TECHNIMOUNT EMS Bracket Pro Series 77-FL User manual

BRACKET PRO SERIE® 77 - FL

USER MANUAL

EMS®

SAFETY AND FLEXIBILITY

WHERE IT MATTERS MOST

BRACKET PRO SERIE®77 - FL

User Manual

EMS

Copyrights

retrieval system, translated in any language, modified in any form or by any means, without the written permission

of Technimount EMS or its affiliate companies.

Trademarks

Product and medical device manufacturer names are Trademarks™ or Registered Trademarks®of their respective

holders.

-Technimount EMS®and Bracket Pro Serie®are registered trademarks of Technologies CGC Inc.

-Laerdal Compact Suction Unit®is a registered trademark of Laerdal Medical Corporation.

For any issues with your Technimount product, its components, or for any technical questions during the

installation, operation, or maintenance, please contact Technical Support at [email protected].

Contact Information

Technimount E.M.S. Holding Inc.

C/O: Regulatory Affairs

3770 Jean Marchand Street, Suite 100-C

Quebec (QC) G2C 1Y6

Canada

[email protected]

www.technimount.com

T + 1 581.700.6613

TF + 1 888.639.2758 (North America)

BRACKET PRO SERIE®77 - FL

User Manual

EMS

Table of Contents

Copyrights .......................................................................................................................................................... ii

Trademarks ........................................................................................................................................................ ii

Contact Information ........................................................................................................................................... ii

1. General Mentions and Considerations ........................................................................................................... 4

........ 1.1. Intended Use.................................................................................................................................................................4

........ 1.2. User Competency ........................................................................................................................................................4

........ 1.3. Warranties .....................................................................................................................................................................4

................. 1.3.1. Warranty Policy ................................................................................................................................................4

................. 1.3.2. Limited Warranty .............................................................................................................................................5

................. 1.3.3. International Warranty Clause.......................................................................................................................5

................. 1.3.4. User Liability .....................................................................................................................................................5

........ 1.4. Claims ...........................................................................................................................................................................5

................. 1.4.1. Damaged or Defective Merchandise ...........................................................................................................5

................. 1.4.2. Return Policy.....................................................................................................................................................6

................. 1.4.3. Return of Material Authorization (RMA)......................................................................................................6

................. 1.4.4. Claim Process...................................................................................................................................................6

2. General Safety Guidelines .............................................................................................................................. 7

........ 2.1. Symbols and Definitions ............................................................................................................................................7

........ 2.2. Labels.............................................................................................................................................................................8

........ 2.3. Safety Measures ..........................................................................................................................................................9

3. Technical Specifications ................................................................................................................................ 10

4. Unpack the Mounting System ........................................................................................................................ 11

5. Bracket Pro Serie 77 - FL Illustrated Parts..................................................................................................... 12

6. Install the Laerdal Compact Suction Unit 4 in the Bracket Pro Serie 77 - FL................................................. 13

........ 6.1. Required Parts..............................................................................................................................................................13

........ 6.2. Required Tools..............................................................................................................................................................13

........ 6.3. Install the Suction Unit in the Bracket Pro Serie 77 - FL......................................................................................13

7. Maintenance................................................................................................................................................... 15

........ 7.1. Required Tools..............................................................................................................................................................16

........ 7.2. Condition-Based Maintenance Plan ........................................................................................................................16

8. Spare Parts..................................................................................................................................................... 18

BRACKET PRO SERIE®77 - FL

User Manual

EMS

1. General Mentions and Considerations

Intended for the purchaser/supervisor, this user manual contains detailed product information and was designed

to assist with the unpacking, assembling (when indicated), and maintenance of the Bracket Pro Serie 77 - FL

mounting system. Its content should be relayed to EMS personnel during training. This document should be used

with the operating guide, which contains specific user-related information such as the operating procedures and

the daily safety checks.

