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Roche cobas 5800, cobas 6800, cobas 8800 User manual

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cobas
®
6800/8800 Systems
Addendum
New solid waste concept
Publication version 1.0
Roche Diagnostics
cobas® 6800/8800 Systems · Publication version 1.0 · Addendum · New solid waste concept
2
Publication information
Revisions
This chapter contains an addition to the Emptying the
solid waste container topic, which was necessary due to
design change.
Operator’s Manuals and User Guides impacted
User Assistances impacted
Publication version Revision date Change description
1.0 December 2017 First version
y Revision history
Software version Revision version Revision date Title
1.2 3.0 September 2016
cobas
®
6800/8800 Systems User Guide Version 3.0
1.2 3.1 August 2017
cobas
®
6800/8800 Systems User Guide Version 3.1
1.3 4.0 October 2017
cobas
®
6800/8800 Systems User Guide Version 4.0
y List of Operator’s Manuals and User Guides impacted
Software version Revision version Revision date Title
1.2 3.0 September 2016
cobas
®
6800/8800 Systems User Assistance Version 3.0
1.2 3.1 August 2017
cobas
®
6800/8800 Systems User Assistance Version 3.1
1.3 4.0 October 2017
cobas
®
6800/8800 Systems User Assistance Version 4.0
y List of User Assistances impacted
Roche Diagnostics
cobas® 6800/8800 Systems · Publication version 1.0 · Addendum · New solid waste concept
3
T
able of contents
Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
About the solid waste compartment . . . . . . . . . . . 6
About the solid waste bag with insert . . . . . . . . . . 6
Emptying and cleaning the solid waste compartment 7
Roche Diagnostics
cobas® 6800/8800 Systems · Publication version 1.0 · Addendum · New solid waste concept
4 Safety
Safety
Infectious waste
WARNING
!
All materials and mechanical components
associated with the solid waste systems are
potentially biohazardous.
Contact with solid waste may result in infection.
r Wear appropriate personal protective equipment. Take
extra care when working with lab gloves. They can
easily be pierced or cut, leading to infection.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If waste comes into contact with your skin, wash the
affected area immediately with soap and water and
apply a disinfectant.
Consult a physician.
Solid waste bags
WARNING
!
Attempting to empty and reuse solid waste bags can
result in spillage.
Spilled solid waste can lead to contamination, risk of
slipping, and risk of personal injury during clean-up.
r Do not attempt to empty and reuse solid waste bags.
r When disposing of solid waste, dispose of the entire
bag.
Environmental harm
WARNING
!
The system generates liquid and/or solid waste.
Liquid waste contains concentrated reaction
solutions, solid waste is potentially biohazardous.
Improper disposal may contaminate the environment.
r Treat solid waste as infectious waste.
r Dispose of waste in accordance with the local
regulations.
Roche Diagnostics
cobas® 6800/8800 Systems · Publication version 1.0 · Addendum · New solid waste concept
5
Overview
Roche recommends that you familiarize yourself with the
new and/or revised content provided in this chapter.
q If you print these pages, Roche recommends
printing them single-sided. In this way, you can easily
insert the new and/or revised content in its appropriate
locations in the existing document.
This document provides an overview of the new solid
waste concept and describes the emptying of the solid
waste compartment.
New solid waste concept The new solid waste concept includes a new solid waste
compartment and uses a new solid waste bag with insert.
It provides an increased waste capacity for up to 4 runs.
The cardboard insert prevents the bag from being
punched with sharp waste items.
Already existing waste concept The existing waste concept includes a smaller plastic
waste container and uses two waste bags (one inside the
other).
u For the existing waste concept refer to the existing
documentation.
In this section
About the solid waste compartment (6)
About the solid waste bag with insert (6)
Roche Diagnostics
cobas® 6800/8800 Systems · Publication version 1.0 · Addendum · New solid waste concept
6 Overview
About the solid waste compartment
The solid waste compartment is made of a solid metal bin
that is firmly connected with the wash/waste drawer.
