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Manufacturer

ADSM

7b rue Lavoisier

69680 Chassieu
France
Phone: +33 428-710-310
Fax: +33 428-710-320

E-mail:

[email protected]

Distributor

Innovative Orthopedic Technologies, LLC

(US and Canada)

1115 Hwy 124

Winnie, TX 77665
U.S.A.
Phone: +1 409-658-1017
Fax:

+1 888-521-5676

E-mail:

[email protected]

Distributor

Innovative Orthopedic Technologies IOT AG

(outside the US and Canada)

Schochenmühlestrasse 4

CH-6340 Baar
Switzerland
Phone: +41 41-749-4099
Fax:

+41 41-511-2248

E-mail:

[email protected]

This document may not be circulated, reproduced, used, or disclosed to
third parties, neither wholly nor in part, without the prior written consent
of ADSM.

Non-compliance may result in liability to indemnify.
Non-contractual pictures.

Please preserve this user manual carefully.

For versions of this manual in other languages, please visit
www.iotiot.com.

Product

PURIST Leg Positioning System

Reference

6813100

BUDI-DI code

37010910DT008PURISTC6

Document number

SUP_7.036

Version

Rev01

Publication date:

15/10/2020

Author

ADSM

Содержание PURIST

Страница 1: ...PURIST Leg Positioning System OPERATING INSTRUCTIONS...

Страница 2: ...340 Baar Switzerland Phone 41 41 749 4099 Fax 41 41 511 2248 E mail info iotiot com This document may not be circulated reproduced used or disclosed to third parties neither wholly nor in part without...

Страница 3: ...ee 13 3 General Safety Notes 14 3 1 Use for the intended purpose 14 3 2 Use in contradiction to intended use 15 3 3 Hazards when used as intended 16 3 4 Qualifications of operating assembly and mainte...

Страница 4: ...rail 64 5 2 11 Removing the traction boot 64 5 3 Prepare PURIST for storage following completion of the operation 65 6 Maintenance Service 66 6 1 Important information 66 6 2 Checks by the user 66 6 3...

Страница 5: ...ser Manual SUP_7 036 It promotes the intended use of the product and contain important information to install operate and maintain the device safely and efficiently Keep these instructions complete le...

Страница 6: ...r of slight bodily injury A hazard which CAN lead to slight bodily injury ATTENTION Warning of damage to components A hazard that CAN cause damage to or malfunctions of the product equipment other dev...

Страница 7: ...ad the user manual Observe important notice in the user manual Read the user manual before installing and using the device CE mark Batch number Reference Manufacturer Unique Device Identifier Prescrip...

Страница 8: ...ips Request for action Result of a request for action Listing 1 o Listing 2 1 6 Acronyms and abbreviations Acronym Abbreviation Meaning PURIST LPS PURIST Leg Positioning System Suction cups The rubber...

Страница 9: ...duction 14 Pendulum 4 Drape holder 15 Gas strut gas compression spring 5 Pendulum mounting bolts 16 Castor 6 Back rotation lock extension 17 Suction cup 7 Hand wheel extension 18 Boom 8 Traction rail...

Страница 10: ...ts of the dismantled product are to be found in these boxes The common names will be used throughout this manual Image Designation Description Common Name Reference PURIST 01 Chassis 681 3117 PURIST 0...

Страница 11: ...SUP_7 036_Rev01 11 80 CAUTION Danger of injury from lifting transport boxes The transport crate weighs more than 15 kg 33 lb Only physically strong persons may carry this crate alone For more details...

Страница 12: ...the leg to be operated on during hip joint replacement The patient must lie on his her back The leg is securely fastened so that it is only movable around the natural hip axis The product is designed...

Страница 13: ...eration PURIST is not intended for direct contact with the skin of the patient Holding the leg be operated on the optimal position for the operating technique of the surgeon PURIST is transportable It...

Страница 14: ...ories designed for it and in accordance with the documentation supplied with it The product is designed exclusively for indoor use The product may only be used by specialist staff who can position the...

Страница 15: ...cting floor WARNING Danger from use in contradiction to its intended use Use of the device in contradiction to that intended can lead to dangerous situations The following are included as being in par...

Страница 16: ...e operator traps his her hands or fingers between the pendulum and the gas strut Adjustments to the extension are to be made with care Do not reach between pendulum and gas strut CAUTION Danger of inj...

