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

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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

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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

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TAF (Temperature-Controlled Air Flow)
In order to interrupt body convection from staff and thereby ensure that the air in the
wound site stays uncontaminated it is crucial that the speed of the air at the level of the
wound is at least 0.25 m/s. Lower air speed results in higher risk of CFU from the staff
reaching the wound site. Higher air speed might cause draughts, dehydration of the patient
and the staff, chilling of the patient and increased turbulence.
Benefits of a three-dimensional world
In the case of traditional LAF ceilings, two parameters are controlled to obtain a reduction
of bacteria-carrying particles at the surgical site.
1. Operating zone
It is really all about the area under the LAF ceiling. Over time, requirements on the size of
this area have increased as more equipment has become necessary for the surgery. A larger
area entails the need of more air supplied per unit of time, necessitating greater circulation.
This results in higher costs for investments and surgery.
2. Air speed
To ensure that the clean, HEPA-filtered air reaches the surgical site and protects against
contamination, the downward-flowing air stream must attain a certain speed. It is difficult
to determine exactly what this speed should be, but recommendations indicate at least
0.27 m/s at the level of the surgical site.
In an operating theatre there is always a stratifying phenomenon involving air temperature.
The air at the ceiling is the hottest and the air at the floor the coldest. The difference in
temperature depends on the amount of heat-generating sources in the room, including the
number of people present, exposure to the sun and heat-generating equipment. The
difference can be as much as several degrees and can shift rapidly over time. Different
temperatures do not mix.
The weight of air varies with temperature. The warm, lighter air rises to the ceiling while
the cold, heavier air falls to the ground. Air of different temperatures under low-
turbulent/laminar conditions does not mix. Instead, it seeks air layers at the same
temperature. When air at a certain temperature is released into a room, it moves until it
finds layer of air with the same temperature. Movement does not stop until then.
If air is blown in through an LAF ceiling it will seek a layer with the same temperature and
the movement will then stop. In some cases, the temperature of the blown air will be equal
to or higher than the existing temperature layer just below the ceiling. The air movement
will stop as soon as the energy from the fan in the LAF ceiling ends and the filtered, clean
air will spread horizontally instead of protecting the operating table.
The speed is controlled by the difference in temperature
If the air blowing in is colder than the air layer at the height of the wound site, the clean
and filtered air will reach the wound site and fulfil its protective purpose. The speed at the
wound site will vary depending on the difference in temperature between the supplied
filtered air and the surrounding air in the room. This is why it is essential that you measure
air speed at the level of the operating table and not only just below the ceiling.

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Due to the above described circumstances it is important to control the difference in
temperature between the supplied air and the existing air at the level of the operating
table and nowhere else.
When Opragon was developed and tested we discovered that it takes a difference in
temperature (ΔT-value) between -1.5 to -2°C to ensure an air speed at the level of the
operating table of 0.25 m/s. This difference is between the supplied clean and filtered air
and the surrounding air at the level of the operating table. Our system constantly monitors
and controls that the supplied air has an under temperature of 1.5-2°C regardless of the
temperature of the surrounding air.
The speed at the outer edge of a free-flowing downwards air flow with a limited cross-
sectional area can either be increased or reduced depending on the temperature difference
to the surrounding stationary air. Cold air has greater density than warm air and vice versa.
A vertical, free-flowing temperature-controlled air flow that is colder than the surrounding
air will sink towards the floor as long as the difference in temperature persists. Thus, it is
impossible to achieve such an air flow if the surrounding air has the same temperature or is
colder than the air supplied.
When air is supplied through an LAF ceiling, it will seek out a layer of air with the same
temperature and air movement will cease there. In unfavourable circumstances, the
temperature of the supplied air will be higher or equal to the temperature in the layer just
below the operating theatre ceiling. Air movement will then cease as soon as the kinetic
energy from the fan in the LAF ceiling dissipates and the clean air is disseminated
horizontally under the ceiling instead of protecting the surgical site. More advanced LAF
systems regulate the temperature of the supplied air so that it maintains the value set by
staff depending on comfort and type of surgical procedure. These systems are intended to
regulate the temperature for staff working under the LAF ceiling. They do not take into
consideration thermal loads that exist in the area. These are from heat from lamps,
electrical equipment, staff and, where applicable, solar radiation. They do not utilise gravity
as a propelling force to control the speed of the downward-flowing air flow either. They do
not control the difference in temperature between the supplied air and the surrounding
stationary air in the rest of the operating theatre. The temperature difference will
consequently vary depending on variations in thermal loads during surgery and the speed
of the air flow will fluctuate during and between surgeries.
The solution to the problem described above is to measure room temperature at the level
of the operating table and control the temperature of the air flow in relation to this value.
This way, air speed in the working area is controlled, which is desirable. The effect of this is
a well controlled air flow at the surgical site and control of the thermal loads in the
operating theatre. In addition, staff can choose a suitable room temperature in which to
work without jeopardising the protection against infection that the clean air flow is
intended to provide.
In order for this to work, a corresponding method is needed to control room temperature
that does not conflict with the temperature-controlled air flow above the operating table.
An effective solution to the problem is to control room temperature by supplying heated or
cooled air through air showers placed in the ceiling outside of the surgical environment. We
then obtain downward-flowing air flows with different speeds in the entire room. This also
enables adjustment of room temperature to the level that staff prefers or the procedure
requires without a change in the air speed at the surgical site.
Thus, instead of controlling one of two parameters that affect the temperature difference
between the supplied air at the surgical site and room temperature, TAF technique and the

