AssistArm Knee Attachment AA-K600 Instructions for Use Rev AB July 2022

AssistArm™ Ankle Attachment

1.

Introduction... 3 1.1.

Definitions... 3

1.1.1.

Security Notice... 3

1.1.2.

Symbols Used...4

1.2.

Schematic presentation of the AssistArm™ Ankle Attachment... 5

1.2.1. 1.3.

AssistArm™ Sterile Kit for Ankle ... 6

Preliminary Safety Notice...6

2.

General Warnings... 7

3.

Using the Device... 8

4.

3.1.

At All Times... 8

3.2.

Installing the Device... 10

3.2.1.

Installing the AssistArm™ Surgical Positioner . ... 11

3.2.2.

Preparing the Patient’s Limb... 11

3.2.3.

Installation of the AssistArm™ Surgical Positioner’s Drape... 12

3.2.4.

Installing AssistArm™ Ankle Attachment . ... 12

3.2.5.

Installation of the Limb on the AssistArm™ Ankle Attachment ... 14

3.3.

Manipulations...15

3.4.

Uninstalling the Device... 16

Cleaning and Sterilization... 16 4.1.

General... 16

4.2.

Cleaning ... 17

4.3.

Sterilization... 17

5.

Storage... 17

6.

Inspection... 17

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1. Introduction This Instruction for Use aims at familiarizing the user with the AssistArm™ Ankle Attachment. This Instruction for Use provides information on installation, use and storage of the product. Instructions for Cleaning, Inspection and Sterilization also accompany this Instruction for Use to describe the methods for cleaning, inspection and sterilization recommended for this product. Use of the AssistArm™ Ankle Attachment is limited to ankle surgery in a sterile environment. The AssistArm™ Ankle Attachment is designed to be used in conjunction with the AssistArm™ Surgical Positioner, the AssistArm™ Traction Unit and the AssistArm™ Sterile Kit for Ankle. It is also possible to use the AssistArm™ Connector if the AssistArm™ Traction Unit is not available. The user must: • • • •

Read carefully the entire contents presented in this Instruction for Use before using the AssistArm™ Ankle Attachment. Always follow the instructions in this Instruction for Use when the AssistArm™ Ankle Attachment is handled. Perform cleaning and sterilization as stated in the Instructions for Cleaning, Inspection and Sterilization before using the product. Keep this Instruction for Use close to AssistArm™ products’ point of use.

1.1. Definitions 1.1.1. Security Notice The following table shows security advisories to be encountered throughout this Instruction for Use.

Symbol

Definition

!

This symbol alerts the user to potential serious outcomes (death, injury, or serious adverse events) to the patient or user.

!

This symbol alerts the user to exercise special care necessary for the safe and effective use of the device.

WARNING!

CAUTION!

NOTE

© CONMED Corporation. 2022

This notice provides guidance on the use of the AssistArm™ Ankle Attachment.

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1.1.2. Symbols Used The following table shows the meaning of various symbols found on the AssistArm™ Ankle Attachment and its literature.

Symbol

Example of use

Definition This symbol indicates that the device cannot be reused. This symbol invites the reader to consult the Instructions for Use for any information required for proper use of the device. This symbol indicates that the device is fragile and must be handled with care.

35°C (95°F) 10°C (50°F)

This symbol indicates the temperature range at which the device should be used.

2015-02-06

This symbol indicates the date by which the device can be used. The device must not be used after this date.

LOT

LOT 20130202

This symbol indicates the lot number of the device.

REF

REF

AA-A700

This symbol indicates the catalog number of the device.

SN

SN

0003

This symbol indicates the serial number of the device. This symbol indicates that the device has been sterilized using ethylene oxide. This symbol indicates that the device has been sterilized using gamma radiation. This symbol indicates that the device has not been sterilized.

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This symbol indicates that the device must not be used if the packaging is damaged.

CONMED Corporation 525 French Road Utica, N.Y. 13502-5994 USA

This symbol identifies the manufacturer of the product.

This symbol indicates that the product meets the essential requirements of Medical Device Directive 93/42/EEC. EC REP MDSS GmbH

This symbol identifies the Authorized

Schiffgraben 41 30175 Hannover Representative in the European GERMANY Community. +49 511 6262 8630

EC REP

1.2. Schematic presentation of the AssistArm™ Ankle Attachment

Figure 1 – Overview Ankle Attachment AssistArm™ Table 1 – Features of the Ankle Attachment AssistArm™

#

NAME

DESCRIPTION

1

Connector for the AssistArm™ Strap for Ankle Procedure

The hole at the end of the accessory is used to connect the metal clip of the AssistArm™ Strap for Ankle Procedure.

