AssistArm Knee Attachment AA-K600 Instructions for Use 2015

AssistArmTM Knee Attachment

Table of Contents 1.

Introduction ... 3 1.1.

Definitions ... 3

1.1.1.

Security notice ... 3

1.1.2.

Symbols Used ... 4

1.2.

Schematic presentation of AssistArmTM Knee Attachment ... 5

1.2.1. 1.3.

AssistArmTM Sterile Kit... 6

Preliminary Safety Notice ... 7

2.

General warnings ... 7

3.

Using the Device ... 9

4.

3.1.

At all times ... 9

3.2.

Installing the Device ... 10

3.2.1.

Installing the AssistArmTM Surgical Positioner ... 12

3.2.2.

Installation of the AssistArmTM Surgical Positioner Drape ... 12

3.2.3.

Positioning AssistArmTM Cushion... 13

3.2.4.

Preparation of the patient's limb ... 14

3.2.5.

Installing the limb... 14

3.2.6.

Positioning the AssistArmTM Knee Attachment... 15

3.2.7.

Application of AssistArmTM Bandage... 15

3.2.8.

Connecting the AssistArmTM Knee Attachment ... 16

3.3.

Manipulations ... 18

3.4.

Uninstalling the device... 19

Cleaning and Sterilization ... 20 4.1.

General... 20

4.2.

Cleaning... 21

4.3.

Sterilization ... 21

5.

Storage ... 21

6.

Inspection... 22

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1. Introduction This Instruction for Use aims at familiarizing the user with the AssistArmTM Knee Attachment. It provides information on installation, use and storage of the product. Instructions for Cleaning and Sterilization also accompany this Instruction for Use to describe the methods for cleaning, inspection and sterilization recommended for this product. Use of AssistArmTM Knee Attachment is limited to knee surgery in a sterile environment. The AssistArmTM Knee Attachment is designed to be used in conjunction with the AssistArmTM Surgical Positioner, the AssistArmTM Connector and the AssistArmTM Sterile Kit. The user must: ● Read carefully the entire content presented in this Instructions for Use before using the AssistArmTM Knee Attachment ; ● Always follow the instructions of this Instructions for Use when the AssistArmTM Knee Attachment is handled; ● Perform cleaning and sterilization as stated in the Instructions for Cleaning 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.

WARNING !

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

This notice provides guidance on the use of the AssistArmTM Knee Attachment. NOTE

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1.1.2. Symbols Used The following table shows the meaning of various symbols found on the AssistArmTM Knee Attachment and the related 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. This symbol indicates the date by which the device can be used. The device must not be used after this date.

2015-02-06

20150202

This symbol indicates the lot number of the device.

AA-K600

This symbol indicates the catalog number of the device.

0003

This symbol indicates the serial number of the device.

STERILE

EO

STERILE

EO

This symbol indicates that the device has been sterilized using ethylene oxide.

STERILE

R

STERILE

R

This symbol indicates that the device has been sterilized using gamma radiation.

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This symbol indicates that the device has not been sterilized. 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.

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

This symbol identifies the Authorized Representative in the European Community.

1.2. Schematic presentation of AssistArmTM Knee Attachment

Figure 1 - AssistArm

© CONMED Corporation. 2015

TM

Knee Attachment overview.

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AssistArmTM Knee Attachment

Table 1 - Components of the AssistArm

TM

Knee Attachment

#

NAME

DESCRIPTION

1

Leg Support

The leg support is designed to be placed on the lateral side of the leg, allowing the user to stabilize and control the position of the member being handled.

2

Connecting Rod

This connecting rod is used to connect the AssistArmTM Knee Attachment to the connecting device chosen for surgery.

3

Cushion Tab

This fastener is used to position and hold the AssistArmTM Cushion provided in the AssistArmTM Sterile Kit.

4

Foot Support

The foot support is positioned under the heel to stabilize the leg and allow better control when positioning it.

1.2.1. AssistArmTM Sterile Kit

AssistArmTM Surgical Positioner Drape

AssistArmTM Bandage AssistArmTM Cushion Figure 2 - AssistArm

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TM

Sterile Kit overview

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1.3. Preliminary Safety Notice The AssistArmTM Knee Attachment is designed to be used in conjunction with the AssistArmTM Surgical Positioner and the AssistArmTM Connector. Please refer to the Instructions for Use for these devices before use. The AssistArmTM Knee Support should only be used during surgical procedures performed on humans. The installation of the AssistArmTM Knee Attachment on the AssistArmTM Surgical Positioner, in combination with the use of the AssistArmTM Connector or any other accessory must be at all times under the supervision of adequately trained medical personnel. Ensure you fully understand the operation of the device before use.

