Instructions For Use - SedanaMedical AnaConDa Mode D'emploi

EN

Instructions for Use

1. INTENDED USE
EN
This Instructions For Use (IFU) describes the use of AnaConDa for Small Tidal Volumes and the
connection of the AnaConDa to the inspiratory port of the ventilator. This placement is intended 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 AnaConDa (between the ventilator/Y-piece and the
patient) the inspiratory side placement only utilises the evaporator function of the AnaConDa and
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 AnaConDa should only be done in a setting
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 AnaConDa IFU.
PRINCIPLES OF OPERATION
The AnaConDa consists of a plastic housing with an agent line for the continuous delivery of
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 AnaConDa and note the following
GENERAL WARNINGS
• Do Not use an AnaConDa if the integrity of the package is breached or if packaging is visibly
damaged.
• Do Not Use an additional standard Heat and Moisture Exchanger (HME) filter when the
AnaConDa 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 AnaConDa, to avoid accumulation of
condensate, with the black face uppermost.
• Do Not re-connect a used AnaConDa that has been disconnected and unattended for 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 AnaConDA, specifically a risk of overdosing by unintentional
filling from the syringe.
• Do Not use the AnaConDa gas sampling port, since it is not giving correct gas-measurements in
the inspiratory side placement.
• Always stop the syringe pump if disconnecting the AnaConDa.
• 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 AnaConDa
• Do Not use AnaConDa 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. AnaConDa can be used with all conventional ventilator modes except oscillator
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.
• AnaConDa is approved for the delivery of volatile agents (VA). Sedana specifically 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
WARNING! or 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
4
For further instructions, practice videos and much more, please visit www.sedanamedical.com
AnaConDa (Anaesthetic Conserving Device) –
Inspiratory Limb Setup
3. PARTS DIAGRAM
The materials needed for the assembly (fig 1)
1. Syringe pump and AnaConDa Syringe
2. Anaesthetic gas analyser
3. Gas sampling line/Nafion line
4. Airway connector
Fig. 1
4. SETUP
4.1. Connecting scavenging
Residual anaesthetic agent scavenging is recommended when using the AnaConDa. Connect
active or passive scavenging according to the manufacturer's instructions for use. During
inspiratory 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.
► Do Not use an AnaConDa Syringe that has been pre-filled and stored for longer than
► Do Not fill the AnaConDa Syringe without the Filling Adaptor. Attempting to fill the syringe
• Open the bottle and screw the Filling Adapter on to the bottle.
• Unscrew the red cap from the red top of the AnaConDa Syringe.
• Fill the AnaConDa Syringe with 10 to 20 ml of air.
• Connect the AnaConDa Syringe tightly to the Filling Adapter.
• Turn the bottle upside down. Fill the AnaConDa Syringe slowly to avoid excessive bubbles.
• 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 AnaConDa Syringe and close with the red cap.
• Label the AnaConDa Syringe with information regarding anaesthetic agent and date of filling or
label according to Hospital protocol.
4.4. Connecting the AnaConDa
► Always use active humidification when the AnaConDa is placed on the inspiratory side.
► Always place the AnaConDa above the active humidification device.
► Set up the active humidifier circuit according to the manufacturer's instructions.
1. Remove the red cap from the AnaConDa and
the purple label from the gas sampling port and
close it.
2. Connect the AnaConDa to the inspiratory port of
the ventilator.
3. Position the AnaConDa with the black side
facing up and the patient side connection point
sloped down towards the active humidifier, with
an angle of about -45 degrees. If not possible
use a short flex tube.
4. Push the flexible extension tube on to the patient
side connection point on the AnaConDa, and
the other side of the tube to the humidifier and
subsequently to the patient.
Not for IV use.
5. SETUP
Replace every 24 hours.
5.1. Priming and start of therapy
► Check that all connections are secure before starting therapy
► Do Not kink or clamp the anesthetic agent line. This might damage the line. The line
► Do Not manually prime or give manual bolus doses, instead always use the syringe pump.
5. Ventilator
6. AnaConDa or AnaConDa-S
7. Gas scavenging system
8. Active humidifier
5 days. AnaConda Syringe is for single patient use.
without the adaptor or with a different adaptor could lead to accidentally using the wrong
medication with AnaConDa.
contains a valve that prevents medication from escaping.
Manual priming and blousing may result in an overdose.
Insp.