c-series Water Bath Additive

Transcription

1 c-series Water Bath Additive 275-3_c-series Water Bath Additive_ _2_275_.pdf FOR U.S. CUSTOMERS ONLY EPA REG. NO EPA EST. NO CAN-002 FOR USE WITH THE Alinity c-series ANALYZERS This product is used to prevent and control microbial contamination in the water bath. Active Ingredients: 5-Chloro-2-methyl-4-isothiazolin-3-one % 2-Methyl-4-isothiazolin-3-one % Inert Ingredients % Total % Keep Out of Reach of Children CAUTION FIRST AID If in eyes: Hold eye open and rinse slowly and gently with water for 15 to 20 minutes. (Remove contact lenses, if present, after the first 5 minutes then continue rinsing the eye.) Call a poison control center or doctor for treatment advice. If on skin and/or on clothing: Take off contaminated clothing. Rinse skin immediately with plenty of water for minutes. Call a poison control center or doctor for treatment advice. If swallowed: Immediately call a poison control center or doctor for treatment advice. Have person sip a glass of water if able to swallow. Do not induce vomiting unless told to do so by the poison control center or doctor. Do not give anything by mouth to an unconscious person. Important: Have the product container or label with you when calling a poison control center or doctor, or going for treatment. Note to physician: Probable mucosal damage may contraindicate the use of gastric lavage. PREPARATION FOR USE 1. c-series Water Bath Additive is ready-to-use. 2. Verify that the bottle has not leaked. 3. Remove the black cap by turning the cap counterclockwise until the cap stops. 4. Align the tabs on the cap with the grooves in the cartridge and pull the cap to remove it. DIRECTIONS FOR USE It is a violation of Federal law to use this product in a manner inconsistent with its labeling. The Alinity c-series Maintenance Solutions cartridge, containing 08P9871 the c-series Water Bath Additive, is placed in the analyzer loading area, then loaded into the analyzer. The c-series Water Bath Additive is automatically dispensed into the water bath during specific operations which control microbial contamination in the water bath. Do not use this product as a disinfectant. PRECAUTIONARY STATEMENTS Hazards to Humans and Domestic Animals CAUTION. Causes moderate eye and skin irritation. Harmful if swallowed or inhaled. Do not get in eyes, on skin or on clothing. Wear protective eyewear and chemically resistant gloves when handling this product. Wash thoroughly with soap and water after handling. Prolonged or frequently repeated skin contact may cause allergic reactions in some individuals. USER SAFETY RECOMMENDATIONS User should: Wash hands before eating, drinking, chewing gum, using tobacco, or using the toilet. Remove clothing immediately if product gets inside, then wash thoroughly and put on clean clothing. Remove personal protective equipment immediately after handling this product. Wash the outside of gloves before removing. As soon as possible, wash thoroughly. ENVIRONMENTAL HAZARDS This chemical is toxic to terrestrial and aquatic plants, fish and aquatic invertebrates. STORAGE AND DISPOSAL Do not contaminate water, food or feed by storage or disposal. Storage: Store at C in original packaging. Product Disposal: Pesticide wastes may be hazardous. Improper disposal of excess pesticide, spray mixture or rinsate is a violation of Federal Law. If these wastes cannot be disposed of by use according to label instructions, contact your State Pesticide or Environmental Control Agency, or the Hazardous Waste Representative at the nearest EPA Regional Office for guidance. Container Handling: Non-refillable container. Do not reuse or refill this container. Offer for recycling if available or discard in trash. Distributed by: ABBOTT LABORATORIES 100 N. Abbott Park Road Abbott Park, IL Net Contents: Bottle 2.3 fl.oz. (68.4 ml) Carton 10 x 2.3 fl.oz (10 x 68.4 ml) G72849R01

2 EPA REG. NO EPA EST. NO CAN-002 c-series Water Bath Additive 2.3 fl.oz. Active Ingredients: 5-Chloro-2-methyl-4-isothiazolin-3-one % 2-Methyl-4-isothiazolin-3-one % Inert Ingredients % Total % Keep Out of Reach of Children CAUTION Refer to accompanying label on outer box for complete information. ABBOTT Wiesbaden, Germany G72850R01