2. General warnings Risk of allergic reaction WARNING !

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

Risk of contamination Inadequate cleaning or sterilization of the AssistArmTM Knee Attachment can lead to a contamination of the patient. WARNING !

Verify that proper cleaning and sterilization was performed in accordance with the Instructions for Cleaning and Sterilization of the AssistArmTM Knee Attachment. Do not use the device if such methods have not been applied.

Risk of injury A broken device or a device with missing parts may cause injury. Before each use, inspect:

CAUTION !

   

AssistArm™ Knee Attachment according to Section 6 of this Instructions for Use; The surgery table as described by the manufacturer; The AssistArmTM Surgical Positioner as described in its Instructions for Use AssistArmTM Connector as described in its Instructions for Use.

Use these products only if they are in good condition and no parts are missing.

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Risk of contamination The use of inadequate single use product can lead to contamination of the patient. WARNING !

The AssistArm™ Knee 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 The use of Inadequate devices can cause injury to the patient. WARNING !

The AssistArm™ Knee 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 Inadequate use of the AssistArmTM Knee Attachment can result in injury to the patient or the user.

CAUTION !

Always use the AssistArmTM Knee Attachment for knee surgery in a sterile environment. Always apply the most restrictive indications among those in this Instruction for Use, the Instructions for Use of the surgical table, the Instructions for Use of the AssistArmTM Surgical Positioner, the Instructions for Use of a complementary accessory used or the Instructions for Use of any equipment that interacts with the AssistArm™ products.

Risk of injury Equipment can break under excessive load and result in attached limb dropping.

WARNING !

Use the AssistArmTM Knee Attachment in combination with the AssistArmTM Surgical Positioner only with patients with a mass less than 180 kg (400lb) unless the manufacturer of the surgical table stipulates a lower mass. In this case, use the AssistArmTM Knee Attachment and AssistArmTM Surgical Positioner only with patients whose weight is less than the indication of expected mass limit for the surgery table.

Risk of injury Immediate use after sterilization may cause burns. CAUTION !

Ensure that the device is at room temperature before handling to avoid burns.

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Compatibility of surgery techniques Always ensure beforehand that the use of the AssistArmTM Knee Attachment is suitable NOTE

for the surgical methods that will be employed during use.

3. Using the Device 3.1. At all times Risk of injury Inadequate handling of the device may cause the collapse of the operated limb and patient injury.

WARNING !

When handling the AssistArmTM Knee Attachment, make sure not to press on one of the buttons that connect it with the AssistArmTM Surgical Positioner or with the AssistArmTM Knee Attachment. This would result in the disconnection of the limb from the device or the fall of the AssistArmTM Surgical Positioner on the ground. Always be sure to handle the device as prescribed.

Risk of injury Injuries can occur when the AssistArmTM Surgical Positioner is unlocked.

WARNING !

Always make sure that a person maintains the patient's limb attached to the AssistArmTM Knee Attachment before pressing the actuating lever of the pedal of the AssistArmTM Surgical Positioner. Failure to do so could result in a drop of the operated limb.

Risk of injury

CAUTION !

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

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Risk of contamination Contamination may occur if the AssistArm™ Sterile Kit accessories are not installed on the AssistArm™ Surgical Positioner and AssistArm™ Knee Attachment. WARNING !

Always use all AssistArm™ Sterile Kit accessories while using the AssistArm™ Surgical Positioner and AssistArm™ Knee Attachment

Risk of property damage Inadequate handling of the device may cause the fall of the AssistArmTM Surgical Positioner on the ground resulting in property damage.

CAUTION !

When handling the AssistArmTM Knee Attachment, make sure you do not unintentionally press on one of the two spring buttons that connects it with the AssistArmTM Surgical Positioner and the AssistArmTM Knee Attachment. This would result in the disconnection of the member from the device or the fall of the AssistArmTM Surgical Positioner to the ground. Always be sure to handle the device as prescribed.

Risk of property damage The application of a large load on the AssistArmTM Knee Attachment can damage it. CAUTION !

Use the AssistArmTM Knee Attachment in combination with the AssistArmTM Surgical Positioner only with patients with a mass less than 180kg (400lb).

Involuntary displacement

NOTE

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

3.2. Installing the Device Risk of contamination Inadequate cleaning or sterilization of the AssistArmTM Knee Attachment can lead to a contamination of the patient. WARNING !

Always verify that the cleaning and sterilization have been made on all of the devices used for surgery. Do not use the device if such methods have not been applied.

