ConMed Corp
ConMed AssistArm Surgical Positioning System
AssistArm Connector AA-CON250 Instructions for Use April 2022
Instructions for Use
439 Pages
Preview
Page 1
AssistArm™ Connector
AssistArm™ Connector (AA-CON250)
© CONMED Corporation. 2022
021-401-1001 AB 04/2022
AssistArm™ Connector
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© CONMED Corporation. 2022
021-401-1001 AB 04/2022
AssistArm™ Connector
AssistArm™ Connector (AA-CON250)
Reference Documents for Joint Use Item Number
Device Name
Document
n/a
n/a
Instructions for Cleaning, Inspection and Sterilization
AA-PSN100
AssistArm™ Surgical Positioner
AssistArm™ Surgical Positioner Instructions for Use
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AssistArm™ Connector
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™ Connector...5 1.2.1. Schematic presentation of the AssistArm™ Surgical Positioner Drape...6 1.3. Preliminary Safety Notice...6 2. General Warnings...6 3. Using the Device...8 3.1. At all times...8 3.2. Installing the Device...9 3.2.1. Installing the AssistArm™ Connector and the Drape... 12 3.3. Removing the AssistArm™ Connector ... 15 4. Cleaning and Sterilization... 15 4.1. General... 15 4.2. Cleaning...16 4.3. Sterilization... 16 5. Storage... 16 6. Inspection... 17
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AssistArm™ Connector
1. Introduction
This Instruction for Use aims at familiarizing the user with the AssistArm™ Connector. 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 AssistArm™ Connector is designed to be used in conjunction with the AssistArm™ Surgical Positioner, some AssistArm™ accessories and the AssistArm™ Surgical Positioner Drape found in all sterile disposable kits required for the use of the different AssistArm™ accessories. The user must: z
ead carefully all of the contents presented in this Instruction for Use before using the R AssistArm™ Connector.
z
lways follow the instructions in this Instruction for Use when the AssistArm™ Connector is A handled.
z
Store 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.
!
This symbol alerts the user to exercise special care necessary for the safe and effective use of the device.
WARNING!
CAUTION!
This notice provides guidance on the use of the AssistArm™ Connector. NOTE
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AssistArm™ Connector 1.1.2. Symbols Used The following table shows the meaning of various symbols found on the AssistArm™ Connector and its literature.
Symbol
Example usage
Definition This symbol invites the reader to consult the documentation for all information necessary for correct use of the device.
! REF SN
This symbol invites the reader to read the accompanying documentation for any important information related to security, such as warnings and precautions, which cannot, for whatever reasons, be included on the device itself.
! REF
AA-CON250
SN 0003
This symbol indicates the catalog number of the device. This symbol indicates the serial number of the device
This symbol indicates that the device has not been sterilized
C ONMED 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.
EC REP
© CONMED Corporation. 2022
EC REP MDSS GmbH Schiffgraben 41 D-30175 Hannover, Germany
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This symbol identifies the Authorized Representative in the European Community.
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AssistArm™ Connector
1.2. Schematic presentation of the AssistArm™ Connector
1
2
3
4
Figure 1 - Overview of the AssistArm™ Connector Table 1 - Components of the AssistArm™ Connector
# 1
2
3
4
NAME Connector’s Body 021-100-1001 Lock (2x) 021-100-1003 Spring (2x) SPR-COM-1002 Button (2x) 021-100-1002
© CONMED Corporation. 2022
DESCRIPTION The Connector’s Body links various devices mechanically while assuring a sterile barrier using the AssistArm™ Surgical Positioner Drape.
When pressed, the Lock releases the connection peg of the AssistArm™ Surgical Positioner or the AssistArm™ accessory used.
The spring maintains tension in the Lock when an accessory is connected.
The button maintains the Lock and the Spring in position in the AssistArm™ Connector.
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AssistArm™ Connector 1.2.1. Schematic presentation of the AssistArm™ Surgical Positioner Drape
AssistArm™ Surgical Positioner’s Drape
Figure 2 - Overview of the AssistArm™ Surgical Positioner Drape
1.3. Preliminary Safety Notice The AssistArm™ Connector is designed to be used in conjunction with the AssistArm™ Surgical Positioner and some AssistArm™ accessories. Please refer to the device’s Instruction for Use before use. The AssistArm™ Connector should only be used during surgical procedures performed on humans. The installation of the AssistArm™ Connector on the AssistArm™ Surgical Positioner, as well as 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 Instructions for Use for the different devices.
