Gamma+ AURION COMPACT Stücklistenhandbuch

USAGE INSTRUCTIONS

COMPACT

multipurpose trolley

CLASS I

pag. I 2

IMPORTANT

Verify immediately the package content (pag. IN 11)

Reproducing, transmitting or saving the following information, or part of them, into an

information search system, as well as translating them, or part of them, into any

language and in any form, is strictly forbidden, unless a written authorization is given by

GAMMA POLIURETANI S.R.L. (from now on we will refer to it simply as GAMMA).

GAMMA decline responsibility for damages deriving from an improper use of the trolley.

It is therefore strongly advisable to read the present manual for a correct use of

COMPACT trolley.

GAMMA reserve the right to modify the technical/functional specifications and

characteristics of subsequent versions of this product at any time, without warning.

Instructions for use are an integral part of the trolley and therefore they must be

kept with it, so that they are always available for consultation. The present

document must follow the trolley’s lifecycle, even when it is transferred to other

users.

Requests for technical information or for other copies of this document are to be

addressed to

GAMMA POLIURETANI S.R.L.

Via Padova 9.

31046 Oderzo (TV) - ITALY

Always remember to quote the serial number printed on the plate (pag. IN 6)

Responsible or authorised representative of the manufacturer:

GAMMA POLIURETANI S.R.L.

Number and year of manufacture: see identification plate on the trolley

Identification code of the present document: 66990020

Revision: 01.00

Printing finished on: 03/2022

INDEX - pag. SO 1

INDEX

INFORMATION...............................................................................................IN 1

General information ........................................................................................IN 4

Identification of COMPACT and of its components ........................................IN 6

Safety..............................................................................................................IN 7

Environmental conditions..............................................................................IN 10

Trasportation and installation........................................................................IN 10

Before use.....................................................................................................IN 11

Safe usage....................................................................................................IN 12

Maintenance .................................................................................................IN 12

Long periods of non-usage...........................................................................IN 13

“Exceptional” trasportation............................................................................IN 13

De-commissioning and disposal...................................................................IN 14

BODY.............................................................................................................BO 1

Single piece body ..........................................................................................BO 2

Top surface....................................................................................................BO 2

Needle tub......................................................................................................BO 2

Sliding top surface .........................................................................................BO 3

Drawer with stainless steel tray.....................................................................BO 3

Transparent swinging pockets.......................................................................BO 4

Pocket catheter holder...................................................................................BO 4

Hooks.............................................................................................................BO 4

Oxygen bottle holder......................................................................................BO 5

Life-saving medicines drawer........................................................................BO 5

Waste bin with lid...........................................................................................BO 6

Water bottle holder ........................................................................................BO 6

Central locking system...................................................................................BO 6

Front opening space......................................................................................BO 8

Ampoule opener ............................................................................................BO 8

Wheels / braking system................................................................................BO 9

CONTAINERS (ACCESSORIES)................................................................. CO 1

Front drawers................................................................................................ CO 2

Dividers......................................................................................................... CO 3

Wirebaskets.................................................................................................. CO 4

Trays............................................................................................................. CO 5

Dispenser...................................................................................................... CO 6

Stainless steel shelves ................................................................................. CO 7

Basins........................................................................................................... CO 8

Doors with seal lock...................................................................................... CO 9

SUPPORTS (ACCESSORIES)......................................................................SU 1

I.V. pole..........................................................................................................SU 2

Telescopic I.V. pole .......................................................................................SU 3

Holding frame ................................................................................................SU 4

Holding bar.....................................................................................................SU 6

Basin holding frame.......................................................................................SU 7

Tub holder......................................................................................................SU 9

Shelf for suction pump.................................................................................SU 10

Oxygen bottle holder (SMALL or LARGE)...................................................SU 11

Rotating instrument carrying tray...................................................................SU 13

Lockable rotating instrument carrying tray...................................................SU 15

Cardiac massage board...............................................................................SU 17

Perimetral protection....................................................................................SU 19

Paediatric mattress......................................................................................SU 20

DEVICES (ACCESSORIES)..........................................................................DE 1

Multiple power outlet......................................................................................DE 2

INFORMATION - pag. IN 1

INFORMATION

This chapter contains all necessary information for both a correct and exhaustive

knowledge of all technical features and general functioning of COMPACT, and the

correct consultation of the present manual.

