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Quality - made in Germany Vacuklav ® 31-B “Class B” autoclave. With a short chamber Vacuklav ® 23-B “Class B” autoclave. With a long chamber Why Class B ? In May of 2004, within the context of harmo- nization of the various national sterilization standards, a European Work Group – as assig- ned by the European Union Commission – published European Standard EN 13060. This new standard replaces the previous national standards for small autoclaves. This new european standard EN 13060 designates small autoclaves as Class “B”, “S”, or “N”. “Class B” autoclaves fulfil the strictest stipulations of this standard and can be used for every type of instruments (also hollow instruments) and every type of packaging. In any case, a “Class B” autoclave must pass a helix test in accordance with EN 867-5:2001. Experts agree that this is possible only with fractionated pre-vacuum technology (pre- liminary air removal by sub-atmospheric pulsing). Vacuklav ® 23-B and Vacuklav ® 31-B fulfil the strictest “Class B” requirements and are absolutely future-proof. MELAG Evidence Based Sterilization

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Page 1: Vacuklav 31-B - We take the worry out of validating your ...medisure.net.au/PDF/Melag PDF Brouchers/B Class... · performed earlier in hospitals, however, now takes place on an outpatient

Quality - made in Germany

Vacuklav®31-B“Class B” autoclave. With a short chamber

Vacuklav®23-B“Class B” autoclave. With a long chamber

Why Class B ?In May of 2004, within the context of harmo-nization of the various national sterilizationstandards, a European Work Group – as assig-ned by the European Union Commission –published European Standard EN 13060. Thisnew standard replaces the previous nationalstandards for small autoclaves. This new

european standard EN 13060 designatessmall autoclaves as Class “B”, “S”, or “N”.“Class B” autoclaves fulfil the stricteststipulations of this standard and can be usedfor every type of instruments (also hollowinstruments) and every type of packaging. Inany case, a “Class B” autoclave must pass a

helix test in accordance with EN 867-5:2001.Experts agree that this is possible only withfractionated pre-vacuum technology (pre-liminary air removal by sub-atmosphericpulsing). Vacuklav®23-B and Vacuklav®31-Bfulfil the strictest “Class B” requirements andare absolutely future-proof.

MELAGEvidence Based Sterilization

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Two different mounts for your special needs – for optimal use of the sterilization chamber

Tube

Open end

MELAcontrol ® Helix

Combi mount Cwith 6 trays

Combi m(after beingwith 3 stan

Vacuklav®31-B / Vacuklav®23-B - Plu

Fractionated pre-vacuum

Fractionated pre-vacuum means that thesystem removes air from the sterilizationchamber in a pulsed process of repeatedevacuation, alternative with period inflow ofsteam. This process satisfies the stricteststandards for the quality of the sterilizationsteam. This technique has accordingly repre-sented the standard for hospital sterilizers foryears now. More and more treatment that was performed earlier in hospitals, however, now

takes place on an outpatient basis. For suchtreatments, therapists now generally usecontainers or multiwrap packages for thesterilized items. Such procedures, however,require autoclaves that are sufficiently power-ful and sophisticated. Many autoclaves thatoperate on the gravitation principle, asextensively used until now in surgeries, havereached the limit of their capability.

Testing

On the basis of new general conditions ofsterilization work – for example, new legislationconcerning medical products and infectionprotection – documentation of sterilizationprocesses has become urgently advisable.The standard EN 867-5 has defined a testreceptacle for “Class B” autoclaves that simu-lates the most difficult requirements placed onthe sterilization of long, narrow-bore instru-ments. MELAG offers its MELAcontrol ®

system for this testing purpose. It consists ofa test unit, the so-called helix, into which theuser inserts an indicator strip. After successfulsterilization, the user dates the indicator stripand archives it for purposes of providinglater evidence. Unlike bacteriological testsMELAcontrol ® results are available imme-diately after sterilization.

Innovative water system

Standard autoclaves operate exclusively onthe basis of water-circulation systems thatcontinuously re-use the water. After beingused once, this water becomes dirty. Theadvanced Vacuklav®31-B and Vacuklav®23-Boperate on a single-use (non-reusable) waterprinciple. This is considerably gentler on theinstruments, and on the autoclave. Thisreduces to a minimum the effort required forcleaning the autoclave – which saves youtime and money.