2. General Warnings
!
WARNING!
!
WARNING!
Risk of allergic reaction 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. Always perform cleaning and sterilization according to the AssistArm™ Connector’s Instructions for Cleaning, Inspection and Sterilization. Do not use the device if such methods have not been applied.
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AssistArm™ Connector Risk of injury A broken device or a device with missing parts may cause injury. Before each use, inspect:
!
CAUTION!
●
he AssistArm™ Connector according to Section 6 of this Instruction for T Use;
●
The surgery table as described by the manufacturer;
●
he AssistArm™ Surgical Positioner as described in the Instruction for T 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. Risk of contamination
!
WARNING!
!
WARNING!
!
CAUTION!
The use of inadequate single use product can lead to contamination of the patient. The AssistArm™ Connector should be used only with AssistArm™ 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. The AssistArm™ Connector should be used only with AssistArm™ products and single use products specifically designed by CONMED Corporation to fit this accessory.
Risk of injury Immediate use after sterilization may cause burns. Ensure that the device is at room temperature before handling to avoid burns.
Risk of injury
!
WARNING!
Equipment may break under excessive load and result in attached limb dropping. Use the AssistArm™ Connector in combination with the AssistArm™ Surgical Positioner only with patients weighting less than 180 kg (400lb) unless the manufacturer of the surgical table stipulates a lower mass. In this case, use the AssistArm™ Connector and AssistArm™ Surgical Positioner only with patients weighing less than the indication of expected mass limit for the surgery table.
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AssistArm™ Connector
3. Using the Device 3.1. At all times
Risk of injury
!
WARNING!
Inadequate handling of the device may cause the fall of the operated limb and patient injury. When handling the AssistArm™ Connector, 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 AssistArm™ Surgical Positioner to fall on the ground. Always be sure to handle the device as prescribed. Risk of injury
!
WARNING!
!
CAUTION!
!
WARNING!
Injuries can occur when the AssistArm™ Surgical Positioner is unlocked. Always make sure that a person maintains the patient’s limb attached to the AssistArm™ Arm Support before pressing the actuating lever of the pedal of the AssistArm™ 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. Always ensure the proper functioning of the AssistArm™ Connector before use. Refer to inspection guide presented in Section 6 of this Instruction for Use. Risk of contamination Contamination may occur if the AssistArm™ Surgical Positioner Drape is not installed on the AssistArm™ Surgical Positioner. Always use an AssistArm™ Surgical Positioner Drape while using the AssistArm™ Surgical Positioner. Risk of property damage
!
CAUTION!
Inadequate handling of the device may cause it to fall on the ground resulting in property damage. When handling the AssistArm™ Connector, 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 AssistArm™ Surgical Positioner on the ground. Always be sure to handle the device as prescribed.
!
CAUTION!
Risk of property damage Applying too much load on the AssistArm™ Connector can damage it. Use the AssistArm™ Connector in combination with the AssistArm™ Surgical Positioner only with patients with a mass less than 180 kg (400 lb).
© CONMED Corporation. 2022
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AssistArm™ Connector
3.2. Installing the Device Risk of contamination
!
WARNING!
!
CAUTION!
Inadequate cleaning or sterilization of the AssistArm™ Connector can lead to contamination of the patient. 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 AssistArm™ Connector on the AssistArm™ Surgical Positioner can damage it. Always make sure that the AssistArm™ Connector is connected to the AssistArm™ Surgical Positioner as prescribed in this Instruction for Use. Risk of injury
!
WARNING!
Inadequate connection of the AssistArm™ Connector and any other device used jointly. Always ensure that the connection between all devices is done correctly and that they are securely attached to each other. This concerns the connection between the AssistArm™ Connector and the AssistArm™ Surgical Positioner and the connection between the AssistArm™ Connector and any other surgical device used.
!
Risk of injury
!
Risk of contamination
CAUTION!