In order to avoid confusion and potential errors on the part of readers, all information

referring to specific components (containers, supports and devices) which might not be

present in your trolley (because they are accessories), are reported in the corresponding

sections (CONTAINERS, SUPPORTS AND DEVICES).

Note:

According to the CE declaration of conformity (supplied together with the trolley) the

manufacturer or his authorized representative in the Community declares and

guarantees that this product complies with the applicable provisions contained in the

directive.

Documents referring to components supplied by third parties and the various annexes

(necessary for a better understanding of the trolley for maintenance) are to be found

inside the package.

INFORMATION - pag. IN 2

CERTIFICATE OF GUARANTEE –PLEASE FILL OUT AND SEND A COPY

SENDER

COMPANY NAME: …………………………………………………………………………………………………………………………………………………………………………………..

ADDRESS: ……………………………………………………………………………………………………………………………………………………………………………………………...

TOWN: ………………………………………………………………………………….POSTCODE: ………………………………………………………………………………………

NATION: ……………………………………………………………………………………………………………………………………………………………………………………………….

DATE OF PURCHASE: …………………/…………………/…………………

TYPE: AURION COMPACT

SERIAL NUMBER: ……………………………………………………………………………………………………………………………………………………………………………….....

INFORMATION - pag. IN 3

GAMMA POLIURETANI S.R.L. GUARANTEE CONDITIONS FOR A PERIOD OF 24 MONTHS

1. This guarantee certificate must be kept until its expiry date and must be produced every time technical service under guarantee is needed. Users who are not able to produce this

document, will lose all guarantee rights. The guarantee starts on the date of delivery of the trolley, and is valid for 24 months.

2. During this period GAMMA guarantee the quality of materials and the sound construction of each trolley. The components of the appliance that in GAMMA’s undisputable opinion are

faulty because of material or manufacturing fault, will be substituted free of charge at the user’s premises by staff from the nearest assistance centre.

3. The guarantee will be valid only if a copy of the original invoice issued to the Customer is produced and the guarantee certificate is sent to GAMMA, complete with the following data:

-buyer’s name;

-model and registration number of the product;

-date of purchase.

GAMMA reserve the right to refuse acknowledgement of the guarantee should these data have been removed or tampered with after purchasing.

4. The following are not covered by guarantee:

4.1 damages (scratches, dents and similar) caused by carelessness, negligence, tampering, incompetent use, or repairs carried out by unauthorized staff;

4.2 damages due to incorrect installation of the appliance and of the accessories, or to faults caused by insufficient or unsuitable electrical installation, or alterations due to weather

or environmental conditions or conditions of any other nature;

4.3 light bulbs, glass components, knobs, rubber seals;

4.4 installation advice and comfort checks;

4.5 general maintenance;

4.6 what can be considered normal wear and tear.

5. GAMMA decline any responsibility for damages which may be directly or indirectly caused to things or people due to the lack of compliance with all prescriptions indicated in the

special “instructions” regarding assembly.

6. GAMMA will not be liable for any damages caused to people or things or by breakdowns or forced interruption of use of the appliance. The parts that are substituted under guarantee

will remain the property of GAMMA.

INFORMATION - pag. IN 4

General information

Foreword

A new generation of hospital trolleys is born, fruit of innovative thinking (an innovative

and sophisticated material like Bayer’s Baydurwas used) and of a detailed design:

COMPACT.

COMPACT is specialised. The new system is designed to offer as many opportunities as

possible for customisation. Although different versions are already available for specific

hospital needs, there are further diversification opportunities thanks to an extremely wide

range of components and accessories.

COMPACT is beautiful. Its elegant shape, the absence of corners, its well harmonised

colours and the Italian style make it a working tool both useful and pleasant to the eye.