Vacuklav® autoclaves are delivered with amount for trays or cassettes included in theprice of the autoclave. Combi mount C (for 6trays or 3 standard-tray-cassettes) will bedelivered as standard. If you work extensively

with standard-tray cassettes, please informus if you would like to have mount B (for 4standard-tray cassettes or 4 trays) instead ofCombi mount C.

Cap with indicator strip

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Foil Holders – for optimized drying

Quick program

The Vacuklav®31-B and Vacuklav®23-B offera quick program for those occasions whenyou need instruments in a hurry. With thepre-warming function activated, unwrappedinstruments which are needed fast can besterilized with a fractionated pre-vacuum inonly 11 minutes. There is no need for waitingtime between sterilization cycles.

Post-Vacuum for best drying results

For years now, bacteriologists have beenpointing out the importance of drying in theautoclave. This has been taken into account bythe experts working on European standards,so that stringent drying criteria apply for“Class B” autoclaves. These criteria stipulate aresidual moisture content not exceeding 0.2%for instruments or 1.0% for textiles.The deep post-vacuum of the Vacuklav®31-Band Vacuklav®23-B is ideally suited to shortendrying times and to optimize drying, especiallywhen wrapped goods (also large amounts oftextiles) are being sterilized.

Big inside – small outside

Even though the Vacuklav®31-B features alarge usable sterilization chamber of 18 litres,and the Vacuklav®23-B offers 22 litres, the twoautoclaves require only little space in the sur-gery. The Vacuklav®31-B fits on a counteronly 50 cm deep, and the Vacuklav®23-Bneeds only a depth of 60 cm.

No water connection required

Vacuum autoclaves that operate with a water-ring vacuum pump require a permanentconnection to the water mains. The twoinnovative MELAG models Vacuklav®31-Band Vacuklav®23-B, however, are effectivelydesigned for everyday surgery work andrequire no permanent water connection. Theeasily accessible water storage tank integratedinto the autoclave has two chambers. Thisarrangement separates the fresh demineralizedor distilled water from the already used water.This enables easy setting up of these modelsin existing surgeries, without additionalinstallation work.

mount Cg rotated 90°)ndard-tray cassettes

Mount Bwith 4 standard-tray cassettes(also for 4 trays)

g and Play - autoclaves: all you need is an

Use of MELAG Foil Holders considerablyenhances the drying process for sterilizeditems that have been sealed in sterilizationpackages. This arrangement prevents waterdroplets from collecting inside the sterilizationpackages when they lie flat on a tray. If thepackages stand vertically in the MELAG FoilHolder, the condensed droplets of waterquickly flow down and out of the packages.The MELAG Foil Holders can be easilystacked: two of them fit into the chamber.

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---------------------------------------MELAG Vacuklav 31-B

---------------------------------------

Programm : Universal-Program134°C wrapped

Datum : 06.04.2003Uhrzeit : 12:23:15 (Start)Charge Nr.: 4---------------------------------------

Pre heating 93,2 °CConductivity 1 µS/cm

Program step Press. Temperat. Timebar °C min

Start 0.02 59.1 00:001.Fractionation

Evacuation -0.92 62.4 02:43Steam entry 0.40 108.7 05:17

2.FractionationEvacuation -0.82 78.5 08:43Steam entry 0.40 110.3 11:59

3. FractionationEvacuation -0.82 79.1 15:19Steam entry 0.40 112.3 18:46

Heat up 2.05 134.2 22:58Steriliz. begin 2.05 134.2 22:58Steriliz. end 2.17 135.7 26:28Press. release 0.20 102.5 27:38Vacuum-Drying

Drying begin -0.22 94.3 28:17Drying press. -0.91 87.9 32:53Drying press. -0.92 74.5 37:53Drying press. -0.92 65.7 42:53Drying End -0.13 66.9 43:28

End 0.00 66.8 43:44

---------------------------------------

PROGRAMM RUN SUCESSFULLY!

