Hygiene Monitoring. Chemical Indicators, BD-Test and Batch- Product Information. CI_01_Eng
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1 Hygiene Monitoring Chemical Indicators, BD-Test and Batch- Control (PCD) Product Information CI_01_Eng
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3 BAG-BD-Check II / BAG-BD-Check Disposable Bowie & Dick Test Pack for the Daily Steam Penetration Test in Pre-Vacuum Sterilizers acc. to ISO BAG-BD-Check II, lead-free Order-No Packaging unit: 30 BAG-BD-Check Order-No Packaging unit: 30 Product features Pre-assembled test pack for the daily Bowie & Dick type test. For use in pre-vacuum sterilizers at 134 C / 3.5 minutes. Size: 14 x 11 cm. Classification: Indicator Type 2 acc. to ISO Instructions for Use 1. Place BAG-Bowie-Dick test pack in empty sterilizer chamber. 2. Run Bowie & Dick test cycle (3.5 minutes at 134 C). 3. Remove test system from chamber after cycle and unwrap test pack. 4. Evaluate BAG-Bowie-Dick test indicator sheet. 5. Documentation of all results. Keep indicator sheet for permanent record. Evaluation of BAG-BD-Check II / BAG-BD-Check (see also evaluation chart): PASS: Test conditions achieved: Uniform color change from blue (BAG-BD-Check II) or light blue (BAG-BD-Check) to black. FAIL: Test conditions NOT achieved: No / incomplete color change from blue/light blue to black. Blue to grey/brown areas in the center of the test sheet indicate residual air and / or insufficient steam penetration. Check test conditions and repeat Bowie & Dick test. Storage: Dry at room temperature (10 38 C) Bd-Check_01_eng verkauf@bag-healthcare.com service@bag-healthcare.com
4 BAG-AutoCheck-Kit II / AutoCheck-Kit Reusable Bowie & Dick Test Pack for the Daily Steam Penetration Test in Pre-Vacuum Sterilizers acc. to ISO BAG-AutoCheck-Kit II Order-No Contents for 30 tests: 30 BAG-AutoCheck-Kit II test sheets, 14 x 11 cm, lead-free, 2 high-grade paper test packs, reusable 15 times BAG-AutoCheck-Kit Order-No Contents for 30 tests: 30 BAG-AutoCheck-Kit II test sheets, 14 x 11 cm, 2 high-grade paper test packs, reusable 15 times Use with small BAG CCS holder Order-No Product features Reusable steam penetration test pack for the daily Bowie & Dick type test. For use in prevacuum sterilizers at 134 C / 3.5 minutes. Classification: Indicator Type 2 acc. to ISO Instructions for Use 1. Place BAG-AutoCheck-Kit indicator sheet in the center of the reusable test pack (between white and green paper sheets). Record date on the cover sheet of the test pack (fields 1-15). 2. Insert test pack into BAG-CCS stainless steel holder and close spring lock. 3. Place test system on the bottom of the empty chamber (horizontal position). 4. Run Bowie & Dick test cycle (3.5 minutes at 134 C). 5. Remove test system from chamber after cycle. CAUTION: Metal holder may be hot! 6. Open spring lock, remove indicator sheet from test pack. 7. Evaluate BAG-AutoCheck-Kit II indicator sheet. 8. Documentation of all results. Keep indicator sheet for permanent record. 9. Dry test pack prior next use. Evaluation of BAG-AutoCheck-Kit II / BAG-AutoCheck-Kit (see also evaluation chart): PASS: Test conditions achieved: Uniform color change from blue (BAG-AutoCheck-Kit II) or light blue (BAG-AutoCheck-Kit) to black. verkauf@bag-healthcare.com service@bag-healthcare.com
5 FAIL: Test conditions NOT achieved: No / incomplete color change from blue / light blue to black. Blue to grey/brown areas in the center of the test sheet indicate residual air and / or insufficient steam penetration. Check test conditions and repeat Bowie & Dick test. CAUTION: Use dry test pack! Easy Insert test pack with indicator into stainless steel holder. Close spring lock. Economic Test pack reusable 15 times. Safe Clear test results. Storage: Dry at room temperature (10 38 C) AutoCheck-Kit II_01_eng verkauf@bag-healthcare.com service@bag-healthcare.com
