AssistArm Surgical Positioner AA-PSN100 Instructions for Use 2020

AssistArmTM Surgical Positioner

AssistArmTM Surgical Positioner (AA-PSN100)

Reference documents for joint use Item Number

Device Name

Document

AA-EXT300

AssistArmTM Rail Extension

AssistArmTM Rail Extension Instructions for Use

AA-TRAC400

AssistArmTM Traction Unit

AssistArmTM Traction Unit Instructions for Use

AA-CON250

AssistArmTM Connector

AssistArmTM Connector Instructions for Use

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AssistArmTM Surgical Positioner

Table of Contents 1.

Introduction ... 3 1.1

2.

1.1.1

Security Notice ... 3

1.1.2

Symbols Used ... 3

1.2

Schematic Presentation of the AssistArm™ Surgical Positioner ... 5

1.3

Preliminary Warnings... 6

Warnings ... 7 2.1

3.

4.

Definitions ... 3

General Warnings ... 7

Operations and Use ... 10 3.1

General... 10

3.2

Installation Set Up ... 12

3.2.1

Installation on the Surgical Table ... 12

3.2.2

Installing the Drapes ... 14

3.3

Use of the Device ... 17

3.4

Removing the AssistArm™ Surgical Positioner ... 18

Cleaning and Decontamination... 18 4.1

General... 18

4.2

Cleaning... 19

4.3

Disinfection ... 19

5.

Storage ... 20

6.

Inspection... 22

7.

Maintenance ... 22

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1. Introduction This Instruction for Use aims at familiarizing the user with the AssistArm™ positioning system. It provides information on storage, installation, use and decontamination of the AssistArm™ Surgical Positioner. The user must: • • •

1.1.

Read the entire content in this Instruction for Use before using the AssistArm™ Surgical Positioner. Always follow the instructions in this Instruction for Use when the AssistArm™ Surgical Positioner is handled. Keep this Instruction for Use close to AssistArm™ products’ point of use.

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 AssistArm™ products. NOTE 1.1.2

Symbols Used

The following table shows the meaning of various symbols found on AssistArm™ products or in its literature.

Symbol

Example of use

Definition This symbol indicates that the device cannot be reused.

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AssistArmTM Surgical Positioner 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.

YYYY-MM-DD

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

LOT

LOT 20130202

This symbol indicates the lot number of the device.

REF

REF AA-PSN100

This symbol indicates the catalog number of the device.

SN

SN 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.

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.

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

1.2.

This symbol identifies the Authorized Representative in the European Community.

Schematic Presentation of the AssistArm™ Surgical Positioner

1 2 2

5

6 5

7 3 4 8 9 Figure 1 - Presentation of the AssistArm™ Surgical Positioner

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AssistArmTM Surgical Positioner Table 1 - Components of the AssistArm™ Surgical Positioner

#

NAME

DESCRIPTION

The Clamping Handle situated on top of the device serves to tighten or to release the grip of the Clamp onto the rail to ensure the stability of the AssistArm™ Surgical Positioner. The handle situated on the Fixed Segment is used to adjust its positioning angle. The Clamp ensures the grip of the AssistArm™ Surgical Positioner onto the rail of the surgical bed. The Fixed Segment is used for the initial positioning of the AssistArm™ Surgical Positioner. The angle in which it is placed influences the positioning capabilities of the device. The Lower Ball Joint allows the Telescopic Segment to move when the actuating lever is pushed down. The Upper Ball Joint allows a precise positioning of the accessory attached to it. The standard connection peg allows the connection of various AssistArm™ accessories. The Telescopic Member allows a linear movement on its axis to increase the positioning options. The Hydraulic Hose assures the link between the AssistArm™ Surgical Positioner and the pedal. The Actuating Lever allows release of the locking mechanisms in the AssistArm™ Surgical Positioner so that it can be freely repositioned.

