AssistArm Arm Support for Lateral Decubitus AA-AS-LD500 Instructions for Use 2015

AssistArmTM Arm Support for Lateral Decubitus

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 the Product ... 5

1.2.1.

Overview of the AssistArmTM Arm Support for Lateral Decubitus ... 5

1.2.2.

AssistArmTM Sterile Kit... 6

1.3.

Preliminary Safety Notice ... 6

2.

General Warnings ...7

3.

Using the Device...9

4.

3.1.

At all times ... 9

3.2.

Installing the device ... 11

3.2.1.

Installing the AssistArmTM Surgical Positioner ... 12

3.2.2.

Installation of the AssistArmTM Surgical Positioner’s Drape ... 12

3.2.3.

Preparing the patient's limb ... 12

3.2.4.

Installing the limb... 13

3.2.5.

Installing the AssistArmTM Arm Support for Lateral Decubitus ... 15

3.3.

Manipulations ... 17

3.4.

Uninstalling the device... 18

Cleaning and sterilization ... 18 4.1.

General... 18

4.2.

Cleaning... 19

4.3.

Sterilization ... 19

5.

Storage ... 19

6.

Inspection ... 19

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AssistArmTM Arm Support for Lateral Decubitus

1. Introduction This Instruction for Use aims to familiarize the user with the AssistArmTM Arm Support for Lateral Decubitus. It 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. The AssistArmTM Arm Support for Lateral Decubitus is designed to be used in conjunction with the AssistArmTM Surgical Positioner, the AssistArmTM Traction Unit or the AssistArmTM Connector and the AssistArmTM Sterile Kit for Shoulder and Knee. The use of AssistArmTM Arm Support for Lateral Decubitus is limited to surgery on the shoulder in a sterile environment. The user must: ● ● ●

Read carefully all of the contents presented in this Instruction for Use before using the AssistArmTM Arm Support for Lateral Decubitus. Always follow the instructions in this Instruction for Use when the AssistArmTM Arm Support for Lateral Decubitus is handled. 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 Arm Support for Lateral Decubitus. NOTE

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AssistArmTM Arm Support for Lateral Decubitus 1.1.2. Symbols Used The following table shows the meaning of various symbols found on the AssistArmTM Arm Support for Lateral Decubitus 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 Instruction 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.

20130202

This symbol indicates the lot number of the device.

AA-AS-LD500

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

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AssistArmTM Arm Support for Lateral Decubitus 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 the Product 1.2.1. Overview of the AssistArmTM Arm Support for Lateral Decubitus

Figure 1 - Overview of the AssistArm Table 1 - Features of the AssistArm

TM

TM

Arm Support for Lateral Decubitus

Arm Support for Lateral Decubitus

#

NAME

DESCRIPTION

1

Connecting Rod

The connecting rod is the male part of the connector and it is located under the device. It is used to attach various devices to each other.

2

Handle

The handle is used to provide support for the patient's hand preventing the arm from moving on the arm support.

3

Forearm Support

The support is designed to support the forearm and stabilize.

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AssistArmTM Arm Support for Lateral Decubitus 1.2.2. AssistArmTM Sterile Kit

AssistArmTM Surgical Positioner Drape

AssistArmTM Bandage AssistArmTM Cushion Figure 2 - AssistArm

TM

Sterile Kit overview

1.3. Preliminary Safety Notice The AssistArmTM Arm Support for Lateral Decubitus is designed to be used in conjunction with the AssistArmTM Surgical Positioner and the AssistArmTM Traction Unit. It is also possible to use the AssistArmTM Connector if the AssistArmTM Traction Unit is not available. Please refer to these devices’ Instruction for Use before use. The AssistArmTM Arm Support for Lateral Decubitus should only be used during surgical procedures performed on humans. The installation of the AssistArmTM Arm Support for Lateral Decubitus on the AssistArmTM Surgical Positioner, in combination with other accessories should be done 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 Instruction for Use for the different devices.

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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 can cause contamination of the patient. WARNING!

Always perform cleaning and sterilization according to Instructions for Cleaning, Inspection and Sterilization of the AssistArmTM Arm Support for Lateral Decubitus. 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: The AssistArmTM Arm Support for Lateral Decubitus according to Section 6 of this Instruction for Use ● The surgery table as described by the manufacturer ● The AssistArmTM Surgical Positioner as described in the Instruction for Use ● Any other accessories used as described in their Instruction for Use Use these products only if they are in good condition and no parts are missing. ●

CAUTION!

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

The AssistArmTM Arm Support for Lateral Decubitus should be used only with AssistArmTM products and 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 AssistArmTM Arm Support For Lateral Decubitus should be used only with AssistArmTM products and single use products specifically designed by CONMED Corporation to fit this accessory.

