Medical CSSD Medical Technology 2008 / 2009

Medical CSSD Medical Technology 2008 / 2009 Bulletin E-07-1008

EBI 15 - Electronic Bowie-Dick-Test and Routine Control PCD Security during Routine Checks Advantages at a glance: Exact and independent measurement of sterilizer performance Definite result «passed / failed» 500 cycles Reuseable After service / calibration Electronic data logging Independently certified according to EN ISO 11140-4

Temperature Infrared Pressure ph-value / Conductivity Humidity Software Calibration Background Information Contents ebro Medical Technology 2008 / 2009 NEW NEW NEW NEW NEW NEW 4 Routine Checks in the CSSD NEW 15 Antenna-Adaptor for EBI 10 / Reducing socket/coupling EBI 15 Data Logger muff AL 150/AL 151/Tri-Clamp Adaptor AL 152-AL 156 4 Pressure/Temperature Data Logger Sets NEW 17 Temperature- and ph-logger ebro Set SL 1500 / SL 1600 (not shown) EBI 30-pH 5 Electronic Bowie Dick Test and Routine Control PCD NEW 18 Temperature- and Conductivity-Logger EBI 15 Data Logger EBI 30-C 6 Routine Checks and Validation in the CSSD 19 Measurement of ph-value and conductivity EBI 10 Wireless Data Logger PHT 810 / PHX 800 / DIST 3 7 Pressure/Temperature / Temp. Wireless Data Logger 21 Temperature / Temperature/Humitidy Data Logger EBI 10-TP231 Luerlock / EBI 10-T100 EBI 20-T/-TE / EBI 20-TH 8 Pressure/Temp. / Temp. Wireless Data Logger Sets NEW 22 Dual-Infrared/ Fold-Back Thermometer / Core Thermometer ebro Starter Sets SL 1000 / SL 1100 TLC 730 / TFX 410 10 Pressure/Temperature Wireless Data Logger Sets NEW 24 Evaluation Software for all ebro Data Logger ebro Validation Sets SL 2000 / 2100 Winlog.med / Winlog.med Validation / Winlog.pro 11 Temperature Wireless Data Logger 26 Calibration Set / High Precision Thermometer EBI 10-T220/221 / EBI 10-T240/241 / EBI 10-T441 AC 100 / TFX 430 12 Pressure/Temperature Wireless Data Logger 27 Calibrations ISO / DKD EBI 10-TP221 / EBI 10-TP321 / EBI 10-TP421 for EBI 10 / EBI 11 / EBI 15 / EBI 125 / EBI 20 / EBI 30 13 Mini-Temperature Data Logger / Mini-Pressure/Temperature Data Logger / EBI 11-T240 / EBI 11-TP100 29 Trainings On-site 14 Accessories for EBI 10, EBI 11 and EBI 15 30 Conditions of Delivery and Payment Interfaces,Antenna,Battery Exchange Sets,Protection Boxes ebro systems are validated by TÜV-Munich conforms to FDA 21 CFR Part 11, according to MPG, DIN EN 285, ISO 17665, ISO 15883

Temperature Pressure 4 Routine checks in the CSSD EBI 15 Data Logger The reprocessing of medical devices requires compliance with the legal requirements for the protection of patients, users and those responsible for the reprocessing treatment of medical products in the CSSD. To ensure the quality of the mechanical treatment of medical products, different tests are required, depending on the cleaning/disinfection procedures used, i.e. a commissioning test, daily routine checks, metrological verification, examination of process parameters and periodic examinations. With the EBI 15 data logger, ebro has developed a reliable, easy to understand measuring system for comprehensive routine checks of steam sterilizers according to EN ISO 11140-3 and 11140-4. The system can check relevant sterilization parameters such as vacuum, compensation time, hold time and sterilization temperature as well as steam penetration analogous to a Bowie & Dick Test. The temperature inside a measuring chamber is compared with the outside temperature. If there is a temperature difference, then this is caused by insufficient steam penetration. On the basis of the temperature difference and of the performance of both temperature curves, a statement can be made regarding the cause of the insufficient steam penetration (leakage, insufficient vacuum, air injection). Essentially, here the same method is used as in determining steam penetration with a Helix PCD (process challenge device). The difference is that here a physical temperature measurement is used instead of a chemical indicator. Winlog.med automatically evaluates the temperature difference during readout and presents the results (where applicable) with cause of error. EBI 15 Set SL 1500 Routine checks of steam sterilizers Set contains: 1 x Data logger EBI 15 1 x Interface IF 150 useable for EBI 15 and EBI 10 1 x Antenna AL 111 1 x Software Winlog.med 1 x Carrying case EBI 15-Set SL 1500 1340-6195 EBI 15/EBI 10-Set - not shown (Consisting: as SL 1500 plus 1 x EBI 10-T100) SL 1600 1340-6196

Electronic Bowie Dick Test and Routine Control PCD EBI 15 Temperature Pressure 5 NEW Type EBI 15 Measuring range Temperature 0 C... +150 C (32 F... 302 F) Measuring range Pressure 0 mbar... 4.000 mbar (0... 400 kpa) Accuracy ±0.1 C (±0.2 F) / ±15 mbar (±1.5 kpa) Resolution 0.025 C (0.045 F) / 1 mbar (100 Pa) Operating temperature 0 C... +150 C (32 F... 302 F) Sensor Temperature: Pt 1000, piezo-resistive pressure sensor Channels 2 temperature, 1 pressure Measurement mode endless mode start / stop time measurement upon start time start immediately until memory full Measuring rate adjustable from 250 ms to 24 h (Depending on measured values or time measuring rate can be modified while recording) Memory 100,000 measured values Communication wireless 2.4 GHz / IEEE 802.15.4 Battery 3.6 V, exchangeable by user Housing material Stainless steel (V4A), PEEK, PPSU, Aluminium Size Ø 90 mm x H = 186 mm Protection class IP 68 Calibration certificate according to ISO 9001/2000 EBI 15 during routine checks of steam sterilizers BOWIE DICK TEST Definite result «passed/failed» at daily check of air evacuation test and steam penetration test according to DIN EN 285 and EN ISO 11140-4. EARLY-WARNING SYSTEM Early identification of possible failures in steam sterilizer. Even smallest quantities of residual air (that do not yet lead to a failed Bowie Dick Test) are detected. VACUUM CHECK Reasonable vacuum check for sterilizers without pressure display according to DIN EN 285. VERIFICATION OF STERILIZATION PARAMETERS Checks sterilization temperature and sterilization time at +134 C (273 F) for 3.5 minutes according to DIN EN 285. CALCULATION OF THEORETICAL STEAM TEMPERATURE Detects over-heated steam inside sterilization chambers by comparing theoretical temperature with actually measured steam temperature. VERIFICATION OF CALIBRATION Fast, easy and simultaneous verification of calibration of measuring instruments/dispays during verification of equipment check. DATA LOGGING Stores up to 100,000 measured values with measuring rate adjustable from 250 ms; graphic presentation of pressure / temperature / time response. DATA RECORDING WITH SOFTWARE Winlog.med > Support at routine check preparation/planning as well as at programming, evaluation, calibration and report generation > Integrated help function provides fast problem presentation of various errors and offers solutions for error correction CALCULATION OF LETHALITY (F 0 ) Monitors deviations between cycles by calculating total quantity of energy expended during sterilization process; this is expressed by F 0 value. EBI 15 Data Logger EBI 15 1340-6190

