Co2ntrol Sofnolime IFU (English) |

Colour indicator Isoflurane, Desflurane and Sevoflurane. Sevoflurane (only) is reported to be During use the white granules will start to turn violet in colour and will able to degrade in contact with strong bases to produce breakdown ® deepen in intensity to indicate exhaustion of Sofnolime® and Sofnolime products of unknown toxicity to humans. Desflurane can degrade to produce SoLo®. The intensity of colour change may vary from one procedure to small amounts of carbon monoxide if it gets warm in the presence of a another. The appearance of a colour change confirms the activity of the strong alkali. Sofnolime® and Sofnolime SoLo® uses a low concentration co ntrol material and indicates the progress of the carbon dioxide absorption. of sodium hydroxide to catalyse the reaction. This ensures a high carbon 2 This allows any severe uneven gas flow (chanelling) within the canister dioxide capacity whilst at the same time minimising the risk of anaesthetic to be identified. agent interactions. Suitable monitoring of inspired carbon dioxide is required to assess when Neither carbon monoxide nor compound A, in other than trace clinically to replace the soda lime as it is the trailing edge of the reaction zone that insignificant amounts, are formed in a properly run circuit. Extreme, INSTRUCTIONS FOR USE changes colour, not the leading edge. A slowly increasing carbon dioxide abnormally hot, dry conditions are required to produce significant quantities of any by-products. Sofnolime® and Sofnolime SoLo® is widely used with ® ® 1. concentration at the outlet will usually begin to occur when the colour Sofnolime and Sofnolime SoLo Press the button; the absorber change has penetrated to around half the depth of the cartridge. these agents and has been shown to exhibit a low interaction compared with swings open on its mounting other brands of soda lime. The reduction of moisture levels in soda lime Carbon dioxide absorber 2. Remove the disposable absorber Colour regeneration should therefore be avoided and the following precautions are suggested: from the mounting If exhausted self-indicating soda lime is left to stand its colour will slowly • Ensure regular change-out of co2ntrol cartridges Warning change back to white, due mainly to small quantities of unreacted sodium • Avoid setting basal or continuous flow of oxygen or fresh gas overnight or hydroxide in the interior of the granules migrating to the surface. over weekends if absorbent is still in place For a full understanding of the performance characteristics of this medical • Ensure valves on gas delivery unit and central gas supply/central gas suction device, the user should carefully read these instructions before use. Sofnolime® and Sofnolime SoLo® in this apparently regenerated condition are switched to ‘park’ between cases and daily respectively should never be used again as it will quickly become exhausted and its • Avoid attempts to dry out circuits between cases (if the co2ntrol Pre-filled absorbers should only be unsealed immediately prior to use to colour will usually change again almost immediately. It is therefore essential absorber is in place) by running the ventilator, setting continuous gas flows ensure the product is fresh and the history is known. to always dispose of absorbers immediately after use. or using central suction • Use low or moderate gas flows to maintain moisture levels in the circuit. Symbols Heat and moisture appearance Some circle systems have the absorber immediately downstream of the 2 Single use, do not reuse The reaction of soda lime with carbon dioxide typically produces a 10-30°C fresh gas inlet which may dry the soda lime more rapidly temperature increase in the absorber. Higher temperature increases are • Bypass the absorber when using high flows for extended periods or Keep away from sunlight Keep dry observed with lower fresh gas flow rates due to the increased carbon remove absorbent when equipment is out of use or on standby for more dioxide loading on the absorber. than a day Should the soda lime be suspected to have dried out (for example, to be less Consult instructions for use Manufacturer Temperatures much above 50°C may indicate abnormal conditions (see Safety aspects). The heat of reaction is often sufficient to cause some of the than about 5% w/w water), or if a sharp temperature increase is observed water in the soda lime to evaporate and condense elsewhere in the during the washing-in phase, or an unusual delay in the increase in inspired Expiry REF Reference number breathing circuit. The patient also contributes some humidity through anaesthetic concentration is observed, the soda lime absorber should be respiration. A water trap is incorporated in the absorber to isolate replaced immediately with a fresh unit. Water should never be added to excess water. Free water in the absorber is not a problem unless it Sofnolime® or Sofnolime SoLo® to try to correct for low moisture as this will ! Warning Temperature limits reaches excessive levels, at which point it can locally flood the granule decrease the efficiency of the absorber due to local flooding. The moisture surface preventing gas contacting and possibly cause clumping of granules content range is factory controlled to meet the required medical specification on standing. (USP 12-19%). LOT Lot number CE mark Spent Sofnolime® and Sofnolime SoLo® canisters may still contain some 3. Before fitting in place, shake Duration in use absorbed or entrained anaesthetic agent which needs to be assessed and Time of first use Date of first use the absorber to level the fill A cartridge of soda lime cannot be expected to give performance of a fixed managed during disposal (see Safety Data Sheet for guidance on disposal). number of hours. Lifetime will depend not only on the original soda lime, ® ® 4. Remove the cap Sofnolime and Sofnolime SoLo do not contain phthalates, medicinal but also on other factors including: products or blood derivatives. 