FM-TCF-D001 Disposable Air Cushion Mask Version 3: 2010/05/30

Technical Construction File of

Disposable Air Cushion Mask
No.: FM-TCF-D001, version 3

According to the EC Medical Device Directive

(93/42/EEC as amended by 2007/47/EC)

Related to the

Disposable Aircushion Mask

Reviewed by

Kelvin Chang

Approved by

Tyson Hsu

Foremount Enterprise Co., Ltd

at
No. 17, Alley 15, Lane 5, Shenan Street, Shengang Hsiang,
Taichung, 42944 Taiwan ROC
FM-TCF-D001 Disposable Air Cushion Mask Version 3: 2010/05/30

TABLE OF CONTENTS

Part One : Introduction

1.1. Company introduction
1.2. Product series

Part Two : Production Description

2.1. Device Description
2.2. Device Specification
2.3. Intended Use and Classification.
2.4. Visual Appearance

Part Three. Design Master File

3.1. Design Description of the Product
3.2 BOM and Key Component & Material
3.3 Flow Chart Of Design And Production

Part Four. Labelling and Marking

4.1 Warning Signs.
4.2 Packing.
4.3 CE Marking, Labels.
4.4 Instruction for Use

Part Five. Declaration of conformity of Applicant Product.

5.1 EC Declaration of Conformity

ANNEX A QUALITY SYSTEM CERTIFICATE

FM-TCF-D001 Disposable Air Cushion Mask Version 3: 2010/05/30

PART ONE. INTRODUCTION

1.1. Company Introduction

1.2. Product Series

FM-TCF-D001 Disposable Air Cushion Mask Version 3: 2010/05/30

1.1. Company Introduction

1.1.1 Basic Information

Manufacturer: Foremount Enterprise Co. Ltd.

Add.: No. 17. Alley 15, Lane 5, Shenan Street, Shengang Hsiang, Taichung, 42944, Taiwan
Tel.: 886-4 25618788

Fax: 886-4 25618798

E-mail: sales@foremount.com

http: //www.foremount.com

1.1.2 Company Profile

Foremount Enterprise Co., Ltd., which began as a small-scale industry just a decade
ago in 1996 for the manufacture of medical supplies, is today one of the most sought after
brands across Taiwan and abroad, provides wide range of medical supplies as well as Original
Equipment Manufacturer (OEM) and Original Design Manufacturer (ODM) services.

Foremount specialized in manufacturing anesthetic and respiratory devices. Over a

decade, Foremount has been supplying a wide range of quality anesthetic and respiratory
products to our customers all over the world. As an OEM/ODM company, we support our
customers in transforming their ideas into reality by providing prompt, reliable and cost
effective solutions through every phase of design, tooling, prototype, manufacture and
packaging. It’s easy to do business with us, and we will provide the most competitive, high
quality and various products to our customer.

Each procedure is abided by the regulations, so we are proud and confident to supply
excellent products for customers. We have certificated with ISO13485/ CMDCAS/Taiwan
GMP.

1.2. Product series

The disposable air cushion mask series in this TCF includes the following products

Disposable (Classic) Cushion Mask

Size Shell Material Cushion Material Description Connector Hook Ring
0 PC/PVC PVC Neonatal 15M
1 PC/PVC PVC Infant 15M
2 PC/PVC PVC Pediatric 22F
3 PC/PVC PVC Small Adult 22F
FM-TCF-D001 Disposable Air Cushion Mask Version 3: 2010/05/30

4 PC/PVC PVC Medium Adult 22F

5 PC/PVC PVC Large Adult 22F
6 PC/PVC PVC Extra Large adult 22F

Disposable Elite Mask

Size Shell Material Cushion Material Description Connector Hook Ring

0 PVC PVC Neonatal 15M
1 PVC PVC Infant 15M
2 PVC PVC Pediatric 22F
3 PVC PVC Small Adult 22F
4 PVC PVC Medium Adult 22F
5 PVC PVC Large Adult 22F

