PURIST Leg Positioning System User Manual Rev 01

Manufacturer

ADSM 7b rue Lavoisier 69680 Chassieu France Phone: +33 428-710-310 Fax: +33 428-710-320 Email: [email protected]

Distributor (US and Canada)

Innovative Orthopedic Technologies, LLC 1115 Hwy 124 Winnie, TX 77665 U.S.A. Phone: +1 409-658-1017 Fax: +1 888-521-5676 Email: [email protected]

Distributor (outside the US and Canada)

Innovative Orthopedic Technologies IOT AG Schochenmühlestrasse 4 CH-6340 Baar Switzerland Phone: +41 41-749-4099 Fax: +41 41-511-2248 Email: [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. Products

Opposite Leg Holders, Perineal Operative Post

References

6813009, 6813040, 6813049, 6813002

BUDI-DI code

37010910DT008PURISTC6

Document number

SUP_7.038

Version

Rev01

Release Date

15/10/2020

Author

ADSM

Opposite Leg Holder, Perineal Operative Post

USER MANUAL Notes for users

Table of contents Table of contents ... 3 1.

Notes for users ... 5

1.1.

Using this user manual ... 5

1.2.

Structure of this user manual ... 5

1.3.

User manuals are part of the device ... 6

1.4.

Warning and hazard symbols ... 7

1.5.

Warning signs and symbols on the product and the packaging ... 8

1.6.

Typographical conventions and symbols ... 10

1.7.

Figures in this user manual ... 10

2.

Information concerning all products ... 11

2.1.

Conformity ... 11

2.2.

Check upon receipt ... 11

2.3.

Product service life ... 11

2.4.

Warranty and guarantee ... 12

2.5.

Original replacement parts ... 12

2.6.

Information on product liability ... 12

3.

Opposite leg holder variants ... 13

3.1. 3.1.1. 3.1.2. 3.1.3.

Product description for opposite leg holder variants ... 13 Full illustration of opposite leg Holder variants ... 13 Scope of delivery and components ... 14 Device properties ... 16

3.2. 3.2.1. 3.2.2. 3.2.3. 3.2.4. 3.2.5.

General safety information ... 17 Intended use ... 17 Use in contradiction to the intended use ... 18 Hazards when used as intended ... 19 Qualifications of operating, assembly and maintenance personnel ... 22 Material compatibility ... 22

3.3. 3.3.1. 3.3.2. 3.3.3. 3.3.4. 3.3.4.1. 3.3.5. 3.3.5.1. 3.3.5.2. 3.3.6. 3.3.6.1. 3.3.7. 3.3.8. 3.3.9. 3.3.10.

Assembly of Opposite Leg Holder variants ... 23 General mounting information ... 23 Mounting sequence ... 23 Safety information for mounting ... 24 Preparation ... 28 Removing the leg section of the operating table 28 Mounting the extension rail on the accessory rail of the operating table ... 29 Extension rail US/EU, Denyer, or Denyer plus 29 Extension rail Denyer plus 30 Mounting the extension deck on the extension rail ... 33 Extension rail US/EU and extension rail Denyer 33 Mounting the ball-heel slider on the extension deck ... 35 Mounting the ball-heel adapter on the ball-heel slider ... 36 Defining the position of the ball-heel slider on the extension deck ... 37 Mounting the traction boot on the ball-heel adapter ... 39

3.4. 3.4.1.

Disassembly ... 42 Opposite Leg Holder US/EU and Denyer/Denyer Plus ... 42

3.5.

Commissioning... 42

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USER MANUAL

Opposite Leg Holder, Perineal Operative Post

Notes for users 3.6. 3.6.1. 3.6.2.

Operation ... 43 Adjusting the extension deck ... 47 Adjusting the ball-heel adapter ... 47

3.7.

Troubleshooting ... 49

3.8.

Technical data ... 50

3.9.

Components and Accessory Parts ... 51

4.

Perineal Operative Post (POP) ... 52

4.1.

