AssistArm Traction Unit AA-TRAC400 Instructions for Use 2015

AssistArmTM Traction Unit

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 AssistArm™ Traction Unit ... 5

1.3.

Preliminary Safety Notice ... 7

2.

General Warnings ... 7

3.

Using the device ... 9 3.1.

At all times ... 9

3.2.

Installing the device ... 10

3.2.1.

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

3.2.2.

Installation of the AssistArm™ Traction Unit ... 14

3.3.

Handling of the AssistArm™ Traction Unit ... 16

3.3.1.

Induce tension ... 17

3.3.2.

Remove tension ... 18

3.3.3.

Rotate ... 18

3.3.4.

Disconnecting the accessory ... 19

3.4.

Uninstallation of the Device... 19

3.4.1. 4.

Removing the AssistArm™ Traction Unit... 19

Cleaning and Sterilization ... 19 4.1.

General... 19

4.2.

Cleaning... 20

4.3.

Sterilization ... 20

5.

Storage ... 21

6.

Inspection... 21

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1. Introduction This Instruction for Use aims at familiarizing you with the AssistArm™ Traction Unit. It will clarify installation, use and storage of the product, among others. Instructions for Cleaning, Inspection and Sterilization also accompany this Instructions for Use to describe the methods for cleaning, inspection and sterilization recommended for this product. The user must: ● ● ● ●

Carefully read the entire content presented in this Instructions for Use before using the AssistArm™ Traction Unit. Always follow the instructions in this Instruction for Use when the AssistArm™ Traction Unit 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. 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 AssistArm™ Knee Attachment. NOTE

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AssistArmTM Traction Unit 1.1.2. Symbols Used The following table shows the meaning of various symbols found on the AssistArm™ Knee Attachment or 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 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.

2015-02-15

201302

This symbol indicates the lot number of the device.

AA-TRAC400

This symbol indicates the catalog number of the device.

0001

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

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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 AssistArm™ Traction Unit

Figure 1 - Presentation of the AssistArm™ Traction Unit

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AssistArmTM Traction Unit Table 1 - Components of the AssistArm™ Traction Unit

#

1

2

3

4

5

6

7

8

NAME

DESCRIPTION

When the traction wheel is rotated, the traction carriage moves toward the connecting rod of the AssistArm™ Surgical Positioner, applying tension to the limb attached to it. Conversely, when the traction wheel is pressed and rotated in the Traction Wheel opposite direction, moving the carriage away from the connecting rod of the AssistArm™ Surgical Positioner, the tension gets released. When the axial rotation lever is raised, it releases the rotation of the traction carriage and the attached accessory. The traction Axial Rotation Lever carriage is fixed in the desired position when the lever is released. This standard connection socket is used to connect the selected accessory for surgery. A button on the side allows installation or Connection Socket uninstallation of an accessory. This standard connection socket is used to connect the Connection Socket for AssistArm™ Traction Unit to the AssistArm™ Surgical Positioner. AssistArm™ Surgical Positioner A button on the side allows installation or uninstallation. The Tension Release Lever is located under the carriage. When lowered, it completely releases the carriage and the applied tension. It is essential to maintain the limb or carriage when the Tension Release Lever lever is lowered as a momentary tension discharge may result and could cause injury. Read the warnings before use. The Dynamometer references the tension applied to the limb connected to the AssistArm™ Traction Unit. It is important to note that it is possible to apply a greater tension than referenced on the dynamometer. Dynamometer Once the tension is higher than the dynamometer’s limit, the tension applied to the limb won’t be referenced by the dynamometer. Read the warnings on the use of the dynamometer carefully before using the device. The connection / disconnection lock is used to allow the Connection/ disconnection connection of the AssistArm™ Traction Unit to the AssistArm™ Lock to the AssistArm™ Surgical Positioner Surgical Positioner or the disconnection of the two devices. The Accessory connection / disconnection lock is used to allow Accessory Connection / the connection of an accessory in the AssistArm™ Traction Unit or Disconnection Lock to disconnect the two devices.