2

Connecting Rod

The connecting rod fits into the standard connector on most AssistArm™ accessories to establish a safe mechanical connection.

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1.2.1. AssistArm™ Sterile Kit for Ankle

AssistArm™ Surgical Positioner Drape

AssistArm™ Strap for Ankle Procedure

Figure 2 – AssistArm™ Sterile Kit for Ankle

1.3. Preliminary Safety Notice The AssistArm™ Ankle Attachment is designed to be used in conjunction with the AssistArm™ Surgical Positioner, the AssistArm™ Traction Unit and the AssistArm™ Sterile Kit for Ankle. It is also possible to use the AssistArm™ Connector if the AssistArm™ Traction Unit is not available. Please refer to these device’s Instructions for Use before use. The AssistArm™ Ankle Attachment should only be used during surgical procedures performed on humans. The installation of the AssistArm™ Ankle Attachment on the AssistArm™ Surgical Positioner, in combination with any other accessories, should be at all times under the supervision of adequately trained medical personnel. It is important to pay close attention when installing the various devices to ensure that they are properly installed. To be sure, always refer to the Instructions for Use of the different devices.

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2. General Warnings

!

WARNING!

Risk of allergic reaction Foreign body sensitivity, known or suspected allergies to the instruments and/or materials may result in allergic reaction.

Risk of contamination

!

WARNING!

Inadequate cleaning or sterilization of the AssistArm™ Ankle Attachment can lead to a contamination of the patient. Verify that proper cleaning and sterilization was performed in accordance with the Instructions for Cleaning, Inspection and Sterilization of the AssistArm™ Ankle Attachment. Do not use the device if such methods have not been applied.

Risk of injury

!

CAUTION!

Inadequate use of the AssistArm™ Ankle Attachment can result in injury to the patient or the user. Always use AssistArm™ Ankle Attachment for the purpose intended. Always apply the most critical indications among those in this Instruction for Use, the Instruction for Use of the surgical table, the Instruction for Use of the AssistArm™ Surgical Positioner, the Instruction for Use of a complementary accessory used or the Instruction for Use of any equipment that interacts with the AssistArm™ products.

Risk of contamination

!

WARNING!

The use of inadequate single use product can lead to contamination of the patient. The AssistArm™ Ankle Attachment should only be used with AssistArm™ products and sterile single use products specifically designed by CONMED Corporation to fit this accessory.

Risk of injury A broken device or a device with missing parts may cause injury.

!

CAUTION!

Before each use, inspect: The AssistArm™ Ankle Attachment according to Section 6 of this Instruction for Use, • The surgery table as described by the manufacturer, • The AssistArm™ Surgical Positioner as described in its Instructions for Use, • Any other accessories used as described in their Instructions for Use. Use these products only if they are in good condition and no parts are missing.

© CONMED Corporation. 2022

•

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Risk of injury

!

WARNING!

The use of inadequate devices can cause injury to the patient. The AssistArm™ Ankle Attachment should only be used with AssistArm™ products and sterile single use CONMED Corporation products specifically designed for this accessory.

Risk of injury

!

WARNING!

!

CAUTION!

Equipment can break under excessive load and result in attached limb dropping. Use the AssistArm™ Ankle Attachment in combination with the AssistArm™ Surgical Positioner only with patients weighing less than 180 kg (400lb) unless the manufacturer of the surgical table stipulates a lower mass. In this case, use the AssistArm™ Ankle Attachment and the AssistArm™ Surgical Positioner only with patients weighing less than the indication of expected mass limit for the surgery table.

Risk of injury Immediate use after sterilization may cause burn. Ensure that the device is at room temperature before handling to avoid burns.

Compatibility of surgery techniques NOTE

Always ensure beforehand that the use of AssistArm™ Ankle Attachment is suitable for the surgical methods that will be employed during use.

3. Using the Device 3.1. At All Times Risk of injury

!

WARNING!