1

Clamping Handle (x2)

2

Clamp

3

Fixed segment

4

Lower Ball Joint

5

Upper Ball Joint

6

AssistArm Coupling

7

Telescopic Member

8

Hydraulic Hose

9

Actuating lever of the pedal

1.3.

Preliminary Warnings

The AssistArm™ Surgical Positioner and its accessories must be used only during surgical procedures performed on humans. The patient’s installation on the AssistArm™ Surgical Positioner must be done at all times under the supervision of adequately trained medical personnel. The AssistArm™ Surgical Positioner and its accessories are designed to support the limb of a patient before, during and after surgery. The AssistArm™ Surgical Positioner has been designed to be attached on the original rails on the edges of the surgical tables. The AssistArm™ Surgical Positioner is compatible with rails which are between 9 mm (0.35 in) and 10 mm (0.39 in) of width and between 25 mm (1 in) and 28.6 mm (1-1/8 in) of height. It attaches to the rail using the clamp. The positioner’s pedal is installed on the floor. In passive mode, the device is locked. The operator has to move the actuating lever of the pedal to the ground with the sole of his foot in order to unlock the positioner. When the operator removes his foot from the pedal, the device will lock again in this new position. The AssistArm™ Surgical Positioner must be used only with AssistArm™ products. © CONMED Corporation. 2020

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2. Warnings 2.1. 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

WARNING!

Preoperative and operating procedures, including knowledge of surgical techniques and proper selection and placement of the AssistArm™/patient are important considerations in the successful utilization of this device. Surgeon must choose proper placement of the AssistArm™ based on the specific procedure and patient history. Risk of injury Risk caused by a user error.

CAUTION!

Follow the instructions of the user manual of the surgical table on which the AssistArm™ Surgical Positioner will be installed and verify that there is no contraindication with the use of the AssistArm™ Surgical Positioner. Always use the most restrictive indications between those of this Instruction for Use and those of the manual of the surgical table, or indications of any equipment having an interaction with the AssistArm™ products. Risk of injury Risk caused by a surgical table that cannot withstand the load induced by the weight of the patient's limb.

WARNING!

Use the AssistArm™ Surgical Positioner only on patients with a mass less than 180 kg (400 lbs) unless the manufacturer of the surgical table stipulates a lower mass. In this case, use the AssistArm™ Surgical Positioner only with patients whose weight is less than the expected mass indication for surgical table. Risk of injury Risk caused by inappropriate positioning of the patient.

CAUTION!

Position the patient as described by the surgical table’s manufacturer or the recommendations of a qualified health professional and verify the patient’s position at all times.

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Risk of injury The material can break when overloaded. WARNING!

Use AssistArm™ products only on patients with a mass less than 180 kg (400 lbs). Risk of injury Equipment in poor condition can cause injury.

CAUTION!

Inspect the AssistArm™ products and the surgical table before each use and use them only if they are in good condition. Refer to the end of each Instruction for Use to properly inspect the AssistArm™ products. Risk of injury Injuries that may occur due to a loose accessory that is accidentally detached.

WARNING!

Only use AssistArm™ branded accessories or authorized by CONMED Corporation. Risk of injury Injuries that may occur due to interference between the surgical table and the device attached to or its environment when position adjustments are made to the surgical table.

CAUTION!

When position adjustments are made with the surgical table, at all times make sure that there is no possibility of interference between the different elements of the surgical table nearby. Risk of injury

WARNING!

Injuries that may occur due to detachment between the AssistArm™ Surgical Positioner and the surgical table or between the AssistArm™ Surgical Positioner and the AssistArm™ connection accessory or between the AssistArm™ connection accessory and the AssistArm™ surgery accessory. Make sure all AssistArm™ Surgical Positioner’s connections along with its accessories are well established by validating each of them during their assembly. Risk of injury Injuries that may occur during installation or removal of the patient on the surgical table.

CAUTION!

Avoid collisions between the patient and the AssistArm™ Surgical Positioner during installation and removal of the patient by positioning the AssistArm™ Surgical Positioner’s telescopic member parallel to the ground.

