Moller Medical Docon 7 User manual

Docon®
Blood mixing scales
7
Instructions for use
en

IMPORTANT
READ CAREFULLY BEFORE USE
KEEP THESE INSTRUCTIONS FOR FUTURE CONSULTATION
© 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 andfigures in these instructionsfor use is indicated bythe version number
on the last page. Möller Medical GmbH reserves the right to make changes in terms of
technology, functions, specifications and design at any time and without prior notifica-
tion.

Docon® 7
Contents
Page 4 of 74
Contents
1General safety information..........................................................................8
1.1 Explanation of the safety symbols employed............................................................8
Symbols in the instructions for use...............................................................8
Symbols on the device.................................................................................8
Symbols on the display ................................................................................9
Symbols on the retail packaging...................................................................9
1.2 Explanation of the format conventions employed ...................................................11
1.3 Manufacturer's responsibility..................................................................................11
1.4 Operator's obligation to exercise diligence .............................................................11
1.5 Non-product-related additional equipment..............................................................13
2Intended use...............................................................................................14
2.1 Proper use - intended use......................................................................................14
2.2 Combination with other products............................................................................14
2.3 Essential performance features..............................................................................14
3Product description ...................................................................................15
3.1 Control elements....................................................................................................15
Touchscreen..............................................................................................15
Reset button...............................................................................................15
3.2 Tray........................................................................................................................15
3.3 Clamp.....................................................................................................................16
3.4 Device handles.......................................................................................................16
3.5 Accessories and options ........................................................................................16
Docon 7 mobile II LSC ...............................................................................16
Holder for Docon 7 mobile II LSC...............................................................17
Docon 7 Basic Barcodereader....................................................................18
Docon 7 status indicator.............................................................................18
Docon 7 sealing option –sealing handle....................................................19
Docon 7 battery..........................................................................................23
Docon 7 transport case..............................................................................25

Docon®7
Contents
Page 5 of 74
Docon 7 table.............................................................................................26
Docon 7 tube holder...................................................................................27
Docon 7 stick..............................................................................................28
3.6 Connection options.................................................................................................29
3.7 User interface.........................................................................................................30
Softkeys.....................................................................................................31
System state ..............................................................................................31
Screen keyboard........................................................................................31
4Setup and commissioning........................................................................ 32
4.1 Transport and storage information..........................................................................32
4.2 Unpack the device and check the scope of supply .................................................32
4.3 Commission the Docon 7 .......................................................................................33
Connect and switch on...............................................................................34
Switch off ...................................................................................................34
4.4 Operation with other devices..................................................................................34
4.5 Suitable operating environment..............................................................................34
4.6 Operation in IT networks ........................................................................................35
4.7 Use of RFID-tagged blood bag systems.................................................................35
Preparation of the blood bag system..........................................................36
5Application and operation ........................................................................ 39
5.1 Blood donation.......................................................................................................39
Preparation for blood collection..................................................................39
Start of blood collection..............................................................................39
Display collection information.....................................................................40
Inflow error messages................................................................................40
Cancel application......................................................................................42
End of blood collection...............................................................................42
Docon 7 mobile II LSC ...............................................................................42
5.2 Data recording........................................................................................................43
DMS Docon................................................................................................43
Record donation data.................................................................................43
Save donation data ....................................................................................44

Docon® 7
Contents
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Transmit donation data...............................................................................44
Process data..............................................................................................44
5.3 Storage conditions..................................................................................................44
6Settings.......................................................................................................45
6.1 Setting options on the device, system menu...........................................................45
Password submenu....................................................................................46
Options submenu.......................................................................................47
Display submenu........................................................................................48
Energy submenu........................................................................................49
Language submenu ...................................................................................51
Locale submenu.........................................................................................52
Donation submenu.....................................................................................53
Communication submenu...........................................................................53
Validation submenu....................................................................................54
Info submenu.............................................................................................55
6.2 Remedying of errors...............................................................................................55
6.3 Service...................................................................................................................57
7Care.............................................................................................................58
7.1 Cleaning and disinfection .......................................................................................58
7.2 Maintenance...........................................................................................................58
Safety check ..............................................................................................58
Service documents.....................................................................................58
7.3 Transport................................................................................................................59
7.4 Battery care when storing the Docon 7...................................................................59
7.5 Disposal.................................................................................................................60
8Device options............................................................................................61
9Notes...........................................................................................................62
9.1 Technical data........................................................................................................62
9.2 Electromagnetic emissions.....................................................................................65
Docon 7 Standard......................................................................................65

