Instructions For Use; Intended Use; Parts Diagram - SedanaMedical Sedaconda ACD Mode D'emploi

EN

Instructions for Use

1. INTENDED USE

EN
This Instructions For Use (IFU) describes the use of Sedaconda
connection of the Sedaconda ACD to the inspiratory port of the ventilator. This placement is intended
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for and enables the delivery of inhaled anaesthetics to patients with tidal volumes of 30-200 ml. The
advantage of the inspiratory side placement is that no dead space is added to the breathing circuit.
In contrast to the standard placement of the Sedaconda
patient) the inspiratory side placement only utilises the evaporator function of the Sedaconda
there is no reflection of inhaled anaesthetic. Therefore, higher inhaled anaesthetic pump rates can be
expected than with standard placement, despite lower tidal volumes.
Administration of isoflurane and sevoflurane using Sedaconda
fully equipped for the monitoring and support of respiratory and cardiovascular function and by persons
specifically trained in the use of inhalational anaesthetic drugs and the recognition and management
of the expected adverse effects of such drugs, including respiratory and cardiac resuscitation. Such
training must include the establishment and maintenance of a patient airway and assisted ventilation.
For more information regarding standard placement, see Sedaconda
PRINCIPLES OF OPERATION
The Sedaconda ACD consists of a plastic housing with an agent line for the continuous delivery of
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isoflurane or sevoflurane from a syringe pump to the miniature vaporizer where any clinical
dosage is immediately vaporized.
2. IMPORTANT USER INFORMATION
2.1 Carefully read these instructions before using Sedaconda
GENERAL WARNINGS
• Do Not use an Sedaconda ACD if the integrity of the package is breached or if packaging is visibly
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damaged.
• Do Not Use an additional standard Heat and Moisture Exchanger (HME) filter when the Sedaconda
ACD is used in the inspiratory side placement. Use of an HME filter will increase dead space in the
circuit and add resistance due to accumulation of water.
Instead active humidification of the respiratory gas is mandatory. Without active humidification the
patient will be subject to dry medical gas without humidification.
• Always place the active humidification device below the Sedaconda
condensate, with the black face uppermost.
• Do Not re-connect a used Sedaconda
any reason for any length of time. Always use a new one. There is a risk of losing control over
the concentration of volatile agent in the Sedaconda
unintentional filling from the syringe.
• Do Not use the Sedaconda ACD gas sampling port, since it is not giving correct gas-measurements
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in the inspiratory side placement.
• Always stop the syringe pump if disconnecting the Sedaconda
• Do Not use the bolus or purge function on the syringe pump unless programmed according to
hospital protocol.
• Sedana recommends the use of pre-programmable function on the syringe pump when delivering a
bolus in order to minimise the risk of overdosing.
• Do Not fold or clamp the agent line.
• Do Not seal the connector on the ventilator side except at disposal of Sedaconda
• Do Not use Sedaconda
® ACD with jet or oscillation ventilation.
• Re-processing of medical devices intended for single use only may result in degraded performance or
a loss of functionality e.g. resistance to breathing might increase. This product is not designed to be
cleaned, disinfected, or sterilized.
• Only use CE-approved ventilators complying with applicable requirements, including standard ISO
60601-2-12. Sedaconda ACD can be used with all conventional ventilator modes except oscillator
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mode for intubated patients. Use ventilator circuits compatible with anaesthetic agents. Use only with
ventilators with an accessible exhaust.
• Only use CE-approved syringe pumps complying with applicable requirements, including standard
ISO 60601-2-24. The pump must be programmable for Becton Dickinson Plastipak/Sherwood
Monoject 50 or 60 ml syringes. The highest switch-off pressure should be applied, to eliminate
pressure alarms due to the narrow lumen of the anaesthetic agent line.
• Anaesthetic gases should be monitored with a CE-approved gas analyser, which complies with its
applicable requirements and with the specifications of standard ISO 80601-2-55.
• Sedaconda ACD is approved for the delivery of volatile agents (VA). Sedana specifically
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recommends the use of isoflurane or sevoflurane, not desflurane or other volatile agents.
• Use polycarbonate-based components with precaution. Components may become degraded or
undergo stress cracking, if used in the patient breathing circuit in the presence of the anaesthetic
gases isoflurane or sevoflurane.
Symbol Description
Indicates a condition which if not followed exactly may cause harm to patient or
WARNING! a user. Do not proceed until the instructions are clearly understood and all stated
conditions are met.
Indicates a condition, which if not followed exactly may cause harm
to the product or equipment. Do not proceed until the instructions are clearly
understood and all stated conditions are met.
NOTE!
Indicates information important for optimal use of the product.
For single use only.
Read the Instruction for Use
carefully before use
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For further instructions, practice videos and much more, please visit www.sedanamedical.com
ACD for Small Tidal Volumes and the
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ACD (between the ventilator/Y-piece and the
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ACD should only be done in a setting
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ACD IFU.
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ACD and note the following
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ACD, to avoid accumulation of
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ACD that has been disconnected and unattended for
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ACD, specifically a risk of overdosing by
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ACD.
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Not for IV use.
Replace every 24 hours.
Sedaconda
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Inspiratory Limb Setup

