FM-TCF-F001 Manual Resuscitator Version 3: 2010/05/30

Technical Construction File of

Manual Resuscitator
Document No.: FM-TCF-F001, version 3

According to the EC Medical Device Directive

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

Related to the

Manual Resuscitator

Reviewed by

Kelvin Chang

Approved by

Tyson Hsu

Foremount Enterprise Co., Ltd

No. 17, Alley 15, Lane 5, Shenan Street,
Shengang Hsiang, Taichung, Taiwan R.O.C.
FM-TCF-F001 Manual Resuscitator 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-F001 Manual Resuscitator Version 3: 2010/05/30

PART ONE. INTRODUCTION

1.1. Company Introduction

1.2. Product Series

FM-TCF-F001 Manual Resuscitator 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: [email protected]

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 manual resucitator in this TCF includes the following products

Disposable Manual Resuscitator

Resuscitator Volume Material
Size Adult Small Adult Child Infant
Bag 1700+ 100ml 1000+100ml 500 ml+ 50ml 320+ 50ml PVC
Reservoir Volume 1000ml 1000 ml 1000 ml 600 ml PVC
FM-TCF-F001 Manual Resuscitator Version 3: 2010/05/30

Reusable manual Resuscitator

Resuscitator Volume Material
Size Adult Child Infant
Bag 1700 + 100ml 500+ 50ml 320+ 50ml Silicone
Reservoir Volume 1000ml 1000 ml 600 ml PVC
FM-TCF-F001 Manual Resuscitator 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-F001 Manual Resuscitator Version 3: 2010/05/30

2.1. Device description

Foremount’s Disposable and Reusable Manual Resuscitator are the portable medical
devices which temporarily augment ventilation in patients during ventilatory insufficiency or
ventilatory failure.

To get the best effect, the Manual Resuscitators offer different sizes of ventilation bag
for adult, child, and infant with a duck-bill valve in the non-rebreathing valve (with or without
pressure limiting valve). An adequate reservoir bag is used with the ventilation bag when the
oxygen gas is supplied to the patient. An adequate mask is attached to the adequate
resuscitator to cover the patient’s nose and mouth. The device is used by CPR-Trained
persons.

Foremount’s Disposable and Reusable PEEP Valve as a medical device to be used in a

constant or intermittent flow system such as resuscitation bags or continuous gas flow
systems to provide positive-end expiratory pressure or Continuous positive airway pressure
when using the manual resuscitators. The device is adjustable, spring actuated valve from
0cm to 20cm H20 pressure, and is mainly used to recruit or stabilize lung units and improve
oxygenation in patients with hypoxemic respiratory failure.

Disposable Manual Resuscitator made of Poly-vinyl-chloride and Polycarbonate is for

single patient use to minimize the risk of cross infection, and Reusable Manual Resuscitator
made of Polsulfone and Silicone material is for reusable and autoclavable up to 134℃ to kill
bateria.
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2.2 Product Specification

Disposable Manual Resuscitator

Features
1. Economical design and cost effective.
2. Leakage free.
3. Slip-free texture and arrow-shape bag with foldable design.
4. Single use to minimize the risk of cross infection.

Resuscitator Volume Material

Size Adult Child Infant
Bag 1700+100 ml 500 +50 ml 320+50 ml PVC
Max Stroke Volume (single
850 + 50 ml 280 + 30 ml 110+ 20 ml
hand)
Reservoir Volume 1000 ml 1000 ml 600 ml PVC (others)
Mask (Option) #5 #3 #1 PVC
Pressure limiting (pop-off)
60+10cmH2O @ 15 lpm 40+ 5cmH2O @15 lpm PC
valve
Patient Valve Connector 22/ 15 mm ISO swivel connector PC
Reservoir Valve connector To bag inlet: 26.5 mm ID, To O2 reservoir: 25 mm OD PC
0-10 cmH2O
Peep Valve (Option) PC
5-20 cmH2O
Ins./expiratory resistance < 5.0 cmH2O @50 lpm <5 cmH2O @ 5 lpm

operating Temperature -18℃ ~+50℃

storage Temperature -40℃ ~+60℃
Shelf life 3 years
Option PEEP valve: 0-10cmH2O/5-20cmH2O

Diverter ring: PC
Manometer: PC
2 or 3 meter Oxygen tube: PVC

Disposable mask with and without anti-magnetic valve available

1. Cushion Mask 2. Elite Mask 3. Rotation Mask

Package Hand carry bag/PP case upon request

FM-TCF-F001 Manual Resuscitator Version 3: 2010/05/30

Reusable Manual Resuscitator

Features
1. Slip-free texture and arrow-shape bag with foldable design,
2. Maximum durability and reliability, autoclavable up to 134℃
3. High transparency provides better patient observation