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Opragon can control both. A downward-flowing flow of clean air is thereby maintained,
over time and independently of thermal loads introduced, at the surgical wound site. The
risk of postoperative infection as a consequence of airborne contagion in the operating
theatre is thereby reduced.
Opragon
The Opragon is the part of an integrated ventilation system for TAF that is visible to the
user.
The Opragon is available in several versions to fit spaces of different sizes and to
accommodate the user's need for working space in the operating zone. The names are
based on the number of air showers, see examples below.
The Opragon is available with through recesses for mounting pendulums, operating lights,
microscopes or other equipment. The Opragon is also available with built-in lighting. We
recommend, if possible, placing ceiling-mounted equipment outside of the Opragon
because it has a small diameter and there will be less impact on air flow in the operating
zone.
Opragon 8
Opragon 16
Opragon 5

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DIMENSIONING MANUAL
1. Selecting Opragon size
The Opragon system is adjusted for different types of applications. Opragon 8 is used for
normal operating theatres, fitted with 8-12 external air showers depending on the size of
the room.
The Opragon 5-6 is often suitable for preparation rooms and smaller operating theatres,
fitted with fewer air showers depending on the air flow and/or the size of the room.
For installations in hybrid rooms Opragon is customised to the conditions and several
solutions are possible. The biggest built solution as of today is an Opragon 30.
The number of external air showers (air showers outside of the Opragon itself) is
determined by several factors such as the size of the room, cleanliness requirements and
air flow. A standard operating theatre of about 60 m2will probably require about 10-12 air
showers.
These air showers work as an active component of temperature control in the room. When
there is a need for heating in the room the air showers supply over-tempered air and in the
opposite case, under-tempered air, but always with a guaranteed over-temperature
compared to the air supplied through the Opragon.
All evacuation of air takes place at floor level to accelerate the evacuation of airborne
bacteria.
Generally the air flow per air shower should be kept within 300-380 m³/h. Normally an air
flow of about 350 m³/h is preferred.
Table 1
Size
Shape
Size
(diam)
Number (n)
of air
showers
Air flow
min
(m³ / h)
max
Opragon 5
Ø 1.3 m
5
1,500
1,900
Opragon 6
Ø 1.6 m
6
1,800
2,300
Opragon 8
Ø 2.0 m
8
2,400
3,000
For other sizes or shapes other than circular/oval, contact Avidicare for information
about the shape and size of operating zones.
When a new system is installed, with the option of a complete TAF installation, an Opragon
8 is normally more than sufficient for most types of surgery.
DIMENSIONING MANUAL

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2. Sound and pressure drops
Resulting sound power levels (LwA) and pressure drops (Pa) are calculated using Chart 1
below. Use the selected air flow per air shower as the initial value.
Chart 1, Sound and pressure drop
Total pressure (Pa)
Sound power level (LwA)
Total pressure (Pa)
Sound power level (LwA)
Flow

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3. Duct connection
The placement and dimension of duct connections are tailored according to need. For the
calculation of the dimension of connecting ducts, a maximum air speed of 3.0 m/s is
recommended. Four main options for duct connection are shown below:
Fig. 1,from side, circular ducts Fig. 2,from above, circular ducts
Fig. 3, from side, rectangular duct Fig. 4, from above, rectangular ducts
When dimensioning ducts, consideration must be taken to the rim against the false ceiling,
the false ceiling and the suspension of the Opragon from the joists if connection is done
from the side, see Fig. 5.
Fig. 5, maximum duct diameter / duct height