Intended use ... 52

4.2.

Use in contradiction to the intended use ... 52

4.3.

Hazards when used as intended ... 53

4.4.

Scope of delivery ... 55

4.5.

Material compatibility ... 56

4.6.

Load bearing capacity ... 57

4.7. 4.7.1.

Preparation ... 59 Removing the leg section of the operating table ... 60

4.8.

Mounting the perineal operative post ... 61

4.9.

Adjust the Femoral Support ... 63

4.10.

Technical data POP ... 64

4.11.

Wear parts ... 65

5.

Maintenance/service ... 66

5.1.

Important information ... 66

5.2.

Checks by the operating company ... 67

5.3.

Maintenance plan ... 67

5.4. 5.4.1. 5.4.2.

Maintenance work ... 68 Cleaning ... 68 Disinfection... 68

6.

Transport, storage, and disposal... 69

6.1.

Transporting while assembled ... 69

6.2.

Decontamination before shipping ... 69

6.3.

Storage ... 69

6.4.

Disposal ... 69

7.

Revision ... 70

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Opposite Leg Holder, Perineal Operative Post

USER MANUAL Notes for users

1.

Notes for users

1.1.

Using this user manual This user manual is intended to ensure safe operation of the products.  Use these products only in accordance with the safety instructions and warnings in this user manual.  If you have any questions regarding the operation of the products, please contact the distributor.

1.2.

Structure of this user manual This user manual describes the use and assembly of the individual products in the following chapters:

Opposite Leg Holder variants

Chapt. 3

Perineal Operative Post

Chapt. 4

Topics concerning all products are discussed in chapters 1, 2, 5 and 6:

SUP_7.038_Rev01

Notes for users

Chapt. 1

Information concerning all products

Chapt. 2

Maintenance/service

Chapt. 5

Transport, storage, disposal

Chapt. 6

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USER MANUAL

Opposite Leg Holder, Perineal Operative Post

Notes for users

1.3.

User manuals are part of the device The following documents forms part of the device: The User Manual of PURIST SUP_7.036 This User Manual

SUP_7.038

It promotes the intended use of the device and contains important information to install, operate and maintain the device safely and efficiently.  Keep this manual complete, legible personnel at all times.

and

accessible to

 Read this manual and especially all safety instructions and warnings thoroughly before you put the devices into operation for the first time.  This manual contributes to reducing the risk of injury or illness and to prevent the risk of damage, malfunction or inefficient operation of the devices.  If transferring the devices to third parties, include these instructions with it.  If you lose these instructions, please order a replacement from your distributor.

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Opposite Leg Holder, Perineal Operative Post

USER MANUAL Notes for users

1.4.

Warning and hazard symbols

DANGER Risk of death or serious injury Failure to observe WILL lead to death or serious injury.

WARNING Risk of death or serious injury Failure to observe CAN lead to death or serious injury.

CAUTION Risk of slight injury A hazard which CAN lead to slight injury.

ATTENTION Warning – property damage A hazard that CAN cause damage to or malfunctions of the product, equipment, other devices, etc.

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USER MANUAL

Opposite Leg Holder, Perineal Operative Post

Notes for users

1.5.

Warning signs and symbols on the product and the packaging Symbol

Meaning  Read the user manual.  Observe important notice in the user manual.  Read the user manual before installing and using the device.

Read the user manual! WARNING

WARNING!

Hazard symbols indicating possible injuries at the location of the symbol. Crushing hazard for hands Warning sign indicating a crushing hazard for hands at the location of the symbol.

Caution: Keep hands clear

Boot Slide

Note Clamping lever for releasing/tightening the ball-heel adapter Note Clamping lever for releasing/tightening the ball-heel slider

Symbol

Meaning CAUTION: SEE INSTRUCTION MANUAL

CE-mark

Batch number Reference number

Manufacturer

Non Sterile Device

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Opposite Leg Holder, Perineal Operative Post

USER MANUAL Notes for users

Body weight

Unique Device Identifier

Prescription-only READ THE INSTRUCTIONS Medical Device

Symbols on the packaging This side up

Fragile; treat with the required care

Keep dry

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USER MANUAL

Opposite Leg Holder, Perineal Operative Post

Notes for users

1.6.