3 Maintenance Solutions Maintenance Solutions Exp. 08P x 12 c-series Water Bath Additive 10 x 68.4 ml Lyophilized Cleaning Solution 10 x 12 ml Cleaning Solution 1 x 150 ml Exp. G72846R01 Abbott GmbH & Co. KG Max-Planck-Ring Wiesbaden Germany Sekisui Diagnostics P.E.I. Inc. 70 Watts Avenue Charlottetown Prince Edward Island C1E 2B9 Canada 8P98_71 US only.indd 1 6/19/2017 4:24:31 PM File: 08P98-TF-71_Eng_POTe.indd Template: Alinity c 2Cartridge KiLa Template.indt Size: 181 mm x 58 mm Drawing: AK4498 Refer to the drawing for stamp fields and material Colors: Text, Symbols: Black; Branding: PMS 233, Text reversed GHS Colors: Warning Symbol: Border: Pantone 185 c / Inside border Symbol: black Material: Refer to drawing

4 c-series Water Bath Additive FOR U.S. CUSTOMERS ONLY EPA REG. NO EPA EST. NO CAN-002 FOR USE WITH THE Alinity c-series ANALYZERS This product is used to prevent and control microbial contamination in the water bath. Active Ingredients: 5-Chloro-2-methyl-4-isothiazolin-3-one % 2-Methyl-4-isothiazolin-3-one % Inert Ingredients % Total % Keep Out of Reach of Children CAUTION FIRST AID If in eyes: Hold eye open and rinse slowly and gently with water for 15 to 20 minutes. (Remove contact lenses, if present, after the first 5 minutes then continue rinsing the eye.) Call a poison control center or doctor for treatment advice. If on skin and/or on clothing: Take off contaminated clothing. Rinse skin immediately with plenty of water for minutes. Call a poison control center or doctor for treatment advice. If swallowed: Immediately call a poison control center or doctor for treatment advice. Have person sip a glass of water if able to swallow. Do not induce vomiting unless told to do so by the poison control center or doctor. Do not give anything by mouth to an unconscious person. Important: Have the product container or label with you when calling a poison control center or doctor, or going for treatment. Note to physician: Probable mucosal damage may contraindicate the use of gastric lavage. PREPARATION FOR USE 1. c-series Water Bath Additive is ready-to-use. 2. Verify that the bottle has not leaked. 3. Remove the black cap by turning the cap counterclockwise until the cap stops. 4. Align the tabs on the cap with the grooves in the cartridge and pull the cap to remove it. DIRECTIONS FOR USE It is a violation of Federal law to use this product in a manner inconsistent with its labeling. The Alinity c-series Maintenance Solutions cartridge, containing 08P9871 the c-series Water Bath Additive, is placed in the analyzer loading area, then loaded into the analyzer. The c-series Water Bath Additive is automatically dispensed into the water bath during specific operations which control microbial contamination in the water bath. Do not use this product as a disinfectant. PRECAUTIONARY STATEMENTS Hazards to Humans and Domestic Animals CAUTION. Causes moderate eye and skin irritation. Harmful if swallowed or inhaled. Do not get in eyes, on skin or on clothing. Wear protective eyewear and chemically resistant gloves when handling this product. Wash thoroughly with soap and water after handling. Prolonged or frequently repeated skin contact may cause allergic reactions in some individuals. USER SAFETY RECOMMENDATIONS User should: Wash hands before eating, drinking, chewing gum, using tobacco, or using the toilet. Remove clothing immediately if product gets inside, then wash thoroughly and put on clean clothing. Remove personal protective equipment immediately after handling this product. Wash the outside of gloves before removing. As soon as possible, wash thoroughly. ENVIRONMENTAL HAZARDS This chemical is toxic to terrestrial and aquatic plants, fish and aquatic invertebrates. STORAGE AND DISPOSAL Do not contaminate water, food or feed by storage or disposal. Storage: Store at C in original packaging. Product Disposal: Pesticide wastes may be hazardous. Improper disposal of excess pesticide, spray mixture or rinsate is a violation of Federal Law. If these wastes cannot be disposed of by use according to label instructions, contact your State Pesticide or Environmental Control Agency, or the Hazardous Waste Representative at the nearest EPA Regional Office for guidance. Container Handling: Non-refillable container. Do not reuse or refill this container. Offer for recycling if available or discard in trash. Distributed by: ABBOTT LABORATORIES 100 N. Abbott Park Road Abbott Park, IL Net Contents: Bottle 2.3 fl.oz. (68.4 ml) Carton 10 x 2.3 fl.oz (10 x 68.4 ml) G72849R01