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Risk of injury Inadequate connection of the AssistArmTM Knee Attachment to the AssistArmTM Surgical Positioner can result in an injury to the patient or the user.

WARNING !

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 AssistArmTM Knee Attachment and the AssistArmTM Surgical Positioner and the connection between the AssistArmTM Connector and the AssistArmTM Knee Attachment.

Risk of contamination

WARNING !

Do not use the AssistArm™ Sterile Kit accessories beyond the expiration date listed on the label. The performance, safety, and/or sterility of the device cannot be assured beyond the expiration date.

Risk of property damage Inadequate connection of the AssistArmTM Knee Attachment to the AssistArmTM Surgical Positioner can lead to property damage. CAUTION !

Always make sure that the AssistArmTM Knee Attachment is connected to the AssistArmTM Surgical Positioner as prescribed in this Instruction for Use.

AssistArm™ Surgical Positioner must be installed prior to decontamination of the lower limb of the patient. Refer to the Instructions for Use: AssistArmTM Surgical Positioner Instructions for Use to ensure that the device is installed as prescribed. NOTE

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3.2.1. Installing the AssistArmTM Surgical Positioner To optimize the use of the device, it is recommended to install the AssistArmTM Surgical Positioner aligned with the patient's hip and to angle the fixed segment toward his feet. An angle of 22.5o of the fixed segment is suitable for a majority of patients.

Figure 3 - Installing the AssistArm

TM

Surgical Positioner

3.2.2. Installation of the AssistArmTM Surgical Positioner Drape Install the AssistArmTM Surgical Positioner Drape on the AssistArmTM Surgical Positioner and on the AssistArmTM Connector. Refer to the Instructions for Use of the AssistArmTM Surgical Positioner for further instruction. Make sure to follow the directions to ensure the integrity of the sterile field.

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3.2.3. Positioning AssistArmTM Cushion ● Take the AssistArm™ Cushion included in the AssistArmTM Sterile Kit and install it on the AssistArmTM Knee Attachment by placing the hole of the AssistArm™ Cushion on the cushion tab of the device as shown in Figure 4. To facilitate insertion, fold the AssistArm™ Cushion as shown in Figure 4.

Figure 4 – Installation of the AssistArm

●

TM

Cushion

When the hole of the AssistArm™ Cushion is down the cushion tab, unfold the sides so that it matches the shape of the AssistArmTM Knee Attachment (see Figure 5).

Figure 5 - Positioning the AssistArm

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TM

Cushion

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AssistArmTM Knee Attachment

3.2.4. Preparation of the patient's limb

Risk of contamination Contamination may occur through a contact of the patient’s lower limb with a contaminant. WARNING !

Preparation of the patient’s lower limb must be performed in a sterile environment.

Risk of contamination Contamination may occur if the integrity of the sterile packaging of the AssistArmTM Sterile Kit is compromised. WARNING !

Always check the packaging before using sterile components.

3.2.5. Installing the limb

Risk of contamination Contamination may occur through contact of the patient’s lower limb with a contaminant. WARNING !

Preparation of the patient’s lower limb must be performed in a sterile environment.

Risk of Injury Injuries may occur if the patient's foot is not properly attached to the AssistArmTM Knee Attachment WARNING !

●

In order to ensure a good grip of the AssistArmTM Knee Attachment on the foot, make sure that the limb is properly fixed as specified in this Instructions for Use.

Install a stockinette on the lower limb of the patient.

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3.2.6. Positioning the AssistArmTM Knee Attachment ● Position the AssistArmTM Knee Attachment with the AssistArm™ Cushion on the lateral side of the patient's leg, be sure to position the heel on the foot support and the malleolus toward the opening provided for this purpose.

Figure 6 - Positioning AssistArm

TM

Knee Attachment

3.2.7. Application of AssistArmTM Bandage ● Use the AssistArm™ Bandage provided in the AssistArm™ Sterile Kit to secure the AssistArm™ Knee Attachment on the patient's leg. ● Carefully wrap the leg, ankle and foot with the AssistArm™ Bandage.

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3.2.8. Connecting the AssistArmTM Knee Attachment

Risk of contamination Contamination may occur due to a contact of the AssistArmTM Knee Attachment with a contaminant. WARNING !

The installation of the AssistArmTM Knee Attachment must be performed in sterile environment.

Risk of Injury Injuries may occur due to an inadequate connection of the AssistArmTM Knee Attachment to the AssistArmTM Connector. WARNING !