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1.3. Preliminary Safety Notice The AssistArm™ Traction Unit is designed to be used in conjunction with the AssistArm™ Surgical Positioner and AssistArm™ accessories. Please refer to these devices’ Instructions for Use before use. The AssistArm™ Traction Unit should only be used during surgical procedures performed on humans. The installation of the AssistArm™ Traction Unit on the AssistArm™ Surgical Positioner in combination with the installation of the AssistArm™ Arm Support for Lateral Decubitus or any other accessory must be performed at all times under the supervision of adequately trained medical personnel. The AssistArm™ Traction Unit connects to the AssistArm™ Surgical Positioner using a quick release connection mechanism provided with a spring loaded button. AssistArm™ accessories connect also with the same type of mechanism. It is important to pay close attention when installing the various components to ensure they are installed properly. To be sure, always refer to the different device’s Instructions for Use. The AssistArm™ Traction Unit has several control elements over the user interface. Refer to Table 1 for a complete description of these commands and be sure to understand how the device works 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 AssistArm™ Traction Unit can lead to contamination of the patient. WARNING!

Verify that proper cleaning and sterilization was performed in accordance with the Instructions for Cleaning, Inspection and Sterilization of the AssistArm™ Traction Unit. 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™ Traction Unit 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, ● The accessory chosen for the procedure 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 products can lead to contamination of the patient. WARNING!

The AssistArm™ Traction Unit 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 AssistArm™ Traction Unit can result in injury to the patient or the user.

CAUTION!

Always use the AssistArm™ Traction Unit for its intended purpose. Always apply the most critical indications among those in this Instructions 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 The use of inadequate devices can cause injury to the patient.

WARNING!

The AssistArm™ Traction Unit should only be used with AssistArm™ products and sterile single use products specifically designed by CONMED Corporation to fit this accessory.

Risk of injury Equipment can break under too much load and cause the attached limb to fall.

WARNING!

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

Risk of injury Precipitated manipulation after sterilization may cause a burn. 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 AssistArm™ Traction Unit is suitable for the surgical methods that will be employed during use.

NOTE

3. Using the device 3.1.

At all times Risk of injury Applying excessive tension on the limb during surgery may result in an injury to the patient.

WARNING!

While applying tension to the AssistArm™ Traction Unit, always pay close 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 Applying excessive tension on the limb during surgery may result in an injury to the patient. CAUTION!

Pay close attention to the dynamometer, taking care to ensure you are viewing the appropriate scale.

Risk of injury Inadequate handling of the device may cause the collapse of the operated and patient injury.

WARNING!

When handling AssistArm™ Traction Unit, make sure not to press on one of the buttons that connect it with the AssistArmTM Surgical Positioner or an AssistArmTM accessory. 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.

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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. Failure to do so could result in a drop of the operated limb.

Risk of injury Injuries may occur when damaged products are used. CAUTION!

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

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

Use the AssistArm™ Traction Unit in combination with the AssistArmTM Surgical Positioner only with patients with a mass less than 180 kg (400 lb).

Involuntary displacement 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. NOTE

3.2.

Installing the device 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.

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Risk of contamination Inadequate cleaning or sterilization of the AssistArm™ Traction Unit can lead to contamination of 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.

Risk of injury Inadequate connection of the AssistArm™ Traction Unit to the AssistArm™ Surgical Positioner or between the AssistArm™ accessory and the AssistArm™ Traction Unit 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. This concerns both the connection between the AssistArm™ Traction Unit and the AssistArm™ Surgical Positioner and the connection between the AssistArm™ accessory and the AssistArm™ Traction Unit.

Risk of contamination Contamination may occur due to a contact of the AssistArm™ Traction Unit with a contaminant. WARNING!

The installation of the AssistArm™ Traction Unit must be performed in sterile environment.

Risk of property damage Inadequate connection of the AssistArm™ Traction Unit to the AssistArm™ Surgical Positioner may result in property damage. CAUTION!

Always make sure that the AssistArm™ Traction Unit is connected to the AssistArmTM Surgical Positioner as prescribed in this Instruction for Use. The AssistArm™ Traction Unit’s locking system will be inaccessible once the sterile drape is installed.

NOTE

Validate the proper functioning of the AssistArm™ Traction Unit’s locking system with the accessory required for surgery before installing the AssistArm™ Surgical Positioner Drape. In case of malfunction of either one of the systems, remove the lock from the AssistArm™ Traction Unit’s body, inspect the parts of the system by following the instructions described in Section 6 of this Instruction for Use and reassemble them only if they are in good condition.