Inadequate handling of the device may cause the collapse of the operated limb and patient injury. When handling the AssistArm™ Ankle Attachment, make sure not to press on one of the buttons that connect with the AssistArm™ Surgical Positioner or with the other additional accessory. This would result in the disconnection of the limb from the device or the fall of the AssistArm™ Surgical Positioner on the ground. Always be sure to handle the device as prescribed.

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Risk of injury

!

WARNING!

Injuries can occur when the AssistArm™ Surgical Positioner is unlocked. Always make sure that a person maintains the patient’s limb attached to the AssistArm™ Ankle Attachment before pressing the actuating lever of the pedal of the AssistArm™ Surgical Positioner. Failure to do so could result in a drop of the operated limb.

Risk of injury The application of excessive traction on the operated limb may result in a patient injury.

!

WARNING!

!

CAUTION!

When using the AssistArm™ Ankle Attachment in combination with the AssistArm™ Traction Unit, always pay attention to the dynamometer. Reaching the last hash mark on the dynamometer does not mean that the tension stops increasing. The position of the carriage on the tension rod is not an indication of the applied tension. When the last hash mark is reached on the dynamometer, it is at the discretion of the surgeon whether or not to induce a greater tension on the patient’s limb.

Risk of injury Injuries may occur when damaged products are used. Always ensure the proper functioning of AssistArm™ Ankle Attachment before use. Refer to inspection guide presented in Section 6 of this Instruction for Use.

Risk of contamination

!

WARNING!

Contamination may occur if the AssistArm™ Sterile Kit accessories are not installed on the AssistArm™ Surgical Positioner and AssistArm™ Ankle Attachment. Always use all AssistArm™ Sterile Kit accessories while using the AssistArm™ Surgical Positioner and AssistArm™ Ankle Attachment.

Risk of property damage

!

CAUTION!

The application of an excessive load on the AssistArm™ Ankle Attachment can damage it. Use the AssistArm™ Ankle Attachment in combination with the AssistArm™ Surgical Positioner only with patients weighing less than 180 kg (400 lbs).

Involuntary displacement NOTE

Applying a force to the limb or the device could result in a temporary displacement of the device. The user must then place the device back in the desired position.

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3.2. Installing the Device Risk of contamination

!

WARNING!

Inadequate cleaning or sterilization of the AssistArm™ Ankle Attachment can lead to contamination of the patient. Always verify that the cleaning and sterilization have been made on all devices used for surgery. Do not use the device if such methods have not been applied.

Risk of injury

!

WARNING!

Inadequate connection of the AssistArm™ Ankle Attachment and any other device used jointly. Always make sure that the connection between different devices is done correctly and that they are securely attached to each other. This concerns both the connection between the AssistArm™ Ankle Attachment and AssistArm™ Surgical Positioner and the connection between the AssistArm™ Ankle Attachment and any other connecting device used.

Risk of property damage

!

CAUTION!

!

WARNING!

NOTE

Inadequate connection of the AssistArm™ Ankle Attachment to the AssistArm™ Surgical Positioner can lead to property damage. Always make sure that the AssistArm™ Ankle Attachment is connected to the AssistArm™ Surgical Positioner as prescribed in this Instruction for Use, and the Instructions for Use of the connection accessory used.

Risk of contamination Do not use the AssistArm™ Sterile Strap beyond the expiration date listed on the label. The performance, safety, and/or sterility of the device cannot be assured beyond the expiration date. The AssistArm™ Surgical Positioner must be installed prior to decontamination of the lower limb of the patient. Refer to the Instructions for Use: AssistArm™ Surgical Positioner Instructions for Use to ensure that the device is installed as prescribed.

Install the connecting device (AssistArm™ Traction Unit or AssistArm™ Connector) as prescribed in their Instructions for Use. NOTE

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NOTE

Make sure you have installed the AssistArm™ Surgical Positioner’s drape supplied in the AssistArm™ Sterile Kit for Ankle as prescribed in the Instructions for Use of the AssistArm™ Surgical Positioner or the AssistArm™ Traction Unit.

3.2.1. Installing the AssistArm™ Surgical Positioner To optimize the use of the device, it is recommended to install the AssistArm™ Surgical Positioner at the extremity of the table and to angle the fixed segment toward the feet, as shown in Figure 3. The angle of the fixed segment relative to the vertical relates to the size of the patient.

Figure 3 – Installing the AssistArm™ Surgical Positioner

3.2.2. Preparing the Patient’s Limb

!

WARNING!