Temperature Pressure 6 Routine Checks and Validation in the CSSD EBI 10 Wireless Data Loggers AUTHOR: IVEN KRUSE Real-time monitoring during routine checks and validation in the CSSD Especially the new standards ISO 17665 and ISO 15883 but also checks through local Health Authorities pose new challenges for all CSSD staff and operators. The standard ISO 17665 defines routine control and validation of the sterilization processes. ISO 15883 and the Guideline of the DGSV, DGKH and LCI define the validation process for washer disinfectors. ebro Electronic has developed a new generation of wireless data loggers to simplify the implementation of respective laws and standards and to lower the present high costs of validation. Of course, a user will ask immediately why a data logger with wireless technology is better than a «normal» data logger or a validation system that operates with thermocouples. Conventional data loggers are programmed before the process begins and then placed in the washer-disinfector or steam sterilizer. The data can be read out and evaluated only at the end of the process. This means that all results for single processes in validation and routine checks are available only at the end of the process. If a flaw is discovered in the process during evaluation, the process must be repeated. Often, this means that several work hours are lost. This is not only annoying, but it also increases the cost of routine checks or validation considerably. In validation systems that work with thermocouples, real-time monitoring of each process is possible. But given the high burden of sensor calibration and their placement in the washer-disinfector or steam sterilizer (which can only be done with a connection port from outside), one recognises very quickly that here there is no savings potential to be found. The new, innovative EBI 10 Data Logger Family from ebro Electronic uses the EBI 10 wireless technology that makes real-time monitoring of routine checks and validation of washer-disinfectors and steam sterilizers possible. The EBI 10 transmits its measured data from the closed washerdisinfector or steam sterilizer. It allows the operator to watch the process live on his monitor and to immediately stop a potentially faulty process saving much work and time. The totally water- and steamtight EBI 10 (IP 68) has a temperature measuring range from -80 C (-112 F) up to +400 C (752 F) and a pressure measuring range from 1 mbar up to 4000 mbar. The memory capacity is 30,000 measured values, making it possible to record processes with a duration of up to 2 hours with a measuring interval of 250 milliseconds. The temperature and pressure accuracy of ±0.05 C (±0.09 F) or ±15 mbar is very high with and documented in the accompanying ISOcertificate. The logger is operated with the special EBI 10 interface with integrated antenna. The system transmits on the worldwide approved frequency 2.4 GHz and meets the IEEE radio standard 802.15.4, providing total conformity. For evaluating the recorded data, the EBI 10 wireless system is complemented by the Software Winlog.med or Winlog.med Validation. Winlog.med is particularly suited for daily routine checks of washer-disinfectors. Here the disinfection parameters A 0 -Value 60, 600, 3000 and temperature-time response are recorded. In routine checks of steam sterilizers, pressure and temperature-time response are documented. Winlog.med evaluates the readings automatically and presents them graphically. At the end of the routine check, Winlog.med presents an unambiguous and faultless assessment of the process (passed/failed). For the annual validation of washer-disinfectors, bed-pan washer-disinfectors and steam sterilizers, Winlog.med is the ideal software choice. Winlog.med offers, in addition to all features of the standard version, a special «mapping» function. This means that the exact position of the temperature and pressure sensors within the washer-disinfector or steam sterilizer to be validated are entered in a three-dimensional model. The serial-number, channel and position of each sensor are recorded during entry. The instrument to be checked was previously selected from a data base. After logger programming, a programming protocol and after readout a result protocol are automatically generated. After validation of the washer-disinfector, Winlg.med Validation automatically delivers a protocol with the following contents: - Data of the washer-disinfector: Model, inventory number, device number, program, data logger charge, last check - Name of tester - Position of sensors, type and serial number of the data loggers - Program selected - Calculated and required A 0 -Value - Release of the validation (yes/no) The automatic report generation for steam sterilizers is exactly the same as with washer-disinfectors, but for steam sterilizers other information is crucial: - Data of the steam sterilizer: Model, inventory number, device number, program, data logger charge, last check - Name of tester - Position of sensors, type and serial number of the sensors - Program selected - Minimal pressure in the vacuum - Compensation time - Sterilization temperature reached / hold time of sterilization temperature - Temperature band - Variance and fluctuation of all sensors - Theoretic temperature -F 0 -Value (lethality calculation) - Release of the validation (yes/no) The Software assigns an OK/not OK to each of the above points, so the person responsible can immediately stop the process in case of an error, saving time and reducing costs. CONCLUSION: With the new EBI 10 wireless data logger system, the user can save much time and money with routine checks and validation. The new system combines the advantages of conventional data logger systems regarding simple sensor placement in the process with real-time transmission of measured data with wireless technology. Of course, the new EBI 10 data loggers fulfil all requirements with respect to routine checks and validation of washer-disinfectors and steam sterilizers according to ISO 15883, DIN EN 554 and ISO 17665. Author: Iven Kruse ebro Electronic GmbH & Co. KG, Peringerstr. 10, D-85055 Ingolstadt Tel.: 0841/95478-20, Fax: 0841/95478-80, E-mail: info@ebro.com, Internet www.ebro.com

Temperature Pressure-Temperature / Temperature Wireless Data Logger EBI 10-TP231 Luerlock / EBI 10-T100 Pressure 7 EBI 10-TP231 Luerlock EBI 10-T100 Simple routine checks of washer-disinfectors According to ISO 15883-4 Pressure/Temperature Data Logger EBI 10-TP231 Luerlock Type Measuring range temp. 0 C... +150 C (32 F... 302 F) Measuring range pressure 1 mbar... 4.000 mbar Accuracy ±0.2 C (-40 C... 0 C) / ±0.4 F (-40 F... 32 F) ±0.1 C (0 C... +140 C) / ±0.2 F (32 F... 284 F) ±0.2 C (+140 C... +150 C) / ±0.4 F (284 F... 302 F) ±10 mbar Resolution Temperature: 0.025 C (0.045 F) Pressure: 1 mbar Measuring rate adjustable: 250 ms, 500 ms, 1s... 24 h Memory 100,000 measured values Operating temperature 0 C... +150 C (32 F... 302 F) Operating pressure up to 7 bar Sensor 1 Temperature (Pt 1000), ext., axial Ø 3 mm / L = 40 mm 1 Pressure (piezo-resistive pressure sensor temperature compensated) Measuring mode Endless Measure upon start temperature Measure upon start time Start / stop time Start immediately until end of memory Communication Wireless 2.4 GHz / IEEE 802.15.4 Eyelet Optional, provided with every type of EBI 10 Battery by user exchangeable Size / Weight Ø 46 mm x 24 mm* / approx. 70 g* Housing material Stainless steel (V4A) / PEEK Protection class IP 68 / NEMA 6 EBI 10-TP231 Luerlock 1340-6155 Type EBI 10-T100 Measuring range temp. -85 C... +400 C (-121 F... 752 F) Accuracy ±0.5 C (-85 C... -40 C) / ±0.9 F (-121 F... -40 F) ±0.2 C (-40 C... 0 C) / ±0.4 F (-40 F... 32 F) ±0.1 C (0 C... +140 C) / ±0.2 F (32 F... 284 F) ±0.2 C (+140 C... +250 C) / ±0.4 F (284 F... 482 F) ±0.5 C (+250 C... +400 C) / ±0.9 F (482 F... 752 F) Resolution Temperature: 0.025 C / 0.045 F Measuring rate adjustable: 250 ms, 500 ms, 1s... 24 h Memory 100,000 measured values Operating temperature -85 C... +150 C (-121 F... 284 F) Operating pressure range up to 20 bar Sensor 1 Temperature (Pt 1000), intern Measuring mode Endless Measure upon start temperature Measure upon start time Start / stop time Start immediately until end of memory Communication Wireless 2.4 GHz / IEEE 802.15.4 Eyelet Optional, provided with every type of EBI 10 Battery by user exchangeable Size / Weight Ø 46 mm x 24 mm* / approx. 70 g* Housing material Stainless steel (V4A) / PEEK Protection class IP 68 / NEMA 6 * Size and weight are shown for EBI 10 body only Monitoring of bed-pan washer-disinfectors Routine checks and validation of steam sterilizers A 0 (60, 600 and 3,000) value calculation according to ISO 15883-1 in washer-disinfectors Pressure/Temperature Data Logger EBI 10-T100 1340-6100