WARNING!
NOTE
Prior to installing connector test knobs to ensure they are adequately tightened.
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 AssistArm™ Surgical Positioner must be installed prior to decontamination of the upper limb of the patient. Refer to the Instruction for Use: AssistArm™ Surgical Positioner Instruction for Use to ensure that the device is installed as prescribed.
Install the AssistArm™ Surgical Positioner as prescribed in its Instruction for Use or in the AssistArm™ surgery accessory’s Instruction for Use. NOTE
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AssistArm™ Connector
NOTE
Make sure you have installed the AssistArm™ Surgical Positioner’s drape supplied in the sterile kit of the accessory as prescribed in the Instruction for Use of the AssistArm™ Surgical Positioner or the AssistArm™ Connector. The AssistArm™ Connector’s locking system will be inaccessible once the sterile drape is installed.
NOTE
Validate the functioning of the AssistArm™ Connector’s locking systems using the surgery accessory before installing the AssistArm™ Surgical Positioner’s drape. In case of malfunction of either one of the systems, remove the lock from the connector’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. An optimal coupling of the AssistArm™ Surgical Positioner’s drape on the AssistArm™ Connector makes the tape’s installation easier.
NOTE
It is not recommended to enlarge the drape’s hole with anything else than the connector itself to avoid overstretching or drape’s damage. Separating the tape from the protective film can be tricky.
NOTE
Use both rubber bands to facilitate separation of the adhesive tape from its protective film.
The buttons on the connector must remain accessible during surgery. Do not cover the upper buttons on the connector with the tape. NOTE
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AssistArm™ Connector z
npack the AssistArm™ surgical positioner’s drape supplied in the sterile kit of the surgery U accessory.
z
Remove the triangular tip of the drape by tearing it at the perforation.
z
Insert the AssistArm™ Connector into the small hole of the drape created by the tear as shown in the following figure. Stop the insertion of the AssistArm™ Connector as the drape is between the two buttons of the connector.
Figure 3 - Insertion of the AssistArm™ Connector in the AssistArm Surgical Positioner’s Drape
z
Remove and reserve the two rubber bands provided with the sterile drape.
z
Continue coupling the drape to the AssistArm™ Connector using the adhesive tape.
z
e sure to unfold the end of the AssistArm™ Surgical Positioner’s Drape on which are written the B 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 infection of the rest of the drape.
Figure 4 - Coupling of the Sterile Drape on the AssistArm™ Connector
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AssistArm™ Connector 3.2.1. Installing the AssistArm™ Connector and the Drape
!
WARNING!
!
WARNING!
!
WARNING!
!
WARNING! z
Risk of contamination Contamination may occur due to contact of the AssistArm™ Surgical Positioner with a contaminant. Handling the AssistArm™ Surgical Positioner during surgery should be performed in a sterile environment. Risk of contamination Contamination may occur by contact between the AssistArm™ Connector or the AssistArm™ Surgical Positioner’s drape with a contaminant. The installation of the AssistArm™ Connector and the AssistArm™ Surgical Positioner’s drape must be performed in a 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. 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 injury Injuries may occur by a bad connection of the AssistArm™ Connector to the AssistArm™ Surgical Positioner. Make sure the AssistArm™ Connector is attached to the AssistArm™ coupling by pulling and pushing in the same direction as the AssistArm™ coupling.
ttach the AssistArm™ Connector to the AssistArm™ coupling of the AssistArm™ Surgical A Positioner.
Figure 5- Attachment of the Connector to the AssistArm™ coupling of the AssistArm™ Surgical Positioner
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AssistArm™ Connector
Figure 6 - Validation of the Mechanical Link between the AssistArm™ Connector and the AssistArm™ Surgical Positioner
z
ull the AssistArm™ Surgical Positioner’s Drape along its telescopic member. Stop at the border P of the sterile environment
Figure 7 - Deployment of the AssistArm Surgical Positioner’s Drape
z
sk for the help of a circulating nurse in order to complete the deployment of the AssistArm™ A Surgical Positioner’s Drape to the bottom of the telescopic member.
