OPTIMUM SOLUTIONS FOR DISINFECTION AND STERILIZATION

Proposal № DGM GS 3_201901

Table of Content

Business Case ........................................................................................................... 3

DGM - Company Profile ............................................................................................. 4
About us .................................................................................................................. 4
Quality ..................................................................................................................... 4
Sustainability ........................................................................................................... 4
Company Highlights ................................................................................................ 5
DGM supplies a wide range of equipment .............................................................. 5
DGM GS-3 - Automatic Endoscope Reprocessor ...................................................... 6
Key features ............................................................................................................ 6
Options .................................................................................................................... 7
DGM SS-8 – Drying Cabinet ...................................................................................... 8
Models..................................................................................................................... 8
Key features ............................................................................................................ 8
Cabinet / instrument connection.............................................................................. 9
Construction ............................................................................................................ 9
Control system and connection interface .............................................................. 10
Device settings, safety features ............................................................................ 10
Standards and Directives ......................................................................................... 11
Customer Service and After Sales Support .............................................................. 12

Quotation Endoscope Resprocessor | DGM GS-3 .............................................. 15

Quotation Endoscope Reprocessor | Washing carts ......................................... 16
Quotation Drying Cabinet | DGM SS-8 ................................................................. 17

General Sales Conditions ........................................................................................ 18

Appendix I Training and instruction Plan .................................................................. 19

Business Case

In this document you will find the net dealer prices (in EUR and EXW, Latvia) of our
Flexible Endoscope Reprocessors (DGM GS-3) and our Drying Cabinet (DGM
SS-8).

Using the “rack” option, two (2) DGM GS-3 machines will be installed on the top of
each other on a mobile shelf. This set up allows asynchronous reprocessing of 2
flexible endoscopes.

• Connectors

Every endoscope have hopes (like biopsy channel, or air/water channel), usually the
number of these hopes are not more than 9 (on the whole market of endoscopy).

So we the main rule for DGM GS: “the number of connectors is equal to the number
of holes”. Couse we use connectors for every hole. The biggest set of connectors
contains not more than 9 connectors.

The number of the connectors in the set depends on the type endoscope and
brand (the highest is for video colonoscopy, usually 7 in rare cases 8 or 9). Price
range for one (1) connector is approximately EUR 50 – 250. The cost depends on the
type of connector. The cheapest as usual is the Water Jet connector. So for pricing it
is better to use the meaning “connectors set”.

The price of an Olympus connectors set for series 30-40, series 70-80, series 90 and
series series 140-180 instruments (not suitable or video bronchoscopes and fiber
bronchoscopes) is respectively EUR 600, EUR 620, EUR 675 and EUR 1.000.

• About water treatment

We recommend using a water softener, cause in internal system of machine we

have. Water line is equipped with two (2) flow meters for checking and validation of
water quantity and with a water filtration system (one 0.45 µm and one 0.1 µm filter).
In the quotation you will find the option.

With this quotation we are confident that we offer a solution that fit in your strategy,
meet your ambition and we are looking forward working together with you in coming
projects.
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DGM - Company Profile

DGM is a global supplier of innovative cleaning, disinfection and sterilization

solutions to the health care, life sciences, pharmaceutical and industrial market. It is
headquartered in Zug, Switzerland, and is represented by a network of sales
subsidiaries and authorized partners. There are more than 400 employees in over
than 25 countries involved in production, distribution and service of DGM infection
control system.

Increasing demands make it ever more important to operate at highest productivity

and efficiency levels. With a combination of products DGM offers the best-possible
solution to each client in any country: the machine from the standard product range
or customized large-scale projects. Through excellent product support and customer
services DGM delivers added value to its customers.

About us
DGM protects lives and health of millions people supplying high tech medical
equipment at affordable prices that satisfy medical organizations' needs. We promote
innovation in the infection control industry and provide healthcare workers with the
information of the latest world healthcare achievements. DGM constantly works on
meeting the satisfaction of customers, employees and shareholders.

