IOT PURIST User manual

PURIST
Leg Positioning System
OPERATING INSTRUCTIONS

Manufacturer
ADSM
7b rue Lavoisier
69680 Chassieu
France
Phone: [phone]
Fax: [phone]
E-mail:[email protected]
Distributor
Innovative Orthopedic Technologies, LLC
(US and Canada)
1115 Hwy 124
Winnie, TX 77665
U.S.A.
Phone: [phone]
Fax: [phone]
E-mail:[email protected]
Distributor
Innovative Orthopedic Technologies IOT AG
(outside the US and Canada)
Schochenmühlestrasse 4
CH-6340 Baar
Switzerland
Phone: [phone]
Fax: [phone]
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

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OPERATING INSTRUCTIONS
Notes for users
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Table of Contents
Table of Contents................................................................................................ 3
1. Notes for users ...................................................................................... 5
1.1. Using this user manual.......................................................................................... 5
1.2. Instructions are part of the product ........................................................................ 5
1.3. Warning and danger symbols ................................................................................. 6
1.4. Warning signs and symbols on the device and the packaging ..................................... 6
1.5. Typographical conventions and symbols .................................................................. 8
1.6. Acronyms and abbreviations .................................................................................. 8
1.7. Figures in this user manual.................................................................................... 8
2. Product description................................................................................ 9
2.1. Overall illustration ................................................................................................ 9
2.2. Scope of delivery and components ....................................................................... 10
2.3. Check upon receipt ............................................................................................. 12
2.4. Device properties ............................................................................................... 12
2.5. Function / Performance description ....................................................................... 12
2.5.1. Performance characteristics ................................................................................. 13
2.6. Product service life ............................................................................................. 13
2.7. Warranty and Guarantee ..................................................................................... 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 maintenance personnel ............................ 21
3.5. Original replacement parts .................................................................................. 21
3.6. Notes on product liability..................................................................................... 21
3.7. Conformity ........................................................................................................ 21
4. 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. Fit the pendulum to the height setting device......................................................... 28
4.3.3. Fit the traction rail to the pendulum...................................................................... 30
4.3.4. Fit the boot holder to the traction rail ................................................................... 34
4.3.5. Fitting the drape holder....................................................................................... 36
4.4. Move PURIST ..................................................................................................... 37
4.4.1. Transport position .............................................................................................. 37
4.5. Final examination ............................................................................................... 40
5. Operation............................................................................................. 41
5.1. Overview........................................................................................................... 41
5.2. Carrying out the individual steps .......................................................................... 42

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OPERATING INSTRUCTIONS
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5.2.1. Drive PURIST to the operating table...................................................................... 43
5.2.2. Adjusting the height ........................................................................................... 43
5.2.3. Mount the traction boot to the boot holder............................................................. 44
5.2.4. Fixing the castors ............................................................................................... 47
5.2.5. Attach the suction cups to the floor....................................................................... 48
5.2.6. Set traction ....................................................................................................... 51
5.2.7. Setting the extension .......................................................................................... 55
5.2.8. Setting abduction / adduction .............................................................................. 60
5.2.9. Setting internal and external rotation of the leg ..................................................... 62
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
6. Maintenance / Service ......................................................................... 66
6.1. Important information......................................................................................... 66
6.2. Checks by the user ............................................................................................. 66
6.3. Maintenance and service ..................................................................................... 67
6.4. Maintenance plan ............................................................................................... 67
6.5. Maintenance work .............................................................................................. 68
6.5.1. Cleaning............................................................................................................ 69
6.5.2. Disinfection........................................................................................................ 70
7. Transport, storage, and disposal.......................................................... 72
7.1. Decontamination before sending .......................................................................... 72
7.2. Transport .......................................................................................................... 73
7.3. Storage ............................................................................................................. 74
7.4. Disposal ............................................................................................................ 74
8. Technical Data ..................................................................................... 75
8.1. Technical data of the PURIST Leg Positioning System.............................................. 75
8.2. Setting ranges (nominal values) ........................................................................... 76
9. Components and accessory parts......................................................... 77
10. Accessories.......................................................................................... 78
11. Revision ............................................................................................... 79
12. Notes ................................................................................................... 80

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OPERATING INSTRUCTIONS
Notes for users
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1. 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.
If you have questions regarding the operation of the product
and the accessories, please contact the distributor.
1.2. Instructions are part of the product
The following documents are a constituent part of the product:
•User 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, legible and accessible to
personnel at all times.
Read these instructions and especially all safety instructions
and warnings with care before you put the device into
operation for the first time.
These instructions contribute to reducing the risk of injury or
illness to people, and risks of damage, malfunction or
inefficient operation of the product.
If you transfer the device to third parties, include these
instructions with it.
If you lose these instructions, please order a replacement from
your distributor.