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AssistArm™ Connector z
ake sure that the circulating nurse manipulates the external end of the AssistArm™ Surgical M Positioner’s Drape and keeps a suitable distance from the part of the drape still folded to avoid any risk of infection as shown in Figure 8.
Figura 8 - Handling the End of the AssistArm Surgical Positioner’s Drape by a Circulating Nurse
z
ontinue deploying the AssistArm™ Surgical Positioner’s Drape by covering the AssistArm™ C Surgical Positioner’s lower ball joint and the bottom of the fixed segment of the positioner as shown in Figure 9.
z
ake the rubber bands reserved earlier, double them and install the first one at the bottom of the T black ring at the upper end of the telescopic member of the AssistArm™ Surgical Positioner and install the second one at the point indicated in Figure 9.
Figure 9 - Installation of the AssistArm™ Surgical Positioner’s Drape
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AssistArm™ Connector
3.3. Removing the AssistArm™ Connector z
Remove the AssistArm™ Surgical Positioner’s Drape from the AssistArm™ Surgical Positioner.
z
emove the AssistArm™ Connector from the AssistArm™ Surgical Positioner by pressing the R connector’s lower lock and withdrawing the connector from the coupling of 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.
!
WARNING!
!
WARNING!
!
WARNING!
Risk of contamination Contamination may occur following an improper disinfection of AssistArm™ products. Carefully follow the instructions of use of the detergents and disinfectants used in cleaning and sterilization of AssistArm™ products. Risk of contamination Infection may occur by improper cleaning of AssistArm™ products. Before disinfecting products, thoroughly clean them with an all-purpose detergent and dry. Risk of contamination Infection may occur through contamination of an AssistArm™ product’s user. The products may be contaminated. Always wear gloves when cleaning and decontaminating AssistArm™ products. Risk of contamination
!
WARNING!
Infection caused by the use of the AssistArm™ Connector in a non-sterile condition. Before first use and after each use, clean and sterilize the AssistArm™ Connector according to the procedures in the Instructions for Cleaning, Inspection and Sterilization. Possible property damage
!
CAUTION!
The AssistArm™ Connector can be damaged if liquid or solid contaminants remain present inside mechanisms. Improper cleaning and disinfection of AssistArm™ products may cause product malfunction. Always follow the procedures in the Instructions for Cleaning, Inspection and Sterilization when cleaning and disinfecting AssistArm™ products.
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AssistArm™ Connector
4.2. Cleaning The AssistArm™ Connector must be cleaned according to the procedure provided for this purpose. Refer to the AssistArm™ Connector’s cleaning procedure presented in the Instructions for Cleaning, Inspection and Sterilization.
4.3. Sterilization The AssistArm™ Connector must be sterilized according to the procedure provided for this purpose. Refer to the procedure for sterilizing the connector shown in the Instructions for Cleaning, Inspection and 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.
5. Storage
!
CAUTION!
Possible property damage The AssistArm™ products can be damaged if liquid or solid contaminants remain present inside mechanisms. Ensure that AssistArm™ products are dry and detergents or disinfectants residue-free.
© CONMED Corporation. 2022
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AssistArm™ Connector
6. Inspection
!
CAUTION!
Risk of injury Equipment in poor condition can cause injury. Do not use an AssistArm™ product if it is damaged. Do not attempt to repair it. Contact your CONMED Corporation representative if you doubt the integrity of an AssistArm™ product
Do not use the AssistArm™ Connector if one of the following observations is made: z
One or more parts are damaged, distorted or missing;
z
Residues are present inside the connector’s body;
z
Residues are present within one of the locks;
z
Screwing a button in the connector’s body is difficult or impossible.
Do not use the AssistArm™ Sterile Kit accessories if one of the following observations is made: z
The sterile accessory is past its expiration date;
z
The sterile accessory is damaged or torn;
z
Sterile packaging is damaged or compromised.
CONMED Corporation 525 French Road, Utica, NY 13502-5994 USA Customer Service: 1-866-426-6633 USA FAX: (727) 399-5256 International FAX: +1(727) 397-4540 email: [email protected] www.conmed.com
© CONMED Corporation. 2022
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EC REP MDSS GmbH Schiffgraben 41 D-30175 Hannover, Germany
021-401-1001 AB 04/2022