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Table of Contents
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Summary of Contents for MELAG MELADOC
- Page 1 Operating Manual ® MELAdoc Label Printer...
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Page 2: General Notes
General notes Please read this Operating Manual before you start operation of the label printer. The instructions include important information. Make sure to keep the Operating Manual near to the product. It represents a component of the product. About this manual Symbols used Symbol Explanation... -
Page 3: Table Of Contents
Contents Table of contents 1 Description of the device ..........4 Intended Use ..................4 Views ....................4 2 Operation ..............5 Inserting the label roll ................ 5 Inserting the inking roller ..............8 Removing the inking roller ..............9 Setting the date ................. -
Page 4: Description Of The Device
1 Description of the device 1 Description of the device Intended Use MELAdoc serves the: Labelling the medical product Documentation of the clearance decision Traceability Views Wheel for setting date Release button to open Label ejection Hinged top section... -
Page 5: Operation
2 Operation 2 Operation Inserting the label roll Press the black release button located on the housing and open the upper section of the label printer backwards. Remove the new label roll from its packaging. Extend around 18 cm and dispose the first 12 labels. Push the roll into the bracket until it clicks into position. - Page 6 2 Operation Kink the label strip and hold it in position whilst closing the top section. Close the label printer. Hold it in position to avoid the label strip from being pulled back into the inside and being slipped to the sides. Kink the free end of the label strip downwards.
- Page 7 2 Operation Guide the hanging label strip below into the opening of the lower shaft located underneath the white guide roll and push in as far as is possible. Press the trigger repeatedly, until the strip has been fully taken in and has left the rear shaft. Continue pushing the label strip if necessary so that the label feed grabs.
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Page 8: Inserting The Inking Roller
2 Operation Inserting the inking roller Remove the new label roll from its packaging. Hold the inking roller horizontal by its ends as depicted. Insert the inking roller in the bracket using a little pressure until it clicks. PLEASE NOTE Do not touch the inking roller at any point other than at its both ends. -
Page 9: Removing The Inking Roller
2 Operation Removing the inking roller Open the label printer as described above. Hold the inking roller horizontal by its ends as depicted. Depress the lever-shaped ejector button with the small arrow. This releases the ends of the inking roller from its anchoring and it can be removed. -
Page 10: Removing Jammed Labels
2 Operation Move the marker to the position to be changed. Turning the black wheel to set the desired value. After having set the value, return the wheel to its starting position. Removing jammed labels Open the label printer as described above. Remove all loose labels in the interior of the label printer. -
Page 11: Batch Clearance And Documentation
3 Batch clearance and documentation 3 Batch clearance and documentation Batch clearance Instrument preparation ends with the documented clearance for storage and use (according to RKI: “Hygiene requirements for the treatment of medical products”). The respective clearance decisions may only be carried out by authorized and expert personnel and must be documented. -
Page 12: Batch Documentation
3 Batch clearance and documentation Using batch control systems For further validation of the success of the sterilization procedure we recommend adding batch indicators. The use of a batch system increases process reliability. The Helix test body (e.g. Helix test body MELAcontrol) can be used as batch indicator for "class B"... - Page 13 3 Batch clearance and documentation Visual control The transparent sterilization packaging must be undamaged and dry. The container must be closed securely or sealed with indicator tape, so that any early opening during the storage time can be recognized easily. Also check the labelling of the container (information regarding the contents).
- Page 14 3 Batch clearance and documentation Staff number Autoclave number Batch number Sterilization date Expire date Post-application documentation After use of the medical product, the labels can be removed from the packaging and fixed to the operation protocol or in the patient records.
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Page 15: Storage Length For Sterile Medical Products
3 Batch clearance and documentation Storage length for sterile medical products Terms Sterile barrier system DIN EN ISO 11607-2:2006 replaces the terms "packaging", "end packaging" and primary packaging" with the single term "sterile barrier system." A sterile barrier system is the minimum level of packaging facilitating successful sterilization, serving as a micro-biological barrier and permitting aseptic provision. - Page 16 3 Batch clearance and documentation Guidelines for the storage period of sterile medical products according to DIN 58953-8 from October 2010 This standard applies to the delivery, storage, commissioning, transport and provision (including the packaging and marking necessary for these ends) of all sterile medical products to be used in healthcare institutions such as hospitals, dental and medical practices.
- Page 17 3 Batch clearance and documentation Table 1: Storage length for sterile medical products Packaging type Storage period Unprotected Protected Sterile barrier system storage storage Paper bag in accordance with Serves provision 6 months, DIN EN 868-4 and heatable, for immediate not longer than self-sealing transparent bag the expiry date...
- Page 18 3 Batch clearance and documentation Figure 2: Measures for use – example...
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Page 19: Maintenance
4 Maintenance 4 Maintenance Maintenance: To guarantee faultless functioning, add a drop of standard silicone- based lubricant at the locations indicated. -
Page 20: Appendix - Accessories
5 Appendix – Accessories Article Description Order no.: MELAdoc labels Replacement rolls (6 pcs.) with 01096 750 labels, incl. 1 inker roller Inker roller For MELAdoc label printer 01094 MELAdoc MELAdoc Documentation sheets, 01091 documentation 10 blocks à 100 sheets sheets MELAcontrol... - Page 22 MELAG Medizintechnik oHG Geneststraße 6-10 10829 Berlin Germany E-Mail: info@melag.de Web: www.melag.de Responsible for content: Technical Office Subject to technical alterations Your stockist:...
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