Страница 17: ...g the device Before the operation ensure that the operating table is adequately fixed to the floor CAUTION Risk of injury The traction force exerted by PURIST during traction exceeds the adhesion of t...

Страница 18: ...therefore explicitly and completely unsuitable for arthroscopic operations at the joint line off label WARNING Danger of contamination from the product This device is not sent in sterile condition The...

Страница 19: ...sinfectants The traction boot may contain residue of disinfectants Avoid direct contact with the patient Use disposable socks Clean contaminated traction boots by manually washing with mild detergent...

Страница 20: ...limly built or have sensitive skin Select optimal boot size and pad the feet appropriately CAUTION Danger of injury due to incorrect interpretation of the scale values for the rotation When the 20 pos...

Страница 21: ...reliability and performance of the device if maintenance is done solely by persons authorized to do this by ADSM assembly is only carried out by competent specialist personnel operation and assembly...

Страница 22: ...g transport crate The transport crate weighs more than 15 kg 33 lb Only physically strong persons may carry this crate alone CAUTION Danger of injury when unpacking and assembling the device Trapping...

Страница 23: ...setting device on its side when it is not assembled to the chassis Ensure it is oriented with the height adjustment handwheel facing upwards as shown Fig 4 3 Pendulum Take out the pendulum Fig 4 4 Bo...

Страница 24: ...ight setting device onto the chassis Fig 4 6 Chassis Fig 4 7 Chassis caution label removable Place chassis on the castors Lock castors so that the chassis will not roll away Fully open star knob by ro...

Страница 25: ...NG INSTRUCTIONS Preparing the Product for Use SUP_7 036_Rev01 25 80 Fig 4 9 Height setting device Carry the height setting device with the gas strut to the chassis in preparation of inserting it into...

Страница 26: ...sert the securing rod 1 into the recess in the interface on the chassis Fig 4 12 Fitting the height setting device step 2 1 Star knob 2 Red assembly marking 3 Red assembly marking hidden The securing...

Страница 27: ...appeared at the position of the assembly marking 1 The height setting is correctly fitted when both red assembly markings tabs are no longer visible from above after the height setting device has been...

Страница 28: ...step 1 1 Bearing block 2 Bearing bolt 3 4 5 Abduction Adduction shaft Lower fork gas strut Gas strut holder Unlock the pendulum locking lever Align the pendulum with the gas strut holder facing toward...

Страница 29: ...Re insert the bearing bolt Remove the securing pin of the lower fork of the gas strut Ensure the pendulum locking lever is still unlocked Deflect the pendulum Position the fork of the gas strut at th...

Страница 30: ...Product for Use SUP_7 036_Rev01 30 80 4 3 3 Fit the traction rail to the pendulum Fig 4 19 Chassis with height setting device and pendulum attached Fig 4 20 Traction rail 1 Traction rail Bring the tra...

Страница 31: ...lock 2 Bearing bolt 3 Guide nipple for the traction rail The interface for the traction rail is located at the height setting device Fig 4 22 Fitting traction rail step 1 Pull the bearing bolt at the...

Страница 32: ...Traction rail 2 Guide nipple Lead the traction rail underneath the guide nipple into the bearing block Fig 4 24 Fitting traction rail step 3 1 Traction rail with slider block 2 Bolt Hold traction rail...

Страница 33: ...Fitting traction rail step 4 1 Traction rail 2 Bolt The traction rail 1 is securely fitted in the height setting device when the bolt 2 is located in the bearing block up to the end stop Fig 4 26 Tra...

Страница 34: ...the traction rail Fig 4 28 Boot holder 1 Boot holder 2 Handle 3 Tilting bearing 4 Guide pin The boot holder 1 is fitted with a tilting bearing 3 that attaches to the interface block Note that the gui...

Страница 35: ...ace block 3 Fig 4 31 Fitting the boot holder step 2 1 Clamp lever 2 Tilting bearing clamping plate 3 Interface block Lay the clamping plate 2 around the interface block 3 Tighten clamping lever 1 In d...

Страница 36: ...ev01 36 80 Fig 4 33 Boot holder fitted to traction rail 4 3 5 Fitting the drape holder Fig 4 34 Drape holder Stick the drape holder at the top into the height setting device Attach the drape to the dr...