The multipurpose trolley you bought does cause particular risks for operators,

provided all prescriptions contained in this document are observed. Therefore, for

a correct and safe use of COMPACT it is necessary to read all chapters of this

manual (except those relative to accessories you are not supplied with) with

particular attention to chapter “Safety” on page IN 7.

Intended use

COMPACT is a medical device to be used solely as a support in giving assistance to

patients in hospital wards or in surgeries.

COMPACT can be used as a means of storing and transporting drugs, medications,

consumables, specialist medical equipment and clinical records, depending on the

accessories installed on it and on the maximum allowable loading weight of the various

components (according to the indications contained in the sections concerning the

various accessories - starting from pag. CO 1)

ATTENTION:

This device is addressed to properly trained staff. Using COMPACT is forbidden

for untrained staff. COMPACT must not be used improperly, i.e. for uses that are

different from its intended use.

Contraindications

All uses that do not correspond with the indications contained in the previous

paragraph (“Intended use”) are not to be considered as possible uses of the

GAMMA COMPACT trolley.

GAMMA do not guarantee safety of users, patients or third persons, if the trolley

is used for different purposes.

User’s responsibility

If the instructions on assembly, use and maintenance of the trolley contained in this

manual are disregarded, GAMMA decline any responsibility. GAMMA accepts no

responsibility for damages incurred to or caused by the trolley, due to:

-improper use of the trolley or use by untrained staff;

-use in contravention to specified National Standards;

-incorrect assembly;

-disregard for safety and personal protection;

-serious lack of periodic maintenance;

-incorrect preparation of the workplace or structure where the trolley is going to be

used;

-unauthorised modifications or servicing;

-use of spare parts of different manufacture;

-failure of the main power supply;

-use of an incorrect power supply.

INFORMATION - pag. IN 5

How to read this manual

The function of the present manual is to inform and guide users in the assembly, use

and maintenance of COMPACT and of its accessories.

Since the natural adaptability of COMPACT to customisation (in compliance with the

indications contained in the present document) make it impossible to supply a specific

document for each variant, the following “compromise” has been reached.

This manual was developed and subdivided into six different sections (the first three

are common to all trolley types, whereas the last three contain the accessories cards(*)),

identified by the icons placed in the lower part of each page (and by the specific page

number). This manual is available in four different languages (indicated by the icons on

the right).

This layout optimises navigation inside the manual, making the manual a dedicated

document, which is easy to consult.

Texts that are highlighted by the following drawing:

must be read very carefully. In fact, if the instruction contained in these texts are

disregarded, the safety of persons and of the trolley could be jeopardized .

(*) a card is composed of one or several sheets of paper containing the instructions

referring to each accessory that can or has actually been installed in order to integrate

the BODY of COMPACT. Cards are grouped in “families” of accessories: containers,

supports and devices.

Who should read the manual

The present document is addressed to all users of the trolley.

Glossary

Term

Meaning

Medical

accessory.

Product which is not a device, but was specifically designed to be

used with a device, in order to use it as was intended by the

manufacturer.

Patient.

Person who is subjected to medical care, tests and the like.

Residual risks.

Risks that prove not to be eliminable during design and

manufacture. The indications contained in this document, on the

plate and on the trolley itself are meant to “compensate” for these

risks.

Third persons

All persons (other than patients, users or doctors) who may have

something to do with the trolley.

User

Who uses the medical device (doctors, paramedical staff and, in

general, users different from patients).

INFORMATION - pag. IN 6

Identification of COMPACT and of its

components

Once the trolley has been unpacked (pag. IN 10), it can be identified thanks to the

special plate.

ATTENTION:

Do not remove the plate.

1) Manufacturer

2) Device in compliance with EU Regulation 2017/745

3) See the user manual

4) Medical device

5) Product number

6) Product code

7) Date of manufacture

8) Unique Device Identification

9) Serial number

This plate contains all essential information about the trolley.

In order to identify the accessories that have been supplied together with the trolley you

bought, it is necessary to refer to the transport document.