Temperature Pressure 8 Routine checks in the CSSD Set SL 1000 / Set SL 1100 ebro Starter-Set SL 1000 for A 0 -Value Calculation For routine checks of washer-disinfectors and bed-pan washer-disinfectors Set contains: 1 x Temperature data logger EBI 10-T100 1 x ph-tester PHX 800 1 x Conductivity tester DIST 3 1 x Interface EBI IF 100 1 x Software Winlog.med 1 x Carrying case Starter Set SL 1000 1340-6070 1 Temperature- and time respective A 0-value monitoring with additional data logger control daily* 3 months 6 months annually** a) RDA with temperature documentation: actual value with separate sensor/recording independent of steering X b) RDA with temperature documentation: actual value with separate sensors/recording steering-dependent X c) RDA with temperature documentation: actual value without separate sensors X d) RDA without temperature documentation or only with specified value X * once a day / ** can be done in the context of a further performance qualification ebro Starter-Set SL 1100 for A 0 -Value Calculation and Pressure Monitoring For routine checks of washer-disinfectors and steam sterilizers Set contains: 1 x Pressure/Temperature data logger EBI 10-TP231 Luerlock 1 x ph-tester PHX 800 1 x Conductivity tester DIST 3 1 x Silicone protection box AL 101 1 x Interface EBI IF 100 1 x Software Winlog.med / 1 x Carrying case Starter Set SL 1100 1340-6071 2 Pressure monitoring/additional testing e.g. pressure measurement or washer arm rotation per batch 6 months annually** a) RDA with pressure documentation: with actual value monitoring X b) RDA without pressure documentation: with actual value monitoring X c) RDA without pressure documentation: without actual value monitoring X ** can be done in the context of a further performance qualification Remarks Please feel free to request an individual offer!

Validation For the validation of disinfection effects, temperature recording systems conforming to norm ISO 15883-1 item 6.2.1 and 6.2.2 are to be employed. Sensors are placed between instruments, in the position of the reference sensor of the automatic cleaning-disinfection unit and in the position of the recording sensor of the recording device as well (if equipped). Problematic hazard areas are to be referred to in the type test or other previous tests. It is recommended to test at least two cycles with six measuring points, or three cycles with four measuring points, for each load category. The employment of bio-indicators as a replacement for thermologgers is not justifiable (see ISO 15883-1, item 6.8.1). Thermal Disinfection following EN ISO 15883, 6.8.2 1 = Adjacent to temperature measuring probe for automatic steering 2 = Point at which temperature is reached most quickly 3 = Point at which temperature is reached most slowly 4 (5, 6) = Reference measuring probe for chamber temperature It is recommended to test at least two cycles with 6 sensors or three cycles with 4 sensors for each load category.

Temperature Pressure 10 Validations in the CSSD Set SL 2000 / Set SL 2100 ebro Validation Set SL 2000 for A 0 -Calculation and Pressure Monitoring For validation of washer-disinfectors Set contains: 1 x Pressure/Temperature data logger EBI 10-TP231 Luerlock 3 x Temperature data logger EBI 10-T441 1 x Interface IF 200 1 x Antenna AL 112 1 x Antenna lead-through 1 x Software Winlog.med Validation 1 x ph-tester PHX 800 1 x Conductivity tester DIST 3 1 x Carrying case Validation Set SL 2000 1340-6072 ebro Validation Set 2100 for A 0 -Value Calculation and Pressure Monitoring For validation of washer-disinfectors and steam sterilizers Set contains: 1 x Pressure/Temperature data logger EBI 10-TP322 Luerlock 5 x Temperature logger EBI 10-T441 1 x Silicone protection AL 101 5 x Silicone protection AL 100 1 x Interface IF 200 1 x Antenna AL 112 1 x Antenna lead-through 1 x Software Winlog.med Validation 1 x ph-tester PHX 800 1 x Conductivity tester DIST 3 / 1 x Carrying case Validation Set SL 2100 1340-6073 Remarks Please feel free to request an individual offer!

Temperature Temperature Wireless Data Logger EBI 10-Series 11 EBI 10-T220/221 EBI 10-T240/241 EBI 10-T441 EBI TIB Type EBI 10-T220/221 Measuring range -85 C... +400 C (-121 F... 752 F) Accuracy ±0.5 C (-85 C... -40 C) / ±0.9 F (-121 F... - 40 F) ±0.2 C (-40 C... 0 C) / ±0.4 F (-40 F... 32 F) ±0.1 C (0 C... +140 C) / ±0.2 F (32 F... 284 F) ±0.2 C (+140 C...+250 C)/±0.4 F (284 F... 482 F) ±0.5 C (+250 C...+400 C) / ±0.9 F (482 F...752 F) Resolution Temperature: 0.025 C / 0.045 F Measuring rate 250 ms, 500 ms, 1 s... 24 h Memory 100,000 measured values Operating temperature (-121 F... 284 F) ** -85 C... +150 C ** Operating pressure range up to 20 bar Sensor 1 Temp. (Pt 1000), ext., radial T220: Ø 1.5 mm / L = 250 mm T221: Ø 1.5 mm / L = 500 mm Measuring mode Endless Measure upon start temperature Measure upon start time Start/stop time Start immediately until end of memory Communication Wireless 2.4 GHz/IEEE 802.15.4 Eyelet, optional provided with every type of EBI 10 Battery by user exchangeable Size / Weight Ø 46 x 24 mm* / approx. 70 g* Housing material Stainless steel (V4A) / PEEK Protection class IP 68 / NEMA 6 For wireless measurements in washer-disinfectors and autoclaves (validation), especially for measurements in small trays. Use EBI TIB for measuring in dry heat sterilizers and furnaces up to +350 C (+662 F) Temp. Wireless Data EBI 10-T220 1340-6104 Logger Temp. Wireless Data EBI 10-T221 1340-6105 Logger Thermal Insulation Box EBI TIB 1340-1894 Type EBI 10-T240/241 Measuring range -85 C... +400 C (-121 F... 752 F) Accuracy ±0.5 C (-85 C... -40 C) / ±0.9 F (-121 F... - 40 F) ±0.2 C (-40 C... 0 C) / ±0.4 F (-40 F... 32 F) ±0.1 C (0 C... +140 C) / ±0.2 F (32 F... +284 F) ±0.2 C (+140 C... +250 C) / ±0.4 F (284 F...482 F) ±0.5 C (+250 C...+400 C) / ±0.9 F (482 F...752 F) Resolution Temperature: 0.025 C / 0.045 F Measuring rate 250 ms, 500 ms, 1 s... 24 h Memory 100,000 measured values Operating temperature (-121 F... 284 F) ** -85 C... +150 C ** Operating pressure range up to 20 bar Sensor 1 Temp. (Pt 1000), ext., axial T240: Ø 1.5 mm / L = 250 mm T241: Ø 1.5 mm / L = 500 mm Measuring mode Endless Measure upon start temperature Measure upon start time Start/stop time Start immediately until end of memory Communication Wireless 2.4 GHz/IEEE 802.15.4 Eyelet, optional provided with every type of EBI 10 Battery by user exchangeable Size / Weight Ø 46 x 24 mm* / approx. 70 g* Housing material Stainless steel (V4A) / PEEK Protection class IP 68 / NEMA 6 Probe length 250 mm and 500 mm. Probe bendable to reach inaccessible places Validation of washer-disinfectors, autoclaves and SIP systems Temp. Wireless EBI 10-T240 1340-6111 Data Logger Temp. Wireless Data Logger EBI 10-T241 1340-6112 Type EBI 10-T441 Measuring range -85 C... +400 C (-121 F... 752 F) Accuracy ±0.5 C (-85 C... -40 C) / ±0.9 F (-121 F... - 40 F) ±0.2 C (-40 C... 0 C) / ±0.4 F (-40 F... 32 F) ±0.1 C (0 C... +140 C) / ±0.2 F (32 F... +284 F) ±0.2 C (+140 C... +250 C) / ±0.4 F (284 F...482 F) ±0.5 C (+250 C...+400 C) / ±0.9 F (482 F...752 F) Resolution Temperature: 0.025 C / 0.045 F Measuring rate 250 ms, 500 ms, 1 s... 24 h Memory 100,000 measured values Operating temperature (-121 F... 284 F) ** -85 C... +150 C ** Operating pressure range up to 20 bar Sensor 2 Temperature (Pt 1000), extern, axial / Ø 1.5 mm / L = 500 mm Measuring mode Endless Measure upon start temperature Measure upon start time Start/stop time Start immediately until end of memory Communication Wireless 2.4 GHz/IEEE 802.15.4 Eyelet, optional provided with every type of EBI 10 Battery by user exchangeable Size / Weight Ø 46 x 24 mm* / approx. 70 g* Housing material Stainless steel (V4A) / PEEK Protection class IP 68 / NEMA 6 * Size and weight are shown for EBI 10 body only ** For measurements over +150 C (302 F) EBI TIB must be used Probe length 500 mm. Probe bendable to reach inaccessible places Validation of washer-disinfectors and autoclaves Temp. Wireless EBI 10-T441 1340-6129 Data Logger