6 BAG-GreenCard Disposable Bowie & Dick Test Pack for the Daily Steam Penetration Test in Pre-Vacuum Sterilizers acc. to ISO Order-No Packaging unit: 30 Intended Use Single-use Bowie-Dick test pack. Use with GreenCard holder (Order-No. 7565). Test card the size of credit card for the daily steam penetration test in pre-vacuum steam sterilizers used as an alternative to the standard towel pack acc. to ISO Size: 9 x 5 cm, 1 mm thin. Classification: Indicator Class 2 acc. to ISO Technical Information Scientific technology has allowed many products, for example, computers, cameras, and Bowie Dick test packs to be reduced in size yet function better than the preceding products. The original Bowie-Dick pack consisted of cloth towels stacked 11 inches high. Disposable Bowie-Dick packs made of paper were invented in the early 1980 s. They were 1% the size of the original towel packs. The new BAG-GreenCard is the next step in that evolution. It is about 1% the size of current disposable Bowie-Dick packs. BAG-GreenCard (90 x 50 x 1 mm / 2 g) BAG-BD-Check II (130 x 100 x 15 mm / 90 g) Towel pack (7 kg) verkauf@bag-healthcare.com service@bag-healthcare.com
7 The BAG-GreenCard The BAG-GreenCard contains a number of features not present in disposable test packs made with paper. The porous matrix that holds air is very compact. The material that is sandwiched in the middle of the BAG-GreenCard is a high-grade blotter paper that is very porous. It allows air and steam to flow freely through all the interstices of the cellulose matrix. The benefits obtained from this feature are that a single layer of this material can now be used to form the porous mass needed for this test. The BAG-GreenCard uses plastic layers on the top and bottom of the card to force the air and steam to flow to and from the edges of the porous layer, which enhances the sensitivity and allows a miniaturization of the test pack system. Sterilant Specific Ink Chemistry To complete the explanation, the indicator ink chemistry used to print the BAG-GreenCard is sterilant specific. Sterilant specific means that the ink actually reacts with steam as well as heat and exposure time. The color change from purple to green is caused by a highenergy hydration reaction. Water molecules from the steam attach themselves to the active ingredient in the indicator ink, causing the active ingredient to change color. Since water molecules and high heat energy are needed to cause this hydration reaction, any air around the ink chemicals will interfere, not only from the reduction in heat energy, but also from the reduction in water molecules available to cause the hydration reaction. This is a doubling of the forces that increase the sensitivity of the test card. The final result is a smaller test pack that is now a test card. In addition to these features, the indicator ink is printed directly onto the porous matrix substrate, thereby allowing the end-user to view the color change without opening a test pack and discarding the paper waste. 01/11 verkauf@bag-healthcare.com service@bag-healthcare.com
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9 BAG-RePac Batch Monitoring System for Steam Sterilization Processes, Indicator-system Type 2 according to ISO Specification BAG-RePac 121 C BAG-RePac 134 C BAG-RePac 18 Min. Product features Order-No Packaging unit (300 tests) 20 sheets with 15 RePac-Indicators each (for 121 C, 134 C or 134 C/18 Min.) 20 paper stacks, reusable 15 times 30 documentation cards for 10 loads each Batch monitoring system for pre-vacuum steam sterilization processes at 121 C or 134 C. Instructions for Use 1. Place RePac-Indicator at the bottom of BAG-RePac metal device (Order-No. 7540). Indicator ink up. 2. Mark reusable paper stack to monitor number of applications and insert paper stack into metal device. Fix system. 3. Place BAG-RePac in sterilizer chamber and run program. 4. After sterilization cycle has finished remove BAG-RePac from chamber. CAUTION: Metal device may be hot! 5. Remove paper stack and dry prior next use. 6. Evaluate RePac-Indicator. 7. Documentation of all results. RePac-Indicator can be fixed to documentation card. Evaluation of BAG-RePac Indicators (see also evaluation chart): a. Sterilization conditions achieved = Complete color change of indicator from purple to green Release Load b. Sterilization conditions NOT achieved = No / incomplete color change of indicator from purple to green. Block Load Storage: Dry at room temperature (10 38 C) Repac_01_Eng verkauf@bag-healthcare.com service@bag-healthcare.com
