Instructions For Use; Intended Use - SedanaMedical AnaConDa Mode D'emploi

EN

Instructions for Use

1. INTENDED USE

EN
AnaConDa (Anaesthetic Conserving Device) is intended for administering isoflurane and sevoflura-
ne to invasively ventilated patients.
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 patent airway and assisted ventilation.
The AnaConDa is intended for single use only and needs to be replaced every 24 hours or when
needed e.g. at unexpected events such as sudden blockage of the airways because of secretion etc.
The AnaConDa is available in AnaConDa 100 ml (AnaConDa ) and AnaConDa 50 ml (AnaConDa-S)
sizes. The instructions contained in this document apply to both devices.
2. PRINCIPLES OF OPERATION
The AnaConDa consists of a plastic housing with an agent line for the continuous delivery of isoflu-
rane or sevoflurane from a syringe pump to the miniature vaporizer where any clinical dosage is im-
mediately vaporized. During continued breathing the volatile anaesthetic agent is reflected through
the reflector consisting of an active carbon filter. The dead space of 100 ml or 50 ml needs to be
considered for all patients and CO
achieved by optimising the ventilator parameters. In addition the AnaConDa is an excellent heat- and
moisture exchanger and it includes an efficient bacterial/ viral filter.
Cross Section Drawing of the AnaConDa
Active Carbon layer
Ventilator/HME
Anaesthetic agent line
3. IMPORTANT USER INFORMATION
3.1 Carefully read these instructions before using AnaConDa and note the following
GENERAL WARNINGS
• Do not use desflurane
• 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
• Isoflurane: Only use room temperature 18 ° – 30 ° Celsius
• Sevoflurane: Only use room temperature 18 ° – 25 ° Celsius
• Do not use an AnaConDa if the integrity of the package is breached or if packaging is visibly
damaged
• Always stop the syringe pump if disconnecting the AnaConDa
• Do not prime the agent line manually. Always use the syringe pump
• Position the patient side connector of the AnaConDa, lower than the machine side, to avoid
accumulation of condensate, with the black face uppermost
• Do not use the bolus or flush function on the syringe pump unless programmed according to
hospital protocol
• Do not fold or clamp the agent line
• Do not use AnaConDa with jet or oscillation ventilation
• Do not use active humidification together with AnaConDa
• Do not use AnaConDa on patients with copious secretions
• 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
• Never seal the connector on the ventilator side except at disposal of AnaConDa
• Only use Isoflurane and Sevoflurane according to their respective SmPC documents.
• Always consider the dead space of the device vs tidal volume when ventilating the patient and
carefully monitor CO at Gas Monitor
2
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 pro-
duct 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 care-
fully before use
4. ADDITIONAL EQUIPMENT REQUIRED (FIG 1)
Only medical devices which bear the CE mark and which comply with its applicable international
standards, may be used. AnaConDa must be used with the following equipment:
• AnaConDa Syringe (REF 26022)
• Syringe pump with settings for BD Plastipak or Monoject Sherwood 50/60 ml syringes
• Anaesthetic gas monitor, which displays concentrations of CO
4
For further instructions, practice videos and much more, please visit www.sedanamedical.com
needs to be carefully monitored. Adjustments to CO
2
Bacterial/viral filter Gas monitor port
Evaporator / Vaporizer
Not for IV use.
Replace every 24 hours.
and anaesthetic gases
2
AnaConDa (Anaesthetic Conserving Device)
• Ventilator
• Applicable adapters for Isoflurane and Sevoflurane use.
• Gas scavenging system
4.1 AnaConDa Syringe
The AnaConDa syringe is the same dimension as a Becton Dickinson Plastipak or Sherwood
Monoject 50ml syringe, however it also has a unique coupling to fit the connector on the agent line
of the AnaConDa. There are boxes to tick on the labelling, to indicate which volatile agent is being
used, Isoflurane or Sevoflurane. The syringes can be pre-filled and stored up to 5 days if stored in a
dark environment at room temperature. Make sure that the syringe is safely closed.
4.2 Syringe pumps
Use only CE-labeled syringe pumps, which comply with its applicable requirements, in particular with
the specifications of standard EN 60601-2-24, and which are programmable pumps with settings for
Becton Dickinson Plastipak or Sherwood Monoject 50/60 ml syringes.
4.3 Anaesthesia gas monitor with gas sampling line
It is mandatory to monitor the anaesthetic gases with a CE-labeled gas monitor, which
complies with its applicable requirements, in particular with the specifications of standard
EN ISO 80601-2-55. The gas monitor must display concentrations of carbon dioxide and anaesthetic
gases to be able to identify the Fet (end-expiratory) concentration, which represents the alveolar
can be concentration. The Fi concentration should not be used. Only read the Fet value, which reflects the
2
alveolar concentration. There are 2 types of gas monitors; side stream or mainstream; both can be
used with AnaConDa.
Side Stream Gas Monitor
When using a side stream monitor, connect the gas monitor sampling line to the gas monitor and to
the AnaConDa gas monitor sampling port. With the side stream monitor, Nafion Dryer Tubing can be
attached between the AnaConDa and the gas sampling line
Mainstream Gas Monitor
When using the mainstream gas monitor connect the required airway adaptor between the
AnaConDa and the patient.
4.4 Ventilator
Use only CE-labeled ventilators which comply with its applicable requirements, in particular
Patient
with the specifications of standard EN 60601-2-12. AnaConDa can be used on all conventional
modes but not on oscillator mode for intubated patients. Use ventilator circuits suitable for use with
anaesthetic agents.
4.5 Filling Adaptor
For safe filling of the AnaConDa syringe the correct filling adaptor must be used. There are 2 types,
one for standard threading bottles and one for Sevorane from AbbVie with Quik-Fil closure.
4.6 Gas scavenging system
Sedana Medical recommends scavenging the exhaust gases from the ventilator and the gas monitor.
Passive Gas Scavenging
There is a passive scavenging system available from Sedana Medical called FlurAbsorb
and FlurAbsorb- S which is used in conjunction with an accessory kit.
Active Gas Scavenging
Active Gas Scavenging can be used if installed or a central vacuum source can be used together
with a pressure equalization system, which can be provided by the manufacturer of ventilators.
5. SYSTEM ASSEMBLY
5.1 Filling the AnaConDa syringe
• Attach the correct Filling Adaptor to the anaesthetic agent bottle
• Connect the syringe to the adapter by pressing and turning it until it is secured
• Turn the bottle with syringe upside down
• Fill the syringe by withdrawing and pushing the plunger back and forth slowly 5-10 times
• Turn the bottle back
• Wait to the count of four of seconds for bottle to equalise before disconnecting
• Remove the syringe from the bottle ensuring that no air bubbles remain in the syringe
• Close the syringe with the syringe closure
• Note on the syringe label which anaesthetic agent is used and date of filling
5.2. Set-up (Fig.1)
• Connect the exhaust from the ventilator and gas monitor to the gas scavenging system (1)
• Position the syringe in the syringe pump (2)
• Set the syringe pump at settings for BD Plastipak or Monoject Sherwood 50/60ml Syringes
• Position the syringe pump at or lower than the patients head