Typographical conventions and symbols Symbol

Meaning Notice with especially useful information and tips

1.7.



Request for action



Result of a request for action

 o

List point 1 List point 2

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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Opposite Leg Holder, Perineal Operative Post

USER MANUAL Information concerning all products

2.

Information concerning all products

2.1.

Conformity These medical products comply with the provision of Medical Device REGULATION (EU) 2017/745 OF THE EUROPEAN 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

All accessories are classified according to annex VIII, chapter III, rule 1 of the MDR: Class I general, non-sterile, no measuring function.

2.2.

Check upon receipt Immediately on receipt, check that the components are complete and undamaged. Report any transport damage to the distributor immediately.

WARNING Risk of contamination These devices are not shipped in sterile condition.  Please clean and disinfect the devices according to the procedures approved by your organization.

2.3.

Product service life The devices were developed for an expected service life of 10 years. This does not apply to wear parts such as pads on the POP and femoral support.

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USER MANUAL

Opposite Leg Holder, Perineal Operative Post

Information concerning all products

2.4.

Warranty and guarantee The warranty provisions form part of the distributor’s General Terms and Conditions. Using unauthorized replacement parts voids the warranty.

2.5.

Original replacement parts The manufacturer shall only be liable for the safety of the products if the products are maintained by authorized maintenance personnel and if original replacement parts are used. This applies to maintenance, repairs and modifications.

2.6.

Information on product liability

Manufacturer’s liability ADSM shall only be liable for safe operation, reliability and performance of the products if: • Assembly and maintenance are carried out solely by persons authorized to do this by ADSM. • the device is operated according to this user manual. • the product is used within the scope of application described here. • no unauthorized modifications are made to the product.

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Opposite Leg Holder, Perineal Operative Post

USER MANUAL Opposite leg holder variants

3.

Opposite leg holder variants

3.1.

Product description for opposite leg holder variants

3.1.1.

Full illustration of opposite leg Holder variants

1

2

3

4

5

6

Fig. 3-1: 1 2 3

Overview of opposite leg holder variants

Extension rail US/EU or extension rail Denyer Extension deck Boot size M

SUP_7.038_Rev01

4 5 6

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Ball-heel adapter Ball-heel slider Extension rail Denyer plus

USER MANUAL

Opposite Leg Holder, Perineal Operative Post

Opposite leg holder variants 3.1.2.

Scope of delivery and components The scope of delivery for the opposite leg holder system consists of the following components:

Extension Rail Denyer

681 3041

1

OLH #ERDP

Extension Rail Denyer Plus

681 3048 681 3037

1

OLH #ER

OLH #ED

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OLH - DENYER PLUS 681 3049

OLH - DENYER 681 3040

OLH - US/EU 681 3009

Reference 681 3035

OLH #ERD

Extension Deck

Description (Common Name) Extension Rail US/EU

1

1

SUP_7.038_Rev01

The common names will be used throughout this manual.

Designation

Quantity

Image

•

X

X

X

X

X

X

Opposite Leg Holder, Perineal Operative Post

USER MANUAL

Ball-Hell Slider

681 3122

X

Ball-Heel Adapter

681 3123

X

1

PURIST / OLH Boot M

Boot size M

688 3314

X

*

PURIST / OLH Boot S

Boot size S

688 3360

Opposite leg holder variants

*

1

1

OLH #BHS

OLH #BHA

*Optional part

The leg holder deck system** includes the following: -

Extension deck

-

Ball-heel slider

-

Ball-heel adapter

-

Boot size M

** This reference is only a reference group and not a product reference.

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X

X

X

X

X

X

*

*

USER MANUAL

Opposite Leg Holder, Perineal Operative Post

Opposite leg holder variants 3.1.3.

