AssistArm Arm Support AA-AS-BC200 Instructions for Use 2015

AssistArmTM Arm Support

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... 5

1.2.2.

AssistArmTM Sterile Kit... 6

1.3.

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 ... 9

3.2.1.

Installing the AssistArmTM Surgical Positioner ... 11

3.2.2.

Installing the AssistArmTM Surgical Positioner’s Drape ... 11

3.2.3.

Preparing the Patient's Limb ... 12

3.2.4.

Installing the Limb on the AssistArmTM Arm Support ... 13

3.2.5.

Installing the AssistArmTM Arm Support... 15

3.3.

Manipulations ... 16

3.4.

Uninstalling the device... 17

Cleaning and sterilization ... 17 4.1.

General... 17

4.2.

Cleaning... 18

4.3.

Sterilization ... 18

5.

Storage ... 18

6.

Inspection... 18

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1. Introduction This Instruction for Use aims at familiarizing the user with the AssistArmTM Arm Support. 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 is designed to be used in conjunction with the AssistArmTM Surgical Positioner, the AssistArmTM Connector and the AssistArmTM Sterile Kit. The use of AssistArmTM Arm Support 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. Always follow the instructions in this Instruction for Use when the AssistArmTM Arm Support is handled. Store this Instruction for Use close to AssistArmTM 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. NOTE

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AssistArmTM Arm Support 1.1.2. Symbols Used The following table shows the meaning of various symbols found on the AssistArmTM Arm Support and in 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)

2015-02-15 LOT

LOT

REF AA-AS-BC200

SN

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

20130202 REF

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

SN 0003

This symbol indicates the catalog number of the device. 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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AssistArmTM Arm Support 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. This symbol identifies the manufacturer of the product.

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

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

This symbol identifies the Authorized Representative in the European Community.

Schiffgraben 41 30175 Hannover GERMANY +49 511 6262 8630

1.2. Schematic Presentation of the Product 1.2.1. Overview of the AssistArmTM Arm Support

Figure 1 - Overview of the AssistArm

TM

Table 1– Components of the AssistArm

Arm Support

TM

Arm Support

#

NAME

DESCRIPTION

1

Connecting Peg

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

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AssistArmTM Arm Support 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 is designed to be used in conjunction with the AssistArmTM Surgical Positioner and the AssistArmTM Connector. Please refer to these devices’ Instructions for Use before use. The AssistArmTM Arm Support should only be used during surgical procedures performed on humans. The installation of the AssistArmTM Arm Support on the AssistArmTM Surgical Positioner, as well as in combination with other accessories should be done at all times under the supervision of adequately trained medical staff. 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 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 the Instructions for Cleaning, Inspection and Sterilization of the AssistArmTM Arm Support. 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!

● ● ● ●

TM

The AssistArm Arm Support according to Section 6 of this Instruction for Use, The surgery table as described by the manufacturer; TM The AssistArm Surgical Positioner as described in the 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.

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

The AssistArmTM Arm Support 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 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 can result in injury to the patient or the user.

CAUTION!

Always use the AssistArmTM Arm Support 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 the AssistArmTM products.

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

Always use all AssistArm™ Sterile Kit accessories while using the AssistArm™ Surgical Positioner and AssistArm™ Arm Support 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 in combination with the AssistArmTM Surgical Positioner with patients weighing less than 180 kg (400 lb) only, unless the manufacturer of the surgical table stipulates a lower mass. In this case, only use the AssistArmTM Arm Support 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 is suitable for the surgical methods that will be employed during use.

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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 Arm Support, make sure not to press on one of the buttons that connect with the AssistArmTM Surgical Positioner or the other with the AssistArmTM Arm Support. 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 Arm Support 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 Injury may occur when damaged products are used. CAUTION!

Always ensure the proper functioning of the AssistArmTM Arm Support before use. Refer to inspection guide presented in Section 6 of this Instruction for Use.

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, make sure not to press on one of the buttons that connects the AssistArm™ Surgical Positioner or the one that connects the AssistArm™ accessory. 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 property damage Applying too much load on the AssistArmTM Arm Support can damage it. CAUTION!

