AVIDICARE OPRAGON User manual

TECHNICAL MANUAL
SYSTEM DESCRIPTION
DIMENSIONING
INSTALLATION
OPERATION AND MAINTENANCE
SPARE PARTS LIST

11
INTRODUCTION 5
SYSTEM DESCRIPTION 6
General information 6
Infections in postoperative wounds are common and serious 6
TAF (Temperature-Controlled Air Flow) 7
Opragon®9
DIMENSIONING MANUAL 10
1. Selecting Opragon size 10
2. Sound and pressure drops 11
3. Duct connection 12
4. Mounting dimensions, weight and adaptation 13
5. Selection of materials 14
6. Lighting 14
7. Determining air flow and number of air showers outside of Opragon 15
8. HEPA filter 16
9. Description of controls 16
INSTALLATION MANUAL 18
Safety instructions 18
Unpacking and packaging material 18
Assembly 18
Mounting/suspension from ceiling 19
Duct connection 22
Commissioning and disinfection 22
Mounting of air showers 23
Mounting of external air showers 23
Safety instructions 27
Product liability 27
Daily inspection 28
Inspection every six months 28
Annual inspection 28
Air shower replacement 29
VALIDATION PROCEDURE 30
Self-check 30
"As built" validation 30
Possible measures 30
"In operation" validation 30

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SPARE PARTS LIST 31
APPENDIX 32
Typical installation, new construction 34

11
INTRODUCTION
This manual is aimed at designers, installers, service personnel and users of the Opragon.
Its purpose is to provide the information necessary for assuring peerless function and
optimal performance.
Instructions, specifications etc. included in this document describe the Opragon as
delivered from Avidicare. Discrepancies may exist due to customer adaptation.
The following documentation (this manual) accompanies the Opragon and includes:
•System description
•Dimensioning manual
•Installation manual
•Operation and maintenance manual
•Spare parts list
•Appendix
Avidicare AB reserves the right, without prior notice, to modify the design and specification
of the Opragon.
PREAMBLE

11
SYSTEM DESCRIPTION
General information
Infections in postoperative wounds are
common and serious
Every human being sheds skin particles, which vary in number depending on the activity
and person, and some of these are colonised with bacteria from the person’s normal
bacterial flora. Patients are exposed to the bacteria-carrying skin particles shed by medical
staff working in an operating theatre and are a risk factor for postoperative infection. The
patient and the surgical site must therefore be protected from these airborne bacteria-
carrying particles (or CFU - Colony Forming Unit). To exemplify the situation, it is estimated
that a person sheds 10,000 skin particles per minute at a normal working rate,
approximately 10% of which are carrying bacteria. This means that every person in the
operating theatre sheds about 1,000 CFU a minute.
There are basically three ways of protecting the patient from these airborne bacteria-
carrying particles:
•Occlusive clothing system that stop the particles from leaving the body and
becoming airborne
•Limiting the number of staff working in the theatre
•Efficient ventilation that wicks away and/or dilutes the levels of airborne CFU and
prevents them from reaching the wound or the instruments
A combination of all of these methods is commonly used.
10,000 skin particles per minute
The exogenous introduction of bacteria is generally accepted as the primary cause of
infections in postoperative wounds. These bacteria originate with staff. Every person sheds
10,000 skin particles per minute when in motion and approximately 10% of these carry
bacteria. The number of bacteria-carrying particles in the air depends upon the number of
persons in the operating theatre, the surgical clothing worn by staff and the efficiency of
ventilation.
The bacteria-carrying particles in the air contaminate the surgical site either directly or
indirectly by contaminating instruments or other sterile equipment.
Several measures to prevent postoperative wound infections are relevant for every surgery
and every patient. One important measure to prevent exogenous introduction of bacteria
into the surgical site, regardless of whether it is a matter of direct or indirect
contamination, is to ensure ventilation that counteracts wound exposure to airborne
bacteria.
SYSTEM DESCRIPTION