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Risk of injury by pinching Injuries that may occur due to a pinch point between the various component parts of the AssistArm™ Surgical Positioner and its accessories during installation or use. CAUTION!

Ensure adequate patient and user clearance from moving parts of AssistArm™ Surgical Positioner and its accessories.

Risk of contamination Contamination may occur if the packaging of the AssistArmTM Surgical Positioner Drape is damaged. WARNING!

Do not use the AssistArmTM Surgical Positioner Drape if its packaging is damaged.

Risk of contamination Contamination may occur if the AssistArm™ Surgical Positioner’s Drape is not properly installed on the AssistArm™ Surgical Positioner. WARNING!

Always refer to this Instruction for Use and the AssistArm™ connection accessory’s Instructions for Use when installing the AssistArm™ Surgical Positioner Drape.

Possible property damage The AssistArm™ products can be damaged if liquid or solid contaminants get inside the mechanisms. CAUTION!

WARNING!

Prevent the ingress of contaminants, detergents and disinfectants in the mechanisms of the AssistArm™ products. Make sure to cover well the spherical joints of the AssistArm™ Surgical Positioner with a waterproof material when they are likely to be exposed to such contaminants.

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.

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3. Operations and Use 3.1.

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

CAUTION!

Always ensure the proper functioning of the AssistArm™ products before use. Refer to the inspection guide presented in Section 6 of this Instruction for Use. Risk of injury Injuries may occur when the AssistArm™ Surgical Positioner is unlocked.

WARNING!

Always make sure that a person maintains the patient's limb before pressing the actuating lever of the pedal. Risk of contamination Contamination may occur if the AssistArm™ Surgical Positioner Drape is not installed on the AssistArm™ Surgical Positioner.

WARNING!

Always use an AssistArm™ Surgical Positioner Drape while using the AssistArm™ Surgical Positioner. Possible property damage The AssistArm™ Surgical Positioner may be damaged if it comes into collision with another device or with the floor.

CAUTION!

Always make sure that the upper end of the AssistArm™ Surgical Positioner is maintained before pressing the actuating lever of the pedal. Possible property damage The AssistArm™ Surgical Positioner may be damaged if an excessive load is applied to the hydraulic hose or its pedal.

CAUTION!

Do not pull on hose. Avoid pushing heavy equipment on the hydraulic hose or on the AssistArm™ Surgical Positioner’s pedal. Possible property damage Improper coupling of an accessory to AssistArm™ Surgical Positioner can damage the unit.

CAUTION!

Always use the AssistArm™ branded accessories with the AssistArm™ Surgical Positioner.

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AssistArmTM Surgical Positioner Possible property damage With the application of an excessive load, the AssistArm™ Surgical Positioner may be damaged.

CAUTION!

The device is designed to support the limb of a patient with a maximum mass of 180 kg (400 lbs). Also, the configuration of the AssistArm™ Surgical Positioner influences its supporting capacity. Always refer to the Instructions for Use of the AssistArm™ surgery accessories to know the optimal positioning according to the type of surgery. Possible property damage A collision of the AssistArm™ Surgical Positioner with a surrounding object can damage the device.

CAUTION!

3.2.

Avoid collisions between AssistArm™ products and surrounding objects (floor, surgical table, stretcher, etc.).

Installation Set Up Risk of injury Injury may occur if the AssistArm™ Surgical Positioner is not properly anchored to the surgical table.

WARNING!

Always ensure that the AssistArm™ Surgical Positioner is compatible with the rail of the surgical table. The AssistArm™ Surgical Positioner is compatible with rails which are between 9 mm (0.35 in) and 10 mm (0.39 in) of width and between 25 mm (1 in) and 28.6 mm (1-1/8 in) of height. Possible property damage A clamping handle inappropriately screwed could damage the AssistArm™ Surgical Positioner.

CAUTION!