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Risk of injury Inadequate use of the AssistArmTM Arm Support for Lateral Decubitus can result in injury to the patient or the user.

CAUTION!

Always use the AssistArmTM Arm Support For Lateral Decubitus for shoulder surgery in a sterile environment. 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 AssistArmTM Surgical Positioner, the Instruction for Use of the AssistArmTM Connector or any equipment that interacts with AssistArmTM products.

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

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

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

WARNING!

Use the AssistArmTM Arm Support for Lateral Decubitus in combination with the AssistArmTM Surgical Positioner with patients weighing less than 180kg (400lb) unless the manufacturer of the surgical table stipulates a lower mass. In this case, use the AssistArmTM Arm Support for Lateral Decubitus and AssistArmTM Surgical Positioner with patients weighing less than the indication of expected mass limit for the surgery table.

Compatibility of surgical techniques

NOTE

Always ensure beforehand that the use of the AssistArmTM Arm Support for Lateral Decubitus is suitable for the surgical methods that will be employed during use.

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AssistArmTM Arm Support for Lateral Decubitus

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

WARNING!

When handling the AssistArmTM Arm Support for Lateral Decubitus, be sure not to press on one of buttons that connects with the AssistArmTM Surgical Positioner or AssistArmTM Arm Support For Lateral Decubitus. This would result in the disconnection of the limb and the device or the fall of the AssistArmTM Surgical Positioner to 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 Arm Support for Lateral Decubitus 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 The application of excessive traction on the operated limb may result in a patient injury.

WARNING!

When using the AssistArmTM Arm Support For Lateral Decubitus in combination with the AssistArmTM 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 Injury may occur when damaged products are used.

CAUTION!

Always ensure the proper functioning of the AssistArmTM Arm Support for Lateral Decubitus 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™ Arm Support for Lateral Decubitus. WARNING!

Always use all AssistArm™ Sterile Kit accessories while using the AssistArm™ Surgical Positioner and AssistArm™ Arm Support for Lateral Decubitus.

Risk of property damage Inadequate handling of the device may cause it to fall on the ground resulting in property damage.

CAUTION!

When handling the AssistArmTM Arm Support for Lateral Decubitus, make sure you do not press on one of the buttons that connect with AssistArmTM Surgical Positioner and the AssistArmTM Arm Support for Lateral Decubitus. This would result in the disconnection of the limb 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 injury Use of the AssistArmTM Arm Support for Lateral Decubitus to laterally distract the shoulder may induce lateral tension in the elbow that could cause injury to the patient. WARNING!

Do not use the device to laterally distract the shoulder.

Risk of property damage Applying excessive load on the AssistArmTM Arm Support for Lateral Decubitus can damage it. CAUTION!

Only use AssistArmTM Arm Support for Lateral Decubitus in combination with the AssistArmTM Surgical Positioner on patients with a mass of less than 180 kg (400 lb).

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 Inadequate cleaning or sterilization of the AssistArmTM Arm Support for Lateral Decubitus can lead to contamination of the patient. WARNING!

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 property damage Inadequate installation of the AssistArmTM Arm Support for Lateral Decubitus on the AssistArmTM Surgical Positioner. CAUTION!

Always make sure that the AssistArmTM Arm Support for Lateral Decubitus is connected to the AssistArmTM Surgical Positioner as prescribed in this Instruction for Use and the Instruction for Use of the connection accessory used.

Risk of injury Inadequate connection of the AssistArmTM Arm Support for Lateral Decubitus and any other device used jointly.

WARNING!

Always make sure that the connection between different devices is done correctly and they are securely attached to each other. This concerns both the connection between the AssistArmTM Arm Support for Lateral Decubitus and the AssistArmTM Surgical Positioner and the connection between the AssistArmTM Arm Support for Lateral Decubitus and any other connecting device used.

Risk of contamination

WARNING!

NOTE

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. The AssistArmTM Surgical Positioner must be installed prior to decontamination of the upper limb of the patient. Refer to the Instruction for Use: AssistArmTM Surgical Positioner Instructions for Use to ensure that the device is installed as prescribed.

Install the connecting device AssistArmTM Traction Unit or AssistArmTM Connector as prescribed in their Instruction for Use. NOTE

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NOTE

Make sure you have installed the AssistArmTM Surgical Positioner’s Drape supplied in the AssistArmTM Sterile Kit as prescribed in the Instruction for Use of the AssistArmTM Surgical Positioner or the AssistArmTM Traction Unit.

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 navel and horizontally angle the fixed segment toward the patient’s feet (see Figure 3).