Disposable Rotation Mask

Size Material Description Connector Hook Ring

0 PVC Neonatal 15M
1 PVC Infant 15M
2 PVC Pediatric 22F
3 PVC Small Adult 22F
4 PVC Medium Adult 22F
5 PVC Large Adult 22F
FM-TCF-D001 Disposable Air Cushion Mask Version 3: 2010/05/30

PART TWO. DEVICE DESCRIPTION

2.1. Device Description

2.2. Product Specification

2.3. Intended Use and Classification

2.4. Visual Appearance

FM-TCF-D001 Disposable Air Cushion Mask Version 3: 2010/05/30

2.1. Device description

The Disposable Air Cushion Mask is a device which made of plastic material like PVC,
PP or PC. It is covered over a patient’s nose and mouth to deliver anesthetic, oxygen gases or
aerosols to the upper airway and including an exhalation system.
The Disposable Air Cushion Mask is secured to patient’s head with silicone harness
which is fixed on a hood ring. A silicone harness is also available. It also provides options for
valved or non-valved.
In addition, the Disposable Air Cushion Mask is a device for restricted usage, such as in
clinics, hospitals, ambulance, and home-care, not used for leisure or sports purposes.

2.2 Product Specification

Disposable (Classic) Cushion Mask

Size Shell Material Cushion Material Description Connector Hook Ring

0 PC/PVC PVC Neonatal 15M
1 PC/PVC PVC Infant 15M
2 PC/PVC PVC Pediatric 22F
3 PC/PVC PVC Small Adult 22F
4 PC/PVC PVC Medium Adult 22F
5 PC/PVC PVC Large Adult 22F
6 PC/PVC PVC Extra Large adult 22F
Connector EN ISO standard 22ID/15OD, Luer 4.3F
Shelf Life 3 years
Optional With and without anti-magnetic valve

Option Harness
Size: Adult (L)/Child(M)
Material: Silicone (transparent green,
transparent white), Rubber (Black)
Option Hook Ring
size: Adult to Child
Material: PE
FM-TCF-D001 Disposable Air Cushion Mask Version 3: 2010/05/30

Disposable Elite Mask

Size Shell Material Cushion Material Description Connector Hook Ring

0 PVC PVC Neonatal 15M
1 PVC PVC Infant 15M
2 PVC PVC Pediatric 22F
3 PVC PVC Small Adult 22F
4 PVC PVC Medium Adult 22F
5 PVC PVC Large Adult 22F
Connector EN ISO standard 22ID/15OD, Luer 4.3F
Shelf Life 3 years
Option Harness
Size: Adult (L)/Child(M)
Material: Silicone (transparent green,
transparent white), Rubber (Black)
Option Hook Ring
size: Adult to Child
Material: PE
FM-TCF-D001 Disposable Air Cushion Mask Version 3: 2010/05/30

Disposable Rotation Mask

Size Material Description Standard Scent Connector Hook Ring

0 PVC Neonatal Cherry/ Strawberry 15M
1 PVC Infant Cherry/ Strawberry 15M
2 PVC Pediatric Cherry/ Strawberry 22F
3 PVC Small Adult Vanilla 22F
4 PVC Medium Adult Vanilla 22F
5 PVC Large Adult Vanilla 22F

Connector EN ISO standard 22ID/15OD, Luer 4.3F

Shelf Life 3 years
Option Harness
Size: Adult (L)/Child(M)
Material: Silicone (transparent green,
transparent white), Rubber (Black)
Option Hook Ring
size: Adult to Child
Material: PE
Option With/ without scent available, scent upon request
FM-TCF-D001 Disposable Air Cushion Mask Version 3: 2010/05/30

2.3 Intended use and classification

2.3.1 Intended Use

The Disposable Air Cushion Masks are placed over a patient’s nose and mouth to deliver
anesthetic, oxygen gases or aerosols from Anaesthesia machine (via the common gas outlet)
to the upper airway. They are intended for single use patient only to prevent cross-infection
between patients. The usage of transparent material assists medical personal to see through
mask to know conditions of patients.

Classification :
1.1. Rule 1

All non-invasive devices are in Class I, unless one of the rules set out hereinafter applies.

Yes, goes to Rule 2.