10 BAG RePac Batch Monitoring System Contents Instructions for Use 1. Place RePac indicator in metal device (ink up) 2. Place paper stack in metal device and fix system 3. Place RePac in sterilizer chamber and run program Paper stack (reusable 15 times) RePac metal cylinder (process challenge device) RePac indicators 121 C / 134 C Instruments, containers, laundry, etc. + Evaluation 1. Remove RePac from sterilizer 2. Remove paper stack and indicator 3. Evaluate indicator a. Sterilization conditions achieved (Release Load) = Complete color change of indicator from purple to green. b. Sterilization conditions NOT achieved (Block Load) = Incomplete color change of indicator from purple to green. Release Load Block Load Documentation Fix RePac indicator to documentation card and record results. BAG RePac Load Control System Easy to use Emulating indicators Class 6 according to ISO Monitors time, temperature and steam quality unique indicators for every sterilzation cycle (121 C or 134 C) with Chromium(III)Chloride chemistry Detection of residual air and non-condensable gases within every load Free from lead, chlorine, cadmium, thallium
11 BAG-TwinTube 2 in 1 Testsystem: Bowie-Dick Test & Batch-monitoring system in only one PCD reliable maintenance-free ISO compliant Product benefits: Only one PCD with different indicators for the Bowie-Dick-Test (134 C / 3,5 min) AND Batch control with 121 C, 15 min or 134 C, 4 min Quick and easy handling no folding of the indicator is necessary Quick readout of the indicator because a color-bar is visual in the green area (PASS) Bowie-Dick-Test compliant to DIN EN ISO (Indicator Type 2) Fullfills as batch-control-system the requirements for a failure-warning-system Use of high quality chemical indicators Type 6 PCD also for Bio-indicators (Sporestrips, BAG-BioCheck-Ampouls) Maintenance free full metal PCD Use: 1. Open the BAG-TwinTube PCD and insert the fitting indicator (SteriScan -Bowie-Dick-Test-Strip or SteriScan Six 121 C or BAG-TwinTube 134 C) 2. Place the into the sterilizer and start your Sterilization cycle 3. Open BAG-TwinTube PCD and take out the indicator (Beware: PCD may be hot!) 4. Check your indicator if the indicator-inc reaches the green field ("PASS") 5. Document your results verkauf@bag-healthcare.com service@bag-healthcare.com
12 Interpretation of SteriScan BD-Test-Strip (Bowie-Dick-Test): a. Sterilization conditions fullfilled = The indicator-window is completely filled with indicator-ink (blue up to dark grey). b. Sterilization conditions not fullfilled = The indicator-window is NOT completely filled with indicator-ink Interpretation SteriScan Six 121 C (134 C BAG TwinTube Indicator ): a. Sterilization conditions fullfilled = The indicator-ink has reached the PASS-field (blue up to dark grey, the PASS-field must not be covered completely). b.. Sterilization conditions not fullfilled = The indicator-ink has not reached the PASSfield. >> FAIL Our Products: REF.: Packing-Unit BAG-TwinTube PCD PCD SteriScan BD-Test-strip Indicators for the Bowie-Dick-Test Indicators BAG TwinTube 134 C Indicators for the batch control at 134 C Indicators SteriScan Six-Indikator 121 C Indicators for the batch control at 121 C Indicators Storage: Dry, at room-temperature TT_FLyer_01_eng verkauf@bag-healthcare.com service@bag-healthcare.com
13 BAG-HeliCheck Batch Monitoring System for Monitoring Sterilization of Hollow Loads in Pre-Vacuum Sterilizers acc. to EN Order-No. Packaging unit indicators + 1 helix device Product features Batch monitoring system for monitoring sterilization processes at 121 C or 134 C Process challenge device (PCD) according to EN Indicator classification: Type 2 according to ISO Monitors time, temperature and steam quality Instructions for use 1. Unscrew the indicator capsule from the lumen end cap. Fold indicator strip at the score line (ink inwards) and insert indicator into the capsule with the fold first. Assemble PCD. 2. Place PCD in the sterilizer (near coolest location, e.g. near door) and run program. 3. After sterilization cycle has finished remove BAG-HeliCheck from chamber. Caution! PCD may be hot and should be handled carefully to avoid thermal injury! 4. Open the indicator capsule and remove indicator strip. 5. Evaluate HeliCheck indicator. 6. Documentation of all results. HeliCheck indicator can be fixed to documentation. 7. Allow the PCD to cool and dry prior to next use. Note: Please also refer to the IFU delivered with the product Evaluation of BAG-HeliCheck: a. Sterilization conditions achieved = Complete color change of all indicator dots from purple to black Release Load b. Sterilization conditions NOT achieved = No / incomplete color change of all indicator dots from purple to green. Block Load Storage: Expiry: Dry at room temperature (10 38 C) 18 months from date of manufacture heli_check_01_eng verkauf@bag-healthcare.com service@bag-healthcare.com
