Moller Medical Docon Seal User manual

Docon® SealM
Docon®Seal
Mobile sealing unit
Instructions for use
en
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© Möller Medical GmbH.
All rights reserved.
No part of this documentation may be reproduced or translated in any way
whatsoever without prior written approval from Möller Medical GmbH. The
status of the information, specifications and figures in these instructions
for use is indicated by the version number on the last page. Möller Medical
GmbH reserves the right to make changes in terms of technology, func-
tions, specifications, design and information at any time and without prior
notification.
Möller Medical GmbH, Wasserkuppenstrasse 29-31, 36043 Fulda, Ger-
many
Möller Medical GmbH, Wasserkuppenstrasse 29-31, 36043 Fulda, Ger-
many
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Docon SealM
Docon Seal
Table of Contents
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Table of Contents
1General Safety Instructions...........................................10
1.1 Explanation of the safety symbols employed......................... 10
1.1.1 Symbols in the instructions for use .............................10
1.1.2 Symbols on the device................................................10
1.1.3 Symbols on the retail packaging.................................11
1.2 Explanation of the format conventions employed.................. 13
1.3 Manufacturer's responsibility ................................................. 13
1.4 Operator's obligation to exercise diligence ............................ 14
1.5 Non-product-related additional equipment............................. 17
2Intended use....................................................................18
2.1 Proper use –intended purpose Docon Seal M...................... 18
2.1.1 Proper use –intended purpose Docon Seal...............18
2.2 Combination with other products ........................................... 18
2.3 Essential performance features............................................. 18
3Product description........................................................19
3.1 Docon SealM, Docon Seal..................................................... 19
3.1.1 Integrated battery pack (Docon Seal M only)..............20
3.2 On/Off button and status display......................................... 20
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Table of Contents
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3.3 Unit base................................................................................20
3.4 Protective caps.......................................................................21
3.5 Connection options.................................................................21
3.5.1 BNC seal handle connection......................................22
3.5.2 Charger socket Docon SealM (Figure 2, b)................22
3.5.3 Mains connection Docon Seal (Figure 3, c)................22
3.6 Seal handle ............................................................................23
3.7 Welding electrodes.................................................................23
3.8 Lever ......................................................................................23
3.9 Docon Seal Handle ................................................................24
3.10 BNC connecting cable............................................................24
3.11 Accessories............................................................................25
3.11.1 Charger and adapter ..................................................25
3.11.2 Transport case............................................................26
3.11.3 Mains cable ................................................................27
4Setup and commissioning.............................................28
4.1 Transport and storage information.........................................28
4.2 Unpacking the device and checking the scope of supply.......28
4.3 Commissioning the Docon SealM..........................................29
4.3.1 Connecting and charging the Docon SealM
battery.........................................................................29
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Table of Contents
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4.3.2 Connecting the seal handle ........................................30
4.3.3 Switching on................................................................30
4.3.4 Switching off................................................................30
4.4 Commissioning the Docon Seal............................................. 30
4.4.1 Connecting and commissioning the Docon Seal.........31
4.5 Overview of button signal statuses........................................ 31
4.6 Suitable operating environments Docon Seal / SealM........... 32
5Application and operation..............................................33
5.1 The sealing process............................................................... 33
5.1.1 Overview of signal statuses on Docon Seal
Handle.........................................................................34
5.2 Storage conditions................................................................. 34
5.3 Battery care when storing the Docon SealM.......................... 35
5.4 Energy-saving mode.............................................................. 35
6Remedying of errors.......................................................38
7Service..............................................................................40
8Care...................................................................................42
8.1 Cleaning and disinfection the devices.................................... 42
8.2 Cleaning the Docon Seal Handle........................................... 43
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Table of Contents
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8.3 Maintenance...........................................................................46
8.3.1 Safety check...............................................................46
8.3.2 Service documents.....................................................46
8.4 Transport................................................................................46
8.5 Disposal..................................................................................48
9Appendix..........................................................................49
9.1 Technical data........................................................................49
9.2 Electromagnetic emissions.....................................................52
9.2.1 Docon SealM..............................................................53
9.2.2 Docon Seal.................................................................54
9.3 Electromagnetic immunity......................................................54
9.3.1 Docon SealM..............................................................55
9.3.2 Docon Seal.................................................................58
9.4 Recommended separation distances.....................................62
9.4.1 Docon SealM..............................................................62
9.4.2 Docon Seal.................................................................62
9.5 Accessories............................................................................62
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Page 9 of 68
IMPORTANT
READ CAREFULLY PRIOR TO USE
KEEP IT FOR LATER REFERENCE
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Docon SealM
Docon Seal
General Safety Instructions
Page 10 of 68
1 General Safety Instructions
1.1 Explanation of the safety symbols employed
In these instructions for use, important information is indicated visually.