Always make sure that the AssistArmTM Knee Attachment is attached to the AssistArmTM Connector by pulling on it in the same orientation as the connecting rod of the AssistArmTM Surgical Positioner.

Risk of property damage Inadequate handling of the AssistArmTM Connector when unlocking the AssistArmTM Surgical Positioner can lead to the later device falling on the floor. CAUTION !

Always make sure that the AssistArmTM Connector is firmly held before unlocking the AssistArmTM Surgical Positioner.

Risk of Injury

WARNING !

Injury may occur if the AssistArmTM Bandage is too tight on the patient's leg. Avoid over tightening the AssistArmTM Bandage on the patient's leg.

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●

●

Connect the AssistArmTM Knee Attachment to the AssistArmTM Connector that have previously been assembled with the AssistArmTM Surgical Positioner and protected by the AssistArmTM Surgical Positioner Drape. Once connected, confirm the correct connection by pulling on the AssistArmTM Knee Attachment and make sure that there is indeed a mechanical linkage preventing disconnection of the device.

Figure 7 - Connection validation of the AssistArm

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TM

Knee Attachment

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AssistArmTM Knee Attachment

3.3. Manipulations Risk of contamination Contamination may occur due to a contact of the AssistArmTM Knee Attachment with a contaminant. WARNING !

The use of the AssistArmTM Surgical Positioner during surgery should be done in a sterile environment.

Risk of injury Injuries may occur when the AssistArmTM Surgical Positioner is unlocked.

WARNING !

Always grasp the patient's leg BEFORE pressing the actuating lever of the pedal and always make sure that the AssistArmTM Surgical Positioner is fully locked before releasing the patient's limb.

Risk of injury Injuries may occur when the user positions the member by directly manipulating the AssistArmTM Connector. CAUTION !

Avoid grasping the AssistArmTM Connector to position the limb. Rather grasp the patient's limb. The desired position may be is unattainable with the AssistArmTM Surgical Positioner.

NOTE

It is possible to temporarily disconnect the AssistArmTM Knee Attachment during the surgery. To do this, grab the patient's leg, push the upper lock of the AssistArmTM Connector and lift the patient's leg to disengage the connecting rod of the AssistArmTM Knee Attachment from the AssistArmTM Connector. When reconnecting the AssistArmTM Knee Attachment to the AssistArmTM Connector, validate the link by pulling on it in the same direction as the connecting of the AssistArmTM Knee Attachment.

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● ● ● ● ●

To change the position of the leg, make sure to hold the leg, then unlock the AssistArm TM Surgical Positioner by pressing the pedal. The AssistArmTM Knee Attachment enables a multitude of limb positions like the extension, flexion, hyper flexion and Figure-Of-4. Unlock AssistArmTM Surgical Positioner. To reach the Figure-Of-4 position, put the leg in flexion and grasp the patient's ankle with one hand and the pivot of the AssistArmTM Knee Attachment on the other, as shown in the Figure 8. Simultaneously, position the patient's leg and rotate the mobile part of the AssistArmTM Knee Attachment by 180°.

Figure 8 – Figure-Of-4 positioning with the knee holder

3.4. Uninstalling the device Risk of Injury Injuries can occur when removing the AssistArmTM Bandage. CAUTION ! ● ● ● ●

Unroll the AssistArmTM Bandage rather than cut it with scissors.

Grasp the patient's leg and press the top lock button of the AssistArmTM Connector. Disengage the AssistArmTM Knee Attachment from the AssistArm ConnectorTM. Unroll the AssistArmTM and remove the stockinet. Dispose of the AssistArmTM Bandage, the stockinet and AssistArmTM Cushion according to the institution’s policies.

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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 Contamination caused by the use of a non-sterile AssistArmTM accessory.

WARNING !

Clean, inspect or sterilize the AssistArmTM accessories with the procedures in their respective Instructions for Cleaning, Inspection and Sterilization before first use and after each use.

Risk of contamination Contamination may occur if AssistArmTM products are inadequately cleaned or sterilized. WARNING !

Carefully follow the Instructions for Cleaning and Sterilization for each AssistArmTM product.

Risk of contamination Contamination may occur due to the contact of a user with a contaminated AssistArmTM product. WARNING !

Products may be contaminated. Always wear gloves when cleaning, inspecting or sterilizing AssistArmTM products.

Risk of property damage The AssistArm™ products can be damaged if liquid or solid contaminants remain present inside the mechanisms. CAUTION !

Inadequate cleaning, inspecting or sterilizing of the AssistArm™ products can cause their malfunctioning. Always follow the procedures for cleaning, inspecting or sterilizing each AssistArm™ product.

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