5. Slide the new co2ntrol • Gas flow rate absorber onto the mounting • Patient size Storage Intended use 07/03/16 • Respiratory and metabolic rate co2ntrol canisters should be kept sealed and stored in a clean, dry co2ntrol can only be used on the following Dragër workstations if they have • Design and packaging of the cartridge and breathing circuits been fitted with the Dragër CLIC® adaptor MX50090: • Handling and condition of the soda lime environment at an even temperature between 0-35°C. Storage at higher • Zeus, Zeus IE temperatures can result in reduced efficiency and service life due to moisture ® • Primus, Primus IE, Apollo, Pallas As a rough guide, Sofnolime will absorb approximately 110-140 litres of loss. When correctly stored, unopened packs will maintain absorption capacity ® for 2 years. • Fabius CE, Fabius GS, Fabius Tiro carbon dioxide per kg of Sofnolime under typical anaesthesia conditions. This equates to around 12 hours per kg for an average patient with a base • Julian metabolism producing 200cm3 of carbon dioxide per minute. Sofnolime Containers must not be stored where they can become subject to • Cicero EM SoLo® will absorb approximately 80-110 litres of carbon dioxide per kg of the following: EK: ® • Direct strong sunlight • Cato Sofnolime SoLo under typical anaesthesia conditions. This equates to • Contact with, or close to, incompatible chemicals or acids • Edition around 9 hours per kg for an average patient with a base metabolism producing 200 cm3 of carbon dioxide per minute. • Partial or total water immersion • Perseus • Atmospheres with abnormal concentrations of carbon dioxide, hydrogen sulphide or other acidic gases The co2ntrol absorber can be replaced during operation. A valve in Do not use with the Cicero A, B, C, monochrome, and Cato

• The disposable absorber has been used for 4 weeks or longer • Powdered soda lime on the skin must be washed off immediately Manufactured by: Molecular Products Ltd Always remove spent absorbers from the device and dispose of immediately. Sofnolime® and Sofnolime SoLo® are not recommended for use with Parkway Harlow Business Park trichloroethylene (Trilene) and chloroform, but can be safely used with Harlow, Essex Replace the absorber quickly to ensure continuous CO2 absorption in the modern anaesthetic gases. The most commonly used gases are nitrous oxide CM19 5FR, UK (N O), Halothane, Enflurane, +44(0)1279 445111 0086 Version 1, 07/03/16, JAW/EK breathing system. 2 Colour indicator Isoflurane, Desflurane and Sevoflurane. Sevoflurane (only) is reported to be During use the white granules will start to turn violet in colour and will able to degrade in contact with strong bases to produce breakdown ® deepen in intensity to indicate exhaustion of Sofnolime® and Sofnolime products of unknown toxicity to humans. Desflurane can degrade to produce SoLo®. The intensity of colour change may vary from one procedure to small amounts of carbon monoxide if it gets warm in the presence of a another. The appearance of a colour change confirms the activity of the strong alkali. Sofnolime® and Sofnolime SoLo® uses a low concentration co ntrol material and indicates the progress of the carbon dioxide absorption. of sodium hydroxide to catalyse the reaction. This ensures a high carbon 2 This allows any severe uneven gas flow (chanelling) within the canister dioxide capacity whilst at the same time minimising the risk of anaesthetic to be identified. agent interactions. Suitable monitoring of inspired carbon dioxide is required to assess when Neither carbon monoxide nor compound A, in other than trace clinically to replace the soda lime as it is the trailing edge of the reaction zone that insignificant amounts, are formed in a properly run circuit. Extreme, INSTRUCTIONS FOR USE changes colour, not the leading edge. A slowly increasing carbon dioxide abnormally hot, dry conditions are required to produce significant quantities of any by-products. Sofnolime® and Sofnolime SoLo® is widely used with ® ® 1. concentration at the outlet will usually begin to occur when the colour Sofnolime and Sofnolime SoLo Press the button; the absorber change has penetrated to around half the depth of the cartridge. these agents and has been shown to exhibit a low interaction compared with swings open on its mounting other brands of soda lime. The reduction of moisture levels in soda lime Carbon dioxide absorber 2. Remove the disposable absorber Colour regeneration should therefore be avoided and the following precautions are suggested: from the mounting If exhausted self-indicating soda lime is left to stand its colour will slowly • Ensure regular change-out of co2ntrol cartridges Warning change back to white, due mainly to small quantities of unreacted sodium • Avoid setting basal or continuous flow of oxygen or fresh gas