Temperature : 135.6 +0.1 /-0.2 °CPressure : 2.17 +0.01/-0.01 barSteriliz. Time : 3 min 30 sTime : 13:06:59 (End)

=======================================256 200301072 3.22 1.15

DocumentationMELAprint ®42 - log printer MELAwin ® documentation software

electrical socket.

In surgeries or hospitals, documentation ofsterilization for prevention of infection is cru-cial to fulfil the state of the art, and to satisfyinsurance requirements. Documentation of thecycles of Vacuklav® autoclaves is possiblewith the MELAprint ®42 log printer via theintegrated serial interface (RS 232).

MELAprint ®42 records the following data:

- Selected program- Date, time, and current cycle number- Date for vacuum, pressure, and temperature- Confirmation of a successful program cycle- Any deviation from required values

The more effective and convenient solution isto integrate sterilization documentation intothe computer system already in use in yoursurgery. MELAG has developed its MELAwin ®

software for this purpose, for installation onyour surgery PC (Windows®95, Pentium®,100 MHz, or better). The serial interface inte-grated into the Vacuklav® connects the auto-clave to your PC. This configuration archivesall data in the PC, instead of printing them outwith the MELAprint ®42. MELAwin ® can addi-tionally document the following information:

- Loading of the autoclave (e.g., instrument sets)

- The name of the current operator- Information on the patients being treated

with the sterilized instruments

MELAsteam ®

MELAsteam ® is a steam cleaning systemavailable as option. MELAsteam ® enables oneadditional function from the Vacuklav®:steam-cleaning of instruments before sterili-zation, with hot steam generated in thechamber of the autoclave. The steam flowsfrom the Vacuklav® through the handleconnected to the autoclave.

Advantages of MELAdest ®65

Distilled water is necessary for successfulsterilization. Poor-quality water will leavespots on your sterilized instruments. WithMELAdest ®65 you produce high-qualitydistilled water in your own surgery.MELAdest ®65 needs only a power supply. Thedistilled water flows into the plastic containerdelivered with MELAdest ®65. You then fill thewater directly from this container into thewater storage tank of the autoclave. Thisprocedure ideally preserves the condition ofyour autoclave as well as the instruments thatyou sterilize.

MELAdest ®65

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Operating convenience

The Vacuklav®31-B and Vacuklav®23-B offer 4 sterilization programs and 2 test programs (Vacuumtest and Bowie & Dick test). The test programs conveniently test autoclave functioning, wheneverneeded in the surgery. The user presses the start button, and the selected program runs automatically,with monitoring by an advanced microprocessor.

Technical data:

Vacuklav ®31-BDimensions:Outside (D x W x H in cm): 57 x 42.5 x 48.5,Inside: Ø 25 cm x 35 cm depth ; volume 18 litresTray (D x W x H in cm): 29 x 19 x 2; Weight 44 Kg

Power supply:230 V / 50 Hz / 2,500 watts

Maximum loads:Instruments: 5 kg / textiles: 1.8 kg

MELAdem ® 47 (1) installed in a sub-cabinet,with water tank (2) and additional tap (3).

➀➁

MELAdem ® 37 with MELAjet ®

MELAdem ®37

The MELAdem ®37 water treatment systemhelps to save time and money. It works on theion-exchange principle, and can be directlyconnected to the Vacuklav®. The installationof the MELAdem ®37 can be directly at theVacuklav®, at the wall (see picture below), orin a sub-cabinet.

MELAdem ®47

If you sterilize many times a day, you needconsiderable amounts of demineralized water.For such applications, MELAG offers itsMELAdem ®47 water treatment system, whichfunctions on the principle of reverse osmosis.Official institutes recommend systems thatfunction on this principle, owing to theirenvironmental friendliness. MELAdem ®47 isdelivered with a water storage tank and with atap for drawing off demineralized water.