1.2. Rule 2
All non-invasive devices intended for channelling or storing blood, body liquids or tissues,
liquids or gases for the purpose of eventual infusion, administration or introduction into
the body are in Class IIa:

Yes, the air-cushion mask intended for channelling gases for the purpose of
introduction into body are Class IIa.

CONCLUSION: THE DEVICE IS CLASS IIa

Therefore, the air cushion mask is classified as class IIa device of CE classification.
Reference: MEDDEV 2.4/1 Rev. 9 June 2010. 4.2 GENERAL EXPLANATION OF
RULES/PRACTICAL ISSUES/EXAMPLES / Rule 2 Channelling or Storing for Eventual
Administration

2.4 Visual Appearance

Disposable (Classic) Cushion Disposable Elite Mask Disposable Rotation Mask

Mask
FM-TCF-D001 Disposable Air Cushion Mask Version 3: 2010/05/30
FM-TCF-D001 Disposable Air Cushion Mask Version 3: 2010/05/30

PART THREE. DESIGN MASTER FILE

3.1. Design Description of the Product

3.2. BOM and Key Component

3.3. Flow Chart of Disposable Air Cushion Mask Production

FM-TCF-D001 Disposable Air Cushion Mask Version 3: 2010/05/30

3.1. Design Description of the Product

We all know that before designing and mass production of a new product, calculating
some characteristics of the product is a very important factor for safety and development. As a
disposable medical device, all disposable air cushion masks are Economic streamline design
to save cost. We will show manufacturing processes for Foremount disposable air cushion
mask below. We purchase raw materials and parts from the qualified suppliers who
manufacture highly purified materials with Certification of analysis or MSDS.

Manufacture Disposable air cushion mask

All disposable air cushion masks are molded through injection, blowing or rotation by
qualified suppliers or in house and are manufactured in the controlled environment.

Incoming Quality Inspection (IQC)

The appearance of parts of aerosol mask such as bubbles, chip, break edge piece, and
cleanness is inspected by visual at IQC. The connection port is gauged, and mask size is
recognized by the marking on the mask at this stage.

Assembly
All types of Disposable Aircushion Masks are assembled by the SOP of Disponsable
Aircushion Masks assembly.

Labelling & Printing

Labelling is done by printing the data of Lot No., Exp. Date, Code No., and Size on the
labels. The Disposable Aircushion Masks are packed upon customer’s request or option, such
as PE bag or boxes.

Final Qualtiy Inspection

The procedure is conducted to do the final inspections of Disponsable Aircushion Masks
before storage or shipping to customers. The Q.C. technicians follow the sampling rules and
inspection checklist to verify the quality. The aerosol masks are only released to be stored or
delivered when all inspections are passed.

Shipping
FM-TCF-D001 Disposable Air Cushion Mask Version 3: 2010/05/30

We will prepare shipping procedures in accordance with the requirements of client’s

order including of labelling of shipping, package, and shipping document. Otherwise, we will
keep the signed shipping notice for 6-year.
FM-TCF-D001 Disposable Air Cushion Mask Version 3: 2010/05/30

3.2. BOM and Key Component

3.2.1 BOM & Key Components

Product Key Components

Disposable (Classic) Cushion Mask Top Shell : PVC/PC
Size: #0 #1 #2 #3 #4 # 5 #6 Air Cushion: PVC
Hook Ring:PE
Disposable Elite Mask Top Shell : PVC
Size: #0 #1 #2 #3 #4 # 5 Air Cushion: PVC
Hook Ring:PE
Disposable Rotation Mask Top shell : PVC
Size: #0 #1 #2 #3 #4 # 5 air cushion: PVC
Hook Ring:PE

3.2.2 Please find the attached folder of 3.2.2 MSDS.

3.3. Flow chart of Disposable Aircushion Mask design and production

3.3.1 Design Procedure of Air Cushion Mask

1. To define and clarify the demand of customer/user

2. To set up the design requirement and specification of air cushion mask
3. To determining the product concept and characteristics of air cushion mask
4. To generate the product concept of air cushion mask
5. To test the product concept of air cushion mask
6. To finialize the product specification of air cushion mask
7. To initial the plan of air cushion mask