Quality

DGM is focused on producing reliable and efficient solutions for sterilization and
infection control. Our equipment is safe, highly productive, user-friendly and
eco-friendly. DGM works to keep prices affordable both for the equipment and the
further maintenance. DGM medical equipment have all certificates needed in
accordance with international standards (CE).

Sustainability

DGM pays a lot of attention to the maintenance of our equipment based on energy
efficiency and resource conservation. Our produce is constructed to use less water,
energy, chemicals. That leads to reduce the consumption of resources used and
helps our clients to decrease costs.

Company Highlights

ü End-to-end solutions
ü A wide range of equipment starting from a standard product range following to
customized large-scale projects
ü Development and innovation, continuous monitoring and implementation of new
technologies in production, development of new models of equipment
ü Manufacturing of equipment meets the needs of users and can be customized to
special local characteristics

DGM supplies a wide range of equipment

ü Steam sterilizers
ü Low-temperature plasma sterilizers
ü Washer disinfectors
ü Flexible endoscope re-processors
ü Drying cabinets
ü Ultrasonic washers
ü Medical Waste Management System
ü Steam disinfectors
ü Furniture and accessories
ü Heat sealers
ü Packaging materials for sterilization and indicators

DGM GS-3 - Automatic Endoscope Reprocessor

DGM GS-3 is an integrated endoscope reprocessing system that provides complete,
consistent, high-level disinfection of flexible endoscopes.
Highest flexibility is granted by the compact design, which assures low cycle costs by
reduced consumption of water, chemicals and energy.

DGM GS-3 endoscope reprocessor is endowed with a stainless steel base for the
storage of process chemicals. Free standing or table top - the DGM GS-3 design
provides an installation set for any facility. Using the “rack” option, two GS 3
machines will be installed on the top of each other on a mobile shelf. This set up
allows asynchronous reprocessing of 2 flexible endoscopes on a small
footprint. Furthermore, DGM GS-3 is useful for rigid endoscopes.

Key features

ü Compatible and tested glutaraldehyde

(thermo-chemical) disinfection
ü 3 level service menu, protected by
passwords (installation, service, user)
ü Leak test at the beginning of the cycle and
continuous monitoring during all the cycle
phases with automatic cycle stop in case of
anomaly
ü Integrated sterile air filter (0.2 µm) channels
purging and drying
ü Final rinse with sterile water: the double-stage
microbiological filtration system (0.45µm and
0.1µm) secures the validated disinfection of process water for the final rinse and
disinfection phases
ü Process documentation through the external printer or USB interface
ü Available in a single-door version. In the open position, the door is an ergonomic
workspace for the connection of endoscopes
ü Possibility of connecting an endoscope with up to 7 channels
ü Designed for processing 1 flexible endoscope, or up to 3 video bronchoscopes of
all types and brands
ü Possibility of thermal processing of rigid endoscopes using specialized trolleys
ü Thermal self-disinfection cycle
ü Microprocessor control
ü HEPA filter for dryer cycle
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Options

ü Light inside the chamber

ü Rack for two EW 1 A.E.R.
ü 3rd chemical dosing pump
ü External printer ST1
ü Water softener
ü Stand on wheels
ü Washing chamber with forced HEPA H14 filtered warm air drying
ü A stainless steel shelf for detergents and disinfectants

The ‘Rack’ option.

DGM SS-8 – Drying Cabinet

DGM drying cabinets are available in several configurations from full width shelves
dedicated to instruments, equipment and general items to mixed solutions for
anaesthesia items and instruments. Blanket warming version available as well.

Cabinets are available in single door or double door pass through versions with glass
doors for a rapid visual inspection of the stored items. Separate drying of anaesthetic
and instrument accessories increases the throughput capacity of a washer
disinfector of a third. Drying cabinets can accept a load volume of more than 2 units
of washer disinfectors.

Models

Drying cabinet is available in single door or double door pass-through version with
glass door for a rapid visual inspection of the stored items.

ü DGM SS8 /1 single door drying cabinet

ü DGM SS8/2 double door pass-through drying cabinet

The cabinet is equipped with stainless steel sloping trays for reprocessed
instruments water dripping and stainless steel net baskets for the housing of the
instruments. The capacity of the standard configuration is 8 flexible
endoscopes. The cabinet can be configured for 9 endoscope capacity as option.