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4. Mounting dimensions, weight and
adaptation
Mounting dimensions
Opragon is attached to the overhead joists using a screw attachment and is fitted at the
bottom with a 30 mm rim for a neat connection to the surrounding false ceiling. Opragon
has a low installation height which means that it can be also installed in cramped spaces
between the false ceiling and the ceiling/joists. Opragon should be mounted Opragon
directly on the joists.
Opragon's overall height is tailored according to need, see Fig. 2 and Fig. 3 below. The
minimum overall height as measured between Opragon's upper edge and the underside of
the surrounding false ceiling is 200 mm. Duct installation is made easier by the fact that
Opragon can be connected in several different ways. If space permits, Opragon can be
mounted suspended from the ceiling/joists so that the desired level of the false ceiling is
obtained.
Figure 2: Mounting directly on the ceiling Figure 3: Suspended mounting
Weight
Table 2 below shows the weight of each size of the Opragon. The values include air
showers. For weights without air showers, reduce by 1.33 kg per air shower.
Table 2, weight* Opragon (height 300 mm**)
Size
Weight
Opragon 5
65 kg
Opragon 6
75 kg
Opragon 8
100 kg
*Not including lighting
Adaptation
The Opragon can be adapted for most types of installation. It is also possible to make
recesses for ceiling pendulums, existing supply joists etc. in connection with an order. If
needed, the Opragon can also be delivered disassembled to facilitate receiving. Contact
Avidicare for support for adaptation and dimensioning.

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5. Selection of materials
Opragon is made of zincified, powder-coated sheet metal. The parts are joined by folding
and spot welding. The air showers consist of a fixed mounting ring of powder-coated
aluminium and a replaceable, permeable part (the air shower) of two layers of soft and
hardened Bulpren foam. Contact Avidicare if adaptation of the component materials, e.g.
stainless sheet steel or special lacquering, is required.
Cross-section of Opragon
6. Lighting
The lighting fixture meets the requirements for ease of bulb replacement and cleaning.
Contact Avidicare for more information, dimensioning and technical specifications.

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7. Determining air flow and number of air
showers outside of Opragon
Determine air flow and number of air showers
Determine the amount of air (QV) to be supplied via external air showers using the
following formula:
QVm3/h= (AOP –ATAF) x 72 + 0,2 x QK
Where:
AOP =Operating theatre area in m²
ATAF = Operating zone area in m²
QK= Air flow Opragon and other devices with under-tempered air in m³/h
The air flow through the air showers is selected within the range of 300-400 m³/h per air
shower, which makes it easy to calculate the number of air showers to be placed outside
the operating zone served by the Opragon.
Figure 6: Opragon 8 with externally located air showers
For calculation of sound pressure levels and pressure drops, see Chart 1 on page 15.

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8. HEPA filter
Opragon is normally delivered and installed separately from the HEPA filter bank.
Placement:
The filter cabinet for the HEPA filter is normally placed outside of the operating theatre,
directly adjacent to the circulation unit. If the circulation unit is placed far from the
operating theatre, it is a good idea to place the filter cabinet separately from the unit
directly adjacent to the operating theatre.
Dimensioning:
The filter bank is dimensioned for the total amount of air that is supplied to the operating
theatre and any adjacent rooms with an airlock function. The filters should be chosen with
an initial pressure drop of about 150 Pa and a final pressure drop of 100 Pa in addition to
that.
Filter quality:
Class H14 filters (according to EN 1822) are recommended for surgeries prone to infection.
The filter cabinet is delivered with sockets for leakage control.
For more detailed dimensioning, consult the unit or filter supplier. Avidicare can also supply
a HEPA filter and filter cabinet with the order.
Please contact Avidicare for more detailed consultation.
9. Description of controls
The flow chart below, Figure 9, shows the basic principles of controlling a TAF installation.
The room temperature sensors GT1:a and GT1:b record room temperature at the level of
the operating table. RB calculates and controls in accordance with the average of GT1:a and
GT1:b and emits an alarm if the difference between these is 1 ºC or greater.
Duct temperature sensor GT3 records the supply air temperature of the under-tempered
air that is supplied to Opragon and any air curtains and controls ST-LK2 via RC so that it
maintains a fixed adjustable lower temperature (-1.5 to -3 ºC) in relation to the average of
GT1:a and GT1:b.
The supply air temperature of the room temperature-regulated air that is supplied to the
external air showers and any adjacent rooms with airlock functions is controlled according
to the following sequence: The average of room temperature sensor GT1:a and GT1:b
controls ST-LK1 and ST-LV in sequence so that they maintain via RC an adjustable room
temperature. Room temperature is adjusted via a set point switch.
Duct temperature sensor GT4 restricts the supply air temperature of the room
temperature-regulated air so that it stays within an adjustable range, ideally between 17 to
27 ºC.
The set point switch for adjusting room temperature and the digital display of the room
temperature set and current values should be placed in the operating theatre to facilitate
adjustment by surgical staff. It should not be easy for surgical staff to adjust the lower
temperature.

