Leica EC Declaration of Conformity for CM1950 Cryostat and Compliance Standards

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14.EC Declaration of Conformity

EC Declaration of Conformity

We herewith declare, in exclusive responsibility, that the

Leica CM1950 Cryostat

was developed, designed and manufactured to conform with the

•Council Directive 2006/95/EC (Low Voltage),

•Council Directive 89/336/EEC, Appendix I (Electromagnetic Compatibility) and

•European council Directive 98/79/EC (IVD)

including their amendments up to the date mentioned below. The following harmonized standards were applied:

•EN 61010-1: 2001

Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1: General requirements

•EN 61010-2-101: 2002

Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment

•EN 591: 2001

Instruction for use for in vitro diagnostic instruments for professional use

•EN 61326-1: 2006

Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements

•EN 61326-2-6: 2006

Electrical equipment for measurement, control and laboratory use - EMC requirements

•EN 61000-3-2: 2000

Electromagnetic compatibility (EMC)

Part 3-2: Limits - Limits for harmonic current emissions

•EN 61000-3-3: 1995 + A1: 2001

Part 3: Limits -

Section 3: Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current ≤ 16A per phase

Electromagnetic compatibility (EMC)

• EN 418: 1992	• EN 1037: 1995
Emergency stop equipment.	Safety of machinery.
Principles for design.	Prevention of unexpected start-up.

In addition, the following in-house standards were applied:

•DIN EN ISO 9001: 2000

Quality management system - requirements.

Leica Biosystems Nussloch GmbH

Postfach 1120

D-69222 Nussloch

October 11, 2007

. . . . . . . . . . . . . . . . . . . . . . . . . . . .

Anne De Greef-Safft

President Biosystems Division

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Contents Leica CM1950 Page Page Table of contents 11.1 12.112.2 12.3Symbols Used in This Manual and Their Meaning Important InformationQualification of Personnel Designated UseSafety and Design General Safety InstructionsUnpacking and Installation Opening the packaging Ramp assembly Transport to the Installation LocationRemoving the packaging Safety Features Microtome knivesKnife guard Securing/Locking the HandwheelCleaning, Disinfection Turning the Instrument Back On Maintenance Handling Specimens DefrostingRemoval of the Microtome Technical Data Technical Data Refrigeration system CM1950, 50 Hz CM1950, 60 HzStandard Delivery Set of filters 5 piecesHandwheel, motorized General Overview Control Panel Fields and Cryostat Chamber Installation Site RequirementsRight side Left sideTransport to the Site Assembling the Handwheel Locking/Unlocking the Handwheel Centering the Handwheel OptionalEmergency-stop function active, or Connection to Power Supply System Existing power systemOnly for instruments sold in Japan Selecting the frequency Installation Installing the Storage Systems Optional For reasons Shelf, Movable OptionalInserting the Section Waste Tray Section waste tray with the a Cutout a facing the userInstalling the Heat Conductor Block, Stationary Optional Installation Mark for suction nozzle Instrument Controls Control Panel Fields on the CM1950 Control Panel Field12 o’clock Position 6 o’clock Retraction 0μm20.0μm 60.0μmCoarse feed functions Motion continues as long as the button is heldBrief press of the button retracts the specimen by 20μm Control panel 3 Motorized sectioning optional Sectioning modesDisinfection Duration 30min Duration 180 min Leica Cryofect is not available in all countriesWorking with the Instrument Turning the Instrument OnConfiguring the Parameters Working with the Instrument Working with the Instrument Manual defrosting of the specimen cooling Entering the trimming thickness Working with the Precooled Cryostat 8.4.1 Preparatory Work Trimming with Extraction Anti-roll Guide Installed Handwheel position 12 3 o’clock, valve open all the way Cutting with Extraction Anti-roll Guide installed Shut off VAC LED in VAC button goes outSpeed 10μm 40% 60% 80% 100% 20μm 30μm 40μmSpeed Extract. value 1μm 5 μm 40% 60% 80% 100% 10μm Working with the Instrument Troubleshooting Problems During WorkProblem Causes Remedies Cryochamber Sections tear Alternately Longer sufficient Temperature Selection Chart in minus C Tissue type Chamber temperatureOptional Accessories Ordering InformationCryofect, VPE Leica Cryofect 4x 350ml When using low-profile blades, the ruler With anti-roll guideLever 6 for the lateral shift Lever 7 for clamping the bladeBlade holder CE with finger rest for NB + BB Inserting the blade into knife holder CE Will result Cleaning the knife holder CE Daily cleaning Unscrew the bolts 35 of the pressure plateNot Visible Optional Accessories Anti-roll guide system Optional Accessories Specimen discs in various dimensions Optional Accessories Maintenance and Cleaning General MaintenanceChanging Fuses Replacement of the Lamp/UVC Lamp Installation of the new lamp This equipment has been cleaned and decontaminated Decontamination Certificate masterNB Microtome knives must be in boxes Yes No indicated belowBU Return Authorization Number Anne De Greef-Safft President Biosystems Division EC Declaration of ConformityWarranty and Service Peoples Republic of China