Key features

ü Drying and storage cabinets for endoscopes

ü 8 endoscopes stored
ü Supplied as standard version with n° 8 cassettes and endoscope fast
connections.
ü Door made in HST temperate glass.
ü Frame and panels in stainless steel AISI 304.
ü Glass lockable doors are reversible and therefore can be configured right or left
opening also during installation.
ü Single and double door (pass through) versions with control panel controlled
locking.
ü High level HEPA H14 air filtering.
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Cabinet / instrument connection

The cabinet is equipped with stainless steel sloping trays for reprocessed
instruments water dripping and stainless steel net baskets for the housing of the
instruments.

The connection system to the endoscope channels is composed by silicon pipes with
universal connectors dedicated to biotic, air and water channels. The net baskets are
laid on the trays and, while loading the trays into the cabinet, the operator connects
the cabinet medical compressed air source.

The cabinet has a fast CPC normally closed connectors. The stainless steel net
baskets allow free air flow for the instrument external surface drying. They’re also
interchangeable with the baskets used in the DGM GS 8 AER (C559 washing cart).

Construction

ü External frame and panels in stainless steel AISI 304

ü Chamber thermal isolation by a mineral wool panels coating 50mm thick
ü Drying chamber coating in polish stainless steel AISI 304
ü HST temperate double glass hinged door reversible and configurable for right or
left opening
ü Tray guides in stainless steel AISI 304
ü Trays and net baskets in stainless steel AISI 304
ü Drying circuit dedicated to an homogeneous heat distribution inside the storage
chamber served by a blower (this homogeneous heat distribution previews
possible high temperature areas, a potential risk for the stored instruments). The
circuit is monitored by a pressure switch.
ü Air drying heating elements power 1500W.
ü High pressure air drying circuit for the instruments channels served by an “oil
free” compressor– air pressure 0,5 bar
ü The filtration system composed by F5 class pre-filter and HEPA H14 filter serves
both drying circuits
ü Easy filters maintenance with access from the frontal superior lifting panel
equipped with gas pistons.

ü Open door sensors.

ü Control panel controlled door locking

Control system and connection interface

ü Control panel with 3 digit LED display

ü RS 232 serial connection for printer

Device settings, safety features

ü Drying chamber temperature set (from room temperature up to +40°C)

ü Visual and acoustic alarm (excludible) for minimum/maximum temperature.
ü Visual and acoustic alarm (excludible) for drying circuit flow incorrect operation
(the alarm is kept until the flow is restored and within parameters).
ü Visual and acoustic alarm (excludible) for incorrect cassette/instrument
connection and for incorrect cabinet/cassettes coupling or alignment.
ü Visual and acoustic advise for HEPA filter maintenance.
ü Visual and acoustic alarm if one of the doors door remains open longer than a
pre-set timing (configurable parameter).
ü All acoustic alarms can be disabled through a general parameter.
ü In the pass-through version the door is interlocked to avoid the simultaneous door
opening.

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Standards and Directives

We supply solutions for infections and sterilization control that provide consistent,
high quality results. DGM global experience has earned a reputation as an expert on
worldwide Standards and Quality considerations.

As experts in infection and sterilization control products and processes, we

understand the market’s varying needs and comply with the strictest international
standards and directives.

Standards and codes

DGM products meet the following provisions and standards:

Europe:

• EN 285 for Large Autoclaves

• EN ISO 17665-1:2006

Directives & Guidelines:

• Medical Device Directive – MDD 93/42/EEC

• Pressure Equipment Directive – PED 97/23 EEC
• 2006/95/EC Low Voltage Directive
• 2004/108/EC EMC Directive
• 2011/65/EU RoHS Directive

Safety and EMC Standards:

• EN 61010-1:2010
• IEC/EN 61010-2-040:2005
• EN 61326-1:2013
• EN 60204-1:2006. EN 60204-1/A1:2009
• EN ISO 14971:2012
• EN ISO 15883-1:2009
• EN ISO 15883-2:2009
• CEN ISO/TS 15883-5:2005
• EN 1717:2000

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Customer Service and After Sales Support

Project Management
DGM provide full project management services with all capital equipment contracts to
ensure installations are completed to the highest level of satisfaction to the customer.
Our project managers and/or engineers can co-ordinate between all parties involved
and will continually communicate to the project team ensuring work is completed
efficiently, effectively and with consideration to the facilities procedures and
processes.