12 Temperature Pressure Pressure/Temperature Wireless Data Logger EBI 10-Series EBI 10-TP221 EBI 10-TP321 EBI 10-TP421 Type EBI 10-TP221 Measuring range 0 C... +150 C (32 F... 302 F) 1 mbar... 4000 mbar Accuracy ±0.1 C (0 C... +140 C) / ±0.2 F (32 F... 284 F) ±0.2 C (+140 C...+150 C) / ±0.4 F (284 F...302 F) ±10 mbar Resolution Temp.: 0.025 C (0.045 F), Pressure: 1 mbar Measuring rate 250 ms, 500 ms, 1 s... 24 h Memory 2 x 50,000 measured values Operating temp. 0 C... +150 C (32 F... 302 F) Operating pressure range up to 7 bar Sensor 1 Temp. (Pt 1000), ext., axial Ø 1.5 mm / L = 500 mm 1 Pressure Measuring mode Endless Measure upon start temperature Measure upon start time Start/stop time Start immediately until end of memory Communication Wireless 2.4 GHz /IEEE 802.15.4 Eyelet, optional provided with every type of EBI 10 Battery by user exchangeable Size / Weight Ø 46 x 24 mm* / approx. 70 g* Housing material Stainless steel (V4A) / PEEK Protection class IP 68 / NEMA 6 Type EBI 10-TP321 Measuring range 0 C... +150 C (32 F... 302 F) 1 mbar... 4000 mbar Accuracy ±0.1 C (0 C... +140 C) / ±0.2 F (32 F... 284 F) ±0.2 C (+140 C...+150 C) / ±0.4 F (284 F...302 F) ±10 mbar Resolution Temp.: 0.025 C (0.045 F), Pressure: 1 mbar Measuring rate 250 ms, 500 ms, 1 s... 24 h Memory 3 x 33.334 measured values Operating temp. 0 C... +150 C (32 F... 302 F) Operating pressure range up to 7 bar Sensor 2 Temp. (Pt 1000), ext., axial Ø 1.5 mm / L = 500 mm 1 Pressure Measuring mode Endless Measure upon start temperature Measure upon start time Start/stop time Start immediately until end of memory Communication Wireless 2.4 GHz /IEEE 802.15.4 Eyelet, optional provided with every type of EBI 10 Battery by user exchangeable Size / Weight Ø 46 x 24 mm* / approx. 70 g* Housing material Stainless steel (V4A) / PEEK Protection class IP 68 / NEMA 6 Type EBI 10-TP421 Measuring range 0 C... +150 C (32 F +302 F) 1 mbar... 4000 mbar Accuracy ±0.1 C (0 C... +140 C) / ±0.2 F (32 F... 284 F) ±0.2 C (+140 C...+150 C) / ±0.4 F (284 F...302 F) ±10 mbar Resolution Temp.: 0.025 C (0.045 F), Pressure: 1 mbar Measuring rate 250 ms, 500 ms, 1 s... 24 h Memory 4 x 25,000 measured values Operating temp. 0 C... +150 C (32 F... 302 F) Operating pressure range up to 7 bar Sensor 3 Temp. (Pt 1000), ext., axial Ø 1.5 mm / L = 500 mm 1 Pressure Measuring mode Endless Start/stop time Measure upon start temperature Measure upon start time Start immediately until end of memory Communication Wireless 2.4 GHz /IEEE 802.15.4 Eyelet, optional provided with every type of EBI 10 Battery by user exchangeable Size / Weight Ø 46 x 24 mm* / approx. 70 g* Housing material Stainless steel (V4A) / PEEK Protection class IP 68 / NEMA 6 * Size and weight are shown for EBI 10 body only For wireless temperature and pressure measurements Especially for the validation of steam sterilizers and washer-disinfectors with 1 external temperature sensor For wireless temperature and pressure measurements Especially for the validation of steam sterilizers and washer-disinfectors with 2 external temperature sensors For wireless temperature and pressure measurements Especially for the validation of steam sterilizers and washer-disinfectors with 3 external temperature sensors Pressure/Temperature EBI 10-TP221 1340-6153 Wireless Data Logger Pressure/Temperature EBI 10-TP321 1340-6161 Wireless Data Logger Pressure/Temperature EBI 10-TP421 1340-6162 Wireless Data Logger

Temperature Pressure Mini Temperature Data Logger / Mini Pressure/Temp. Data Logger EBI 11-T240 / EBI 11-TP100 13 EBI 11-T240 NEW EBI 11-TP100 NEW full-scale full-scale Available in 2nd quarter 2009 Type EBI 11-T240 Channels 1 Temperature Measuring range 0 C... +150 C (32 F... 302 F) Accuracy ±0.1 C (±0.2 F) Resolution 0.01 C (0.02 F) Measuring rate 1 s... 24 h, adjustable Memory 15,000 measured values Operating temperature 0 C... +150 C (32 F... 302 F) Storage temperature -30 C... +150 C (-22 F... 302 F) Measuring probe 1 temperature, extern, axial Ø 1.5 mm / probe length = 500 mm Sensor PT 1000 Measuring mode Endless Start / stop measurement Start immediately until end of memory No measurement Communication One-port interface in housing and contact area on underside of instrument Battery by user exchangeable Battery lifetime 0.1 s measuring rate: 64 h 1 s measuring rate: 25 days 1 min measuring rate: 42 weeks 15 min measuring rate: 50 weeks Dimensions Ø 16.5 mm x 22 mm (without probe) Housing material V4A Protection class IP 68 Temperature measurements in table-model steam sterilizers A 0 -Value calculation according to ISO 15883-1 Monitoring and validation of steam sterilizers, washer-disinfectors and bed-pan washer-disinfectors under cramped conditions Mini Temperature Logger, 1-channel, EBI 11-T240 1340-6291 ext.,ø 1.5 mm, L = 250 mm Starter Set (1 Logger, 1 Interface, 1 Battery exchange set, 1 Winlog.pro in an carrying case) SL 1001 1340-6090 Type Channels Measuring range Accuracy Resolution Measuring rate Memory Operating temperature Storage temperature Sensor Measuring mode Communication Temperature/Pressure measurements in table-model steam sterilizers Routine checks and validation of steam sterilizers, washer-disinfectors and bed-pan washer-disinfectors under cramped conditions Mini Pressure/Temperature Logger EBI 11-TP100 1340-6295 Accessories EBI 11-TP100 1 Temperature 1 Pressure internal 0 C... +150 C (32 F... 302 F) 1 mbar... 4,000 mbar Temp.: ±0.1 C (±0.2 F) / Pressure: ±10 mbar Temp.: 0.01 C (0.02 F) / Pressure: 1 mbar 1 s... 24 h, adjustable 2 x 7,500 measured values 0 C... +150 C (32 F... 302 F) -30 C... +150 C (-22 F... 302 F) Temperature: PT 1000 / Piezo-resistive pressure sensor Endless Start / stop measurement Start immediately until end of memory No measurement One-port interface in housing and contact area on underside of instrument ebro-gimp protocol by user exchangeable Protocol Battery Battery lifetime 1 s measuring rate: 4 days 1 min measuring rate: 15 weeks 15 min measuring rate: 30 weeks Dimensions Ø 16.5 mm x 35 mm Housing material V4A Protection class IP 68 4-port Interface for EBI 11 EBI IF 300 1340-6003 Evaluation Software Winlog.med 1340-2365 (Version: Validation) Validation