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AssistArmTM Traction Unit An optimal coupling of the AssistArm™ Surgical Positioner’s Drape on the AssistArm™ Traction Unit makes the tape’s installation easier.

NOTE

It is not recommended to enlarge the drape’s hole with anything else than the connecting part of the AssistArm™ Traction Unit itself to avoid overstretching or damage.

Use both rubber bands to facilitate separation of the adhesive tape from its protective film. NOTE

AssistArm™ Surgical Positioner must be installed prior to the patient's limb decontamination. Refer to the Instructions for Use: AssistArm™ Surgical Positioner Instructions for Use to ensure that the device is installed as required in the Instructions for Use.

For an ankle surgery, refer to the AssistArm™ Ankle Attachment Instructions for Use.

For shoulder surgery in lateral decubitus position, refer to the Instructions for Use: AssistArm™ Arm Support for Lateral Decubitus Instructions for Use.

3.2.1. Installation of the AssistArm™ Surgical Positioner’s Drape ● Before installing the AssistArm™ Surgical Positioner’s Drape and connect the AssistArm™ Traction Unit to the AssistArm™ Surgical Positioner be sure to position the carriage at the end of the tension rod where is located the dynamometer (see Figure 2). To do this, you can use the Tension Release Lever or press one of the Traction Wheels and turn.

Figure 2 - Preparation of the AssistArm™ Traction Unit

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AssistArmTM Traction Unit ● ● ●

Unwrap the AssistArm™ Surgical Positioner’s Drape provided in the AssistArm™ Sterile Kit. Remove the tape and the two elastic bands and save for later. Remove both elastic bands located on the tape from the drape, double them and install them over the AssistArm™ Traction Unit’s connection mechanism as shown in Figure 3.

Figure 3 - Preparation AssistArm™ Traction Unit with two elastic bands

●

●

Insert the AssistArm™ Traction Unit’s connecting mechanism into the small hole of the AssistArm™ Surgical Positioner’s Drape situated at the tapered rubber part as shown in the following figure. Stop the insertion when the sterile drape is in the hollow portion of the cylinder. Complete the installation of the AssistArm™ Surgical Positioner’s Drape to the AssistArm™ Traction Unit’s connecting mechanism using the tape previously reserved.

Figure 4 - Installation of the AssistArm™ Surgical Positioner’s Drape

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Be sure to unfold the end of the AssistArm™ Surgical Positioner’s Drape on which are written the instructions as shown in the following figure. This end will be handled by a circulating nurse, who must have a sufficient length of drape to avoid contamination of the rest of the drape.

Figure 5 - Installing the AssistArm™ Surgical Positioner’s Drape

3.2.2. Installation of the AssistArm™ Traction Unit

Risk of contamination Contamination may occur due to a contact of the AssistArm™ Traction Unit or the AssistArm™ Surgical Positioner’s Drape with a contaminant. WARNING!

The installation of the AssistArm™ Traction Unit and the AssistArm™ Surgical Positioner’s Drape must be performed in sterile environment.

Risk of contamination Contamination may occur through contact with a circulating nurse with the sterile part of the AssistArm™ Surgical Positioner's Drape. WARNING!

Make sure the circulating nurse keeps a suitable distance from the folded portion of the AssistArm™ Surgical Positioner's Drape when deploying it.

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Risk of injury Injuries may occur due to an inadequate connection of the AssistArm™ Traction Unit to the AssistArm™ Surgical Positioner. WARNING!

●

Always make sure that the AssistArm™ Traction Unit is attached to the AssistArm™ Surgical Positioner by pulling on it in the same orientation as the connecting rod of the AssistArm™ Surgical Positioner.

Connect the AssistArm™ Traction Unit to the connecting rod of the AssistArm™ Surgical Positioner. Once connected, validate the connection by pulling on the AssistArm™ Traction Unit and make sure that there is no backlash that could lead to a disconnection.

Figure 6 - Connecting the AssistArm™ Traction Unit to the AssistArm™ Surgical Positioner.