This information is essential for avoiding risks to the donor and operating
personnel and avoiding damage to and malfunctioning of the device.
1.1.1 Symbols in the instructions for use
Caution
Information
1.1.2 Symbols on the device
Caution, hot surface
Docon Seal Handle: Tissue burns can result due to incor-
rect use or if the electrodes on the seal handle come into
direct contact with tissue.
Serial number
Lithium ion battery
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General Safety Instructions
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Return and disposal as per the WEEE Directive
Refer to instruction manual/booklet
Class II equipment
Conform ANSI/AAMI ES 60601-1
CAN/CSA 22.2 No. 60601-1-08
Alternating current
The rating plate is located on the back of the device.
1.1.3 Symbols on the retail packaging
Catalog number
Batch code
Serial number
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General Safety Instructions
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Keep dry
Limitation
Temperature limitation
Manufacturer
Fragile, handle with care
Attention: Under US Federal law, this device may be only
sold to a physician or ordered by a physician.
Further information on the symbols used can be found on our homepage:
www.moeller-medical.com/glossary-symbols.
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Docon SealM
Docon Seal
General Safety Instructions
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1.2 Explanation of the format conventions employed
In these instructions for use, different fonts are used to improve orientation
Font
Use
Bold
Buttons in instructions.
Italics
Device options, buttons and references to chapter and
sections in the body text.
1.3 Manufacturer's responsibility
The manufacturer may only be regarded as responsible for the
safety, reliability and suitability for use of the devices if:
•Assembly, expansions, resetting, changes and repairs
are performed by individuals authorised by the manufac-
turer.
•The electrical installation in the room in question complies
with the relevant requirements and regulations (e.g. VDE
0100, VDE 0107 or IEC specifications).
•The devices are used in accordance with the instructions
for use and the country-specific regulations and national
deviations are observed.
•The conditions stated in the technical data are observed.
The manufacturer undertakes to accept returned old devices according to
the Electronic Equipment Act.
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General Safety Instructions
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1.4 Operator's obligation to exercise diligence
The operator is responsible for the proper operation of the medical devices.
In line with the German Medical Device Operator Ordinance, the user must
perform a wide range of duties and assume responsibility when handling
medical devices within the framework of his activities.
Whenever the Docon Seal series devices is handled and used, precise
knowledge and compliance with these instructions for use is necessary.
These instructions do not replace user training to be provided by the med-
ical device consultant. The device may only be operated by persons with
the necessary training or knowledge and experience.
The Docon Seal series devices are subject to special pre-
cautionary measures with respect to electromagnetic com-
patibility (EMC) and must be installed and operated in ac-
cordance with the EMC guidelines specified in Chapter 9.4.
If one of the devices no longer seals properly due to a mal-
function, the device must not be used any further and must
be inspected by the technical service.
Performance and safety may be impaired if OEM device partsare not used.
All work which requires tools must be performed by the manufacturer's
technical service or parties authorised by the latter.
The user must not touch one or several device connections
and the donor at the same time!
The Docon Seal Handle may be used in the vicinity of the
donor.
While the Docon SealM is being charged on the power unit, no sealing
processes are permitted. The device itself prevents this from happening.
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General Safety Instructions
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Any serious incident that hasoccurred in relation to the device
should be reported to the manufacturer and the competent
authority of the Member State in which the user and/or donor
is established.
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General Safety Instructions
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Modification to the Docon Seal series devices is not permit-
ted.