We have invested in a training regime to promote a proven methodology to our

project managers. The program provides fully comprehensive Project Management
capabilities specifically designed for installations within controlled environments. As a
commitment to support and invest in this area of our business, all our project
managers have received this training.

Training
DGM have a number of training packages to suit the needs of each specific
customer. Our partners can use our telephone support for assistance after the
training. Optionally the training can be repeated four (4) weeks later to ensure total
user understanding is achieved.

In addition we also offer more detailed training packages for your onsite engineering
group. These packages can be tailored to suit your people’s specific skills and
engineering proficiency levels and can provide you with the knowledge to avoid
trivial/user faults which can often lead to unnecessary callouts therefore saving costs
and improving site operating up times and efficiencies.

Customer Relations
As a commitment to continually improve our customer service levels, DGM invest
and update customer related software. We also extend the opportunity for all
office-based staff to develop themselves with customers service courses. DGM
continually develop its Quality Management systems in line with new legislations and
guidelines to further improvement the service we deliver.

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In addition to the above the biggest area of importance is with the relations we
create, DGM pride themselves on the attention to detail and the relations that exist
with our customers. Perception surveys and periodic review meetings are all
important areas to allow us to maintain a high level of customer’s service and
satisfaction.

Technical Support
DGM have a designated phone number, which connects directly to the service
department and engineers team. Our software allow 24/7 contact and support to be
provided.

Our staff is able to provide technical assistance from within the office and all
engineers are contactable via mobile phones with email capability and internet
access. DGM set Key Performance Indicators (KPI’s) within our service agreements
for each piece of equipment we maintain. We promise to provide technical
assistance via telephone with the Service Level Agreement agreed. These KPI’s are
periodically reviewed in management meetings internally and in review meetings with
the client.

As a leading manufacturer investment within technical support is of primary

importance. Our management continually monitors existing accounts, new accounts
and trends to ensure engineering staffing levels are of an optimal level to allow our
response times and high service levels to be maintained minimizing downtime and
compromise to our customer’s processes.

Callout’s and Emergency Response

Unlike other suppliers providing support and maintenance services to a dedicated
market segment DGM engineers work within medical, laboratory and pharmaceutical
establishments, therefore we have experienced engineers able to secure your
processes. With this in mind it allows us to respond quickly to emergency callouts
without compromising your security.

Availability of Spares
Critical proprietary and non-proprietary spare spares kept in stock and available for
delivery to site the following day from our warehouses. This allows the engineer to
source a limit downtime and reducing carriage costs. For any items that are not in
stock with DGM we have an express service arrangement with our supply partners to
provide back-up.

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Maintenance engineers
DGM has a team engineers based
in several countries providing fast
and effective emergency support as
well as planned and preventive
services. Our engineers are trained
and highly experienced with
autoclaves and other relevant
infection control products. All
engineers have undergone and
achieved training ensuring a high
level of support and competency to
the equipment proposed.

Availability of Spares for Life Time of Equipment

We guarantee availability of spares for the lifetime of the equipment proposed.

Concise and clear Service Reports

Callout and service reports are generated after each intervention.

Instructions Manuals
All offered equipment comes complete with an Operation and/or Maintenance
manual.

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Quotation Endoscope Reprocessor | DGM GS-3

Description Unit price Total price

DGM GS-3 * 15.295 15.295

DGM GS-3 * – ‘rack’ version 30.590 -

- rack 2.210 -
- two (2) washing carts are included - -

- Printer 565 -
- Built in water softener 780 -

Total net dealer price in EUR and EXW Riga (Latvia) 15.295

* Including: 0,45µm + 0,1µm water filtering system, instrument drying system, drain pump, self
disinfection connection set, stainless steel cabinet for chemical storage with level control. The
cabinet is used as a stand for the machine. + washing cart)

Multi colored tubes are included. Leak test connector (Pentax).