NOTE: Technimount continually seeks advancements in product design and quality. While this user

manual contains the most updated product information available at the time of printing, it

may contain minor differences from the current version. For more information, please contact

Customer Service at [email protected].

1.1. Intended Use

The mounting system is designed to secure the Laerdal Compact Suction Unit 4 with 300 ml disposable canister

and tubing during air or ground EMS and critical care transport.

1.2. User Competency

The Bracket Pro Serie 77 - FL is intended for EMS personnel who have received the proper training, necessary to

operate the device in the field, according to its intended use, as outlined in this user manual and operating guide.

Please read all provided documentation thoroughly before using this device to ensure the safe operation of this

device and provide a safe environment for patients and EMS personnel.

1.3. Warranties

1.3.1. Warranty Policy

This statement constitutes Technimount’s entire warranty policy with regards to Technimount products.

Technimount makes no other warranty or representation, neither expressed nor implied, except as stated herein.

There is no warranty of merchantability or warranty of fitness for any particular purpose. Under no circumstances

will Technimount be held liable hereunder for incidental or consequential damages, arising from or in any manner,

related to sales or use of any such device.

Technimount E.M.S. Holding Inc. (Technimount) guarantees to the original "Purchaser" of the "Product" with which

this "Limited warranty" is included, that the product will be free from "Defects" in workmanship and materials under

normal use for a "Warranty period" of one (1) year from the product purchase date by the purchaser. During the

warranty period, the product will be repaired or replaced according to the "Limited warranty" without charge to the

purchaser for parts or labor. The parts and product may be repaired or replaced with new or refurbished parts or

products. Herein this Limited Warranty, "Refurbished" means parts and products which have been returned to the

factory, specifically. If the product is repaired or replaced within the warranty period, the greater of the remaining

warranty period will apply, or three (3) months from the date of repair or replacement. If the product is repaired or

replaced after the warranty period has expired, the warranty period for the repair or replacement will expire three (3)

months after the repair or replacement date.

BRACKET PRO SERIE®77 - FL

User Manual

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1.3.2. Limited Warranty

Technimount products are intended to retain medical devices in place in the case of a single crash impact.

Technimount products must not be reused if involved in a crash and must thereafter be replaced. If the end user

uses a Technimount product following a crash, it is at the end user’s own risk. Technimount will not be held liable.

The limited warranty does not apply to normal wear that could result from normal use. It does not apply when

the product or any of its components have been disassembled or repaired by someone not authorized by

"Technimount". It does not cover repair or the replacement of any product or part thereof damaged by neglect,

misuse, moisture, liquids, exposure to heat, accidents, abuse, and non-compliance with the instructions for

installation and use provided with the product.

The limited warranty does not cover physical damage to the surface of the product. The decision to repair, replace

or refuse the coverage is final and at the sole discretion of Technimount, without any compensation or obligation

from Technimount. The product defined as a "Mounting system", "Mounting solution" or "Bracket" used to attach

and secure the medical devices, is specifically designed to fulfill this requirement. Any other use will void the

warranty and Technimount shall not be held liable on any claim if the product has been modified or adapted for

use.

1.3.3. International Warranty Clause

This warranty abides by the Canadian domestic policy. Warranty outside Canada may vary by country. Please

contact Customer Service at [email protected] for more information.

1.3.4. User Liability

The purchaser and administrator are responsible to validate regulations and standards for safety in their region,

to comply with applicable safety regulations. Technimount is not responsible to inform the purchaser or the

administrator of any applicable legislation for safety in their area.

The administrator is responsible for providing proper training to any personnel who will install, operate and perform

maintenance on Technimount products.

1.4. Claims

1.4.1. Damaged or Defective Merchandise

ICC Regulations require that claims for damaged merchandise must be made with the carrier within fifteen (15)

days of the reception date. Do not accept damaged merchandise unless such damage is noted on the delivery

receipt at the time of reception. Upon prompt notification, Technimount will file a freight claim with the appropriate

carrier for damages incurred. Claims are limited in amount to the actual replacement cost. If the claim has not

been received by Technimount within the fifteen (15) day period following the date of delivery, or the damage was

not noted on the delivery receipt at the time of receipt, the customer will be responsible for the full payment of the

original invoice.