No liquids must be allowed to penetrate the current-carrying
parts of the device.
When cleaning, ensure that no cleaning agent runs into the
connector sockets.
Remove the charger from the Docon SealM or the power cord
from the Docon Seal before cleaning.
Replace connecting cables of all kinds even if they are only
slightly damaged; make sure not to roll over cables.
Keep the cables away from heat sources. This prevents the
isolation from melting which could cause a fire or an electric
shock.
Do not use force to push plugs into sockets.
When removing plugs, do not pull on the cables. To remove
if necessary, release the plug lock.
Do not expose the Docon Seal series devices to excessive
heat or fire.
Do not subject the Docon Seal series devices to major im-
pacts.
If excessive heat, fumes or smoke are seen, immediately dis-
connect the Docon Seal series devices from the power sup-
ply.
Do not extinguish the Docon Seal series devices with water
in the event of fire.
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General Safety Instructions
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1.5 Non-product-related additional equipment
Additional equipment which is connected to the analogue and digital device
interfaces must demonstrably satisfy the relevant EN specifications (e.g.
EN 60950 for data processing devices and EN 60601-1 for electromedical
devices). Whoever connects additional devices to the signal input or output
part, is the system configurer and thus responsible for ensuring that the
valid version of the system standard EN 60601-1 is observed.
Should you have any queries, please contact your distributor or the manu-
facturer's technical service.
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Docon SealM
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Intended use
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2 Intended use
2.1 Proper use –intended purpose Docon Seal M
The Docon SealM is a medical device and is used for sealing the hoses
during blood donation or when processing and storing blood bags and to
facilitate simple disconnection. The device is transportable and can also
be used to seal hoses attached to donors.
No form of use other than the intended use described here is permitted.
2.1.1 Proper use –intended purpose Docon Seal
The Docon Seal is a medical device and is used for sealing the tubes dur-
ing blood donation, plasmapheresis or when processing and storing blood
bags and to facilitate simple disconnection. The device can also be used
to seal tubes attached to donors.
No form of use other than the intended use described here is permitted
The integrated sealing unit emits electromagnetic radiation
during sealing.
Incorrect use or direct contact between the seal handle elec-
trodes and tissue can result in tissue burns.
2.2 Combination with other products
Only use tubes which have been specified and approved by the device
manufacturer.
2.3 Essential performance features
The Docon Seal series devices do not have any essential performance
features.
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Docon SealM
Docon Seal
Product description
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3 Product description
Docon SealM or
Docon Seal
Protective caps
On/Off button and
status display
BNC - seal handle
connection (Docon
Seal Handle)
Unit base
Figure 1: Docon SealM
3.1 Docon SealM, Docon Seal
The Docon Seal series devices supply the required HF energy through the
BNC connection cable to the Docon Seal Handle. Up to 150 successive
sealing processes can be carried out.
If the temperature of the seal generator exceeds a defined value as a result
of successive operations, the unit shuts down. Sealing is then no longer
possible.
The unit must now be allowed to cool down. The length of time needed to
cool down depends on the ambient temperature and may take up to 20
minutes.
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Docon Seal
Product description
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3.1.1 Integrated battery pack (Docon Seal M only)
The firmly integrated lithium-ion battery pack supplies the sealing unit with
the energy it requires for up to 2000 sealing processes. The battery does
not reach full capacity until after a few charge cycles.
If not in use for extended periods, the Docon SealM must
be stored in a charged state. See Storage conditions
After use, store the Docon Seal series devices in accord-
ance with the hygiene regulations. Also note the storage
conditions on page 51.
, page 34. Due to its integrated battery pack, the device
must be disposed of properly.
Batteries must not be disposed of as domestic waste.
Physical properties mean that as the battery ages, its ca-
pacity drops, and it must be replaced with a new one. In
this case, contact the manufacturer or your distributor.
3.2 On/Off button and status display
The Docon Seal series devices are switched on and off using the button
on the front panel. This status display provides you with information about
the operational and charge state of the devices.
3.3 Unit base
For tabletop operation, the Docon Seal series devices must be placed on
the base provided.
This allows the heat generated during operation to be dissipated to the
environment.
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