Resuscitator Volume Material

Size Adult Child Infant
Bag 1600 + 100ml 500+ 50ml 320+ 50ml Silicone
Max Stroke Volume (single hand) 850+ 50ml 280 + 30ml 110+ 20ml
Reservoir Volume 1000ml 1000 ml 600 ml PVC
Mask (Option) #5 #3 #1 Silicone
Pressure limiting (pop-off) valve 60 cmH2O+ 10cmH2O@ 15 lpm 40cmH2O+ 5cmH2O @15 lpm PSU/ PC
Patient Valve Connector 22/ 15 mm ISO swivel connector PSU/ PC
Reservoir Valve connector To bag inlet: 29 mm ID, To O2 reservoir: 25 mm OD PSU/ PC
Peep Valve (Option) 0-10 + 3.0 cmH2O @Calibrated at 5 lpm PSU/ PC
Ins./Expiratory Resistance < 3.0 cmH2O @50 lpm
Sterilization Temperature 121℃ or 134℃
Storage Temperature -40℃ ~+60℃
Operating Temperature -18℃ ~+50℃
Shelf Life 3 Years
Option PEEP valve: 0-10cmH2O/5-20cmH2O

Diverter ring: PSU/PC

Manometer: PC
2.1 meter Oxygen tube: Silicon

Silicone Mask
1. Pryamid Mask
2. 2-piece mask

Package Hand Carry Bag/PP case upon request

FM-TCF-F001 Manual Resuscitator Version 3: 2010/05/30
2.3 Intended use and classification

2.3.1 Intended use

Foremount’s Disposable and Reusable Manual Resuscitatora are intended for manual
pulmonary resuscitation and emergency respiratory support. For use by CPR-trained personnel
only, in hospital and pre-hospital settings.
The reange of application for the sizes are:
Infant: ≦10Kg, Child: ≦30 Kg, Adult: >30 Kg

Disposable and Reusable PEEP Valve:

Foremount Peep Valves elevate the pressure in a patient’s lungs above atmospheric
pressure at the end of exhalation. They are used in the hospital, extended care facility,
emergency medical services and patient transport to conjunction with manual resuscitators
and other ventilatory support equipment to provide positive end expiratory pressure.

2.3.2 Classification :
The Manual Resuscitator is classified into class IIa of medical devices, according to Rule
2 in Annex IX if the directive 93/42/EEC, because it is a invasive medical device and used
through human mouth.

1.5. Active therapeutical device

Any active medical device, whether used alone or in combination with other medical
devices, to support, modify, replace or restore biological functions or structures with a
view to treatment or alleviation of an illness, injury or handicap.

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 manual resuscitator intended for channelling gases for the purpose
of introduction into body are Class IIa.

CONCLUSION: THE DEVICE IS CLASS IIa

Therefore, the manual Resuscitator is classified as class IIa device of CE classification. As the
FDA classification, this kind of airway is class II medical device as well.
FM-TCF-F001 Manual Resuscitator Version 3: 2010/05/30

2.4 Visual Appearance

FM-TCF-F001 Manual Resuscitator 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 Manual Resuscitator Production

FM-TCF-F001 Manual Resuscitator 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 Manual Resuscitator is Economic streamline design to save
cost. We will show manufacturing procedures of Foremount’s Manual Resuscitator below.
We utilizes the plastics material and parts from the qualified suppliers who manufacture
highly purified materials with Certification of analysis or MSDS.

Manufacture Manual resuscitator

All manual resuscitators are injection molded by qualified suppliers and are
manufactured in the controlled environment.

Incoming Quality Inspection

The appearance of parts of Manual Resuscitator such as bubbles, chips, and break
edge piece is inspected by visual at IQC.
Assembling
Manual Resuscitators are assembled by SOP of Manual Resuscitator assembly.
Labeling & Printing
Labeling is done by printing the data of LOT No., Exp. Date, Code no and Size on
the labels. Manual Resuscitator is packed upon customer request such as PE bag and so
on.
Inspection for Finished Manual resuscitator
The procedures are conducted to do the final manual resuscitator inspection before
storage or shipping to customer. The Q.C. technicians follow the sampling rule and
inspection checklist to verify the quality. The manual resuscitators are only released to be
stored or delivered when all inspections are passed.
Shipping
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-F001 Manual Resuscitator Version 3: 2010/05/30