5 EPA REG. NO EPA EST. NO CAN-002 c-series Water Bath Additive 2.3 fl.oz. Active Ingredients: 5-Chloro-2-methyl-4-isothiazolin-3-one % 2-Methyl-4-isothiazolin-3-one % Inert Ingredients % Total % Keep Out of Reach of Children CAUTION Refer to accompanying label on outer box for complete information. ABBOTT Wiesbaden, Germany G72850R01

6 Alinity c-series Maintenance Solutions 08P98 Onboard solutions used to perform the automated daily maintenance procedure and selected diagnostic procedures on the Alinity c analyzer. The c-series Water Bath Additive is an antimicrobial solution used to prevent and control microbial contamination in the water bath. Cleaning Solution is used to remove protein from sample and reagent probes, mixers, the ICT probe and the ICT module. c-series Water Bath Additive: 5-Chloro-2-methyl-4-isothiazolin-3-one (02184%), 2-Methyl-4-isothiazolin-3-one (0.777%). Lyophilized Cleaning Solution: Protease enzyme (10.4%). Preservative: sodium azide (0.1%). Distributed in the USA by: Abbott Laboratories, Abbott Park, IL USA G72848R01

7 Maintenance Solutions 150 ml 08P98 Exp. ABBOTT Wiesbaden, Germany G71811R01 08P _Eng_ViLa.indd 1 5/20/2016 1:33:26 PM File: 08P _Eng_ViLa.indd Commodity: /R06 Size: 5.52 in X 1.46 in Colors: Text, Symbols: Black; Branding: PMS 2757, PMS 376

8 Maintenance Solutions Created June en Maintenance Solutions 08P9871 G72847R01 XXXX Package insert instructions must be carefully followed. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert. NAME Alinity c-series Maintenance Solutions INTENDED USE The Alinity c-series Maintenance Solutions are onboard solutions used to perform the automated daily maintenance procedure and selected diagnostic procedures on the Alinity c analyzer. The c-series Water Bath Additive is an antimicrobial solution used to prevent and control microbial contamination in the water bath. Cleaning Solution is used to remove protein from sample and reagent probes, mixers, the ICT probe and the ICT module. For additional information, refer to the Alinity ci-series Operations Manual. CONTENTS / MATERIALS PROVIDED Component Quantity c-series Water Bath Additive 10 x 68.4 ml Lyophilized Cleaning Solution 10 x 12 ml Cleaning Solution 1 x 150 ml Component Uses per cartridge Uses per kit c-series Water Bath Additive Working Cleaning Solution c-series Water Bath Additive Active ingredients: 5-Chloro-2-methyl-4-isothiazolin-3-one % 2-Methyl-4-isothiazolin-3-one % Inert Ingredients % Total % Lyophilized Cleaning Solution Active ingredients: Protease enzyme (10.4g/L) Preservative: sodium azide (0.1%) MATERIALS REQUIRED BUT NOT PROVIDED 04R4701 Alinity Reagent Replacement Caps Calibrated pipette WARNINGS AND PRECAUTIONS For In Vitro Diagnostic Use Do not use components beyond the expiration date. Do not mix materials from different kit lot numbers. Do not mix solutions prepared at different times. Do not reuse the solution containers, bottles, or caps due to the risk of contamination and the potential to compromise performance. Safety Precautions The following warnings and precautions apply to c-series Water Bath Additive: EPA REG. NO EPA EST. NO CAN-002 For use with the Alinity c-series analyzers This product is used to prevent and control microbial contamination in the water bath. Keep Out of Reach of Children CAUTION FIRST AID If in eyes: Hold eye open and rinse slowly and gently with water for 15 to 20 minutes. (Remove contact lenses, if present, after the first 5 minutes then continue rinsing the eye.) Call a poison control center or doctor for treatment advice If on skin and/or on clothing: Take off contaminated clothing. Rinse skin immediately with plenty of water for minutes. Call a poison control center or doctor for treatment advice If swallowed: Immediately call a poison control center or doctor for treatment advice. Have person sip a glass of water if able to swallow. Do not induce vomiting unless told to do so by the poison control center or doctor. Do not give anything by mouth to an unconscious person. PRECAUTIONARY STATEMENTS Hazards to Humans and Domestic Animals CAUTION. Causes moderate eye and skin irritation. Harmful if swallowed or inhaled. Do not get in eyes, on skin or on clothing. Wear protective eyewear and chemically resistant gloves when handling this product. Wash thoroughly with soap and water after handling. Prolonged or frequently repeated skin contact may cause allergic reactions in some individuals. USER SAFETY RECOMMENDATIONS User should: Wash hands before eating, drinking, chewing gum, using tobacco, or using the toilet. Remove clothing immediately if product gets inside, then wash thoroughly and put on clean clothing. Remove personal protectve equipment immediately after handling this product. Wash the outside of gloves before removing. As soon as possible, wash thoroughly. ENVIRONMENTAL HAZARDS This chemical toxic to terrestrial and aquatic plants, fish and aquatic invertebrates. STORAGE AND DISPOSAL Do not contaminate water, food or feed by storage and disposal. Storage: Store at C in original packaging. Product Disposal: Pesticide wastes may be hazardous. Improper disposal of excess pesticide, spray mixture or rinsate is a violation of Federal Law. If these wastes cannot be disposed of by use according to label instructions, contact your State Pesticide or Environmental Control Agency, or the Hazardous Waste Representative at the nearest EPA Regional Office for guidance. Container Handling: Non-refillable container. Do not reuse or refill this container. Offer for recycling if available or discard in trash. 1 08P _Eng_AcIn 8_22_17.indd 1 8/22/2017 1:14:32 PM