Risk of contamination Contamination may occur through a contact of the patient’s lower limb with a contaminant. Preparation of the patient’s lower limb must be performed in a sterile environment.

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!

WARNING!

Risk of contamination Contamination may occur if the integrity of the sterile packaging of the AssistArm™ Sterile Kit for Ankle is compromised. Always check the packaging before using sterile components.

3.2.3. Installation of the AssistArm™ Surgical Positioner’s Drape Install the AssistArm™ Surgical Positioner’s Drape on the AssistArm™ Surgical Positioner and AssistArm™ Traction Unit or the AssistArm™ Connector. Refer to the Instructions for Use of the AssistArm™ Surgical Positioner and of the AssistArm™ Traction Unit. Make sure to follow the directions to ensure the integrity of the sterile field. 3.2.4. Installing AssistArm™ Ankle Attachment

Risk of contamination

!

WARNING!

Contamination may occur due to contact of the AssistArm™ Ankle Attachment with a contaminant. Installation of the AssistArm™ Ankle Attachment must be performed in a sterile environment.

Risk of injury

!

WARNING!

Injuries may occur due to an inadequate connection of the AssistArm™ Ankle Attachment to the AssistArm™ Connector or the AssistArm™ Traction Unit. Always make sure that the AssistArm™ Ankle Attachment is attached to the AssistArm™ Connector or the AssistArm™ Traction Unit by pulling on it in the same orientation as the connecting rod of the AssistArm™ Surgical Positioner.

Risk of property damage

!

CAUTION!

Inadequate handling of the AssistArm™ Connector or the AssistArm™ Traction Unit when unlocking the AssistArm™ Surgical Positioner can lead to the latter device falling on the floor. Always make sure that the AssistArm™ Ankle Attachment is firmly held before unlocking the AssistArm™ Surgical Positioner.

Risk of injury

!

WARNING!

Injuries may occur when the patient’s foot is not properly installed in the AssistArm™ Strap for Ankle Procedure. To enable a good grip of the AssistArm™ Strap for Ankle Procedure, make sure the pads are in place on the heel and the forefoot as shown in Figure 6.

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•

Connect the AssistArm™ Ankle Attachment to the connector of the accessory used and confirm the correct connection by pulling on the AssistArm™ Ankle Attachment. Make sure that there is indeed a mechanical linkage preventing disconnection of the device (see Figure 4 and Figure 5).

Figure 4 – Connection validation of the mechanical link between the AssistArm™ Ankle Attachment and the AssistArm™ Traction Unit

Figure 5 – Connection validation of the AssistArm™ Ankle Attachment and the AssistArm™ Connector

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3.2.5. Installation of the Limb on the AssistArm™ Ankle Attachment

Risk of contamination

!

WARNING!

Contamination may occur through contact of the patient’s lower limb or the AssistArm™ Ankle Attachment with a contaminant. Preparation of the patient’s lower limb on the AssistArm™ Ankle Attachment must be performed in a sterile environment.

Risk of injury

!

WARNING!

!

WARNING! • • •

Injuries may occur if the patient’s foot is not properly attached to the AssistArm™ Strap for Ankle Procedure. In order to ensure the stability of the member on the AssistArm™ Ankle Attachment, make sure that the limb is properly fixed before unlocking the AssistArm™ Surgical Positioner.

Risk of injury Injuries may occur if excessive pressure is applied causing the strap to break. Use care when applying pressure to ensure strap integrity.

Position the AssistArm™ Ankle Attachment assembled on the AssistArm™ Surgical Positioner near the patient’s foot so that the AssistArm™ Strap for Ankle Procedure can be connected to it. Remove the AssistArm™ Strap for Ankle Procedure from its packaging. Install the AssistArm™ Strap for Ankle Procedure on the operated foot that has been previously disinfected as shown in Figure 6.

Figure 6 – Installation of the AssistArm™ Strap for Ankle Procedure

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Grab the patient’s foot with one hand and the connector of the AssistArm™ Strap for Ankle Procedure in the other. Connect the AssistArm™ Strap for Ankle Procedure to the hole at the end of AssistArm™ Ankle Attachment as shown in Figure 7.

Figure 7 – Connection of the AssistArm™ Ankle Attachment

3.3. Manipulations Risk of contamination

!

WARNING!

Contamination may occur due to a contact of the AssistArm™ Surgical Positioner with a contaminant. Handling the AssistArm™ Surgical Positioner during surgery should be done in a sterile environment.

