IOT PURIST Operating Instructions Manual
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IOT PURIST Operating Instructions Manual

Leg positioning system
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PURIST
Leg Positioning System
OPERATING INSTRUCTIONS

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  • Page 1 PURIST Leg Positioning System OPERATING INSTRUCTIONS...
  • Page 2 (US and Canada) 1115 Hwy 124 Winnie, TX 77665 U.S.A. Phone: +1 409-658-1017 Fax: +1 888-521-5676 E-mail: info@iotiot.com 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: info@iotiot.com...

  • Page 3: Table Of Contents

    Preparing the Product for Use .............. 22 4.1. Required tools, equipment, and staff ..............22 4.2. Unpacking the PURIST Leg Positioning System ............22 4.3. Assembling the PURIST Leg Positioning System ............. 24 4.3.1. Mounting the height setting device onto the chassis..........24 4.3.2.
  • Page 4 5.2.10. Accessory rail ..................... 64 5.2.11. Removing the traction boot .................. 64 5.3. Prepare PURIST for storage following completion of the operation ......65 Maintenance / Service ................. 66 6.1. Important information ..................66 6.2. Checks by the user ..................... 66 6.3.

  • Page 5: Notes For Users

    PURIST OPERATING INSTRUCTIONS Notes for users Notes for users 1.1. Using this user manual This user manual should make it possible for you to work safely with the device.  Use this product only in accordance with the safety instructions and warnings in this user manual.

  • Page 6: Warning And Danger Symbols

    PURIST OPERATING INSTRUCTIONS Notes for users 1.3. Warning and danger symbols DANGER Danger of death or serious bodily injury Failure to observe WILL lead to death or serious bodily injury. WARNING Danger of death or serious bodily injury Failure to observe CAN lead to death or serious bodily injury.
  • Page 7 PURIST OPERATING INSTRUCTIONS Notes for users Instruction/caution sign on the pendulum Ensure star knob is fully OPEN before assembly. Chassis caution label (removable)  Read the user manual.  Observe important notice in the user manual.  Read the user manual before installing and using the device.

  • Page 8: Typographical Conventions And Symbols

    PURIST Leg Positioning System Suction cups The rubber suction cups attached to the locking feet of the booms hold the PURIST in place by means of vacuum. 1.7. Figures in this user manual Some of the figures in this user manual are schematics where the colors do not necessarily correspond to the final product.

  • Page 9: Product Description

    PURIST OPERATING INSTRUCTIONS Product description Product description 2.1. Overall illustration Handle Traction rail with traction slider block Abduction / adduction lever Traction hand wheel Release knob for abduction / adduction Pendulum Drape holder Gas strut (gas compression spring) Pendulum mounting bolts...

  • Page 10: Scope Of Delivery And Components

    PURIST OPERATING INSTRUCTIONS Product description 2.2. Scope of delivery and components The PURIST Leg Positioning System (LPS) is delivered in two transport boxes. The following parts of the dismantled product are to be found in these boxes: • The common names will be used throughout this manual.
  • Page 11 PURIST OPERATING INSTRUCTIONS Product description 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, please read chapter “Preparing the Product for Use”.

  • Page 12: Check Upon Receipt

    The product is designed for use on an electrically conducting floor by having electrically conducting castors. 2.5. Function / Performance description The PURIST is a leg positioning system that is used with an operating table. It may only be used in combination with an operating table.

  • Page 13: Performance Characteristics

    PURIST may only be used by specialist staff who can position the patient correctly and have made themselves familiar with the product from the user manual. The period of use of PURIST is about 1 to 4 hours per surgical operation. 2.5.1. Performance characteristics •...

  • Page 14: General Safety Notes

    PURIST OPERATING INSTRUCTIONS General Safety Notes General Safety Notes 3.1. Use for the intended purpose The product is intended solely for use in human hip joint replacement. The product may only be used in combination with an operating table. The patient must lie in the supine position (on the back) during use of the product.

  • Page 15: Use In Contradiction To Intended Use

    PURIST OPERATING INSTRUCTIONS General Safety Notes 3.2. Use in contradiction to intended use The device including the approved accessories must not be used for any other purpose than that indicated in chapter “Use for the intended purpose”. WARNING Danger of death or serious bodily injury...