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

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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. WARNING!

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

3.2. Installing the Device Risk of contamination Inadequate cleaning or sterilization of the AssistArmTM Arm Support 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 on the AssistArmTM Surgical Positioner can damage it. CAUTION!

Always make sure that the AssistArmTM Arm Support is connected to the AssistArmTM Surgical Positioner as prescribed in this Instruction for Use and the Instruction for Use of the AssistArmTM Connector.

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

WARNING!

NOTE

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 and the AssistArmTM Surgical Positioner and the connection between the AssistArmTM Arm Support and the AssistArmTM Connector. The AssistArmTM Surgical Positioner must be installed prior to decontamination of the upper 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.

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Install the AssistArmTM Connector as prescribed in its Instructions for Use. NOTE

NOTE

Make sure the AssistArmTM Surgical Positioner’s Drape supplied in the AssistArmTM Sterile Kit has been installed as prescribed in the Instructions for Use of the AssistArmTM Surgical Positioner or the AssistArmTM Connector.

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.

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 vertically angle the fixed segment (see Figure 3).

Figure 3 - Installing the AssistArm

TM

Surgical Positioner

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

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AssistArmTM Arm Support 3.2.3. Preparing the Patient's Limb

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.

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

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

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

● ●

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

Install a 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

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AssistArmTM Arm Support 3.2.4. Installing the Limb on the AssistArmTM Arm Support

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

Preparation of the patient’s upper limb on the AssistArmTM Arm Support 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 and the AssistArmTM Surgical Positioner. WARNING!

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

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

Always make sure that the patient’s forearm is lying in the grooved part of the AssistArmTM Arm Support.

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 firmly attached on the AssistArmTM Arm Support 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 can damage the AssistArmTM Bandage. CAUTION!

Avoid wrapping the Connection Peg of the AssistArmTM Arm Support with the AssistArmTM Bandage.

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

Figure 5 - Installation of the AssistArm

TM

Cushion on the AssistArm

TM

Arm Support



Install the patient's arm on the AssistArmTM Arm Support 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 beginning with the patient's wrist. Completely envelope the patient’s hand to ensure firm grasp of the support’s handle by the hand of the patient. Continue wrapping the arm up to the patient’s elbow. Use the last meter (3 feet) of the AssistArmTM Bandage to wrap a second layer near the support’s connecting Peg.

Figure 6 - Installing the AssistArm Bandage for Shoulder Surgery on the Patient’s Upper Limb

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AssistArmTM Arm Support 3.2.5. Installing the AssistArmTM Arm Support

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

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

Risk of injury Injury may occur due to an inadequate connection of the AssistArmTM Arm Support to the AssistArmTM Connector. WARNING!

Always make sure that the AssistArmTM Arm Support 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 device falling on the floor. CAUTION!

● ● ●

Always make sure to firmly hold the patient’s limb before unlocking the AssistArmTM Surgical Positioner.

Maintain the AssistArmTM Connector with one hand and press the pedal’s actuating lever 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 to the AssistArmTM Connector.

Figure 7 - Connection Validation of the Mechanical Link between the AssistArm TM AssistArm Connector

●

TM

Arm Support and the

Lock the AssistArmTM Surgical Positioner by releasing the pedal and make sure the connection is completely engaged.

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3.3. Manipulations Risk of contamination Contamination may occur due to 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 Injuries may occur when the user positions the member by directly manipulating the AssistArmTM Connector. CAUTION!

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

NOTE

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

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

● ● ● ● ●

Unroll the AssistArmTM Bandage rather than cutting it with scissors.

Grasp the patient's arm. Push the lock button of the AssistArmTM Connector to release the connecting peg of the AssistArmTM Arm Support. Disengage the AssistArmTM Arm Support 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 product.

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.

WARNING!

Clean, inspect or sterilize the AssistArmTM Arm Support 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 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.

4.3. Sterilization The AssistArmTM Arm Support 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.

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 may be damaged if a heavy load rests on it.

CAUTION!

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

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

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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