Страница 37: ...nt the accessories on the PURIST so that the center of gravity is as low as possible and lies close to the height setting device 4 4 1 Transport position Fig 4 35 PURIST in the transport position PURI...

Страница 38: ...ds A toppling PURIST can cause serious injury PURIST may only be pushed over thresholds CAUTION Risk of injury when moving the assembled product The product has a high center of gravity If the abducti...

Страница 39: ...can cause serious injury The suction cups may only be released when the leg of the patient is in the normal horizontal position or there is no connection with the patient Fig 4 36 Accessory rails 1 Ac...

Страница 40: ...t the traction unit has been correctly fixed in place Make sure that the rubber surfaces of the suction cups have been cleaned Make sure that all screws have been tightened WARNING Danger of contamina...

Страница 41: ...s are easily accessible CAUTION Danger of injury for osteoporotic patients Leg fractures may occur if excessive mechanical force is applied to the bones of osteoporotic patients e g by rotation of the...

Страница 42: ...g table Check the intended installation environment o Freedom from cracks and gaps in the flooring where the suction cups are to be placed o Cleanliness of the flooring where the suction cups are to b...

Страница 43: ...to the transport condition see Chap 4 4 1 Release the locks on the castors Drive PURIST to the operating table while holding firmly onto accessory rails 1 2 5 2 2 Adjusting the height Fig 5 2 Height a...

Страница 44: ...ote The figures in these operating instructions show the equipment without the patient Note At the top the boot holder has three recesses offset by 20 for the upper fastening button of the boot The se...

Страница 45: ...left rotation 2 20 position left rotation 3 20 position right rotation The two side recesses are offset by 20 from the neutral position and thus enable an asymmetrical pivot range In position 2 rotat...

Страница 46: ...foot and move the traction boot towards the boot holder Fig 5 6 Mount the boot 2 1 Upper fixing knob 2 Upper recess in the boot holder of the desired starting position 3 Lower recess in the boot holde...

Страница 47: ...fixing knob 1 has engaged in the recess 2 5 2 4 Fixing the castors Fig 5 9 Castor 1 Locking lever The four lockable castors ensure the non slip stand of the product Press down lever 1 with your foot t...

Страница 48: ...lowing conditions are satisfied The rubber surfaces must be free of dust and grease The floor covering under the suction cups must be cleaned and free from cracks and gaps The suction cups must press...

Страница 49: ...ction cup 1 Suction cup 2 Loss of vacuum indicator 3 Toggle lever Note Incorrect attachment If the loss of vacuum indicator 2 on the toggle lever 3 is visible the suction cup 1 is not correctly attach...

Страница 50: ...Suction cup 2 Loss of vacuum indicator 3 Toggle lever If the suction cup 1 has been attached properly the loss of vacuum indicator 2 on the toggle lever 3 is no longer visible Make sure that suction c...

Страница 51: ...the bones and joints CAUTION Risk of injury The pulling force exerted by PURIST during traction can exceed the adhesion of the operating table to the floor The operation is delayed or cannot be carrie...

Страница 52: ...d and the surfaces under them are clean have no cracks or gaps Ensure that the suction cups are properly cleaned before starting the operation Before starting the operation ensure that the floor where...

Страница 53: ...m The pendulum is locked in this position Fig 5 16 Hand wheel for fine level traction Adjust traction on the traction rail Reset it if necessary to the initial value Turn the hand wheel to set the tra...

Страница 54: ...action slider block 3 Hand wheel Traction can also be applied by pulling the traction slider block 2 with the rotation grip 1 Grasp the rotation grip with both hands Pull the traction slider block to...

Страница 55: ...il 4 is adjusted in height by turning one of the two hand wheels 1 The hand wheels 1 are secured by a latch 2 against inadvertent lowering of the traction rail 4 The pendulum 6 is secured by the pendu...

Страница 56: ...is set CAUTION Danger of injury due to fingers hands getting trapped There is a danger that the operator traps his her hands or fingers between the pendulum and the gas strut Adjustments to the extens...

Страница 57: ...in this position CAUTION Risk of injury The setting of the extension has an immediate effect on the position of the patient s leg Increasing or decreasing the extension could result in injuries to the...

Страница 58: ...ng lever 1 pendulum locking lever Loosen the pendulum locking lever 1 before operating the hand wheel for the extension Pull up the locking lever 1 and turn a quarter revolution Leave the locking leve...