  • Page 16: Hazards When Used As Intended

    PURIST OPERATING INSTRUCTIONS General Safety Notes 3.3. Hazards when used as intended 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 traction of the leg.
  • Page 17 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 carried out using the device.
  • Page 18 If the adhesion of the suction cups to the floor gives way suddenly, this can result in abrupt movements of the PURIST and the patient.  Ensure that the suction cups are properly cleaned before starting the operation.
  • Page 19 PURIST OPERATING INSTRUCTIONS General Safety Notes WARNING Risk of contamination from the product  Properly disinfect traction boot before and after surgery.  Apply a bandage to avoid direct contact between patient and traction boot during patient preparation and before the traction boot is fitted to the leg to be operated on.
  • Page 20 CAUTION Risk of injury from PURIST breaking The PURIST may break in case of heavy patients over 227 kg (500 lb.).  Use product only for patients of max. 227kg (500 lb.) SUP_7.036_Rev01...

  • Page 21: Qualifications Of Operating, Assembly And Maintenance Personnel

    PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. Medical Device Class The PURIST Leg Positioning System and his accessories are classified according annex VIII,...

  • Page 22: Preparing The Product For Use

    Trapping of fingers can occur when assembling individual parts.  Only allow the product to be unpacked and assembled by expert personnel. 4.2. Unpacking the PURIST Leg Positioning System  Open the transport crates.  Remove the following parts in sequence.
  • Page 23 PURIST OPERATING INSTRUCTIONS Preparing the Product for Use  Take out the height setting device with the gas strut.  Always lay the height 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.

  • Page 24: Assembling The Purist Leg Positioning System

    PURIST OPERATING INSTRUCTIONS Preparing the Product for Use 4.3. Assembling the PURIST Leg Positioning System The steps in the assembly are described in the following: • Mounting the height setting device onto the chassis • Fix the pendulum to the height setting and attach the gas strut.
  • Page 25 PURIST OPERATING INSTRUCTIONS Preparing the Product for Use  Carry the height setting device with the gas strut to the chassis in preparation of inserting it into the interface. Fig. 4-9: Height setting device SUP_7.036_Rev01 25 (80)
  • Page 26 PURIST OPERATING INSTRUCTIONS Preparing the Product for Use 1 Securing rod on the height setting device 2 Red assembly marking  Note the two red markings (2) on the height setting device.  Once the height setting device has been fitted to the chassis, the red markings should no longer be visible.
  • Page 27 PURIST OPERATING INSTRUCTIONS Preparing the Product for Use Assembly marking position  The red tab must have disappeared 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 tightened.

  • Page 28: Fit The Pendulum To The Height Setting Device

    PURIST OPERATING INSTRUCTIONS Preparing the Product for Use 4.3.2. Fit the pendulum to the height setting device 1 Bearing block 2 Bearing bolt Abduction / Adduction shaft Lower fork gas strut Gas strut holder Fig. 4-15: Pendulum interface  Unlock the pendulum locking lever ...
  • Page 29 PURIST OPERATING INSTRUCTIONS Preparing the Product for Use  Set bearing block pendulum onto abduction / adduction shaft.  Re-insert the bearing bolt. Fig. 4-17: Fitting the pendulum, step 2  Remove the securing pin of the lower fork of the gas strut.

  • Page 30: Fit The Traction Rail To The Pendulum

    PURIST OPERATING INSTRUCTIONS Preparing the Product for Use 4.3.3. Fit the traction rail to the pendulum Fig. 4-19: Chassis with height setting device and pendulum attached 1 Traction rail  Bring the traction rail (1) to the height setting device.
  • Page 31 PURIST OPERATING INSTRUCTIONS Preparing the Product for Use 1 Bearing block 2 Bearing bolt 3 Guide nipple for the traction rail The interface for the traction rail is located at the height setting device. Fig. 4-21: Height setting device interface ...
  • Page 32 PURIST OPERATING INSTRUCTIONS Preparing the Product for Use 1 Traction rail 2 Guide nipple  Lead the traction rail underneath the guide nipple into the bearing block. Fig. 4-23: Fitting traction rail, step 2 1 Traction rail with slider block 2 Bolt ...
  • Page 33 PURIST OPERATING INSTRUCTIONS Preparing the Product for Use 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.