1. Universal program Vacuklav ®31-B Vacuklav ®23-B

Sterilization temperature: 134°CSterilization pressure: 2.1 barSterilization time: 3:30minOperational time (without drying):Warm start with 0.5 kg instruments: 25min 30 minCold start with 5 kg instruments: 28min 35 minDrying period: 15min

2. Gentle program

Sterilization temperature: 121°CSterilization pressure: 1.1 barSterilization time: 20minOperational time (without drying):Warm start with 0.5 kg textiles: 27min 29minCold start with 1.8 kg textiles: 45min 46minDrying period: 20min

3. Prion program

Sterilization temperature: 134°CSterilization pressure: 2.1 barSterilization time: 20minOperational time (without drying):

Warm start with 0.5 kg instruments: 42min 45minCold start with 5 kg instruments: 45min 52minDrying period: 15min

4. Quick program(a “class S” program)

Sterilization temperature: 134°CSterilization pressure: 2.1 barSterilization time: 3:30minOperational time (without drying):Warm start with 0.5 kg instruments: 11min 13minCold start with 5 kg instruments: 19min 24minDrying period: 10min

Vacuklav ®23-BDimensions:Outside (D x W x H in cm): 72 x 42.5 x 48.5,Inside: Ø 25 x 45 depth ; volume 22 litresTray (D x W x H in cm): 42 x 19 x 2; Weight: 51 kg

Power supply:230 V / 50 Hz / 2,500 watts

Maximum loads:Instruments: 5 kg / textiles: 1.8 kg

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Quality and precision for most exacting hygienic requirements

MELAfol ® - available as rolls or as bags

MELAseal ® with reel dispenser “advanced”

MELAclean ®

10.04.5E-GD-MVAC31B

More than 50 years ago, MELAG beganin Berlin to specialize in the manufacture ofsterilization equipment. As a result of high-level quality consciousness, reliability, andinnovative eagerness – together with thehighest in safety objectives – the family-runenterprise MELAG has succeeded in becominga leading producer of sterilization equipment.

Verification of this success has been the saleof more than 345,000 MELAG units aroundthe world. Decades of experience, moderncomputer-aided production technology inapplication on over 7,000 sq. metres ofproduction floor, the employment of highest-quality materials, and an experienced andreliable staff – all these have made MELAGequipment renowned for its quality andconvenience of operation. MELAG corporatepolicy includes systematic specialization in alimited line of products. This enables MELAG

as a successful, medium-size business toemploy its highly specialized developmentteam to effectively satisfy market demandsand to further develop the MELAG line ofproducts as a leading international provider.The entire MELAG staff is proud to have madean important contribution to the protectionof the health of patients and of medicalstaff, with the equipment and accessories itproduces for reliable sterilization and safestorage of sterilized articles.

MELAclean ®

Disinfection Cleanser

Proper instrument preparation before sterili-zation is of utmost importance. Only cleaninstruments can be reliably sterilized; wherethere is residue on an instrument, successfulsterilization is not possible.In most surgeries, however, cleaning anddisinfection of the instruments takes place byhand. This type of cleaning, however, carriesthe risk of many possibilities of mistakes andcarelessness – and the staff in the surgery isalso subject to the danger of infection. Thereis no chance of such risk with the advancedMELAclean ® cleaning and chemical disinfectionsystem. MELAclean ® cleans, disinfects (withMELAclean ® Disinfection Cleanser), rinses,and dries the instruments fully automatically.

Sterile storage

Between removal from the autoclave and theirnext use, sterilized items must be stored so asto be protected from contamination. With thesealing machines MELAseal ® and the sterili-zation package MELAfol ®, MELAG offers theproper, cost-effective components required.

MELAfol ®

MELAfol ® packages guarantee sterile storageof sterilized items. MELAfol ® is a clear sterili-zation package. It consists of a special combi-nation of paper and plastic sheeting that isimpervious to microorganisms, highly resis-tant to tearing, highly transparent, effectivelyclosed by hot sealing, and wrinkle-resistant.The peel-open sealing seam makes theMELAfol ® packages easy to open.

MELAseal ®

With MELAseal ® the operator can sealthe sterilization packages without physicalexertion, to produce optimal sealing seams10 mm wide (German standard DIN 58953stipulates at least 8 mm). These sealingmachines are available in two versions:- MELAseal ®101 „comfortable“- MELAseal ®100 „economic“.

www.melag.com

MELAG