Clamping handles can loosen completely. When a clamping handle is completely unscrewed from the device, it must be screwed back in and the operator must ensure that at least two (2) full rotations are involved in the threads before continuing the installation process.

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AssistArmTM Surgical Positioner 3.2.1

Installation on the Surgical Table Risk of injury Injury may occur if the AssistArm™ Surgical Positioner is not properly anchored to the surgical table.

WARNING!

Always ensure that the AssistArm™ Surgical Positioner is installed on the rail of the surgical table by confirming the absence of backlash at the clamp. Validate that there is no backlash at the clamp by pulling and pushing on the lower ball joint in various directions parallel to the ground. Retighten the clamp’s handle if a backlash is observed and validate again the absence of backlash. Possible damage property A clamping handle inappropriately screwed could damage the AssistArm™ Surgical Positioner.

CAUTION!

Do not pull on hose. Make sure the angulation system’s handle is properly tightened before pursuing with the following steps.

The AssistArm™ Surgical Positioner must be installed prior to decontamination of the patient’s limb. NOTE • Remove the AssistArm™ Surgical Positioner’s pedal off the fixed segment of the device and place it on the ground. • Unscrew the clamp’s handle so that the clamp’s jaw provides sufficient clearance for the installation of the device on the rail of the surgical table. • Two methods can be used to install the AssistArm™ Surgical Positioner on the rail of the surgical table. The following two figures illustrate both methods.

Figure 2 – Installation of the AssistArm™ Surgical Positioner Using the First Method

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Figure 3 – Installation of AssistArm™ Surgical Positioner Using the Second Method

• Screw the clamp’s handle firmly.

Figure 4 – Tightening of the AssistArm™ Surgical Positioner Clamp Using the Clamp’s Handle

Figure 5 – Validation of the Absence of Backlash at the Clamp

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AssistArmTM Surgical Positioner • Unlock the AssistArm™ Surgical Positioner by pressing the actuating pedal’s lever and position the telescopic member parallel to the ground. Make sure you keep a safe clearance between the AssistArm™ Surgical Positioner and the floor when adjusting the height of the table.

Figure 6 – Positioning of the Telescopic Member for the Patient’s Limb Preparation

3.2.2

Installing the Drapes 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. Risk of contamination Contamination may occur by contact between the AssistArm™ Surgical Positioner with the patient’s drapes.

WARNING!

When installing the AssistArm™ Surgical Positioner’s drape, place the positioner to an elevation angle of about forty-five (45) degrees in full extension so that the upper ball joint is located as far as possible from the patient’s drape. Risk of contamination Contamination may occur by contact between the AssistArm™ Surgical Positioner with the medical staff.

WARNING!

When installing the AssistArm™ Surgical Positioner’s drape, position the AssistArm™ Surgical Positioner in order to avoid contact between the staff and the device.

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AssistArmTM Surgical Positioner 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.

• Cover the lower ball joint attached to the device with a waterproof fabric as shown in the following figure.

Figure 7 - Covering of the Lower Ball Joint Using a Waterproof Fabric

• Perform decontamination of the patient’s limb. • Install the patient’s sterile drapes. • Unlock the AssistArm™ Surgical Positioner using the pedal and position it as shown in the following figure.

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Figure 8 - Positioning the AssistArm™ Surgical Positioner to Install the AssistArm™ Surgical Positioner’s Drape

• Make sure that the risk of contact with staff is minimized by positioning the device as shown in the following figure.

Figure 9 - Orientation of the AssistArm™ Surgical Positioner Minimizing the Risk of Contact with Staff

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3.3.

Use of the Device Risk of contamination Contamination may occur due to contact of the AssistArm™ Surgical Positioner with a contaminant.

WARNING!

Handling the AssistArm™ Surgical Positioner during surgery should be performed in a sterile environment. Risk of injury Injuries may occur when the AssistArm™ Surgical Positioner is unlocked.

CAUTION!

Always grasp the patient's limb BEFORE pressing the actuating lever of the pedal.

