MELAG MELAdoc User manual

Operating Manual
MELAdoc®
Label Printer

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
Indicates a situation which if not avoided could entail
damage to the instruments, the practice equipment or
the device.
Draws your attention to important information.
Formatting rules
Symbol
Explanation
see Chapter 2
Reference to another text section within this
manual.
Fig. 1/(3)
Reference to a detail in a figure – in the example,
to part no. 3 in figure 1.

Contents
3
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................................................................................. 9
Removing jammed labels................................................................ 10
3 Batch clearance and documentation .......................... 11
Batch clearance .............................................................................. 11
Batch documentation ...................................................................... 12
Storage length for sterile medical products..................................... 15
4 Maintenance .............................................................. 19
5 Appendix – Accessories............................................. 20

1 Description of the device
4
1 Description of the device
Intended Use
MELAdoc serves the:
Labelling the medical product
Documentation of the clearance decision
Traceability
Views
1) Wheel for setting date
2)
Release button to open
3)
Label ejection
4)
Hinged top section
5)
Label printing trigger
Figure 1: Side view of the label printer
1
2
3
4
5

2 Operation
5
2 Operation
Inserting the label roll
1. Press the black release button located on the housing and
open the upper section of the label printer backwards.
2. Remove the new label roll from its packaging.
3. Extend around 18 cm and dispose the first 12 labels.
4. Push the roll into the bracket until it clicks into position.
5. Lay the free label strip c. 15 cm over the label guide.
The first label on the strip must finish directly on the guide.

2 Operation
6
6. Kink the label strip and hold it in position whilst closing the top
section.
7. 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.
8. Kink the free end of the label strip downwards.
This makes it easier to feed the free label strip into the label
printer as will be described.

2 Operation
7
9. 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.
10. 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.
11. Remove the first printed label issued from the guide.
It will have been printed over several times.
The label printer is now ready to print.

2 Operation
8
Inserting the inking roller
1. Remove the new label roll from its packaging.
2. Hold the inking roller horizontal by its ends as depicted.
3. 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. Otherwise, the ink will colour.

2 Operation
9
Removing the inking roller
1. Open the label printer as described above.
2. Hold the inking roller horizontal by its ends as depicted.
3. 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.
4. Dispose the inking roller in the domestic waste.
Setting the date
1. Pull out the setting wheel to change the personal number,
date etc.

2 Operation
10
2. Move the marker to the position to be changed.
3. Turning the black wheel to set the desired value.
4. After having set the value, return the wheel to its starting
position.
Removing jammed labels
1. Open the label printer as described above.
2. Remove all loose labels in the interior of the label printer.
3. Open the label guide upwards. In this way you can access
and remove the jammed labels.
4. Shut the label guide.
5. If necessary use a commercial label remover to remove
adhesive residues.
6. Return the label roll into the label printer.

3 Batch clearance and documentation
11
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.
The clearance procedure consists of the steps:
1. Procedure clearance,
2. Batch clearance,
3. Clearance of the sterilized equipment
Documentation of the procedure clearance
Daily routine inspection and commissioning of steam sterilizers is
described in DIN 58946-7.
Visual inspection
Visual inspection of the autoclave chamber, the door seal, door lock,
and where necessary, further checks in accordance with the
manufacturers instructions.
Inspection of the operating materials
Quality of the feed water, cooling water provision, electricity provision
and available output media for the log output.

3 Batch clearance and documentation
12
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" autoclaves.
Batch documentation
Documentation of the batch clearance
The batch clearance ends with the batch documentation and assesses
the success of the sterilization procedure.
Documentation of the (daily) procedure clearance is carried out by
filling out the batch control sheet, the labels, entries and signature. An
unsuccessful clearance must also be documented.
Assessing the success of the process
The success of the sterilization procedure is assessed by the
sterilization log or the autoclave display message.
A sterilization log requires written evaluation. The sterilization log can
be printed and signed or a label can be affixed to the rear side.
Controlling the batch indicators added
The impossibility of making a certain prediction of the likely
appearance of a successfully coloured indicator after five or more
years (return discolouration), means that it is necessary to make a
written record of the successful colour change. It is not necessary to
store the indicators.
Labelling and clearance of the sterilized goods
Every sterilization package must be controlled and cleared after
successful sterilization.

3 Batch clearance and documentation
13
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).
Controlling the treatment indicators
The treatment indicators on the transparent sterilization packaging or
the indicator tape used must have coloured successfully.
Labelling the sterile goods
The sterile goods are cleared by
adding a label. It is possible that
individual items in a batch cannot
be cleared e.g. due to damage to
the individual transparent
sterilization packaging.

3 Batch clearance and documentation
14
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. This enables traceability
via the patient records from the
application to sterilization process.
Staff number
A
utoclave number
B
atch number
Sterilization date
Expire date

3 Batch clearance and documentation
15
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.
Protective packaging
The protective packaging is designed to provide the sterile barrier
system with protection up until its final application.
Packaging system
The sterile barrier system and protective packaging combine to form
the packaging system.
Peel test
A procedure to determine the peeling characteristics of paper/plastic
composite material in accordance with DIN EN 868-5, Appendix E.

3 Batch clearance and documentation
16
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.
This standard applies to all medical products delivered in a sterile state
and which are to be handled in such a manner so as that their quality
is maintained until coming to aseptic application.
According to DIN 58953-8 section 7.1.1, responsibility for compliance
with the specified storage requirements and period is lies with the
operator of the institution.
According to section 7.2, loss of sterility is dependent less on the
length of the storage time as from external influences during storage,
as well as transport and handling. An ideal storage time can thus not
be generally specified. Table 1 only makes recommendations
regarding the storage length of sterile medical products.
The following requirements apply to the storage of sterile medical
products:
The rooms must be dry, cool and easy to clean.
The rooms must not be accessible to everyday activity.
We recommend protected storage in cupboards or drawers.

3 Batch clearance and documentation
17
Table 1: Storage length for sterile medical products
Packaging type
Storage period
Sterile barrier system
Unprotected
storage1)
Protected
storage
Paper bag in accordance with
DIN EN 868-4 and heatable,
self-sealing transparent bag
and tubing of paper and plastic
composite film in accordance
with DIN EN 868-5, or other
equivalent packaging.
Serves provision
for immediate
use2).
Should be
avoided as a
method of
storage.
6 months,
not longer than
the expiry date
Packaging system (a
combination of a sterile barrier
system and sterile packaging)
5 years, as far as the manufacturer
has not determined an alternative
expiry date.
1) On shelves in rooms which do not correspond with room class 1 as defined by DIN
1946-4:2008-12 (Ventilation and air conditioning).
2) Immediate use means application / use of the product within a maximum of 2 days / 48
hours.
Specification of a suitable storage time is to be taken from the hygiene
plan. Responsibility for the storage conditions and length rests with the
practice operator.

3 Batch clearance and documentation
18
Figure 2: Measures for use – example

4 Maintenance
19
4 Maintenance
Maintenance:
To guarantee faultless
functioning, add a drop
of standard silicone-
based lubricant at the
locations indicated.

5 Appendix – Accessories
20
5 Appendix – Accessories
Article
Description
Order no.:
MELAdoc labels
Replacement rolls (6 pcs.) with
750 labels, incl. 1 inker roller
01096
Inker roller
For MELAdoc label printer
01094
MELAdoc
documentation
sheets
MELAdoc Documentation sheets,
10 blocks à 100 sheets
01091
MELAcontrol
Batch control
system
Consisting of 1 Helix test body and
250 indicator strips
01080
*Exclusively available from a specialist stockist