  • Page 34: Fit The Boot Holder To The Traction Rail

    PURIST OPERATING INSTRUCTIONS Preparing the Product for Use 4.3.4. Fit the boot holder to the traction rail 1 Interface block The traction slider block with the interface block (1) is located on the traction rail. Fig. 4-27: Traction rail interface...
  • Page 35 PURIST OPERATING INSTRUCTIONS Preparing the Product for Use 1 Tilting bearing clamping lever 2 Tilting bearing clamping plate 3 Interface block on traction slider block  Loosen clamping lever (1).  Set the boot holder with the tilting bearing onto the interface block (3).

  • Page 36: Fitting The Drape Holder

    PURIST OPERATING INSTRUCTIONS Preparing the Product for Use Fig. 4-33: Boot holder fitted to traction rail 4.3.5. Fitting the drape holder  Stick the drape holder at the top into the height setting device.  Attach the drape to the drape holder using clamps so that the operator can see the foot rotation.

  • Page 37: Move Purist

    CAUTION Danger of overturning PURIST can tilt over when it is loaded with accessories that are not in the transport position.  Mount the accessories on the PURIST so that the center of gravity is as low as possible and lies close to the height setting device.
  • Page 38 OPERATING INSTRUCTIONS Preparing the Product for Use CAUTION Danger of overturning The PURIST can tilt over when it is pulled over thresholds. A toppling PURIST can cause serious injury.  PURIST may only be pushed over thresholds. CAUTION Risk of injury when moving the assembled product...
  • Page 39 (horizontal) position or there is no connection with the patient. 1 Accessory rail 2 Accessory rail The PURIST can now be moved using the accessory rails (1, 2).  When transporting the PURIST over thresholds: push, don't pull. Fig. 4-36: Accessory rails SUP_7.036_Rev01...

  • Page 40: Final Examination

     Prior to use in the operating room, the product must be fully cleaned and disinfected. CAUTION Risk of injury from PURIST breaking The PURIST may break in case of heavy patients over 227 kg (500 lb.).  Use product only for patients of max. 227kg (500 lb.) Fig.

  • Page 41: Operation

    “Performing the individual steps”.  Cover the PURIST LPS, before surgery starts. It is important to make sure that the controls 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.

  • Page 42: Carrying Out The Individual Steps

    Castor movements can be blocked. Check the functioning of the suction cups. Check the cleanliness of the suction cups. • Drive the PURIST to the operating table. • Check the intended installation environment Freedom from cracks and gaps in the flooring where the suction cups are to be placed.

  • Page 43: Drive Purist To The Operating Table

    Move PURIST 5.2.2. Adjusting the height Hand wheel for height adjustment Star knob  Turn the hand wheel (1) to set the PURIST to the desired working height for the operator.  Tighten star knob on chassis. Fig. 5-2: Height adjustment SUP_7.036_Rev01...

  • Page 44: Mount The Traction Boot To The Boot Holder

    PURIST OPERATING INSTRUCTIONS Operation 5.2.3. Mount the traction boot to the boot holder  Select the proper boot size (S or M).  Clean contaminated traction boots by manually washing with mild detergent and warm water.  Before each use, inspect for visible damage and defects of surfaces, seams and bonds, and control the adhesion of the closures to ensure proper operability of the traction boot.
  • Page 45 PURIST OPERATING INSTRUCTIONS Operation 1 Central recess (neutral position) The central recess allows a symmetrical pivot range for the rotation of 120° in both directions. Together with the ab- or adduction, a total rotation of 160° is possible in both directions.
  • Page 46 PURIST OPERATING INSTRUCTIONS Operation 1 Upper fixing knob 2 Lower fixing knob 3 Boot There are two fixing knobs (1, 2) on the sole of the boot. The boot (3) is fitted to the boat holder by means of the two fixing knobs.

  • Page 47: Fixing The Castors

    PURIST OPERATING INSTRUCTIONS Operation 1 Upper fixing knob 2 Upper recess The traction boot is correctly fitted when the upper fixing knob (1) has engaged in the recess (2). Fig. 5-8: Mount the boot 4 5.2.4. Fixing the castors 1 Locking lever The four lockable castors ensure the non-slip stand of the product.