9 The following warnings and precautions apply to Lyophilized Cleaning Solution (as sold): DANGER Lyophilized Cleaning Solution (as sold) contains a protease enzyme from Aspergillus. H315 Causes skin irritation. H319 Causes serious eye irritation. H334 May cause allergy or asthma symptoms or breathing difficulty if inhaled. H335 May cause respiratory irritation. Prevention P261 Avoid breathing dust. P280 Wear protective gloves / protective clothing / eye protection. P271 Use only outdoors or in a well-ventilated area. P284 In case of inadequate ventilation wear respiratory protection. P264 Wash hands thoroughly after handling. Response P304+P340 IF INHALED: Remove person to fresh air and keep comfortable for breathing. P342+P311 If experiencing respiratory symptoms: Call a POISON CENTER or doctor / physician. P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P337+P313 If eye irritation persists: Get medical advice / attention. P302+P352 IF ON SKIN: Wash with plenty of water. P332+P313 If skin irritation occurs: Get medical advice / attention. P362+P364 Take off contaminated clothing and wash before reuse. Disposal P501 Dispose of contents / container in accordance with local regulations. The following warnings and precautions apply to Cleaning Solution (as sold): Contains sodium azide. EUH032 Contact with acids liberates very toxic gas. P501 Dispose of contents / container in accordance with local regulations. The following warnings and precautions apply to Lyophilized Cleaning Solution (as sold)+ Cleaning Solution (as sold) = Cleaning Solution as used DANGER H334 EUH032 Prevention P261 P284 Response P304+P340 The Cleaning Solution as used contains a protease enzyme from Aspergillus and sodium azide. May cause allergy or asthma symptoms or breathing difficulty if inhaled. Contact with acids liberates very toxic gas. Avoid breathing mist / vapors / spray. In case of inadequate ventilation wear respiratory protection. IF INHALED: Remove person to fresh air and keep comfortable for breathing. P342+P311 Disposal P501 If experiencing respiratory symptoms: Call a POISON CENTER or doctor / physician. Dispose of contents / container in accordance with local regulations. Safety Data Sheets are available at or contact your local representative. For a detailed discussion of safety precautions during system operation, refer to the Alinity ci-series Operations Manual, Section 8. PREPARATION FOR USE c-series Water Bath Additive 1. c-series Water Bath Additive is ready-to-use. 2. Verify that the bottle has not leaked. 3. Remove the black cap by turning the cap counterclockwise until the cap stops. 4. Align the tabs on the cap with the grooves in the cartridge and pull the cap to remove it. Working Cleaning Solution 1. Tap the Lyophilized Cleaning Solution bottle right side up on a flat surface before opening, to remove excess material from the cap. IMPORTANT: Wait several minutes before removing the cap to allow suspended particles to settle. 2. Hold the Lyophilized Cleaning Solution bottle right side up on a flat surface. Carefully remove the cap to avoid inhaling lyophilized material. 3. Prepare the working Cleaning Solution by adding 12 ml of Cleaning Solution to the Lyophilized Cleaning Solution bottle. IMPORTANT: Allow the liquid to run down the inside of the bottle to minimize aerosolization of lyophilized material. 4. Replace the cap and mix by gentle inversion. Document the date of preparation. 5. Remove the yellow cap from the by turning the cap counterclockwise until the cap stops. 6. Align the tabs on the cap with the grooves in the cartridge and pull the cap to remove it. 7. Transfer the contents of the working Cleaning Solution into the of the cartridge that is. The prepared, capped working Cleaning Solution is stable for 14 days when stored at 2 to 8 C, but no longer than the expiration date. STORAGE Do not use past expiration date. The prepared c-series Maintenance Solutions cartridge may be stored on the instrument. Storage Temperature Maximum Storage Time Unopened 15 to 30 C Until expiration date Onboard System Temperature 14 days (336 hours) Opened 2 to 8 C 14 days after opening Additional Storage Instructions Store tightly capped with new replacement cap. Note: Removing the cartridge from the instrument invalidates onboard tracking. If the cartridge is removed from the analyzer, you must manually track the opened maximum storage time. 2 08P _Eng_AcIn 8_22_17.indd 2 8/22/2017 1:14:32 PM