The COMPACT “family”

Starting from a standard body, COMPACT is designed to be customised with a wide

range of accessories (which are the distinguishing features of the various versions),

according to the specific needs of each hospital ward.

For this reason, your COMPACT is composed of a standard BODY - which is the same

for all trolleys –on which some accessories are then assembled by GAMMA or by

yourself.

Standard components (standard body)

As far as the description of standards components is concerned, refer to the layout on

page BO 1 and following.

“Accessory” components

Accessories have been divided by function:

-CONTAINERS (layout and description starting from pag. CO 1);

-SUPPORTS (layout and description starting from pag. SU 1);

-DEVICES (layout and description starting from pag. DE 1).

Note: obviously it is not possible to assemble all available accessories on one

single trolley! For additional information contact GAMMA.

ATTENTION:

Assembly and disassembly of all accessories are to be carried out when power

supply (if present) is disconnected form the trolley.

It is forbidden to use accessories that are not supplied by GAMMA.

Environmental conditions for the use of accessories are reported on pag. IN 10.

For a correct and safe use of accessories with COMPACT it is necessary to read

carefully the text contained in sections “INFORMATION” (from pag. IN 1) and

“BODY” (from pag. BO-1) of the usage instructions of the trolley.

INFORMATION - pag. IN 7

Safety

Guarantees about safety and hygiene

If COMPACT is used properly and according to the instructions supplied by

GAMMA, it will not cause hazards for operators. GAMMA decline responsibility for

any damages which may be caused to persons or things due to an improper use

of the trolley.

Using spare parts different from those supplied by the manufacturer may cause

damages to people or to the trolley.

•COMPACT is safe. It is in line with the highest safety standards thanks to the

materials used, to its rounded shape, to the absence of sharp metal parts and to the

attention paid to the fitting of all the accessories.

•COMPACT is innovative. It was manufactured with state-of-the-art materials, such

as rigid polyurethane Baydur , which is unchangeable with time, resistant to

chemical agents, not subject to corrosion and auto extinguishing.

•The solutions adopted for the design and manufacture of the trolley comply with all

safety principles, considering the technological achievements universally

recognised.

•During the design and manufacturing processes, risks were eliminated or reduced

as much as possible (implementation of safety in the design and manufacture of the

trolley) and the necessary protection measures were adopted against those risks

that could not be eliminated.

•Users are informed on residual risks. For instance, in the case of components

and accessories that have to support a load (such as I.V. poles or drawers)

the maximum allowable load is indicated both in the corresponding card and

on the component itself. If the label is damaged or becomes unreadable, it is

necessary to replace it.

•Materials were chosen on the basis of their reduced toxicity and flammability.

•Considering the intended use of the trolley, attention was paid also to the mutual

compatibility between materials and fabrics, biological cells and body fluids.

•The trolley was designed so as to reduce as much as possible all risks due to the

accidental leakage of substances in the trolley (considering the trolley itself and the

characteristics of the environment it is to be used in)

•The trolley was designed, manufactured and packed in such a way that its features

and its performance –considering its intended use –are not subjected to alteration

during storage and transportation.

•The normal stress the trolley is subjected to under normal usage conditions does

not alter the features and performances described in this document; therefore, the

clinical condition of patients, their safety and the safety of third persons cannot be

jeopardised (during the device’s lifecycle)

•The distinguishing features of the materials used do not change when they come

into contact with human body fluids or other fluids (especially as far as flammability

is concerned); therefore, safety is guaranteed with all substances and materials that

come into contact with the trolley during normal use (or maintenance)

•It is necessary to report any major accident occurring in relation to the

devices to the manufacturer and to the competent authority of the Member

State in which it is established.

•COMPACT was designed and manufactured in compliance with the following

standards and decrees:

•the device comply with the general safety and performance requirements of

Regulation (EU) 2017/745 (MDR) Annex I,

•the manufacturing company is certified according to UNI EN ISO 9001 and UNI

CEI EN ISO 13485.

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