Claims for any short or broken merchandise must be made within thirty (30) days of invoicing. For details, refer to

the claim process or contact Customer Service at [email protected].

BRACKET PRO SERIE®77 - FL

User Manual

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1.4.2. Return Policy

Technimount’s mounting and bracket systems for portable medical device may be returned up to sixty (60) days

from the reception date, if:

-The received product does not match what was originally ordered.

-The product does not meet the Technimount technical sheet specifications.

-The product is not compatible with the device on which it was intended to be installed onto.

To return a Technimount product,

-A Return of Merchandise Authorized (RMA) must be requested and approved by Technimount prior to

returning the product.

-Products must be returned undamaged and in its original packaging, appropriately identified with the

approved RMA number. Returns will not be approved on a modified or damaged item.

-Charges may apply if the package received is damaged or items are missing.

-Purchaser is responsible for a restocking fee (refer to Table 1).

Table 1: Restocking fees

RESTOCKING FEES

Prior to thirty (30) days 10%

Prior to forty-five (45) days 25%

Prior to sixty (60) days 30%

For any manufacturing defect, refer to the conditions within the warranty policy or contact Customer Service at

[email protected] for additional information.

1.4.3. Return of Material Authorization (RMA)

The Technimount Customer Service department is responsible for all merchandise returns and will provide a Return

of Merchandise Authorization (RMA) number, upon approval. The RMA must be printed and placed on the returned

merchandise. Technimount reserves the right to charge shipping and restocking fees (refer to Table 1) for the

returned items. Special, modified, or discontinued items are not subject to returns.

1.4.4. Claim Process

Upon reception of the returned merchandise, a thorough inspection will be performed. If the merchandise is

compliant with the return policy or it is found that the product is defective, Technimount will take corrective

actions and close the claim. If, however, it is found that the product is not defective, but rather misused or abused,

the product will not be covered by the warranty. Details of our findings and conclusions will be provided shortly

thereafter. To submit a claim, contact Customer Service at customerser[email protected] to obtain a Return

of Material Authorization (RMA) form and return instructions.

BRACKET PRO SERIE®77 - FL

User Manual

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2. General Safety Guidelines

Pictograms, safety symbols and labels are used to alert the user to a potentially hazardous situation, which, if

not avoided, may result in minor or moderate injury to the user or patient or cause damage to the device or other

property. This includes the special care necessary for the safe and effective use of the device to avoid damage that

may occur from use or misuse. The terms "Warning" and "Caution" herein carry special meaning and should be

carefully reviewed.

WARNING -Indicates a hazardous situation that, if not avoided, could result in death or serious injury.

CAUTION -Indicates a hazardous situation that, if not avoided, could result in minor or moderate injury.

Always read and abide by all the safety guidelines identified within this document.

2.1. Symbols and Definitions

WARNING -General Warning

Alerts the reader of a potentially hazardous situation, which, if not avoided, may result in death or

serious injury to the user or patient or cause damage to the device or other property. This includes the

special care necessary for the safe and effective use of the device to avoid damage that may occur

from use or misuse.

CAUTION -Safe Working Load/Load Balance

Indicates the total maximum charge for a safe use of device.

CAUTION -General Mandatory Action

Call for action. Alerts the reader to potential risk to people not following the mandatory action

specified by the supplementary sign.

CAUTION -Follow Instructions for Use

Call for action. Reminds the reader to consult the user manual for information.