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15 BAG-ChemoStrip Chemical Indicator for Monitoring Steam Sterilization Processes Order-No. Packaging Unit BAG-ChemoStrip 121 C BAG-ChemoStrip 134 C BAG-ChemoStrip 18 Min Monitors Time + Temperature + Steam Quality Product features Chemical indicator for final container / package control Use in pre-vacuum sterilizers at 121 C, 134 C or 134 C/18 minutes respectively Monitors time, temperature and steam quality Excellent indicator stability before and after exposure Classification: Type 6 according to ISO Instruction for Use 1. Place BAG-ChemoStrip in containers and packages 2. Run sterilization cycle 3. Evaluate color change 4. Documentation of results Evaluation of BAG-ChemoStrip 121 C / 134 C / 18 (see also evaluation chart): a. Sterilization conditions achieved = Complete color change of all digits 121 / 134 from purple to green b. Sterilization conditions NOT achieved = No / incomplete color change of all digits 121 / 134 from purple to green Storage: Dry at room temperature (10 38 C) Chemostrip_02_EN verkauf@bag-healthcare.com service@bag-healthcare.com
16 BAG-Integraph Chemical Indicator for Monitoring Steam Sterilization Processes Order-No. Packaging unit Product features Chemical indicator for final container / package control Optimized for gravity sterilizers working at 121 C / 134 C (one indicator for both temperatures), use in pre-vacuum sterilizers is also possible Extended timing dot: Additional spot for 30 minute-cycles at 121 C Monitors time, temperature and steam quality Excellent indicator stability before and after exposure Classification: Type 5 according to ISO Instruction for Use 1. Place BAG-Integraph in containers and packages 2. Run sterilization cycle 3. Evaluate color change 4. Documentation of results Evaluation of BAG-Integraph: a. Sterilization conditions achieved = Standard cycle (5 min./134 C or 15 min./121 C): Complete color change of upper bars from purple to green NOTE: The "extended timing" dot will only change after extended exposition to steam! b. Sterilization conditions NOT achieved = No / incomplete color change of upper bars from purple to green Storage: Expiry: Dry at room temperature (10 38 C) 3 years from date of manufacture integr_flyer_01_eng verkauf@bag-healthcare.com service@bag-healthcare.com
17 BAG-BlackCheck C Chemical Indicator for Monitoring Steam Sterilization Processes laminated Order-No. Packaging unit Product features Chemical indicator for final container / package control, laminated Use in all steam sterilization cycles at 121 C / 134 C (one indicator for both temperatures) Monitors time and temperature Excellent indicator stability before and after exposure Classification: Type 4 according to ISO Instruction for Use 1. Place BAG-BlackCheck C in containers and packages 2. Run sterilization cycle 3. Evaluate color change 4. Documentation of results Evaluation of BlackCheck C: a. Sterilization conditions achieved = Complete colour change of the symbol from yellow to black b.sterilization conditions NOT achieved = No / incomplete colour change of the symbol from yellow to black, brown or beige color also indicates insufficient conditions. NOTE: Delamination of the upper layer of the indicator can occur during long sterilization cycles or wet steam conditions. Deep pre-vacuum cycles can cause the same effect. Nevertheless this delamination will not influence the reaction of the indicator. Storage: Expiry: Dry at room temperature (10 38 C) 3 years from date of manufacture blackcheck01_eng verkauf@bag-healthcare.com service@bag-healthcare.com