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OPERATING INSTRUCTIONS
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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.
CAUTION
Danger 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 devices etc.
1.4. Warning signs and symbols on the device and the packaging
Symbol
Meaning
WARNING
WARNING
Danger symbols which indicate possible personal injuries at the
location of the symbol.
Caution: Keep hands clear
CAUTION
Warning sign that indicates danger of hands being crushed at
the location of the sign.
Pendulum locked / released

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Instruction/caution sign on the pendulum
Chassis caution label (removable)
Read the user manual
Read 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
Prescription-only
Non Sterile Device
CAUTION: SEE INSTRUCTION MANUAL
READ THE INSTRUCTIONS
Medical Device
Body weight
CAUTION:
Ensure star knob is fully OPEN before assembly.

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Symbols on the packaging
This side up
Fragile; treat with the required care
Keep dry
1.5. Typographical conventions and symbols
Symbol
Meaning
Notice with especially useful information and tips

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 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.

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OPERATING INSTRUCTIONS
Product description
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2. Product description
2.1. Overall illustration
1
Handle
12
Traction rail with traction slider block
2
Abduction / adduction lever
13
Traction hand wheel
3
Release knob for abduction / adduction
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 mounting bolts
19
Chassis
9
Foot rotation release
20
Star knob for fixing the height setting device
10
Traction boot
21
Height setting device
11
Boot holder
22
Hand wheel for height adjustment
10
13
12
14
15
16
11
22
19
21
19
18
17
20
3
1
2
7
9
6
4
5
8

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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.
Image
Designation
Description
(Common Name)
Reference
PURIST #01
Chassis
681 3117
PURIST #02
Height setting device
681 3118
PURIST #03
Pendulum
681 3119
PURIST #04
Traction rail
681 3114
PURIST #05
Boot holder
681 3120
PURIST #06
Drape holder
681 3116
PURIST / OLH –Boot
M
Traction Boot (M)
688 3314

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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”.

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2.3. Check upon receipt
Immediately on receipt: check to see that the components are
complete and undamaged.
Report any damage during transport to the distributor
immediately.
WARNING
Risk of contamination
This device is not sent in sterile condition. There is a danger of
contamination.
Please clean and disinfect the product according to the
procedures approved by your organization.
2.4. Device properties
The device is intended to hold and position the foot of 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 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.
PURIST is transportable. It may not however be transported when
attached to the patient.
PURIST is designed exclusively for indoor use.
The product is to be used in combination with the accessories
designed for it and in accordance with the documentation supplied
with it.

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PURIST may be used on patients who have a body weight of up
to 227 kg (500 lb). Should, however, the safe working load of the
operating table be lower than this, the table load has priority.
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
•The patient must lie on his / her back. Holding the leg to be
operated on by means of a foot holder during the operation.
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 may not however be transported
when attached to the patient.
2.6. Product service life
The device was developed for an expected service life of 10 years.
After these 10 years of operation, the manufacturer will only be
responsible for the safe and correct performance of the device if
a complete inspection, normally covered by a warranty
agreement, has been carried out and documented.
2.7. Warranty and Guarantee
The warranty provisions form a part of the distributor’s General
Terms and Conditions.
Changes to the device without the manufacturer's permission or
use of non-approved spare parts or accessories will void this
warranty.

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OPERATING INSTRUCTIONS
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3. 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. The patient can be under a partial or
general anesthetic.
The product is to be used in combination with the accessories
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 patient correctly and have made themselves familiar with the
product from the user manual.
The period of use of the product is about 1 to 4 hours per
procedure / surgery.
The product may be used on patients who have a body weight of
up to 227 kg (500 lb.). Should, however, the safe working load of
the operating table be lower than this, the table load has priority.
Cleaning and disinfection are required.
Maintenance shall be performed in accordance with the user
manual.