10 For information on unloading cartridges, refer to the Alinity ci-series Operations Manual, Section 5. DIRECTIONS FOR USE It is a violation of Federal law to use this product in a manner inconsistent with its labeling. The Alinity c-series Maintenance Solutions cartridge, containing the c-series Water Bath Additive, is placed in the analyzer loading area, then loaded into the analyzer. The c-series Water Bath Additive is automatically dispensed into the water bath during specific operations which control microbial contamination in the water bath. Do not use this product as a disinfectant INSTRUMENT PROCEDURE Place the Alinity c-series Maintenance Solutions cartridge in the reagent and sample manager (RSM). For instructions on loading cartridges on the RSM, refer to the Alinity ci-series Operations Manual, Section 5. INDICATIONS OF INSTABILITY OR DETERIORATION Instability or deterioration should be suspected if there are visible signs of leakage, or if ICT module calibration does not meet the Alinity ci-series Operations Manual criteria. LIMITATIONS OF THE PROCEDURE Accurate and reproducible results are dependent upon properly functioning instruments and reagents, storage of product as directed, and good laboratory technique. Alinity is a trademark of Abbott Laboratories in various jurisdictions. All other trademarks are property of their respective owners. Abbott GmbH & Co. KG Max-Planck-Ring Wiesbaden Germany Sekisui Diagnostics P.E.I. Inc. 70 Watts Avenue Charlottetown Prince Edward Island C1E 2B9 Canada Distributed in the USA by Abbott Laboratories Abbott Park, IL USA Customer Service: Contact your local representative or find countryspecific contact information on Created August Abbott Laboratories Note for number formatting: A space is used as thousands separator (example: specimens). A period is used to separate the integer part from the fractional part of a number written in decimal form (example: 3.12%). Key to Symbols Consult instructions for use Manufacturer Temperature limitation Sufficient for Use by/expiration date After Reconstitution Contains Sodium Azide. Contact with acids liberates very toxic gas. In Vitro Diagnostic Medical Device Lot Number Product of GB Produced for Abbott by List Number R1 Position R2 Position Reserved for Cleaning Solution For use by or on the order of a physician only (applicable to USA classification only). Serial number 3 08P _Eng_AcIn 8_22_17.indd 3 8/22/2017 1:14:33 PM