Figure 3 – Installing the AssistArm

TM

Surgical Positioner

3.2.2. Installation of the AssistArmTM Surgical Positioner’s Drape Install the AssistArmTM Surgical Positioner’s Drape on the AssistArmTM Surgical Positioner and the AssistArmTM Traction Unit. Refer to the Instruction for Use of the AssistArmTM Surgical Positioner and of the AssistArmTM Traction Unit. Make sure to follow the directions to ensure the integrity of the sterile field. The AssistArmTM Connector can replace the AssistArmTM Traction Unit. 3.2.3. Preparing the patient's limb

Risk of contamination

WARNING!

Contamination may occur if the integrity of the sterile packaging of the AssistArmTM Sterile Kit is compromised. Always check the packaging before using sterile components.

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

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

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Risk of injury Injury may occur when the patient's hand does not grasp the AssistArmTM Arm Support for Lateral Decubitus handle. CAUTION!

● ●

To allow a good grip of the AssistArmTM Arm Support for Lateral Decubitus on the arm, make sure that the patient’s hand is open as shown in Figure 4.

Install stockinet on the upper limb to be operated (see Figure 4). Solidify stockinet with a gauze bandage (clean) by keeping the patient’s hand open.

Figure 4 – Installing the stockinet

3.2.4. Installing the limb

Risk of contamination Contamination may occur through contact of the patient’s upper limb or the AssistArmTM Arm Support for Lateral Decubitus with a contaminant. WARNING!

Preparation of the patient’s upper limb on the AssistArmTM Arm Support for Lateral Decubitus must be performed in a sterile environment.

Risk of injury Injury may occur by pinching the patient’s skin between a metal edge of the AssistArmTM Arm Support for Lateral Decubitus and the AssistArmTM Surgical Positioner. WARNING!

Always make sure that the AssistArmTM Cushion completely covers the AssistArmTM Arm Support for Lateral Decubitus and that no metal edge is exposed.

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Risk of injury Injury may occur by pinching the patient’s skin between a metal edge of the AssistArmTM Arm Support for Lateral Decubitus and the AssistArmTM Bandage. WARNING!

Always make sure that the patient’s forearm is lying in the hollow part of the AssistArmTM Arm Support for Lateral Decubitus.

Risk of injury Injury may occur from inadequate wrapping of the AssistArmTM Bandage around the patient's arm. WARNING!

Always make sure that the patient’s limb is stable on the AssistArmTM Arm Support for Lateral Decubitus before unlocking the AssistArmTM Surgical Positioner.

Risk of injury Injury may occur if the AssistArmTM Bandage is too tight on the hand or the patient's arm. WARNING!

Avoid over tightening the AssistArmTM Bandage on the patient's arm.

Risk of property damage Entrapment of the AssistArmTM Bandage in the locking mechanism of the AssistArmTM Connector or the AssistArmTM Traction Unit can damage the AssistArmTM Bandage. CAUTION!

● ●

Avoid wrapping the Connection rod of the AssistArmTM Arm Support for Lateral Decubitus with the AssistArmTM Bandage.

Remove the AssistArmTM Cushion from its packaging. Install it on the AssistArmTM Arm Support for Lateral Decubitus by inserting the handle into the hole of the AssistArmTM Cushion.

Figure 5 – Installation of the AssistArm

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Cushion on the AssistArm

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Arm Support for Lateral Decubitus

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AssistArmTM Arm Support for Lateral Decubitus ● ● ●

Install the patient's arm on the AssistArmTM Arm Support for Lateral Decubitus and close the patient's hand around the handle of the support. Remove AssistArmTM Bandage from its packaging. Wrap the patient's arm and AssistArmTM Arm Support for Lateral Decubitus beginning with the patient's wrist. Completely coat the patient’s hand to ensure good holding of the support’s handle by the hand of the patient. Continue wrapping the arm until the arm support is completely covered. Use the last meter (3 feet) of the AssistArmTM Bandage to wrap a second layer near the support’s connecting rod. 3.2.5. Installing the AssistArmTM Arm Support for Lateral Decubitus

Risk of contamination Contamination may occur due to contact of the AssistArmTM Arm Support for Lateral Decubitus with a contaminant. WARNING!

Installation of the AssistArmTM Arm Support for Lateral Decubitus must be performed in a sterile environment.

Risk of injury Injury may occur due to an inadequate connection of the AssistArmTM Arm Support for Lateral Decubitus to the AssistArmTM Connector or the AssistArmTM Traction Unit. WARNING!

Always make sure that the AssistArmTM Arm Support for Lateral Decubitus is attached to the AssistArmTM Connector or the AssistArmTM Traction Unit 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 or the AssistArmTM Traction Unit when unlocking the AssistArmTM Surgical Positioner can lead to the device falling on the floor. CAUTION!