Temperature Pressure 14 Accessories useable for EBI 10, EBI 11 and EBI 15 NEW Interface EBI IF 100 useable for EBI 10 and EBI 11 4-port Interface EBI IF 200 useable for EBI 10 Interface EBI IF 150 useable for EBI 15 USB connector Colored LED signals status (program, read out, error) Including antennas AL 111 Works with Winlog.pro, Winlog.med, Winlog.med Validation USB connector Colored LED signals status (program, read out, error) Including antennas AL 111 Works with Winlog.pro, Winlog.med, Winlog.med Validation USB connector Colored LED signals status (program, read out, error) Including antennas AL 111 Works with Winlog.pro, Winlog.med, Winlog.med Validation Thermal Insulation Box EBI TIB Must be used from +150 C (302 F) to +400 C (752 F) Thermal protection for data loggers Used for R-Loggers Stainless steel 160 x 160 x 82 mm Surrounding temperature Ø78mm Height: 44 mm Ø78mm Height: 50 mm Thermal Silicone Protection Box AL 100 Silicone Protection Box AL 101 Applicable in steam sterilizers up to max.+250 C (482 F) Max. residence time approx. 40 min at +150 C (302 F) Protects EBI 10 temperature logger from heat spikes Protects EBI 10 temperature logger from mechanical damage Enhances lifetime of EBI 10 temperature logger Applicable in steam sterilizers up to max.+150 C Max. residence time approx. 40 min at +150 C (302 F) Protects EBI 10 pressure and/or temperature logger from heat spikes Protects EBI 10 pressure and/or temperature logger from mechanical damage Enhances lifetime of EBI 10 pressure and / or temperature logger Battery Exchange Set AL 103 With tools for EBI 10 and EBI 15 (Lubricated O-rings, batteries, exchange tool, screwdriver for recessed head screws, screw, operating instruction) Interface for EBI 10 and EBI 11 EBI IF 100 1340-6001 NEW Interface for EBI 15 and EBI 10 EBI IF 150 1340-6194 4-port Interface for EBI 10 EBI IF 200 1340-6002 NEW 4-port Interface for EBI 11 (not shown) EBI IF 300 1340-6003 Antenna (not shown) AL 111 1340-6006 Antenna for steam sterilizer (not shown) AL 112 1340-6007 Thermal Insulation Box EBI TIB 1340-1894 Thermal Silicone Protection Box AL 100 1340-6020 Silicone Protection Box AL 101 1340-6021 Battery Exchange Set for EBI 10 and EBI 15 AL 103 1100-0117 Battery Set for EBI 10 and EBI 15 (Batteries, o-rings, lubricant) AL 104 1100-0118 Battery Exchange Set for EBI 11 (Batteries, o-rings, lubricant) AL 113 1100-0120

Temperature Pressure 15 Antenna Adaptor for EBI 10 useable in Steam Sterilizers for Antenna AL 112 Antenna AL 112 Reducing socket / Coupling muff Sealing tape (Part No. 1340-2130) is necessary (Reducing socket/coupling muff already included in validation sets) Reducing socket AL 151 Antenna adaptor AL 150 1" 1 /2 " 1 /2 " Tri-Clamp Adaptor Tri-Clamp adaptor AL 153 1" Ø 50.5 1 /2 " Tri-Clamp adaptor AL 152 Tri-Clamp dummy cover AL 154 Dummy cover Tri-Clamp sealing AL 156 Tri-Clamp compression fitting AL 155 Antenna adaptor with 1 /2" external thread AL 150 1340-6040 Reducing socket 1" to 1 /2" internal thread AL 151 1340-6041 Tri-Clamp adaptor 50.5 mm to 1" (internal thread) AL 152 1340-6042 Tri-Clamp adaptor 50.5 mm to 1 /2" (internal thread) AL 153 1340-6043 Tri-Clamp dummy cover 50.5 mm AL 154 1340-6044 Tri-Clamp compression fitting AL 155 1340-6045 Tri-Clamp sealing AL 156 1340-6046 Antenna for steam sterilizers AL 112 1340-6007

EBI 30-pH & EBI 30-C... ebro ph-logger and ebro Conductivity Logger The data loggers EBI 30-pH and EBI 30-C from ebro Electronic enables the user to monitor ph-value or conductivity as well as temperature and time during routine controls and validation in the CSSD.

ph-value / Conductivity Temperature- and ph-logger EBI 30-pH 17 NEW Exchangeable Electrode! Type EBI 30-pH Measuring probe temperature Pt 1000 Measuring range temperature 0 C... 100 C (32 F... 212 F) Resolution temperature 0.01 C (0.02ºF) Accuracy temperature ±0.2 C (±0.4 F) Measuring range ph 1 ph... 14 ph Resolution 0.01 ph Accuracy ±0.02 ph Housing material Stainless steel V4A Dimensions L = 400 mm Ø 25 mm Weight 700 g Memory 16,000 readings Measuring rate 1s... 24 h Protection class IP 68 Battery by user exchangeable Interface RS 232 EBI 30-pH Measures ph-values in drain of washerdisinfectors Routine checks of washer-disinfectors Monitors ph-value, temperature and time directly during process Attributes Programming and readout with PC Fast data transfer Temperature resistant up to +100 C (212 F) High accuracy Waterproof ph-logger EBI 30-pH 1340-6301 Starter Set (Logger, interface, evaluation software) EBI 30-pH-Set 1340-6300 NEW Replacement Electrode for EBI 30-pH EBI 30-pH Electrode 1340-6302

ph-value / Conductivity 18 Temperature- and Conductivity-Logger EBI 30-C NEW Exchangeable Electrode! Type EBI 30-C Sensor temperature PT1000 Measuring range conductivity 0 μs/cm... 2.000 μs/cm Measuring range temperature 0 C... +100 C (32 F... 302 F) Accuracy conductivity 1% of measured value Accuracy temperature ±0.2 C (±0.4 F) Resolution of measuring signal conductivity 0.1 μs/cm Resolution temperature 0.01 C (0.02ºF) Memory 16,000 measurements/channel Measuring rate 1s... 24h Operating temperature 0 C... +100 C (32 F... 212 F) Storage temperature 0 C... +100 C (32 F... 212 F) Protection class IP 68 Battery by user exchangeable Type SL-750 resistant against high temperatures Battery life >24 months @ measuring rate 15 min. and +25 C (77 F) Dimensions L = 400 mm, 25 mm Housing material Stainless steel V4A Weight 700 g EBI 30-C Measuring of conductivity-values in drain of washer-disinfectors Attributes Automatic temperature compensation High accuracy Monitoring of conductivity, temperature and time directly during process Programming and readout with interface and PC 0.5... 2000 μs/cm = high-resolution measurement especially for checking residue after the final rinse with deionized water Battery field-replaceable Factory calibration certificate Conductivity-Logger EBI 30-C 1340-6311 Starter Set (Logger, interface, evaluation software) EBI 30-C-Set 1340-6310 NEW Replacement Electrode for EBI 30-C EBI 30-C Electrode 1340-6312

ph-value / Conductivity ph-value Measurements in Washer-Disinfectors ph-meter PHT 810 / ph-tester PHX 800 / Conductivity-Tester DIST 3 19 ph-meter PHT 810 ph-tester PHX 800 Conductivity-Tester DIST 3 Type PHT 810 ph range 0... 14pH ph accuracy ±0.03 ph ph resolution 0.01 ph Memory Hold, Max/Min Input socket BNC Battery life up to 5 years Display LCD, 12 mm Operating temp. -10 C... +50 C (14 F... 122 F) Storage temp. -25 C... +60 C (-13 F...140 F) Dimensions 110 x 54 x 22 mm Temperature manual compensation Weight approx. 200 g Certificate 2 point factory calibration certificate (included with ph-meter Set) Type PHX 800 Measuring range 0.0... 14.0 ph Resolution 0.1 ph Accuracy ±0.2 ph Operating temp. 0 C... 50 C (32 F... 122 F) Housing material ABS-plastic Dimensions 170 x 32 x 15 mm Weight approx. 70 g Battery 4 x 1.5 V A76/LR44 Battery life approx. 150 h Automatic after approx. 15 min deactivation Type DIST 3 Measuring range 0.0... 1999 μs/cm Resolution 1 μs/cm Accuracy ±2% of measuring range Operating temperature 0 C... 50 C (32 F... 122 F) 95% rh (max. humidity) Dimensions 175 x 41 x 23 mm Weight approx. 78 g Battery 4 x 1.5 V Battery life approx. 150 h ph-value measurements in Washerdisinfectors Dishwater Fluids Attributes Easy calibration on keypad Current value memory Automatic ph-calibration Replacement electrode Factory calibration certificate According to DIN EN 15883-1, -2, -3 ph-meter PHT 810 1340-5810 (without electrode) ph-meter Set ST 2000 1339-0621 Replacement electrode AT 200 1339-0631 Fluid in washer-disinfectors Labor Attributes Hold-function Auto-lock function Exchangeable battery Waterproof Adjustable ph-tester PHX 800 1340-5800 Validation of washer-disinfectors, bed-pan washer-disinfector and steam sterilizer Attributes Easy handling Fast measuring Exchangeable battery Conductivity Tester DIST 3 1340-5830