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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
Electromagnetic fields and rise in potential due to leakage
currents of other devices can give rise to potential differences
between the device and the patient.
The device may only be used on an electrically conducting
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
particular contradiction to the intended use:
•Use of the product for a purpose other than hip joint
replacement in human medicine.
•Use of the device in environments not set up according to the
relevant provisions and guidelines for the erection of medical
rooms.
•Use of a damaged device.
•Use of an incorrectly assembled device.
•Allowing unqualified personnel to use the device.
•Use of accessory rails during an operation. Only for in-house
transport and storage.
•Modification to the device without permission from the
manufacturer.

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OPERATING INSTRUCTIONS
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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.
Do not use the device for osteoporotic patients or use the
device with caution.
The operating surgeon is responsible for checking the patient's
bone quality and for avoiding excessive load on the bones and
joints.
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 extension are to be made with care.
Do not reach between pendulum and gas strut.
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 traction slider block when
operating the traction.
Adjustments to the traction are to be made with care.
Do not reach between pendulum and traction slider block.
CAUTION
Danger of injury due to defective components
Defective components pose a risk of injury.
Stop using the device.
Replace defective components only with original replacement
parts.
Heed the notes on original replacement parts and product
liability if using non-original replacement parts.

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WARNING
Danger of injury due to thrombosis
Holding the leg in one position for a long time during an operation
can give rise to blood clots in the veins (thrombosis).
The attending physician must take measures to counter this
in operations of longer duration.
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.
CAUTION
Risk of injury
The traction force exerted by PURIST during traction exceeds the
adhesion of the patient to the operating table. The patient, or
his / her pelvis is shifted.
Before the operation, ensure that the patient is adequately
secured to the operating table.
Use a suitable “perineal operative post” to secure the patient
against slipping.
Also use a suitable holder for the other leg to secure the patient
against slipping.
CAUTION
Risk of injury
If the boot is too large, the foot can slip out of it during traction.
Use correct size boot and pad the foot correctly to minimize
foot rotation and movement in the boot.

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CAUTION
Risk of injury
The traction force exerted by PURIST during traction can exceed
the adhesion of the suction cups to the floor of the operating
theater. 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.
Before starting the operation, ensure that the floor where
the equipment is set up has been thoroughly cleaned and
has no cracks or gaps.
The operator must be aware of the fact that, in rare
occurrences and with inadequate vacuum, the traction force
can decrease abruptly. PURIST is 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. There is a danger of
contamination.
Please clean and disinfect the product according to the
procedures approved by your organization.
The product must be covered during the operation.
The operator must remain in the non-sterile area behind the
product during the operation.
WARNING
Risk of infection from the boot
Pathogens can accumulate in the boot.
Avoid direct contact with the patient.
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.
Use disposable socks.
Clean contaminated traction boots by manually washing
with mild detergent and warm water.
Check if the boot is in good condition. Replace it if necessary.

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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.
WARNING
Danger from electric shock
The application part of the device is classified as Type B.
The application of defibrillators and defibrillator monitors is to
be conducted as per manufacturer instructions
WARNING
Chemical hazard from disinfectants
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 and warm water.
Check if the boot is in good condition. Replace it if necessary
CAUTION
Danger from injuries caused by the traction boot (bruises,
crushing)
Frequent use and cleaning can have a negative effect on the boot
material. In operations which last several hours, pressure sores
can occur –especially with patients who are slimly built or have
sensitive skin.
Check if the boot is in good condition. Replace it if necessary.
Make sure of sufficient cushioning and correct fixture of the
foot in the boot. Ensure to pad the foot correctly to minimize
foot rotation and movement in the boot.

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CAUTION
Risk of injury
Frequent use and cleaning can have a negative effect on the boot
material.
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.
In case of wear, replace the traction boot in time.
CAUTION
Danger of traction boot injuries
In operations which last several hours, pressure sores can occur
–especially with patients who are slimly 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° positions of the boot holder are used, the
maximum foot rotation in the direction of the arrow is 20 ° greater
than indicated on the scale.
Add 20° to the scale value in the direction of the arrow,
subtract 20° in the opposite direction.
The operating surgeon is responsible for determining the bone
quality of the patients and for preventing excessive stress on
the joints and bones.
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.)