overnight or hydroxide in the interior of the granules migrating to the surface. over weekends if absorbent is still in place For a full understanding of the performance characteristics of this medical • Ensure valves on gas delivery unit and central gas supply/central gas suction device, the user should carefully read these instructions before use. Sofnolime® and Sofnolime SoLo® in this apparently regenerated condition are switched to ‘park’ between cases and daily respectively should never be used again as it will quickly become exhausted and its • Avoid attempts to dry out circuits between cases (if the co2ntrol Pre-filled absorbers should only be unsealed immediately prior to use to colour will usually change again almost immediately. It is therefore essential absorber is in place) by running the ventilator, setting continuous gas flows ensure the product is fresh and the history is known. to always dispose of absorbers immediately after use. or using central suction • Use low or moderate gas flows to maintain moisture levels in the circuit. Symbols Heat and moisture appearance Some circle systems have the absorber immediately downstream of the 2 Single use, do not reuse The reaction of soda lime with carbon dioxide typically produces a 10-30°C fresh gas inlet which may dry the soda lime more rapidly temperature increase in the absorber. Higher temperature increases are • Bypass the absorber when using high flows for extended periods or Keep away from sunlight Keep dry observed with lower fresh gas flow rates due to the increased carbon remove absorbent when equipment is out of use or on standby for more dioxide loading on the absorber. than a day Should the soda lime be suspected to have dried out (for example, to be less Consult instructions for use Manufacturer Temperatures much above 50°C may indicate abnormal conditions (see Safety aspects). The heat of reaction is often sufficient to cause some of the than about 5% w/w water), or if a sharp temperature increase is observed water in the soda lime to evaporate and condense elsewhere in the during the washing-in phase, or an unusual delay in the increase in inspired Expiry REF Reference number breathing circuit. The patient also contributes some humidity through anaesthetic concentration is observed, the soda lime absorber should be respiration. A water trap is incorporated in the absorber to isolate replaced immediately with a fresh unit. Water should never be added to excess water. Free water in the absorber is not a problem unless it Sofnolime® or Sofnolime SoLo® to try to correct for low moisture as this will ! Warning Temperature limits reaches excessive levels, at which point it can locally flood the granule decrease the efficiency of the absorber due to local flooding. The moisture surface preventing gas contacting and possibly cause clumping of granules content range is factory controlled to meet the required medical specification on standing. (USP 12-19%). LOT Lot number CE mark Spent Sofnolime® and Sofnolime SoLo® canisters may still contain some 3. Before fitting in place, shake Duration in use absorbed or entrained anaesthetic agent which needs to be assessed and Time of first use Date of first use the absorber to level the fill A cartridge of soda lime cannot be expected to give performance of a fixed managed during disposal (see Safety Data Sheet for guidance on disposal). number of hours. Lifetime will depend not only on the original soda lime, ® ® 4. Remove the cap Sofnolime and Sofnolime SoLo do not contain phthalates, medicinal but also on other factors including: products or blood derivatives. 5. Slide the new co2ntrol • Gas flow rate Intended use absorber onto the mounting • Patient size Storage • Respiratory and metabolic rate 07/03/16 co2ntrol canisters should be kept sealed and stored in a clean, dry co2ntrol can only be used on the following Dragër workstations if they have • Design and packaging of the cartridge and breathing circuits been fitted with the Dragër CLIC® adaptor MX50090: • Handling and condition of the soda lime environment at an even temperature between 0-35°C. Storage at higher • Zeus, Zeus IE temperatures can result in reduced efficiency and service life due to moisture ® • Primus, Primus IE, Apollo, Pallas As a rough guide, Sofnolime will absorb approximately 110-140 litres of loss. When correctly stored, unopened packs will maintain absorption capacity ® for 2 years. • Fabius CE, Fabius GS, Fabius Tiro carbon dioxide per kg of Sofnolime under typical anaesthesia conditions. This equates to around 12 hours per kg for an average patient with a base • Julian metabolism producing 200cm3 of carbon dioxide per minute. Sofnolime Containers must not be stored where they can become subject to • Cicero EM SoLo® will absorb approximately 80-110 litres of carbon dioxide per kg of the following: • Cato ® EK: • Direct strong sunlight Sofnolime SoLo under typical anaesthesia conditions. This equates to • Contact with, or close to, incompatible chemicals or acids • Edition around 9 hours per kg for an average patient with a base metabolism producing 200 cm3 of carbon dioxide per minute. • Partial or total water immersion • Perseus • Atmospheres with abnormal concentrations of carbon dioxide, hydrogen sulphide or other acidic gases The co2ntrol absorber can be replaced during operation. A valve in Do not use with the Cicero A, B, C, monochrome, and Cato