Docon®7
Contents
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Docon 7 Seal..............................................................................................65
Docon 7 RFID ............................................................................................66
Docon 7 WLAN option................................................................................67
9.3 Electromagnetic immunity ......................................................................................68
9.4 Recommended separation distances......................................................................70
9.5 Accessories............................................................................................................71

Docon®7
General safety information
Page 8 of 74
1 General safety information
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 also avoiding damage
to and malfunctioning of the device.
Symbols in the instructions for use
Caution
Information
Symbols on the device
Caution - hot surface
Sealing handle: Tissue burns can result due to incorrect use or if
the sealing handle electrodes come into direct contact with tissue.
Stand - by
Serial number
Catalog number
Alternating current
Return and disposal as per the WEEE Directive
USB host
RJ45 network connection
Consult instructions for use
Class II equipment

Docon®7
General safety information
Page 9 of 74
Compliant with ANSI/AAMI ES60601-1
CAN/CSA 22.2 No. 60601-1-08
The rating plate is located below the tray.
Symbols on the display
A USB memory stick is connected
Docon 7 is connected to the power supply
Clamp open
Clamp closed
Battery operation + charge level display
Battery indicator while charging Akkuanzeige beim Laden
Scanner is connected
WLAN operation
Network operation
Docon 7 status indicator connected
Symbols on the retail packaging
Catalog number
Batch code
Serial number

Docon®7
General safety information
Page 10 of 74
Do not use if package is damaged
Stacking limit, do not store more than 4 packs high
Keep dry
Humidity, limitation
Temperature limit
Manufacturer
Date of manufacture (YYYY-MM-DD)
Total length
Caution
Fragile, handle with care
Top, store the right way up
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

Docon®7
General safety information
Page 11 of 74
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, reliabil-
ity and suitability for use of the device if:
Assembly, expansions, resetting, changes and repairs are performed
by individuals authorised by the manufacturer.
The electrical installation in the room in question complies with the rel-
evant requirements and regulations (e.g. VDE 0100, VDE 0107 or IEC
specifications).
The device is 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 old devices as per the German Electrical and Elec-
tronic Device Act (ElektroG).
1.4 Operator's obligation to exercise diligence
The operator is responsible for the proper operation of the medical device. In line with the
German Medical Device Operator Ordinance (MPBetreibV), the user must perform a wide
range of duties and also assume responsibility when handling medical devices within the
framework of his activities.
Whenever the Docon7 is handled and used, precise knowledge and compliance with these
instructions for use is necessary. These instructions do not replace user training to be pro-
vided by the medical device consultant. The device may only be operated by persons with
the necessary training or knowledge and experience.
The Docon 7may only be operated in roomsin which operating personnel who
monitor the donation process are present for the entire course of continuous
operation.

Docon®7
General safety information
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Performance and safety may be impaired if Original Equipment Manufacturer device parts
are not used.
All work which requires tools must be performed by the manufacturer's technical service or
parties authorised by the latter.
In environments in which the perfect functioning of the ground wire connection
cannot be guaranteed, the Docon 7 must be battery-operated.
The user must not touch one or several device connections (USB, LAN and
docking connection) of the Docon 7 and the donor at the same time!
The Docon 7 mobile and the sealing handle may be used in the vicinity of the
donor.
The Docon 7 may be operated at a multiple portable socket which is approved
as per 60601-1 with a maximum of 2 devices. Operation with more than 2 de-
vices at such multiple sockets is not permitted as it cannot be ensured that the
approved values for leakage current will not be exceeded (see EN 60601-1). In
such cases, a separator, e.g. an isolation transformer approved for medical use,
must be used.
Position the Docon 7 during normal donation operation so that the user is able to simply
disconnect it from the power supply by pulling out the power cord.
The Docon 7 must not be changed.
No liquids must be allowed to penetrate the current-carrying parts of the device.
When cleaning, ensure that no cleaning agents are sprayed into the sockets.
Pull the plug out before cleaning the Docon 7.
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 melt-
ing 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, re-
lease the plug lock.
Do not expose the Docon 7 to excessive heat or fire.
Do not subject the Docon 7 to major impacts.
If excessive heat, fumes or smoke are seen, immediately disconnect the Do-
con 7 from the power supply.
Do not extinguish the Docon 7 with water in the event of fire.

Docon®7
General safety information
Page 13 of 74
Any serious incident that has occurred in relation to the device should be re-
ported to the manufacturer and the competent authority of the Member State in
which the user and/or the donor is established
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 60601-1for 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 manufacturer's tech-
nical service.
No additional active device (device with its own power supply) may be con-
nected to the USB interface of the Docon 7.