Device properties The Opposite Leg Holder (OLH) is an extension of the operating table which is mounted on the accessory rails on the left or right of the operating table for surgeries on the hip, pelvis or lower extremities. The device allows safe and reproducible positioning of the nonoperative leg while the patient is in a supine position. Fixing the foot in the Traction Boot provides support for the entire leg. The Traction Boot can be moved on a slide rail using a slide. This makes the product suitable for different leg lengths up to 1100 mm inner leg length. Leg abduction can be achieved with a pivot bearing. The Opposite Leg Holder is supplied in three variants: •

SUP_7.038_Rev01

The OLH Leg Holder Deck System is mounted directly on either: o the Extension Rail US/EU (3/8"x 1 1/8" or 10 x 25 mm) or o the Extension Rail Denyer (6.35 x 38.1 mm) or o the Extension Rail Denyer Plus (6.35 x 38.1 mm)

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USER MANUAL Opposite leg holder variants

3.2.

General safety information

3.2.1.

Intended use The device is designed exclusively for the described intended use. The device Opposite Leg Holder, Opposite Leg Holder Denyer, and Opposite Leg Holder Denyer Plus are accessories for operating tables that are mounted on the accessory rails on the left or right of the operating table for surgeries on the hip, pelvis or lower extremities. The dimensions and load data for the accessory rails have to be compatible with the Opposite Leg Holder. The accessories listed are intended exclusively for use in combination with the medical device: •

PURIST Leg Positioning System

The device allows safe and reproducible positioning of nonoperative leg during the surgery while the patient is in a supine position. Fixing the foot in the Traction Boot provides support for the entire leg. The Traction Boot can be moved on a slide rail using a slide. This makes the product suitable for different leg lengths up to 1100 mm inner leg length. Leg abduction can be achieved with a pivot bearing. The product may only be used as an accessory for operating tables where the lateral accessory rails are compatible with the product with regard to geometry and load capacity. Installation and operation are carried out by specialized surgical staff who are familiar with patient positioning. The period of use of the product is about 1 to 4 hours per procedure/surgery.

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USER MANUAL

Opposite Leg Holder, Perineal Operative Post

Opposite leg holder variants 3.2.2.

Use in contradiction to the intended use The device must not be used for any other purpose than that indicated in chapter Intended use.

CAUTION Hazard from use in contradiction to the intended use Use of the device in contradiction to the intended use can lead to dangerous situations. The following are particularly regarded as contradictions to intended use:

 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 the product to exert traction on the leg.  Operating the clamping lever with a hammer. Only operate the clamping lever by hand.

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USER MANUAL Opposite leg holder variants

3.2.3.

Hazards when used as intended

WARNING Risk of injury from thrombosis Holding the leg in the same position for a long period of time during a surgery can give rise to blood clots in the veins (thrombosis).  The attending physician has to take counter measures during longer surgeries.

WARNING Risk of contamination from the product This device is not shipped in sterile condition. There is a risk of infection.  Please clean and disinfect the product according to the procedures approved by your organization.  The product has to be covered during the surgery.  The operator has to remain in the non-sterile area behind the product during the surgery.

WARNING Risk of injury from tilting of the operating table If the product is not mounted on the middle section of the operating table, the operating table may tilt and cause injuries.  Only mount the product on the middle section of an operating table.  Ensure to follow user instructions of the OR table used. Sometimes flipping the OR table 180 degrees may influence the stability of the OR table.

CAUTION Risk of injury from defective components Defective components pose a risk of injury.  Stop using the device.  Replace defective components only with original spare parts.  Observe the liability information concerning the use of nonoriginal spare parts.

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USER MANUAL

Opposite Leg Holder, Perineal Operative Post

Opposite leg holder variants

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.

 Replace the boot when necessary.  Make sure of sufficient cushioning and correct fixture of the foot in the boot.  Select optimal boot size.

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