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Figure 9:Control diagram

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INSTALLATION MANUAL
Safety instructions
•Read the installation instructions carefully before the Opragon is mounted and save
this document for future reference.
•Observe all warnings and follow the recommendations.
•The guarantee issued by Avidicare AB is valid only if the equipment is mounted in
accordance with these instructions.
•Inspect the product carefully when unpacking and contact Avidicare AB
immediately if visible damage or defects are discovered.
•The Opragon is delivered disinfected with covers on all connections and air shower
locations. These covers should be kept in place until otherwise indicated in the
installation instructions. This does not apply to models delivered in sections.
•All mounting and adjustments must be carried out by Avidicare personnel or
according to agreement.
•The assembly should be started and deployed (with mounted HEPA-filters) a few
days before the air showers are mounted. The protective plastic film that covers
the outlets for the showers can be cut out with a clean knife to let the air flow
through. In conjunction with the mounting of the air showers the plastic film can be
removed entirely.
•The air showers are delivered packaged from the factory. Observe necessary
hygiene and safety measures when mounting these in order to avoid
contamination.
Unpacking and packaging material
The Opragon is delivered with a pressure distribution box and air showers in separate
boxes. The larger Opragon models are delivered disassembled to facilitate receiving. The
pressure distribution box is packed in a wood fibre crate to protect against transport
damage. Remove the top of the crate by removing the screws along the edge. The air
showers are delivered wrapped in plastic and in a box. Inspect packaging materials and
boxes for any damage that may have occurred during transport before beginning
unpacking. If there is any damage that you suspect may have damaged the contents,
document this and contact the shipping agent before unpacking.
All storage must be in a temperature-controlled and clean storage space.
Assembly
The larger Opragon models are delivered in two or more sections depending on size. These
parts must be assembled in a unit before Opragon can be suspended from the ceiling. If
INSTALLATION MANUAL

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Opragon is symmetrically divided, the shape of the holes in the edge-reinforced end-pieces
is identical. Asymmetrical division may occur with customised units or units fitted with
lighting. The shape of the hole pattern will then be unique to the required end-pieces,
making incorrect assembly impossible. The joints are sealed with sealing strips intended for
the purpose and delivered with the Opragon.
Figure 9: Symmetrical hole pattern Figure 10: Asymmetrical hole pattern
Mounting/suspension from ceiling
Before suspending the Opragon from the ceiling the following steps should be taken. Mark
the center of the operating table in an appropriate manner.
Figure 11: Center the Opragon
When the center has been marked, place the Opragon above the mark. Protect the
Opragon so that it is not damaged or scratched. The curtain around the Opragon is
protected by a black plastic strip which is removed after the unit has been mounted to the
ceiling. Use a laser fitted spirit-level to locate the right places to drill in the joist above.

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Figure 12: Laser to find the right drilling places
After these measures have been taken the suspension can begin.
The Opragon is fitted with a rim, Figure 13, that is connected to the false ceiling. When
mounting directly on concrete joists, M8 or M10 expansion-shell bolts, respectively, are
used. If the Opragon is to be mounted suspended from the joists, two U-sections are
attached to the joists with M8-M10 expansion-shell bolts and two U-sections are attached
to the Opragon perpendicular to these using M8-M10 bolts. The Opragon is then
suspended in the U-sections mounted in the joists using threaded bar sections, which
enables horizontal adjustment and adaptation of height to the ceiling. If the joists are of the
cassette type, the designer's instructions for mounting on joists must be followed, as
incorrectly drilled holes can reduce the strength of the joints. With regard to other types of
joists or if you have any questions about how the Opragon should be mounted, contact
Avidicare.
Figure 13: Rim supporting the false ceiling

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A suspension may look like the following example:
Drill holes in the joist above that fit anchor bolts of the appropriate size (M10)
Figure 16: Anchor bolt
Place and tighten the anchor bolts so they are installed securely. Remove the nuts and fit
adapters for threaded rods.
Figure 17 and 18: Threaded rods
Attach the threaded rods to the adapters and place a securing nut on each (at the end
closest to the floor). This should then be locked against the Opragon when adjusted to the
right height.
Figure 19: Placement of anchor bolt and threaded rods
Lift the Opragon with a suitable lifting device, taking care not to damage the Opragon.
Secure the Opragon to the lifting device so that it cannot fall off or cause bodily injury.