Instructions For Use - SedanaMedical AnaConDa Mode D'emploi

EN

Instructions for Use

1. INTENDED USE
AnaConDa (Anaesthetic Conserving Device) is intended for administering isoflurane and
EN
sevoflurane 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
isoflurane or sevoflurane from a syringe pump to the miniature vaporizer where any clinical
dosage is immediately vaporized. During continued breathing the volatile anaesthetic agent
is re-circulated through the reflector consisting of an active carbon filter. The dead space of
100ml or 50ml needs to be considered for all patients and CO
Adjustments to CO can be achieved by optimising the ventilator parameters. In addition the
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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
Anesthetic agent line from pump
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
• Only use room temperature isoflurane or sevoflurane
• 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
• Isoflurane and sevoflurane are approved for general anaesthesia in the Operating Room but
are not approved for use in the Intensive Care Unit
• Always consider the dead space of the device vs tidal volume when ventilating the patient and
carefully monitor CO at Gas Monitor
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3.2 SYMBOLS
Symbol Description
WARNING! Indicates a condition which if not followed exactly may cause harm to patient
or a user. Do not proceed until the instructions are clearly understood and all
stated conditions are met.
CAUTION! 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.
SIS Enanvändarlicens: Strohmayer Consulting and Services AB / Beställd av Kristina Strohmayer, Kundnummer 132292,
EN 980:2008 (E) 2010-03-19
SS-EN 980:2008 (E)
5.18 Symbol for "CONSULT INSTRUCTIONS FOR USE"
Read the Instruction for Use carefully before use.
Replace every 24 hours.
NOTE 1 Synonym for "Consult instructions for use" is "Consult operating instructions".
NOTE 2 This symbol corresponds to that given in ISO 7000-1641 and to symbol number 5.3 in ISO 15223-1:2007.
5.19 Symbol for "BIOLOGICAL RISKS"
4. ADDITIONAL EQUIPMENT REQUIRED (FIG 1)
NOTE This symbol corresponds to that given in ISO 7000-0659 and to symbol number 5.1 in ISO 15223-1:2007.
5.20 Symbol for "KEEP AWAY FROM SUNLIGHT"
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 Plastipac or Monoject Sherwood 50 ml syringes 18
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needs to be carefully monitored.
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Bacterial / viral filter Gas monitor port
Evaporator / Vaporizer
Not for IV use.
For further instructions, practice videos and much more, please visit www.sedanamedical.com
AnaConDa (Anaesthetic Conserving Device) –
Administration system for anaesthetic agents
• Anaesthetic gas monitor, which displays concentrations of CO
• Ventilator
• Filling Adapter (REF 26042, 26064)
• 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 ml syringes.
4.3 Anaesthesia gas monitor with gas sampling line
It is mandatory to continuously 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 concentration. The Fi concentration should not be used. Only read the Fet value,
which reflects the 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
(REF 26053) 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
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
Patient
2 types, one for standard threading bottles (REF 26064) and one for Sevorane (REF 26042)
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
(REF 26096) which is used in conjunction with an accessory kit (REF 26072).
- 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 (REF 26042 or REF 26064) 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
Fig. 1
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 50ml Syringes
• Position the syringe pump at or lower than the patients head
When a side stream gas monitor is used:
- Remove the red cap on the AnaConDa (3)
- Connect the gas monitor sampling line (4) to the gas monitor (5) and to the AnaConDa gas
monitor sampling port (6).To reduce the amount of humidity in the line and water trap a nafion
dryer tubing (REF 26053) can be attached between the AnaConDa and the gas sampling line
and anaesthetic gases
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