Standard supplied with each connector set of Pentax.
Separate price EUR 225.

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Quotation Endoscope Reprocessor | Washing carts

Code Description Price, euro

Washing cart for 1 flexible

endoscope with
instrument supports with
F 566 € 900
connection pipes and mesh
basket for smallware
(in standard version)

Washing cart for 1 flexible
endoscope without instrument
F 575 supports with connection € 850
pipes and mesh basket for
smallware

Washing cart for fibro/video
bronchoscopes and
cystoscopes
F 569 - nr.3 fibro € 1250
- nr.2 video
with connection pipes and
mesh basket for smallware

Wash cart for nr. 6 rigid
endoscopes:
6 injection sleeves (max
F 570 € 900
length 450 mm), 5 Luer lock
connections (max length 350
mm)

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Quotation Drying Cabinet | DGM SS-8

Description Unit price Total price

DGM SS-8/1 (one glass door) 12.850 12.850 *

Option(s)
- ST2 printer (built-in) 720 -
- Humidity sensor 950 -
- UV light 850 -
- Four (4) wheels for drying cabinets instead of feet 200 -
- ST2 printer (built-in) 720 -

Total net dealer price in EUR and EXW Riga (Latvia) 12.850

* Please add EUR 850 for a double door (pass through) version.

Mesh removable basket for endoscope.

Compatible with SS 8 drying cabinets.
C 961 – 160 euro per unit (Total for 11 baskets – € 1760)

Information:
The DGM SS 8 has standard a capacity for eight (8) endoscopes.

9991849
Cabinet configured with capacity of 9 endoscopes
€ 800,00

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General Sales Conditions

1. Terms and Conditions

Delivery Terms EXW Riga, Latvia, Incoterms 2000
Delivery time 3- 4 Months after receipt of the purchase order, the agreed payment,
and the specification of all the technical details. Any delay regarding the receipt of the
down payment or of the complete technical specification will involve postponements
on the delivery day.
Quotation Validity: 3 months and all prices in EUR.

2. Guarantee
DGM Pharma - Apparate Handel AG guarantees their equipment by the term of one
(1) year as of the delivery date against design and/or mechanical, electrical and/or
electronic parts manufacture defects.

Technical assistance is included (travel expenses of our engineer excluded). This

guarantee does not include material wear, defects due to misuse or lack of skill or the
actions of use or maintenance taken, which do not tally with the instructions laid
down in the manuals.

An additional warranty for the second and third year can be purchased during the first
year of warranty at the price of 3% of the unit price (including options). Purchase
price is not less than EUR 750 per year.

3. Payment:
• 100% Confirmed irrevocable Letter of Credit or pre-payment.
• Letter of Credit under EUR 12.500 please add EUR 425 to the price or change the
Letter of Credit to pre-payment.
• All expenses related to the Letter of Credit will be charged on applicants account.
• EUR 250 will be added if documents such as EUR1 or Certificates as Country of
Origin are required per document.
• EUR 250 administration cost will be charged if DGM will arrange the transport.
4. Price increase
In case of an extreme increase of raw material costs and parts a re-calculation of
price will be made after consulting the customer.

5. Other
The manufacturer retains the right to implement technical modifications during the
course of further development.

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Appendix I |Training and instruction Plan

User Training

ü Basic principles cleaning, disinfection and sterilization

ü Functional principles of cleaning, disinfection and sterilization

ü DGM Medical Equipement:

o Functional description
o Test programs
o Sterilization programs
o Human Machine Interface (HMI)
o Cycles explanation
o Error explanation
o Sterilization preparation
o Maintenance
o Hand-on session

Technical Training

The first part of the training is identically to the User Training.

ü Basic principles cleaning, disinfection and sterilization

ü Functional principles of cleaning, disinfection and sterilization

ü DGM Medical Equipment:

Additional

o Theoretical explanation
o Practical explanation
o Diagrams (piping)
o Electrical drawing
o Software Management

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