BRACKET PRO SERIE®77 - FL

User Manual

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2.2. Labels

Labelling on the surface of the Technimount product, quickly identify potential risks, contains the serial number and

provides information to the user. A manufacturing label, including the serial number (Figure 1), can be seen on the

Technimount product

1. Manufacturing label

Figure 1: Location of the manufacturing label (back of bracket shown)

BRACKET PRO SERIE®77 - FL

User Manual

EMS

2.3. Safety Measures

Carefully read all safety measures herein before installing, operating, or performing the maintenance of the

Technimount product.

WARNING -Risk of Injury

Regulations and standards for safety are the sole responsibility of the end user. Ensure that the

installation specifications meet the local and regional compliance requirements before use. Product

incompatibility could cause unpredictable functioning resulting in injury to the patients or EMS

personnel.

CAUTION -Safe Handling and Operation

-The Bracket Pro Serie 77 - FL is intended for Laerdal Compact Suction Unit 4 with 300 ml

disposable canister and tubing. For a mounting system for a suction unit with a 800 ml disposable

canister, please contact Customer Service at [email protected].

-Do not modify the product, or any of its components and use only as described in this user

manual. Modifying the product or improper use could cause unpredictable functioning, resulting in

injury to the patients or EMS personnel.

-The administrator is responsible for providing proper training to any personnel who will install,

operate, and perform maintenance on Technimount products.

-Improper use of the Technimount product may damage the device or cause injury to the patients

or EMS personnel.

CAUTION -Safe Practice

-Follow the recommended maintenance plan and its guidelines, as described in the user manual

and operating guide.

-Always ensure that the medical device is secured in the bracket with all four (4) screws before use,

to prevent it from falling from the mounting system.

-Always keep the user manual and operating guide within reach of the product, even if the device

is subsequently sold, to prevent undue risk to the device, patients, and EMS personnel. The user

documentation is an integral part of the device.

-Practice installing, removing, and safely operating the medical device until the manipulations have

been perfected, before use with patients. Improper use of any Technimount product may damage

the device or cause injury to the patients or EMS personnel.

-If any serious incident occurs with the mounting solution, immediately stop using the product, and

report this incident to Technical Support at technicalsuppor[email protected] and the applicable

regulatory agency.

CAUTION -Working Load/Load Balance

The Safe Working Load (SWL) is 4.1 lb (1.86 kg). Do not overload the system.

CAUTION -Follow Instructions for Use

-Always read and abide by all the safety guidelines identified, as well as follow instructions provided

within this document.

-Refer to the manufacturer’s user manual for safety precautions and user instructions for the safe

use of the Laerdal Compact Suction Unit 4 with 300 ml disposable canister and tubing.

BRACKET PRO SERIE®77 - FL

User Manual

EMS

3. Technical Specifications

Product Name Bracket Pro Serie®77 - FL

Description

Mounting system is designed to secure the Laerdal Compact Suction Unit®4

with 300 ml disposable canister and tubing during air or ground EMS and critical

care transport

Part Number 770-11-LASP-FL

Features -Access to the medical device's LED display, connectors, etc.

-Protective rubber cushions inside the bracket

Operating Environment EMS/CCT (Air and ground)

Compliance -Tested in compliance with FAA, 14 CFR § 23 & 27 (applicable sections)

-Tested in compliance with SAE J3043 and AMD-028

Compatible Mounting System Micro Base

Dimensions (W X D X H) 7.09 in. X 3.6 in. X 8.19 in. (18.01 cm X 9.14 cm X 20.80 cm)

Weight 1.5 lb (0.68 kg)

Composition

-Bracket: aluminum 6061-T6 with blue anodized finish

-Bottom micro disc: aluminum 6061-T6 with silver anodized finish

-Cushion: UL 94 HF-1 fire retardant EPDM closed cell foam

Safe Working Load (SWL) 4.1 lb (1.86 kg)

Operating Temperature - 31° F to 113° F (- 35° C to 45° C)

Installation Suction unit retained in mounting system by retaining frame and screws

Model & Configuration

Options

Contact Customer Service at [email protected]

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