From monitoring storage temperature of drugs to temperature measurement in hospital kitchens ebro Data Logger Family EBI 20 For comprehensive monitoring of temperature and humidity during storage of drugs and of medical products in hospitals, in the field of anesthetics, in hospital kitchens and in drug stores. ebro Handheld Instruments TFX 410 and TLC 730 We offer you reliable monitoring not only in the medical field, but also in the field of food technology. In hospitals especially in food storage and in the preparation of patient s meals HACCP plays in important role and appropriate measurements must be carried out. With ebro handheld instruments, the necessary measurements are accomplished quickly and easily.

Humidity Temperature Data Logger / Temperature-/Humidity Data Logger EBI 20-T/-TE & EBI 20-TH Temperature 21 EBI 20-T/-TE EBI 20-TH EBI 20-T/-TE Type Measuring range -30 C... +60 C (-22 F... 140 F) Accuracy ±0.5 C (-20 C... +40 C) ±0.9 F (-4 F... +104 F) ±0.8 C (±1.4 F) for the remaining measuring range Resolution 0.1 C (0.2 F) Memory 1 channel, 8,000 measured values Sensor NTC Operating temperature -30 C... +60 C (-22 F... 140 F) Measuring rate 1 min to 24 h Measurement mode endless start/stop measurement start with key Battery 3V lithium (CR2450), exchangeable by user Battery lifetime > 24 months, measuring rate 15 min. at +25 C (77 F) Protection class IP 67 Housing material ABS Dimensions 69 x 48 x 22 mm Weight 45 g EBI 20-TH Type Measuring range temp. -30 C... +60 C (-22 F... 140 F) Measuring range humidity 0%... 100% rh Accuracy temperature ±0.5 C (-20 C... +40 C) / ±0.9 F (-4 F... 104 F) ±0.8 C (±1.4 F) for the remain. measuring range Accuracy humidity ±3% rh (10%... 90%) Resolution temperature 0.1 C (0.2 F) Resolution humidity 0.1% rh Memory 8,000 measured values, i.e. 4,000 measured values per channel Sensor NTC for temperature / capacitive for humidity Operating temperature -30 C... +60 C (-22 F... 140 F) Storage temperature -40 C... +70 C (-40 F... 158 F) Measuring rate 1 min... 24 h Measuring mode immediate loop measurement, measurement from starting point, start immediately until memory full, start/stop measurement, start with key Battery 3V lithium (CR2450), exchangeable by the user Battery lifetime > 24 months, measuring rate 15 min. at +25 C (77 F) Protection class IP 52 Housing material ABS Dimensions 69 x 48 x 22 mm Weight 45 g Secure temperature monitoring Medicine refrigerator Storage monitoring Transport of medicines and vital parts Cooling- / freezer rooms Secure temperature- and humidity monitoring Transport of medicines and vital parts Cooling- / freezer rooms Storage monitoring Temperature logger EBI 20 T 1601-0000 Starter Set (logger, evaluation software, interface) EBI 20-T-Set 1601-0005 Temperature logger with external probe EBI 20-TE 1601-0002 Temperature logger Set (logger, evaluation software, interface) EBI 20-TE-Set 1601-0007 Temperature/humidity logger EBI 20-TH 1601-0050 Temperature/humidity logger set (Logger, evaluation software, interface) EBI 20-TH-Set 1601-0055 Accessories EBI 20 wall bracket EBI 20-WM 1601-0030 EBI 20 truck wall bracket EBI 20-WM-1 1601-0033 Remarks ISO-calibration certificate available against extra charge.

22 Infrared Temperature Dual Infrared/Fold-Back Thermometer / Core Thermometer TLC 730 / TFX 410 TLC 730 NEW TFX 410 Type TLC 730 Measuring range -50 C... +350 C (-58 F... 662 F) Accuracy Infrared ±4 C at -50 C... -30.1 C / ±7.2 F at -58 F... -22 F ±2.5 C at -30 C... -18.1 C / ±4.5 F at -22 F... -0.4 F ±1.5 C at -18 C... -0.1 C / ±2.7 F at -0.4 F... 32 F ±1.0 C at 0 C... +65 C / ±1.8 F at 32 F... 149 F ±2.0 C or 2% at +65 C... +350 C / ±3.6 F at 149 F... 662 F Accuracy Thermocouple ±0.8 C at -18 C... +120 C / ±1.44 F at -0.4 F... 248 F ±1 C (±2 F) or 1% for remaining range - the larger value is applicable Resolution 0.1 C / 0.2 F Sensor Thermocouple Type K Operating temperature -25 C... +50 C (-13 F... 122 F) Storage temperature -40 C... +70 C (-40 F... 158 F) Battery 2 x Mignon AAA, by user exchangeable Battery lifetime 15 h by permanent use Dimensions 48 x 24 x 172 mm without probe Housing material ABS Weight approx. 140 g Protection class IP 55 Certificate 4 Point Factory calibration Automatic deactivation 2 h, disactable Type TFX 410 Measuring range -50 C +300 C (-58 F... 572 F) Accuracy ±0.3 C (±0.5 F) Resolution 0.1 C (0.2 F) Sensor Pt1000 Operating temperature -25 C... +50 C (-13 F... 122 F) Storage temperature -30 C... +70 C (-22 F... 158 F) Battery 3.0 V Lithium, by user exchangeable Battery life approx. 5 years Dimensions 54 x 22 x 109 mm (without probe) Housing material ABS Weight approx. 90 g Protection class IP 67 Certificate 3 point factory calibration certificate Deactivation automatically after 2 hours Hospital Kitchens Receiving department Food service Cooling-/ Refrigerator chamber Attributes Surface measuring with Infrared Core measuring with penetration probe Dual laser (disactable) High- and low limit visible and audible alarm Hospital Kitchens Food service Receiving department Attributes High definition Waterproof Cooling-/ Refrigerator chamber Factory calibration certificate Exchangeable battery Dual Infrared/Core Thermometer TLC 730 1340-5730 Thermometer with probe TPX 410, TFX 410 1340-5410 60 cm silicone cable

No matter what software requirements you may have: ebro has the right software to meet your needs. - Winlog.med - Winlog.med Validation - Winlog.pro