Always make sure to firmly hold the AssistArmTM Connector or the AssistArmTM Traction Unit before unlocking the AssistArmTM Surgical Positioner.

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AssistArmTM Arm Support for Lateral Decubitus ● ● ●

Maintain the connection accessory with one hand and press the actuating lever of the pedal of the AssistArmTM Surgical Positioner. Grasp the patient's arm with the other hand and bring it to the connector. Connect the AssistArmTM Arm Support for Lateral Decubitus to the connector on the accessory.

Figure 6 - Connection validation of the mechanical link between the AssistArm TM Decubitus and the AssistArm Traction Unit

TM

Arm Support for Lateral

Figure 7 - Connection validation of the mechanical link between the AssistArm TM Decubitus and the AssistArm Connector

TM

Arm Support for Lateral

●

Lock the AssistArmTM Surgical Positioner by releasing the pedal and ensure the connection is secure.

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

Handling the AssistArmTM Surgical Positioner during surgery should be performed in a sterile environment.

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

WARNING!

Always grasp the patient’s arm 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 arm.

Risk of injury Use of the AssistArmTM Arm Support for Lateral Decubitus to laterally distract the shoulder may induce lateral tension in the elbow that could cause injury to the patient. WARNING!

It is not recommended to use the device to laterally distract the patient's shoulder. Do not use the device to laterally distract the shoulder.

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

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

NOTE

It is possible to temporarily disconnect, during the surgery, the AssistArmTM Arm Support for Lateral Decubitus from the connection accessory. To do this, grasp the patient’s arm, push the lock button of the connection accessory and lift the patient's arm to disengage the connecting rod of the AssistArmTM Arm Support for Lateral Decubitus from the connection accessory. When attaching the AssistArmTM Arm Support for Lateral Decubitus to the connection accessory, verify the mechanical link by pulling on it in the same direction as the connecting rod of the AssistArmTM Arm Support for Lateral Decubitus.

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3.4. Uninstalling the device Risk of injury Injuries can occur when removing the AssistArmTM Bandage. Unroll the AssistArmTM Bandage rather than cutting it with scissors.

CAUTION!

● ● ● ● ●

Grasp the patient's arm. Push the lock button of the connection accessory used to release the connecting rod of the AssistArmTM Arm Support for Lateral Decubitus. Disengage the AssistArmTM Arm Support for Lateral Decubitus from the connector. Unroll the AssistArmTM Bandage, the gauze bandage and remove the stockinet. Dispose of the AssistArmTM Bandage, the stockinet, the gauze bandage and the AssistArmTM Cushion 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 Contamination may occur if AssistArmTM products are inadequately cleaned or sterilized. WARNING!

Carefully follow the Instructions for Cleaning, Inspection and Sterilization for each AssistArmTM products.

Risk of contamination Contamination of a user by an AssistArmTM product. WARNING!

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

Risk of contamination Contamination caused by the use of a non-sterile AssistArmTM Arm Support for Lateral Decubitus. WARNING!

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

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4.2. Cleaning The AssistArmTM Arm Support for Lateral Decubitus 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 AssistArmTM Arm Support for Lateral Decubitus.

4.3. Sterilization The AssistArmTM Arm Support for Lateral Decubitus must be sterilized according to the procedure provided for this purpose. Refer to the sterilization procedure described in the Instructions for Cleaning, Inspection and Sterilization of the AssistArmTM Arm Support for Lateral Decubitus.

WARNING!

Do Not Re-sterilize the AssistArm™ Sterile Kit accessories. 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 The AssistArmTM Arm Support for Lateral Decubitus may be damaged if a heavy load rests on it. CAUTION!

Do not apply excessive load on the AssistArmTM Arm Support for Lateral Decubitus during storage. Refer to storage procedure described in the Instructions for Cleaning, Inspection and Sterilization of the AssistArmTM Arm Support for Lateral Decubitus.

6. Inspection Risk of injury A device in poor condition can cause injury. Do not use an AssistArmTM product if damaged or if it has a crack in a weld. CAUTION!

Do not attempt to repair it. Contact your CONMED Corporation representative if you have any doubt about the integrity of an AssistArmTM product.

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AssistArmTM Arm Support for Lateral Decubitus The AssistArmTM Arm Support for Lateral Decubitus must be inspected using the procedure foreseen for this purpose. Refer to inspection procedure described in the Instructions for Cleaning, Inspection and Sterilization of the AssistArmTM Arm Support For Lateral Decubitus.

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.

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

© CONMED Corporation. 2015

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

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