Leica CM3050 S instruction manual EC Declaration of Conformity, Dag Graupner Managing Director

Page 63

10. EC Declaration of Conformity

EC Declaration of Conformity

We herewith declare, in exclusive responsibility, that the

Leica CM3050S – Cryostat

was developed, designed and manufactured to conform with the

•Council Directive 73/23/EEC (Low Voltage),

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

•European council Directive 98/79/EG (IVDD).

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 61326-1: 1997 + A1: 1998 + A2: 2001 + A3: 2003

Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General 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 fluctuations and flicker in low-voltage supply systems for equipment with rated current £ 16 A 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.

Leica Microsystems Nussloch GmbH

Postfach 1120

D-69222 Nussloch

January 12, 2004

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

Dag Graupner

Managing Director

Image 63

Contents Leica CM3050 S Page Important note Table of Contents Table of Contents EC Declaration of Conformity Symbols used in this manual and their meaning Important informationSerial- number Any other use of the instrument is considered improper GeneralDesignated use Qualification of personnelSicherheit Integrated safety devicesUnlocking SafetyLocking the handwheel LockingActivating the emergency stop function Deactivating the emergency stopKnife guard Electrical connections Site requirementsKnife guard/handwheel lock Defrosting/Handling frozen tissueFrozen parts of the instrument and frozen accessories Handling microtome knives/bladesInfectious/radioactive material Disinfection and cleaning11Removing/reinstalling the microtome MaintenanceDisplay message ‘Dry microtome’ Repacking InstallationUnpacking and installation General site requirementsStandard delivery Further accessories Inserting the accessories Prior to switching on the instrument Footswitch FunctionModels with footswitch Connecting the footswitchOverview Instrument PropertiesInstrument Properties Technical Data Microtome Rotary microtome Operating the instrument for the first time OperationAutomatic cutout for sectioning motor Switching on/fusesSwitching on Mains switch / automatic cutout for the instrumentActivates / deactivates a number of functions Control panel Key functions in control panelDisplay functions in control panel Lock / unlock keyY M I C R O T O M E 15-minute steps Specimen temperature Instruments with specimen cooling only= Preset counter activated Cryochamber temperaturePreset counter Instruments with sectioning motor only Press key until menu item ‘Preset counter’ is displayedPress lock/unlock key to activate or de- activate ON/OFF Real timeStarting time of automatic defrost cycle Duration of defrost cycleStop Status displayThese parameters can be displayed via the ar- row keys Refrigeration stateSection thickness Total section thickness counter Instruments with sectioning motor Control panel Instruments without sectioning motorActivating a sectioning mode Sectioning mode 1 Intermittent strokeStart / stop motorized sectioning Press sectioning window key once more Emergency stop Functional area B all models Coarse feed keys Coarse feed ‘fast forward’ Travelling speed 1,000 μm/sTo start, press and hold Setting the section thickness Selecting trimming thicknessMotorized trimming ‘Defrosting Handling frozen tissue’ Chapter Daily operation of the instrument‘Knife guard / Handwheel lock’ Chapter See .3.4 ‘Menu functions’ item Installing the 90 prismFreezing specimens with the 90 prism Mobile heat extractorThermoblock Inserting specimen discs into the specimen headSpecimen orientation Insert the knife / disposable blade into the knife holder Trimming / sectioning Inserting the knifeManual trimming SectioningSwitching off the instrument for a longer period of time Finishing work 5.6.1 Daily routine stepsLock handwheel Defrosting Automatic chamber defrost cycleInstruments with specimen cooling Manual chamber defrost cycle Troubleshooting, applications tips Remedies Potential problems causes and remedies Problem CausesProblem Causes Luke-warm specimen disc Microtome defective Problem Causes RemediesTissue Reference chart for temperature settings in minus CAllow to soak for 15 minutes Disinfection, cleaning and maintenanceSafety instructions On disinfection and cleaning Spray disinfection with Leica CryofectRemove section waste from the chamber and dispose of it CleaningSwitch the instrument off Disinfection with conventional disinfectants‘Disinfection and cleaning’ Chapter Reinstalling the microtome Place plastic coupling 11 on handwheel couplingUnlock handwheel Removing the sliding window Installing the replacement lampExchanging the fluorescent light lamp RemovalDecommissioning and disposal Warranty and serviceWarranty Technical service informationElectrohydraulic height adjustment Safety instructionsAppendix Installation Maintenance and care TroubleshootingControl keys Consumables Ordering information accessories Knife holdersAccessories Specimen discsDag Graupner Managing Director EC Declaration of ConformityNB Microtome knives must be in boxes This equipment has been cleaned and decontaminatedDecontamination Certificate master Dear CustomerBU Return Authorisation Number