Risk of injury Injuries may occur when the AssistArm™ Surgical Positioner is unlocked. CAUTION!

Always ensure that the AssistArm™ Surgical Positioner is fully locked before releasing the patient's limb. Risk of injury Injuries may occur when the user positions the limb while manipulating directly the AssistArm™ connection accessory.

CAUTION!

Avoid grasping the AssistArm™ connection accessory to perform positioning. Rather grasp the patient's limb. The desired position may be unreachable by the AssistArm™ Surgical Positioner.

NOTE

It is possible to temporarily disconnect the AssistArm™ surgery accessory from the AssistArm™ connection accessory during the surgery. To do so, grasp the patient’s limb, push the connecting device’s upper lock and lift the patient's limb to disengage the AssistArm™ coupling of the surgery accessory from the connection accessory. When attaching the surgery accessory to the connection accessory, validate the mechanical link by pulling and pushing in the same direction as the AssistArm™ coupling of the AssistArm™ Surgical Positioner.

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3.4.

Removing the AssistArm™ Surgical Positioner

• Remove the AssistArm™ Surgical Positioner from surgical table’s rail by unscrewing the clamp’s handle.

4. Cleaning and Decontamination 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 following an improper disinfection of AssistArm™ products. WARNING!

Carefully follow the instructions of use of the detergents and disinfectants used in cleaning and decontamination of AssistArm™ products. Risk of contamination Contamination may occur by improper cleaning of AssistArm™ products.

WARNING!

Before disinfecting products, thoroughly clean them with an all-purpose detergent and dry.

Risk of contamination Contamination may occur through contamination of an AssistArm™ product’s user. WARNING!

The products may be contaminated. Always wear gloves when cleaning and decontaminating AssistArm™ products. Possible property damage The AssistArm™ Surgical Positioner can be damaged if liquid or solid contaminants remain present inside mechanisms.

CAUTION!

Improper cleaning and bad disinfection of AssistArm™ products may cause a malfunction of the products. Always follow the procedures on the following pages when cleaning and disinfecting AssistArm™ products.

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4.2

Cleaning

CAUTION!

Possible property damage Some chemicals can damage the AssistArm™ Surgical Positioner. Do not use the following chemicals for cleaning and disinfecting the AssistArm™ Surgical Positioner or any other product having a pH greater than 7: • Acetone; • Products containing alcohol; • Perchloroethylene; • Halides. All external surfaces of the AssistArm™ Surgical Positioner including the hydraulic hose, the pedal, the lower segment of the telescopic member and spherical parts of spherical joints must be cleaned and rinsed after each use. Unlock the AssistArm™ Surgical Positioner using the pedal to clean and disinfect the spherical parts of spherical joints and the lower segment of the telescopic member.

NOTE

The AssistArm™ Surgical Positioner shall in no case be automatically cleaned (washer/disinfector, ultrasonic bath) or sterilized. NOTE • Fully extend the telescopic member of the AssistArm™ Surgical Positioner. Using a cloth and an all-purpose cleaner, clean every outer surface of the AssistArm™ Surgical Positioner. Use enough detergent to remove all traces of dirt on the device. • Rinse with a clean damp cloth and rinse off all external surfaces of the machine and the spherical parts of the ball joints to remove any detergent residue.

4.3

Disinfection Possible property damage Some chemicals can damage the AssistArm™ Surgical Positioner. Use only one of these solutions as a disinfectant and ensure they have a pH less than or equal to 7:

CAUTION!

• • •

Aldehydes; Quaternary ammonium compounds; Guanidine derivatives.

All external surfaces of the AssistArm™ Surgical Positioner including the hydraulic hose, pedal, the lower segment of the telescopic member and the spherical parts of the ball joints must be disinfected after each use. NOTE

Unlock the AssistArm™ Surgical Positioner using the pedal to clean and disinfect the spherical parts of the ball joints and the lower segment of the telescopic member.

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