18 Cross-Checks EO Chemical Indicator for Monitoring Ethylene Oxide (EO) Sterilization Processes Order-No. Packaging unit Product features Chemical indicator for final container / package control For use in ethylene oxide sterilization cycles Monitoring time, temperature and gas concentration Excellent indicator stability before and after exposure Classification: Type 4 according to ISO Instruction for Use 1. Place Cross-Checks EO in containers and packages 2. Run sterilization cycle 3. Evaluate color change 4. Documentation of results Evaluation of Cross-Checks EO: a. Sterilization conditions achieved = Complete color change of Indicator field from yellow to brown b. Sterilization conditions NOT achieved = No / incomplete color change of indicator field from yellow to brown. Repeat cycle. Storage: Dry at room temperature (10 38 C) EO_02_Eng Country of Origin USA; manufactured by Getinge/steritec verkauf@bag-healthcare.com service@bag-healthcare.com
19 Dry Checks Chemical Indicator for Monitoring Dry Heat Sterilization Processes Order-No Packaging unit 250 BAG-DryCheck Dry Heat Indicator Labels Order-No Packaging unit 1000 Product features Chemical indicators for dry heat sterilization cycles at C Visible conformation that the item was exposed to a dry heat sterilization process Identification of processed versus unprocessed items Monitors time and temperature Classification: Type 1 according to ISO Instruction for Use 1. Place Dry Checks in containers and packages / Place BAG-DryCheck labels onto products and packages 2. Run sterilization cycle 3. Evaluate color change 4. Documentation of results Evaluation of Dry Checks: a. Sterilization conditions achieved = Complete color change of both marks ( ) from green to black b. Sterilization conditions NOT achieved = No / incomplete color change of both marks from green to black Storage: Dry at room temperature (10 38 C) Dry checks: Country of Origin USA; manufactured by Getinge/steritec DryC_01_Eng verkauf@bag-healthcare.com service@bag-healthcare.com
20 Cross-Checks P H 2 O 2 Chemical Indicator for Monitoring Low Temperature Hydrogen Peroxide / Plasma (VH2O2) Sterilization Processes Order-No. Packaging unit Product features Chemical indicator for container / package control Use in hydrogen peroxide / plasma (VH2O2) sterilization cycles Monitors exposure to hydrogen peroxide during diffusion stage of the cycle Excellent indicator stability before and after exposure Classification: Process indicator Instructions for Use 1. Place Cross-Checks P in containers and packages 2. Run sterilization cycle 3. Evaluate color change 4. Documentation of results Evaluation of Cross-Checks P: a. Sterilization conditions achieved = Complete color change of indicator ( ) from blue to pink (according to reference color of arrow). b. Sterilization conditions NOT achieved = No / incomplete color change of indicator from blue to pink. Storage: Dry (30-60% humidity) at room temperature (10 38 C) in protective cover. Country of Origin USA; manufactured by Getinge/steritec P_01_Eng verkauf@bag-healthcare.com service@bag-healthcare.com
21 Cross-Checks F Chemical Indicator for Monitoring Low Temperature Steam and Formadehyde (FORM) sterilization processes Order-No. Packaging unit Product features Chemical indicator for final container / package control Use in LTSF low temperature steam and formaldehyde sterilization cycles Monitors exposure to formaldehyde sterilization conditions Excellent indicator stability before and after exposure Classification: Type 4 according to ISO Instructions for Use 1. Place Cross-Checks F in containers and packages 2. Run sterilization cycle 3. Evaluate color change 4. Documentation of results Evaluation of Cross-Checks F: a. Sterilization conditions achieved = Complete color change of indicator ( ) from purple to green. b. Sterilization conditions not achieved = No / incomplete color change of indicator from purple to green. Storage: Dry (30-60% humidity) at room temperature (10 38 C) in protective cover. Country of Origin USA; manufactured by Getinge/steritec F_01_Eng verkauf@bag-healthcare.com service@bag-healthcare.com
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24 Your contact to BAG Order Entry: Phone +49 (0) 6404 / Fax +49 (0) 6404 / export@bag-healthcare.com Customer Service: Phone + 49 (0) / Fax + 49 (0) / service@bag-healthcare.com Address: BAG Health Care GmbH Amtsgerichtsstrasse Lich/GERMANY Phone +49 (0) 6404 / Fax +49 (0) 6404 / info@bag-healthcare.com Website
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