Software 24 Evaluation Software for all types of ebro Data logger Winlog.med, Winlog.med Validation, Winlog.pro NEW Winlog.med Software for routine checks In the medical field Winlog.med Validation Software for validation In the medical field Winlog.pro General Software for ebro data loggers NEW Winlog.med An evaluation software for data loggers, specifically designed for cleaning and sterilization processes in central sterilization departments. Most process flows during daily routine checks are handled automatically. Winlog.med An easy-to-use software for programming, evaluation, calibration and report generation. User-friendly Automatic evaluation of all measured data Unambiguous results (passed / failed) Evaluation according to EN 285, EN ISO 11140-4, EN 15883, ISO 17655 Winlog.med Validation An evaluation software for data loggers, specifically designed for validation of washer-disinfectors and steam sterilizers in central sterilization departments. Most process flows during daily routine checks and annual validation are handled automatically. Winlog.med Validation An easy-to-use software for programming, evaluation, calibration and report generation. User-friendly Automatic evaluation of all measured data Mapping: sensor placement captured in three dimensional definition Automatic report generation Unambiguous results (passed / failed) Evaluation according to EN 285, 554, EN 15883, ISO 17655 Winlog.pro The general software for programming and evaluation of ebro data loggers. User-friendly Automatic evaluation of all measured data Graphic and numeric presentation of data process Supports all types of ebro data loggers Wireless real-time online monitoring for loggers with radio communication Formula editor for calculating A 0 -value, F 0 -value and theoretic steam temperature User-defined functions can be generated Module for calibration and adjustment of NEW data loggers System requirements: For the software to operate smoothly on your computer, your computer must meet the following requirements: Processor speed (CPU) with at least 1GHz 512 MB working storage 200 MB free hard disc storage USB (Universal Serial BUS) Microsoft Windows 2000, XP, or Vista (32 Bit) Evaluation Software (Standard version) Winlog.med 1340-2360 Evaluation Software (Validation version) Winlog.med Validation 1340-2365 General Software Winlog.pro 1340-2355

Quality, Service and Reliability... at Calibration and Certification ebro offers more than just calibration... In our DKD-accredited, on-site calibration laboratory (DKD-K-46201) we determine the accuracy of your valuable measuring instruments. We test and calibrate not only ebro instruments, but also instruments from other manufacturers at fair prices. DKD-calibration is mandatory for measuring equipment used by certified experts and for measuring equipment used in the CSSD where highest safety standards must be met. ebro calibrates with state-of-the-art equipment from top manufacturers within only 5 working days. Traceability to national and international standards plays an important role. The results of the calibration are documented in detail in a so-called ISO- Calibration Certificate with proof of traceability. All ebro service capacities like repairs, service, factory calibration, ISO-calibration and DKD-calibration are concentrated under one roof. Your advantages: short distances fast delivery perfect service all in one

Calibration 26 Calibration Set / High Precision Thermometer (Reference device) AC 100 / TFX 430 AC 100 TFX 430 Type AC 100 Measuring range +50 C... +200 C (122 F... 392 F) Accuracy ±0.05 C (±0.09 ºF) Setting accuracy 0.01 C (0.02ºF) Resolution 0.01 C (0.02ºF) Warm-up time 10 C / Min (50ºF/min.) Cooling-off time 3 C / Min (37ºF/min.) Stabilizing time 20 Min. Filling capacity of bath 400 ml Supply voltage 230V / 50 Hz, other supply voltage on request Weight approx. 10 kg Carrying case black Type TFX 430 Measuring range -100 C... +500 C (-148 F... 932 F) Accuracy ±0.05 C (-100 C... +200 C) ±0.09 C (-148 F... 392 F) Remaining measuring range: ±0.2 C (±0.4 F) Resolution 0.01 C (-100 C... +199.99 C) 0.02 C (-148 F... 392 F) Remaining measuring range: 0.1 C (0.2 F) Operating temperature -20 C... +50 C (-4 F... 122 F) Storage temperature -30 C... +70 C (-22 F... 158 F) Measuring probe Pt 100 Measuring rate 1-15 sec., adjustable Battery 3 V lithium, by user exchangeable Battery life approx. 5 years Deactivation automatically after 2 hours Dimensions 109 x 54 x 22 mm Housing material ABS Protection class IP 67 Weight approx. 90 g Mobile calibration on site Calibration before and after validation Process control Reference measuring Different types of probes available Attributes Portable calibration bath With safety lock for transport With transport case Very high accuracy DKD-Calibration Certificate Attributes High accuracy Factory calibration certificate Battery exchangeable by user Mobile calibration bath AC 100 1340-6030 Replacement calibration oil AC 110 1340-6031 Precision-Thermometer Pt 100 - Set* TFX 430-Set 1340-5432 * (Thermometer TFX 430, probe TPX 130, extension cord AX 110, DKD-calibration, Alu case AG 130)

Calibration Calibrations ISO / DKD for Data Loggers: EBI 15 / EBI 10 / EBI 11 / EBI 125 / EBI 20 / EBI 30 27 Calibration ISO Type Description Part No. EBI 15 3-Point-ISO 1) 1020-5070 EBI 10-T... / 1 Channel 3-Point-ISO 1) 1020-5046 EBI 10-T... / 2 Channel 3-Point-ISO 1) 1020-5047 EBI 10-TP... / 2 Channel 3-Point-ISO 1) 1020-5055 EBI 10-TP... / 3 Channel 3-Point-ISO 1) 1020-5056 EBI 10-TP... / 4 Channel 3-Point-ISO 1) 1020-5057 EBI 11-T... / 1 Channel 3-Point-ISO 1) 1020-5065 EBI 125-A... / 1 Channel 3-Point-ISO 1) 1020-5021 EBI 125-A... / 2 Channel 3-Point-ISO 1) 1020-5022 EBI 125-A-PT... / 2 Channel 3-Point-ISO 1) 1020-5037 EBI 125-A-PT... / 3 Channel 3-Point-ISO 1) 1020-5038 EBI 85-A 3-Point-ISO 1) 1020-5023 EBI 85-A-TT 3-Point-ISO 1) 1020-5024 EBI 20-T/-TE 2-Point-ISO 1) 1020-5034 EBI 20-T/-TE 3-Point-ISO 1) 1020-5035 EBI 20-TH 2-Point-ISO 1) 1020-5036 EBI 20-TH 3-Point-ISO 1) 1020-5049 EBI 30-pH 3-Point-ISO 1) 1020-5043 EBI 30-C 3-Point-ISO 1) 1020-5044 Calibration DKD Type Description Part No. EBI 10-T... / 1 Channel 3-Point-DKD 2) 1020-5540 EBI 10-T... / 2 Channel 3-Point-DKD 2) 1020-5541 EBI 10-TP... / 2 Channel 3-Point-DKD 2) 1020-5542 EBI 10-TP... / 3 Channel 3-Point-DKD 2) 1020-5543 EBI 10-TP... / 4 Channel 3-Point-DKD 2) 1020-5544 EBI 11-T... / 1 Channel 3-Point-DKD 2) 1020-5565 EBI 125-A... / 1 Channel 3-Point-DKD 2) 1020-5511 EBI 125-A... / 2 Channel 3-Point-DKD 2) 1020-5512 EBI 125-A-PT... / 2 Channel 3-Point-DKD 2) 1020-5521 EBI 125-A-PT... / 3 Channel 3-Point-DKD 2) 1020-5522 EBI 85-A 3-Point-DKD 2) 1020-5513 EBI 85-A-TT 3-Point-DKD 2) 1020-5514 EBI 20-T/-TE 3-Point-DKD 2) 1020-5530 EBI 20-TH 3-Point-DKD 2) 1020-5531 Calibration Miscellaneous Type Description Part No. Extra calibration point additional calibration point ISO 1020-5100 Extra calibration point additional calibration point DKD 1020-5105 Calibration with preliminary values ISO or DKD 1020-5101 Certificate of traceability Certificate of traceability 1020-5102 Double certificate D/E additional certifikat 1020-5103 Time calibration Time calibration 1020-5104 Calibration label red Calibration label red 3040-0549 1) According to DIN ISO 9000ff incl. Certificate Calibration as per ISO 9000ff Modern quality assurance systems like ISO 9000ff, QS 9000, GxP and FDA require regular testing and measuring equipment checks, which also includes the calibration of these devices. ebro ISO calibration is an economical, fast and precise option for the fulfillment of these requirements. Calibration is done by calibration experts in a special laboratory The results are documented in detail, including traceability information, in a so-called ISO certificate Manufacturer-independent calibration, devices from other manufacturers can be calibrated Calibration also includes device adjustment, if necessary (only for ebro devices) We recommend that calibration be completed once per year for thermometers and once every 6 months for pressure and humidity meters. We will be happy to include you in our ebro calibration reminder service free of charge. DKD Calibration DKD calibration is often needed for working standard measuring equipment, measuring equipment used by certified experts and for certain measurement procedures in medicine and pharmaceuticals in other words, everywhere where an especially high degree of safety is required. This calibration is done by special DKD laboratories that are monitored by the Physikalisch- Technische Bundesanstalt (PTB). Calibration is done by accredited laboratories Calibration is internationally recognized DKD calibration is done by specially certified persons only DKD calibration is documented in detail, including traceability Manufacturer-independent calibration, devices from other manufacturers can be calibrated We recommend that calibration be completed once per year for thermometers and once every six months for pressure and humidity meters. 2) According to DKD (Traceability to German Standard) incl. Certificate

Wireless Logger Wireless Data Loggers for CSSD Process Monitoring in realtime Routine checks and validation in washer-disinfectors & steam autoclaves According to ISO 15883, ISO 17665

Training On-site Know-how for practical Use! ebro Trainings lead to success! 1. Software training 2. Calibration training 3. Validation training At ebro, training courses take place in small groups and are scheduled as required. If you are interested in training on site at ebro, please contact your regional ebro representative (see www.ebro.com).