Страница 59: ...he extension Raise traction rail reduce extension The latch 1 must not be pulled to raise the traction rail reduce the extension The traction rail moves by 75 mm for each revolution of the hand wheel...

Страница 60: ...ed state without patient when the pendulum is locked The pendulum must always be locked when the PURIST is not in use CAUTION Danger of injury from the return movement of the pendulum Always hold the...

Страница 61: ...2 Under load when already out the lever must first be pressed before the knob can be pressed safety function Move the abduction adduction lever 1 Let go of the release knob 2 in order to lock the abdu...

Страница 62: ...p Grasp the rotation grip 2 with both hands Press with your thumbs on the rotation lever 1 to turn the boot holder containing the foot of the patient CAUTION Danger of trapping a hand A hand can get t...

Страница 63: ...astening button of the boot The selection of the recess during the assembly of the boot can influence the pivot range of the foot rotation available during the operation CAUTION Danger of injury due t...

Страница 64: ...ly be used for in house transport and storage of accessories 5 2 11 Removing the traction boot Fig 5 33 Removing the boot 1 Locking pin To remove the traction boot from the boot holder the small black...

Страница 65: ...IST and accessories following the operation Bring the rotation to the zero position Bring abduction adduction to the zero position Bring the extension to the zero position Bring the height setting to...

Страница 66: ...Medical Products Act Maintenance consists of Inspection work which the user can carry out Maintenance tasks that are carried out by persons expressly authorized within the framework of service perfor...

Страница 67: ...d for the device to be operated optimally and free of malfunctions If regular checks reveal increased wear shorten the required maintenance intervals to be in accord with the de facto appearance of we...

Страница 68: ...el Check the functioning of the gas strut Specialized medical personnel 6 5 Maintenance work ATTENTION Damage to parts caused by improper cleaning and disinfection Do not use the following products fo...

Страница 69: ...to the procedures approved by your organization WARNING Danger of explosion The use of cleaning agents containing alcohol can lead to the formation of ignitable mixtures Do not use cleaning agents wh...

Страница 70: ...Danger of explosion If agents containing alcohol are used these can form ignitable mixtures which can lead to explosions in high frequency applications Do not use agents containing alcohol in high fre...

Страница 71: ...chloride lauryl dimethyl benzyl ammonium chloride myristyldimethyl benzyl ammonium chloride benzethonium chloride benzyl di hydroxyethyl cocosalkyl ammonium chloride dialkyl dimethyl ammonium chlorid...

Страница 72: ...storage and disposal 7 1 Decontamination before sending WARNING Danger of contamination After usage medical devices can contain germs and represent a contamination hazard Prior to transport the user...

Страница 73: ...in the following approved transport containers Original cardboard packaging for the transport of partially dismantled products A suitable transportation crate must be used to prevent possible structu...

Страница 74: ...ction Technical Data 7 4 Disposal Please take care to properly dispose of or recycle the device and or that the pertinent legal requirements are taken into account For this reason this product may not...

Страница 75: ...m in 500 1000 19 69 39 37 Height mm in 1295 50 98 Weight kg lb 40 88 Working conditions Temperature range C 10 40 Relative humidity 10 80 Atmospheric pressure kPa 70 106 Storage conditions Temperature...

Страница 76: ...75 mm hand wheel revolution Internal rotation without abduction adduction 120 20 10 External rotation without abduction adduction 120 20 10 INCH Resolution Height setting of traction rail from floor 4...

Страница 77: ...ription Common Name Category1 681 3117 PURIST 01 Chassis 2 681 3118 PURIST 02 Height setting device 2 681 3119 PURIST 03 Pendulum 2 681 3114 PURIST 04 Traction rail 2 681 3120 PURIST 05 Boot holder 2...

Страница 78: ...OPERATING INSTRUCTIONS PURIST Accessories SUP_7 036_Rev01 78 80 10 Accessories Operating instructions for accessories are included with the respective accessory...

Страница 79: ...PURIST OPERATING INSTRUCTIONS Revision SUP_7 036_Rev01 79 80 11 Revision Version Release Date Company Reason for Change Rev01 15 10 2020 ADSM Creation...

Страница 80: ...OPERATING INSTRUCTIONS PURIST Notes SUP_7 036_Rev01 80 80 12 Notes...

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