Risk of injury

!

WARNING!

Injuries may occur when the AssistArm™ Surgical Positioner is unlocked. Always hold the patient’s limb attached to the AssistArm™ Ankle Attachment BEFORE pressing the actuating lever of the pedal and always make sure that the AssistArm™ Surgical Positioner is fully locked before releasing the patient’s limb.

Risk of injury

!

CAUTION!

Injuries may occur when the user positions the member by directly manipulating the AssistArm™ Connector or the AssistArm™ Traction Unit. Avoid grasping the connector to position the limb. Rather grasp the AssistArm™ Ankle Attachment.

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3.4. Uninstalling the Device • • • • •

Grasp the patient’s leg. Remove the tension in the AssistArm™ Strap for Ankle Procedure so that it can be easily manipulated. Disengage the attachment of the AssistArm™ Strap for Ankle Procedure from the hole at the end of the AssistArm™ Ankle Attachment. Remove the AssistArm™ Strap for Ankle Procedure from the patient’s foot. Dispose of the AssistArm™ Strap for Ankle Procedure according to the institution’s policies.

4. Cleaning and Sterilization 4.1. General Except for single-use products, the AssistArm™ products must be cleaned, inspected and sterilized properly after each use.

Risk of contamination

!

WARNING!

Contamination may occur if AssistArm™ products are inadequately cleaned or sterilized. Carefully follow the Instructions for Cleaning, Inspection and Sterilization for each AssistArm™ products.

Risk of contamination

!

WARNING!

!

WARNING!

Contamination caused by the use of a non-sterile AssistArm™ Ankle Attachment. Clean, inspect or sterilize the AssistArm™ Ankle Attachment, connection accessories and the AssistArm™ Surgical Positioners with the procedures in their respective Instructions for Cleaning, Inspection and Sterilization before first use and after each use.

Risk of contamination Contamination of a user by an AssistArm™ product. Products may be contaminated. Always wear gloves when cleaning, inspecting, or sterilizing AssistArm™ products.

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4.2. Cleaning The AssistArm™ Ankle Attachment must be cleaned according to the procedure provided for this purpose. Refer to the cleaning procedures described in the Instructions for Cleaning, Inspection and Sterilization of the AssistArm™ Ankle Attachment.

4.3. Sterilization The AssistArm™ Ankle Attachment must be sterilized according to the procedure provided for this purpose. Refer to the sterilization procedures described in the Instructions for Cleaning, Inspection and Sterilization of the AssistArm™ Ankle Attachment.

!

WARNING!

Do Not Re-sterilize the AssistArm™ Sterile Strap. Single Use Only. The ability to effectively clean and re-sterilize these single use devices has not been established and subsequent re-use may adversely affect the performance, safety and/or sterility of these devices.

5. Storage Risk of damage

!

CAUTION!

The AssistArm™ Ankle Attachment may be damaged if a heavy load rests on it. Do not apply excessive load on the AssistArm™ Ankle Attachment during storage. Refer to storage procedure described in the Instructions for Cleaning, Inspection and Sterilization of the AssistArm™ Ankle Attachment.

6. Inspection Risk of injury

!

CAUTION!

A device in poor condition can cause injury. Do not use an AssistArm™ product if damaged. Do not attempt to repair it. Contact your CONMED Corporation representative if you have any doubt about the integrity of the product.

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The AssistArm™ Ankle Attachment must be inspected using the procedure foreseen for this purpose. Refer to the inspection procedure described in the Instructions for Cleaning, Inspection and Sterilization of the AssistArm™ Ankle Attachment. Do not use the AssistArm™ Sterile Kit accessories if one of the following observations is made: • • •

The sterile accessory is past its’ expiration date; The sterile accessory is damaged or torn; Sterile packaging is damaged or compromised.

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EC REP

CONMED Corporation 525 French Road Utica, N.Y. 13502-5994 USA

© CONMED Corporation. 2022

MDSS GmbH Schiffgraben 41 30175 Hannover GERMANY +49 511 6262 8630

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Support de cheville AssistArmMC

EC REP

CONMED Corporation 525 French Road Utica, N.Y. 13502-5994 États-Unis

© CONMED Corporation. 2022

MDSS GmbH Schiffgraben 41 30175 Hannover ALLEMAGNE +49 511 6262 8630

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