SedanaMedical Sedaconda ACD Mode D'emploi page 5

• Place the filled Sedaconda Syringe in the syringe pump.
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• Open the red syringe cap and connect the Sedaconda
Sedaconda syringe.
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• Program the syringe pump to prime the anaesthetic agent line with a bolus of 1.2 ml. Never prime
manually.
• Start the syringe pump at 2 ml/hour and titrate the clinical dosage according to patient requirements.
5.2. Dose titration
• Titrate the dose according to clinical evaluation. The use of and dose of concomitant medications
should be reviewed when starting treatment with Sedaconda
• Increase the syringe pump rate in steps of 0.5 to 1 ml/hour until the desired FET% has been reached.
• Monitor the patient clinical status and hemodynamics closely to determine whether bolusing or dose
changes are needed.
• If necessary, program the syringe pump to give small bolus doses of 0.2 to 0.3 ml. Never use the
purge function or manual bolus. Caution: the age and size as well as the condition of the patient need
to be taken into account.
5.3. Ending therapy
There are two options to end the therapy.
For rapid wake-up, stop the syringe pump. The FET% directly starts to drop – the patient will normally
wake up within minutes unless other drugs are given.
For slow wake-up, reduce the syringe pump rate stepwise according to clinical needs. The FET% will
be reduced according to the reduced pump rate.
6. REPLACING AN EMPTY SEDACONDA
DEVICE
In order to reduce the risk of inadvertent awakening, the Sedaconda
should be changed without delay. Drug concentration will drop as soon as the syringe pump is stopped.
6.1. Changing the Sedaconda Syringe
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Change the Sedaconda Syringe after one use, as soon as it empties.
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• Prepare a new Sedaconda ® Syringe according to the steps above, part 4.3.
• Stop the syringe pump.
• Disconnect the anesthetic agent line from the used Sedaconda
Syringe with the red cap.
• Remove the used Sedaconda Syringe from the syringe pump.
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• Place the filled Sedaconda Syringe in the syringe pump and unscrew the red cap.
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• Connect the Sedaconda ACD anesthetic agent line to the new Sedaconda
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• Start the syringe pump with the same rate as before.
• Dispose of the used Sedaconda Syringe according to hospital protocols.
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6.2. Changing the Sedaconda ACD
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Change the Sedaconda ACD after 24 hours of use, or earlier in the event of abnormal secreti-
► ®
ons or blockages. The Sedaconda ACD is for single patient use only.
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• Prepare a new Sedaconda ACD.
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• Stop the syringe pump.
• Disconnect the anesthetic agent line from the Sedaconda
Syringe with the red cap.
• Disconnect the used Sedaconda ACD from the ventilator inspiratory port side first.
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• Disconnect the used Sedaconda ACD from the flexible extension tube side next.
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• Insert the new Sedaconda ® ACD by connecting at the inspiratory port first and then to the flexible
extension tube.
• Connect the anesthetic agent line to the Sedaconda
• Program the syringe pump to prime the anesthetic agent line with a bolus of 1.2 ml. Never prime
manually.
• Start the syringe pump with the same rate as before.
7. DISPOSAL OF PRODUCTS
Syringes with remaining liquid anesthetic must be disposed of according to local routines for special
waste. All other products can be disposed of in the standard hospital waste.
Recommended replacement intervals:
Item Changing interval
Sedaconda ACD-L Single patient use
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Sedaconda ACD-S Changed every 24 hour or earlier if needed
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Sedaconda syringe Single use
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Nafion line Single patient use, with a maximum length use of 7 days
Gas sampling line Replaced as needed in accordance to hospital hygiene regulations
Multi patients use
FlurAbsorb Capacity of up to 5 syringes (à 50ml), 24 hours use or when signs
of increased resistance are detected
FlurAbsorb Accessory Kit Single patient use
Single Use Filling Adapter
Isoflurane/Sevoflurane Single use
Standard screw top bottles
Single patient use
Water trap
Max days of use according to the manufacturer's instructions
8. PROCEDURES AFFECTING DRUG DELIVERY
Procedures that may affect drug delivery include:
• Endotracheal suctioning
• Bronchoscopy
• Nebulisation
For endotracheal suction, there are two possible ways, either with closed suction system or adapter
with bronchoscopy cap. If clinically needed a bolus of inhaled anaesthetic can be given shortly before
suctioning.
ACD anaesthetic agent line to the
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ACD.
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SYRINGE AND SEDACONDA ACD
® ®
ACD and Sedaconda Syringe
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Syringe and close the Sedaconda
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Syringe.
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Syringe and close the Sedaconda
® ®
Syringe in the syringe pump.
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For further instructions, practice videos and much more, please visit www.sedanamedical.com
Sedaconda ACD (Anaesthetic Conserving Device) –
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Inspiratory Limb Setup
During bronchoscopy minor leakage may occur. Open only the smallest opening of the bronchoscopy
adapter in order to minimise leakage. Inhaled anaesthetic delivery is reduced by the bronchoscope.
Additional medications should be considered to facilitate the procedure.
Ambient concentration measurements during these procedures have shown transient elevations but
these elevations are short-lived and below recommended exposure limits, indicating minimal risks for
staff.
During nebulisation, the nebuliser should be placed in the breathing circuit according to the
manufacturer's instructions for use. Use the device according to normal daily procedures.
TECHNICAL SPECIFICATION
Anaesthetic Agents
Syringe
Stability of filled syringes
Tidal volume working range
Sedaconda ACD dead space
®
Resistance to gas flow at 60 l/min
Moisture loss
Filter capacity: Bacterial filtration
Viral Filtration
Weight
Agent Line Length
Connectors (According to ISO 5356)
Gas Sampling Port
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In case of a serious incident please contact the competent authority and the legal manufacturer
Sedana Medical Ltd.
Sedana Medical Ltd., Unit 2A The Village Centre,
Two Mile House, Naas, Co. Kildare, W91 PWH5, Ireland
100 ML 50 ML
Only use room temperature sevoflurane (18°-25°C) and
isoflurane (18°-30°C)
Only use the Sedaconda syringe
®
5 days
350-1200 ml 200-800 ml
at Y-piece & ET-tube at Y-piece & ET-tube
30-200 ml on inspiratory 30-200 ml on inspiratory
placement placement
Approx. 100 ml Approx. 50 ml
2.5 cm H2O (250 pa) 3.0 cm H2O (300 pa)
5 mg/l (@ 0.75L X 12 bpm) 5 mg/l (@ 0.5L X 15 bpm)
7 mg/l (@ 1.0L x 10 bpm) 6 mg/l (@ 0.75L x15 bpm)
99,867 %
99,76 %
50 g
2.2 m
15F/22M-15M
Female Luer Lock
3000 176-2103/EN/Rev.1 2021-03
EN
2797
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