  • Page 48: Attach The Suction Cups To The Floor

    5.2.5. Attach the suction cups to the floor Note According to tests on normal, commercially available flooring, PURIST can withstand a traction force of at least 450 N (100 pounds force). The suction cups only function when the following conditions are satisfied: •...
  • Page 49 PURIST OPERATING INSTRUCTIONS Operation 1 Boom 2 Suction cup 3 Toggle lever  Press the boom (1) down firmly.  Press down firmly the toggle lever (3) on the suction cup (2). Fig. 5-12: Lock suction cup 1 Suction cup...
  • Page 50 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 cups are functioning correctly by pulling and pushing the PURIST and that they hold the PURIST in position. Fig. 5-14:...

  • Page 51: Set Traction

    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 carried out using the device.  Before the operation, ensure that the operating table is adequately fixed to the floor.
  • Page 52 If the adhesion of the suction cups to the floor gives way suddenly, this can result in abrupt movements of the PURIST and the patient. The suction cups only function if they have been cleaned and the surfaces under them are clean have no cracks or gaps.
  • Page 53 PURIST OPERATING INSTRUCTIONS Operation 1 Locking lever for the pendulum The pendulum is locked in this position. Fig. 5-15: Pendulum locking lever Adjust traction on the traction rail. Reset it if necessary to the initial value.  Turn the hand wheel to set the traction on the slider block.
  • Page 54 PURIST OPERATING INSTRUCTIONS Operation 1 Rotation grip 2 Traction 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 the desired measurement.

  • Page 55: Setting The Extension

    PURIST OPERATING INSTRUCTIONS Operation 5.2.7. Setting the extension 1 Hand wheel 2 Latch 3 Pendulum locking lever 4 Traction rail 5 Pendulum bearing axis 6 Pendulum 7 Gas strut The extension of the patient's leg is set by the vertical movement of the traction rail (4).
  • Page 56 PURIST OPERATING INSTRUCTIONS Operation 1 Label with note about direction 2 Label with note about danger 3 Pendulum locking lever  Note that the pendulum locking lever (3) is released before the extension is set. Fig. 5-20: Extension controls 2...
  • Page 57 PURIST OPERATING INSTRUCTIONS Operation 1 Pendulum locking lever The pendulum is locked in this position. Fig. 5-22: Pendulum locking lever 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 patient's leg.
  • Page 58 PURIST OPERATING INSTRUCTIONS Operation 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 lever (1) in this position ...
  • Page 59 PURIST OPERATING INSTRUCTIONS Operation 1 Latch 2 Hand wheel Lower traction rail / raise extension  Pull on the latch (1) and turn the hand wheel (2) to lower the traction rail / raise the extension. Raise traction rail / reduce extension The latch (1) must not be pulled to raise the traction rail/reduce the extension.

  • Page 60: Setting Abduction / Adduction

    Only actuate the abduction/adduction in the unloaded 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 ...
  • Page 61 PURIST OPERATING INSTRUCTIONS Operation 1 Abduction / Adduction lever 2 Release knob  Pull the abduction / adduction lever (1) upwards out of the holder and hold fixed.  Press the release knob (2). Under load (when already out), the lever must first be pressed before the knob can be pressed (safety function).

  • Page 62: Setting Internal And External Rotation Of The Leg

    PURIST OPERATING INSTRUCTIONS Operation 5.2.9. Setting internal and external rotation of the leg 1 Rotation lever 2 Rotation grip  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.
  • Page 63 PURIST OPERATING INSTRUCTIONS Operation 1 Scale  The rotation can be read off in degrees on the scale (1).  Let go of the rotation lever once the movement has been completed.  Ensure that the boot holder clicks into place at the desired position.

  • Page 64: Accessory Rail

    PURIST OPERATING INSTRUCTIONS Operation 5.2.10. Accessory rail 1 Accessory rail 2 Accessory rail Accessory devices can be attached to the accessory rails (1, 2). The accessory rails may only be used for in-house transport and storage of accessories. Fig. 5-32: Accessory rail 5.2.11.

  • Page 65: Prepare Purist For Storage Following Completion Of The Operation

    PURIST OPERATING INSTRUCTIONS Operation 5.3. Prepare PURIST for storage following completion of the operation  Clean and disinfect PURIST and accessories following the operation.  Bring the rotation to the zero position.  Bring abduction / adduction to the zero position.