● ●

Deploy the AssistArm™ Surgical Positioner’s Drape along the telescopic member of the AssistArm™ Surgical Positioner. Stop at the border of the sterile environment. Ask for the help of a circulating nurse in order to complete the deployment of the AssistArm™ Surgical Positioner’s Drape to the bottom of the telescopic member of the AssistArm™ Surgical Positioner. Make sure that the circulating nurse manipulates the external end of the AssistArm™ Surgical Positioner’s Drape and keeps a suitable distance from the part of the drape still bent to avoid any risk of contamination.

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Continue deploying the AssistArm™ Surgical Positioner’s Drape by covering the AssistArm surgical positioner’s lower ball joint and the bottom of the fixed segment of the positioner. For details, refer to the AssistArm™ Surgical Positioner’s Instructions for Use. ● Refer to the chosen AssistArm™ accessory’s Instructions for Use for details on how to install these on the AssistArm™ Traction Unit.

3.3.

Handling of the AssistArm™ Traction Unit Risk of injury Applying excessive tension on the operated limb may result in an injury to the patient.

WARNING!

When applying a tension to the AssistArm™ Traction Unit always pay close 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 A quick release of tension could result in injury to the patient.

WARNING!

Always make sure to hold the limb when a tension-release mechanism of the AssistArm™ Traction Unit is used.

Risk of contamination Contamination may occur from a contact of the AssistArm™ Traction Unit with a contaminant. WARNING!

The handling of the AssistArm™ Traction Unit during surgery should be done in a sterile environment.

Risk of contamination Contamination may occur from a contact of the AssistArm™ Surgical Positioner with a contaminant. WARNING!

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

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Risk of injury Injuries can occur when the user positions the limb by directly manipulating the AssistArm™ Traction Unit’s connecting mechanism. WARNING!

Avoid grabbing the AssistArm™ Traction Unit’s connection mechanism to perform positioning. Instead grab 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 accessory during the surgery. To do so, hold the patient's limb, push the connecting lock mechanism on the carriage of the AssistArm™ Traction Unit and lift the patient's limb to disengage the connecting rod of the AssistArm™ accessory. When reconnecting the AssistArm™ accessory to the AssistArm™ Traction Unit, validate the mechanical link by pulling on the limb in the same orientation as the connecting rod of the accessory.

3.3.1. Induce tension ● To induce tension on the limb connected to the AssistArm™ Traction Unit through an accessory, turn the Traction Wheel. Always reference the dynamometer when tension is induced so that it does not exceed the last hash mark. Positioning of the carriage on the tension rod is not a guarantee 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.

Figure 7 - Applying a tension with the AssistArm™ Traction Unit

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AssistArmTM Traction Unit 3.3.2. Remove tension ● To remove the tension applied previously, it is possible to press the Tension Release Lever while carefully support the limb attached to the AssistArm™ Traction Unit (see Figure 8). ● It is also possible to remove the tension by pushing the drive wheel and turning it (see Figure 8).

Figure 8 - Removing a tension force with the AssistArm™ Traction Unit

3.3.3. Rotate ● To rotate the limb connected to the AssistArm™ Traction Unit through an accessory, hold the limb and lift the Rotation Lever (see Figure 9). Rotate the limb around the axis to the desired position and release the Rotation Lever. Make sure the position is secured before releasing the patient’s limb.

Figure 9 - Rotations with the AssistArm™ Traction Unit

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AssistArmTM Traction Unit 3.3.4. Disconnecting the accessory ● To disconnect the accessory from the AssistArm™ Traction Unit simply press the lock button on the side of the traction carriage.

3.4.

Uninstallation of the Device

3.4.1. Removing the AssistArm™ Traction Unit ● Remove the AssistArm™ Traction Unit from the AssistArm™ Surgical Positioner by pressing the lock button and by disengaging the device from the connecting rod of the AssistArm™ Surgical Positioner. ●

Remove the AssistArm™ Surgical Positioner’s Drape from the AssistArm™ Surgical Positioner.

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, Inspection 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 reprocessing AssistArmTM products.

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

Inadequate reprocessing of the AssistArm™ products can cause their malfunctioning. Always follow the procedures for reprocessing each AssistArm™ product.

4.2. Cleaning AssistArm™ Traction Unit 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™ Traction Unit.

4.3. Sterilization

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

The AssistArm™ Traction Unit 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™ Traction Unit.

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