Background Information 30 Conditions of Delivery and Payment Conditions of Delivery and Payment 1. General 1.1 These Conditions of Delivery and Payment shall apply as binding conditions to the business relationship as a whole, to the present agreement, to all deliveries arising from future business transactions between the parties and to other performance. 1.2 Other conditions applied by Customer and not expressly acknowledged by us in writing shall remain non-binding for us, even if not expressly refused by us. 1.3 All other agreements, changes or supplements to agreements and ancillary agreements must be confirmed by us in writing. Statements by our staff and representatives shall be deemed effective in law only when confirmed by us in writing. 2. Offer and Order Confirmation 2.1 Our offers are subject to confirmation. The scope of our obligation to perform shall be determined solely by our written order confirmation. 2.2 Any documents forming the basis of an offer or order confirmation, such as sketches, drawings, cost estimates and other documentation, shall be utilised by Customer for the agreed purpose only and shall not be reproduced or made available to third parties by Customer without our express permission. Said documents shall be returned to us at our request. 3. Delivery and Delay 3.1 Punctual adherence to delivery deadlines assumes the timely supply of documentation and other necessary information to us by Customer and furthermore assumes that payment obligations on behalf of Customer do not fall into default. 3.2 In the case of our inability to comply with binding delivery dates for reasons of force majeure or other unavoidable circumstances such as war, industrial action, lockout or delay in the provision to us of parts, goods or services ordered from third parties, Customer shall be entitled to specify an appropriate extension of the delivery period with a minimum of four weeks, after the expiry of which Customer shall be entitled to withdraw from the contractual agreement in the form of a registered letter. 3.3 Should our delivery of the goods or services be rendered impossible under the circumstances given for reasons beyond our control, we shall be deemed exempt from our obligation to deliver. This shall also apply if said circumstances affect our operations to such an extent that our fulfilment of the agreement is hindered. 3.4 Customer shall be entitled to claim compensation against us, whether for withdrawal from the agreement or delay in delivery, in the circumstances given above. This shall not apply in cases where gross negligence or intention is imputed to us. 3.5 We shall be entitled to execute part-deliveries. 4. Acceptance and Transfer of Risk 4.1 Unless fixed acceptance periods are agreed, Customer shall undertake to accept the delivery item within eight days of notification of its completion. 4.2 If Customer has submitted an order on call, he shall undertake to call up the delivery item or all items, in the case of multiple orders within a period of twelve months from the date of ordering. If Customer fails to call up the order within this period we shall be entitled to undertake unsolicited dispatch and invoicing of the goods, or to withdraw from the contract and demand the return of any bulk discount already granted on the basis of the on-call order for earlier orders. 4.3 Risk shall be transferred to Customer on acceptance of the delivery item, in the case of groundless refusal on the part of Customer to accept the delivery item, or in the case of inaction on the part of Customer after the expiry of the time limit given in 4.1 and 4.2 above or a specifically agreed time limit for acceptance. If dispatch of the delivery item to Customer or a third party is agreed, risk shall be transferred when the delivery item is passed to the carriage agent (mail, rail, carrier etc.). In all cases risk is transferred with the commencement of use of the delivery item. If we accept goods returned for reasons over which we have no control, risk shall lie with Customer until the delivery item arrives at our premises. 5. Prices and Conditions of Payment 5.1 Unless otherwise specified, prices given by us are ex works exclusive of statutory Value Added Tax and packing costs. Packing of our choice will be invoiced. 5.2 Our invoices are due within 10 days at 2% discount or in full within 30 days of the invoice date. Invoices for repairs are due immediately, strictly in full. 5.3 Prices are valid for a period of four months after receipt of our order confirmation. If longer delivery times have been agreed and prices of raw materials, wages and salaries, freight or public duties increase after conclusion of the agreement, shall be entitled to increase prices by an appropriate amount. 5.4 If Customer exceeds the time limit for payments, he shall be deemed to be in default from receipt of our first reminder. We reserve the right to charge default interest to the amount of 3% above the German Central Bank discount rate applicable at the time. 5.5 We are under no obligation to accept bills of exchange, which in all cases shall be deemed to be accepted only when the amount has been credited to our account. We accept no liability for the timely presentation, protest, notification or returning of the bill in the case of non-redemption. In case of default we shall reserve the right to exercise the claims specified in 5.4. 5.6 If Customer fails to meet his obligations of payment to a significant extent, ceases to render payment instalments or fails to redeem a cheque or bill of exchange, or if any serious deterioration in Customer's business status comes to our knowledge, we shall be entitled to demand payment in advance and call in all deliveries outstanding. 5.7 In the case of requests for modification or alteration issued on the part of Customer after order confirmation, we shall invoice Customer for any resulting additional costs. 6. Retention of Title 6.1 The goods delivered shall remain our property until all accounts arising from our business transactions with Customer have been settled in full. Retention of title shall be upheld if individual claims against Customer are included in an open account. A Customer indicating his status as reseller when ordering shall be entitled to resell the reserved goods as part of normal business transactions; however, pledging or cession by security shall not be permitted. In the case of resale of the reserved goods on credit, Customer shall undertake to secure our rights. 6.2 Claims arising from resale of the reserved goods shall be transferred to us by Customer at the time of conclusion of the agreement concerning resale of our delivery; we accept said transfer. 7. Warranty 7.1 Defects in the delivery items about which we are informed after the transfer of risk shall be repaired by us at our own option or replaced by us. We shall also be entitled to replace the goods if repair proves unsuccessful. Written notification of defects must be received by us within fourteen days of transfer of the delivery items to the Customer in the case of visible defects, or immediately after discovery in the case of hidden defects. 7.2 Any alterations or modifications to the goods undertaken by the recipient of the goods shall render null and void all obligation on our part to replace the goods. Defective items shall be returned freight and carriage free and shall be retained for our inspection. If the complaint proves justified we shall, at our own option, replace the goods free of charge and carriage free after return of the defective goods, or repair the defective goods. Claims concerning rescission of the contract, price reduction or compensation shall be excluded. 7.3 We accept no liability for damages arising for the following reasons: Faulty operation by Customer or a third party, inappropriate or improper use, non-observance of our operating instructions, chemical, electrochemical or electrical influence, alterations or maintenance work not approved by us. 7.4 Further claims on the part of Orderer shall be excluded, particularly claims concerning the reimbursement of damages not arising from the delivery item itself. This shall not apply in cases where intention or gross negligence are imputed to us. 8. Place of Fulfilment, Place of Jurisdiction 8.1 The place of fulfilment for delivery and payment shall be Ingolstadt. The place of jurisdiction for all disputes, including those involving bills of exchange or cheque processes, shall be Ingolstadt. 8.2 If a condition of these Terms and Conditions is or becomes invalid, the validity of all other conditions remains unaffected.

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ebro Electronic GmbH & Co. KG Peringerstraße 10 D-85055 Ingolstadt Tel.+49(0)841-95478-0 Fax+49(0)841-95478-80 Internet: www.ebro.com E-Mail: info@ebro.com 100 Distributors worldwide - one close-by: www.ebro.com All names are registered tradenames or trademarks of ebro Electronic GmbH & Co. KG