  • Page 66: Maintenance / Service

    OPERATING INSTRUCTIONS Maintenance / Service Maintenance / Service A list of the available replacement parts and consumables can be obtained from the distributor IOT. 6.1. Important information As with every technical device, this one also requires • proper operation in accordance with this user manual •...

  • Page 67: Maintenance And Service

    PURIST OPERATING INSTRUCTIONS Maintenance / Service 6.3. Maintenance and service The device contains the following mechanical components that are subject to operational wear: • Castors • Suction cups • Traction drive • Pendulum belt • Guides • Tilt bearing of abduction / adduction •...

  • Page 68: Maintenance Work

    PURIST OPERATING INSTRUCTIONS Maintenance / Service Interval Maintenance task Personnel As needed Tighten bolts Medical technician from the user Before each Check device for defects Specialized medical personnel Clean and disinfect the device Specialized medical personnel Clean sealing edges of suction cups...

  • Page 69: Cleaning

    PURIST OPERATING INSTRUCTIONS Maintenance / Service 6.5.1. Cleaning WARNING Risk of contamination This device is not sent in sterile condition.  Please clean and disinfect the device according 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.

  • Page 70: Disinfection

    PURIST OPERATING INSTRUCTIONS Maintenance / Service 6.5.2. Disinfection The methods used for disinfecting must comply with the valid legal provisions and guidelines for disinfecting and for prevention of explosions. Do not use any corrosives, solvents or gas-forming disinfecting agents. WARNING...
  • Page 71 PURIST OPERATING INSTRUCTIONS Maintenance / Service Active agent group Active agents 2-ethyl-1-hexanal, formaldehyde, glutardialdehyde, glyoxal, Aldehydes o-phthaldialdehyde, succinaldehyde Quaternary compounds Alkyl-didecyl-polyoxethyl-ammonium propionate, alkyl- dimethyl-alkylbenzyl-ammonium chloride, alkyl-dimethyl- ethyl-ammonium chloride, alkyl-dimethyl-ethylbenzyl ammonium chloride, benzalkonium propionate, benzalkonium chloride (alkyl-dimethyl-benzyl-ammonium chloride, cocos- dimethyl-benzyl-ammonium chloride, lauryl-dimethyl-benzyl-...

  • Page 72: Transport, Storage, And Disposal

    PURIST OPERATING INSTRUCTIONS Transport, storage, and disposal Transport, 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 must clean and disinfect the device according to the procedures authorized by his organization.

  • Page 73: Transport

    PURIST OPERATING INSTRUCTIONS Transport, storage, and disposal 7.2. Transport The product has to be disassembled before transportation. Disassembling of the product has to be carried out in reverse order of the assembling order according chapter 4.3. ATTENTION Danger of damage The height setting device may tilt over when the star knob is loosened before removing the pendulum.

  • Page 74: Storage

    For this reason, this product may not be disposed of in ordinary industrial or household waste. Dispose of the individual component parts separately. IOT, as distributor, will provide you with support regarding proper disposal, if necessary. SUP_7.036_Rev01 74 (80)

  • Page 75: Technical Data

    PURIST OPERATING INSTRUCTIONS Technical Data Technical Data 8.1. Technical data of the PURIST Leg Positioning System Designation or name Nominal values Service life, years General information Length, mm/in. 1100/43.31 Width (suction cups in – out), mm/in. 500 - 1000/19.69 - 39.37 Height, mm/in.

  • Page 76: Setting Ranges (Nominal Values)

    PURIST OPERATING INSTRUCTIONS Technical Data 8.2. Setting ranges (nominal values) METRIC Resolution 4 mm /hand wheel Height setting of traction rail from floor 1015 mm revolution, no resolution, +200 mm continuous 15 mm /hand wheel Traction revolution, no +132 mm...

  • Page 77: Components And Accessory Parts

    PURIST OPERATING INSTRUCTIONS Components and accessory parts Components and accessory parts Only use accessories on the PURIST Leg Positioning System that have been officially approved by ADSM. Contact IOT for any questions. Order Designation Description (Common Name) Category number Chassis...

  • Page 78: Accessories

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

  • Page 79: Revision

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

  • Page 80: Notes

    OPERATING INSTRUCTIONS PURIST Notes 12. Notes SUP_7.036_Rev01 80 (80)

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