One waste bag with insert can be inserted into the
compartment. It is fixed by means of a fastener.
About the solid waste bag with insert
The solid waste bag with insert is autoclavable and
contains a cardboard insert.
The cardboard insert must be unfolded before use. It
ensures that the maximum waste volume is used due to
the optimal placement of the bag within the
compartment. It also prevents the bag from being pierced
with sharp waste items.
A Wash/waste drawer C Solid waste bag with
insert
B Solid waste
compartment
D Solid waste bag
fastener
A
B
C
D
A Folded solid waste bag
with insert
B Cardboard insert
(unfolded)
A
B
Roche Diagnostics
cobas® 6800/8800 Systems · Publication version 1.0 · Addendum · New solid waste concept
7
Emptying and cleaning the solid waste
compartment
During a run, the system collects the used processing
plates, tip racks, waste inserts, and the empty reagent
and MGP cassettes in the solid waste compartment.
q Be sure to follow laboratory best practices and
change your lab gloves following any handling of liquid or
solid waste materials.
c At the latest after four full runs (4x 96 tests).
If the solid waste compartment is full, the system starts
the next run and creates a high priority task prompting
the operator to empty the solid waste compartment. The
solid waste of the current run stays on the processing
module until the full solid waste compartment is emptied.
j m Wear personal protective equipment.
r To empty and clean the solid waste
compartment
1
On the Monitoring tab, choose the wash/waste
drawer.
2
Check the fill level of the solid waste compartment.
3
If you need to empty the solid waste compartment,
choose the Open drawer button.
I The user who has opened the drawer is listed in
the audit trail for all loading and unloading
activities carried out while the drawer was open.
1
2
Roche Diagnostics
cobas® 6800/8800 Systems · Publication version 1.0 · Addendum · New solid waste concept
8 Emptying and cleaning the solid waste compartment
4
Wait for the wash/waste drawer to automatically open
slightly and then manually open it fully. Turn the solid
waste compartment to the right side until it clicks into
place.
5
Remove the solid waste bag fastener.
6
CAUTION! Risk of personal injury, infection, and
contamination. Do not empty and reuse solid waste
bags.
6 Close the full solid waste bag.
7
CAUTION! Risk of personal injury, infection, and
contamination. The solid waste bag may be pierced by
sharp objects inside.
7 Check the solid waste bag for perforation while
removing it from the solid waste compartment.
8
Dispose of the solid waste bag according to local
regulations.
9
If you notice any perforation of the solid waste bag
and find liquid inside the solid waste compartment,
decontaminate the solid waste compartment.
• Follow the decontamination procedure.
4
5
6
7
9
Roche Diagnostics
cobas® 6800/8800 Systems · Publication version 1.0 · Addendum · New solid waste concept
9
10
If you do not find liquid inside but see that it is
necessary to clean the solid waste compartment, use
a lint-free cloth moistened with deionized water.
• Repeat the cleaning procedure using lint-free
cloths moistened with 70% ethanol.
r To insert a new solid waste bag into
the compartment
1
WARNING! Risk of personal injury or contamination of
the system if using solid waste bags that were not
supplied by Roche.
1 Use new lab gloves. Unfold the solid waste bag and
the cardboard insert entirely.
2
Insert the solid waste bag until it touches the ledge at
the front of the compartment. Do not push it down to
the base of the compartment.
I Make sure that the solid waste bag line the solid
waste compartment.
3
Place the waste bag fastener back on the solid waste
compartment.
10
1
2
3
Roche Diagnostics
cobas® 6800/8800 Systems · Publication version 1.0 · Addendum · New solid waste concept
10 Emptying and cleaning the solid waste compartment
4
Choose the Confirm that solid waste container is
empty. button.
f The fill level of the solid waste changes to 0%.
5
If you have to empty the liquid waste or reload a wash
reagent container, leave the wash/waste drawer open.
Otherwise, close the wash/waste drawer.
4
/