steam sterilization pre vacuum cycle 121 C 250F 30min DO NOT STERILIZE THE SINGLE USE PRODUCTS 2 4 Storage The devices have to be stored in dry conditions area shall be ventilated safe from dust humidity insects and others pests any other potentials contamination sources No extreme temperature and humidity rate are allowed The user have to prevent any mix up damage deterioration contamination or another adverse effects to
18. t or laterally support is sliding even see figure 22 Lock the height and the lateral position of the 4 blade screwing the knob with the wrench see figure 23 Figure 25 Figure 24 Retractor Kit LLPRO2 A USER MANUAL 1 3 11 Container The container is composed of 1 base 2 trays and 1 cover It is reusable Each component has its own place use the silk screening image to store correctly the instruments inside the container The first tray to be inserted is the blade tray The last one is the retractor tray They are not swappable see figure 18 The handles of the retractor tray are retractable dTig Rieti A Retractor tray as e eN i lt Base Figure 26 Retractor Kit LLPRO2 A Instructions for cleaning sterilization and maintenance 2 Instructions for cleaning sterilization and maintenance 2 1 Handling prior to cleaning Recommendations for the handling of these surgical instruments are as follows Do not let blood or tissue dry on the instrument Rinse the instrument immediately after use and before decontamination As much as possible manipulate instruments made from different metals separately Check the functionality and cleanliness of each instrument before use Time dwell between use and cleaning of the devices should be minimal Devices should be carried into wet wraps from the surgery room to the cleaning room Some devices should b
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