3.2. BOM and Key Component

3.2.1 BOM & Key Component

Product Key Component

Disposable Reservoir Bag: PVC
Manual Patient connector: PC
Resuscitator Reservoir Valve connector: PC
Pressure limiting valve (POP-OFF) adult:
60cmH2O: PC
Pressure limiting valve (POP-OFF)
child/infant :40 cmH2O: PC

oxygen tube: PVC, 2.1/3 meter

PEEP valve: PC

Diverter ring: PC

Manometer: PC
Reusable
Manual Reservoir Bag: Silicone
Resuscitator
Patient connector: PSU

Reservoir Valve connector: PSU

Pressure limiting valve (POP-OFF) adult:
60cmH2O: PSU
Pressure limiting valve (POP-OFF)
child/infant :40 cmH2O : PSU

oxygen tube: PVC, 2.1/3 meter

PEEP valve: PSF

Diverter ring: PSF

Manometer: PSF

Please kindly find the attached folder that is named of 3.2.1 MSDS.
FM-TCF-F001 Manual Resuscitator Version 3: 2010/05/30
3.3. Flow chart of airway design and production

3.3.1 Design Procedure of Manual Resuscitator

1. Define and clarify the demand of customer/user

2. Set up the design requiremnet and specification of manual resuscitator
3. Determine the product concept and characteristics of manual resuscitator
4. Generate the product concept of manual resuscitator
5. Test the Product concept of manual resuscitator
6. Finalize the product spec of manual resuscitator
7. initial the plan of manual resuscitator

Define and Understand Think the Generate the Design and

clarify Question the question Question Concept Test
Step 1 Step 2 Step 4 Step 5 Step7
Step 3 Step 6
FM-TCF-F001 Manual Resuscitator Version 3: 2010/05/30
3.3.2 Design Flow Chart of Manual Resuscitator
Design Flow Chart of Manual Resuscitator

Feasibility Study

Review of
Feasibility Mass Production
Report

OK
OK

Design and Review of

Development NG Trail
Production

NG

Functional
Tests
Trial Production

OK

3.3.3 Production Control Procedure Of Manual Resuscitator

1. Order arrangement (lot)
2. Component and material arrangement (supplier control)
3. Component Check and confirmation (raw material/component IQC)
4. Production arrangement (lot tracebility/ IPQC)
5. Package- labeling and printing ( FQC/ lot no/product name/code/ manufacturate date/
expired date/ IFU..)
6. Proceed for shipment (OQC)
FM-TCF-F001 Manual Resuscitator Version 3: 2010/05/30
3.3.4 Product Flow Chart of Manual Resuscitator
FM-TCF-F001 Manual Resuscitator Version 3: 2010/05/30

PART SEVEN. LABELLİNG AND MARKİNG

4.1 Warning Signs

4.2 Packing

4.3 CE Marking, Labels

4.4 Instruction for Use

FM-TCF-F001 Manual Resuscitator Version 3: 2010/05/30

4.1 Warning Signs.

 Exp. Date:2011-11

Caution

Manufacturing date Latex Free

 Single use

● NON-STERILE

 Phthalate

4.2 Packing
Product Name Packing Type Packing details
1. Disposable Manual 1PCS in one automatic packing.
1P
Resuscitator
2. Disposable Manual 6 PCS in one carton.
6P
Resuscitator
3. Reusable Manual 1PCS in one automatic packing.
1P
Resuscitator
4. Reusable Manual 6 PCS in one carton.
6P
Resuscitator
FM-TCF-F001 Manual Resuscitator Version 3: 2010/05/30

4.3 CE marking, Labels.

0434
Disposable Manual Resuscitator Jetable insufflateur manuel

2009 2012
0434

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

Reusable Manual Resuscitator Réutilisable insufflateur manuel

REF

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
FM-TCF-F001 Manual Resuscitator Version 3: 2010/05/30
4.4 Instruction for Use
Please kindly find the attached folder which is named of 4.4 IFU.
FM-TCF-F001 Manual Resuscitator Version 3: 2010/05/30

PART FIVE. DECLARATION OF CONFORMITY OF

APPLICANT PRODUCT.

5.1. EC Declaration of Conformity.

FM-TCF-F001 Manual Resuscitator Version 3: 2010/05/30

5.1 EC Declaration of Conformity

Please kindly find the attached folder that is named of 5.1 EC DOC.
FM-TCF-F001 Manual Resuscitator Version 3: 2010/05/30
ANNEX A QUALITY SYSTEM CERTIFICATE
Please kindly find the attached folder which is named of ANNEX A QUALITY SYSTEM
CERTIFICATE.