3. PARTS DIAGRAM

The materials needed for the assembly (fig 1)
1. Syringe pump and Sedaconda
2. Anaesthetic gas analyser
3. Gas sampling line/Nafion line
4. Airway connector
ACD and
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Fig. 1
4. SETUP
4.1. Connecting scavenging
Residual anaesthetic agent scavenging is recommended when using the Sedaconda
active or passive scavenging according to the manufacturer's instructions for use. During inspiratory
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side placement additional moisture accumulates in the filter, which causes it to fill quicker. The
FlurAbsorb should therefore be changed after 5 syringes (à 50 ml), 24 hours or on demand when
resistance increase. For more information see the IFU for FlurAbsorb.
4.2. Connecting the anaesthetic gas analyser
• If the gas analyser requires a water trap or a special connection/adapter, use a new connector (check
the replacement intervals in the IFU of the gas analyser).
• Connect the gas analyser exhaust to the scavenging system.
• Switch on the gas analyser.
• Connect the airway connector between the Y-piece and the endotracheal tube.
• Connect the Nafion line to the airway connector.
• Connect the gas sampling line between the Nafion line and the gas analyser.
4.3. Filling the syringe
Always store isoflurane and sevoflurane at room temperature.
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Do Not use an Sedaconda
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5 days. Sedaconda
Do Not fill the Sedaconda
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ACD without the adaptor or with a different adaptor could lead to accidentally using the wrong medica-
tion with Sedaconda
• Open the bottle and screw the Filling Adapter on to the bottle.
• Unscrew the red cap from the red top of the Sedaconda
• Fill the Sedaconda
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• Connect the Sedaconda
• Turn the bottle upside down. Fill the Sedaconda
• Note: To avoid bubbles, try slowly moving the Syringe plunger back and forth.
• Unscrew the Syringe from the filling adapter.
• Remove any air from the Sedaconda
• Label the Sedaconda
according to Hospital protocol.
4.4. Connecting the Sedaconda
Always use active humidification when the Sedaconda
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Always place the Sedaconda
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Set up the active humidifier circuit according to the manufacturer's instructions.
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1. Remove the red cap from the Sedaconda
and the purple label from the gas sampling port
and close it.
2. Connect the Sedaconda
port of the ventilator.
3. Position the Sedaconda
side facing up and the patient side connection
point sloped down towards the active humidifier,
with an angle of about -45 degrees. If not possib-
le use a short flex tube.
4. Push the flexible extension tube on to the patient
side connection point on the Sedaconda
and the other side of the tube to the humidifier
and subsequently to the patient.
5. SETUP
5.1. Priming and start of therapy
Check that all connections are secure before starting therapy
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Do Not kink or clamp the anesthetic agent line. This might damage the line. The line contains a
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valve that prevents medication from escaping.
Do Not manually prime or give manual bolus doses, instead always use the syringe pump.
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Manual priming and blousing may result in an overdose.
ACD (Anaesthetic Conserving Device) –
Syringe 5. Ventilator
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6. Sedaconda ACD-L or Sedaconda
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7. Gas scavenging system
8. Active humidifier
Syringe that has been pre-filled and stored for longer than
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Syringe is for single patient use.
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Syringe without the Filling Adaptor. Attempting to fill the syringe
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® ACD.
Syringe.
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Syringe with 10 to 20 ml of air.
Syringe tightly to the Filling Adapter.
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Syringe slowly to avoid excessive bubbles.
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Syringe and close with the red cap.
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Syringe with information regarding anaesthetic agent and date of filling or label
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ACD
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ACD is placed on the inspiratory side.
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ACD above the active humidification device.
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ACD
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ACD to the inspiratory
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Insp.
ACD with the black
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ACD,
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ACD-S
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ACD. Connect
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