Define and Understand the Think the Generate the Design and test
clarify Question question question concept

Step 2 Step 5
Step 1 Step 3 Step 4 Step 6 Step7
FM-TCF-D001 Disposable Air Cushion Mask Version 3: 2010/05/30

3.3.2 Design Flow Chart

Design Flow Chart of Air Cushion Mask

Feasibility Study

Review of
Feasibility Mass Production
Report

OK
OK

Review of
Design and NG Trail
Development Production

NG

Functional
Tests Trial Production

OK

3.3.3 Production Control Procedure of Air Cushion Mask

1 To arrange order (LOT)

2 To arrange component and raw material (Supplier Control)
3 To check and inspect components. (raw material/component IQC)
4 To arrange production (LOT Tracebility/ IPQC)
5 Packages- labeling and printing. (FQC/ LOT NO. /Product Name/Code/ Manufacturing
Date/ Expiration Date/ Instruction for Use)
6 To proceed shipment (OQC)
FM-TCF-D001 Disposable Air Cushion Mask Version 3: 2010/05/30

3.3.4 Product Flow Chart of air cushion mask

＜Flow chart of Air cushion Mask＞

Manufacturin
＜Sale＞ ＜Purchasing＞ ＜Warehouse＞ ＜Supplier＞ ＜QC＞
g

P∕O
Receive

Place
Inner Check
Order Stock
Place
Order for NG
Related
Parts
Produce
Parts
Related
IQC
Parts
Assembly
of masks
＆ parts

Package
of masks
＆ parts
Product
OQC

Shipping Stock
FM-TCF-D001 Disposable Air Cushion Mask Version 3: 2010/05/30

PART FOUR. LABELING AND MARKING

4.1. Warning Signs

4.2 Packing

4.3. CE Marking, Labels.

4.4 Instruction for Use

FM-TCF-D001 Disposable Air Cushion Mask Version 3: 2010/05/30

4.1 Warning Signs

 Exp. Date: 2011-11

 Caution

Manufacturing date Latex Free

 Single use

 Phthalate

4.2 Packing
The quantity in one carton will vary by different size or client’s request.

Product Name Packing Type Packing details

1. Classic air 1PCS in one packing.
1P
cushion mask
2. Classic air Will vary by different size or client’s request.
Vary
cushion mask
3. Disposable 1PCS in one packing.
1P
Elite Mask
4. Disposable Will vary by different size or client’s request.
Vary
Elite Mask
5. Disposable 1PCS in one packing.
1P
Rotation Mask
6. Disposable Will vary by different size or client’s request.
Vary
Rotation Mask
FM-TCF-D001 Disposable Air Cushion Mask Version 3: 2010/05/30

4.3 CE Marking, Labels.

0434

Disposable Aircushion Mask

Jetable Masque de Aircushion

Single package Label

0434 2010 2013

REF

Single use only! It may cause re and/or cross-infection if

reused.
Health Effects related to Phthalates: Organ system toxicity
(non-reproductive), Endocrine system, Reproduction and fertility, Birth or
developmental effects, Persistent and bioaccumulative, Brain and nervous
system, Immune system (including sensitization and allergies)

Foremount Enterprise Co., Ltd.

No. 17, Alley 15, Lane 5, Shenan Street, Shengang Hsiang,

Taichung, 42944 Taiwan
Wellkang Ltd
Suite B, 29 Harley Street LONDON W1G 9QR England,
United Kingdom

4.4 Instruction for Use

Please find the attached folder of 4.4 IFU.

FM-TCF-D001 Disposable Air Cushion Mask Version 3: 2010/05/30

PART FIVE. DECLARATION OF CONFORMITY OF

APPLICANT PRODUCT.

5.1 EC Declaration of Conformity.

FM-TCF-D001 Disposable Air Cushion Mask Version 3: 2010/05/30

5.1 EC Declaration of Conformity

Please kindly see the attached folder that is named 5.1 EC DOC.

ANNEX A QUALITY SYSTEM CERTIFICATE

Please kindly find the attached folder of ANNEX A QUALITY SYSTEM CERTIFICATE