Docon®7
Intended use
Page 14 of 74
2 Intended use
2.1 Proper use - intended use
The Docon 7 is a medical device and serves to mix the blood during a blood donation with
the anticoagulant in the blood bag and to stop the blood supply once an adjustable volume
has been reached. In addition, internal information on the donation as well as external data
entered by the user can be collated and transferred to an EDP system.
Only those who fulfil the general criteria for blood donations are permitted to donate blood,
e.g. "Guidelines for the Preparation of Blood and Blood Components and for the Use of
Blood Components" and "Guide to the preparation, use and quality assurance of blood
components".
2.2 Combination with other products
Blood bag systems are necessary to allow blood to be donated. The Docon 7
may only be operated with bag systems which satisfy all the statutory require-
ments made of blood bag systems.
Furthermore, the max. capacity of the bag systems must not exceed 1000 ml.
2.3 Essential performance features
The Docon 7 does not have any essential performance features.

Docon®7
Product description
Page 15 of 74
3 Product description
Figure 1: Docon 7
3.1 Control elements
Touchscreen
The user can input data into the Docon 7 via the touchscreen. To enter information either
a finger or a suitable stylus can be used. To select a button on the screen, press on the
touchscreen around the button applying gentle pressure.
Reset button
If the Docon 7 stops functioning properly and no longer reacts to the usual inputs, press the
Reset button. This can be found on the rear of the device to the left of the power plug
socket. This resets the Docon 7 to its original state.
3.2 Tray
The Docon 7 tray which is used to hold the bag system is secured on the swing carrier by
a magnet. This detaches if overloaded which reduces the risk of the Docon 7 being dam-
aged.
Device handle
Clamp
Touchscreen
Reset button
Tray

Docon®7
Product description
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3.3 Clamp
This serves to clamp off the blood removal tube when the final volume is reached.
The blood removal tube is inserted from the rear through the clamp. The tube can be run
out to the right or left, depending on the position of the scales towards the donor bed.
Tube recognition is contact-free. As such, the sensor is not subject to mechanical wear.
Two-stage clamping of the tube ensures double security. After inserting thetube, the clamp
automatically locks the tube inlet and both tube outlets to prevent the tube from inadvert-
ently escaping. At the same time, the tube is directly clamped at the inlet (position 1).
The clamped tube inlet is released when donation commences, and the blood starts to flow
(position 2).
The clamp remains locked during donation and switches to position 1 when the donation
volume has been reached. Once the donation is complete, press the clamp button to unlock
the clamp and remove the tube.
To guarantee maximum safety for donors, the clamp is closed immediately in
the event of a power failure when operating with a 230 V network.
This can be countered if the device is fitted with a battery.
3.4 Device handles
The device handles have multiple functions. On the one hand, they serve to ensure simple
handling and, on the other hand, to protect the tray from being knocked accidentally.
The handles thus provide a protective function for the weighing system in order to prevent
incorrect measurements due to damages to mechanical components.
3.5 Accessories and options
Operation of the Docon®7with additional accessories such as transducers or
cables, which are not defined for the intended use with the device, may result
in increased electromagnetic emissions, reduced immunity to interference or
faulty operation.
Docon 7 mobile II LSC
The Docon 7 mobile is used to input barcodes during donation.
In order to ensure protection of the back, the Docon 7 can be operated using the scanner
keyboard. The current status of the donation is also shown on the colour display and signal
states are indicated by a flashing LED. The Docon 7 mobile includes a 1-D laser scanner.

Docon®7
Product description
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Figure 2: Docon 7 mobile II LSC
Holder for Docon 7 mobile II LSC
Depending on the situation at hand, the following holders are available for the Docon 7
mobile II LSC:
Table base
Plug-in base
Swan neck
Table assembly system (for assembly on the Docon 7 table)
You can find order information on the options described above on Page 71.

Docon®7
Product description
Page 18 of 74
Docon 7 Basic Barcodereader
The Docon 7 Basic Barcode Reader can be used as an alternative to our Docon 7 mobile
II LSC for the purposes of barcode scanning. It has the ability to scan a very large area,
simplifying reading long barcodes from a shorter distance.
Figure 3: Docon 7 Basic Barcodereader
Docon 7 status indicator
The Docon 7 status indicator can be secured in a raised position to improve signal recog-
nition (e.g. on the donor's bed). It can be fixed in place using either a magnet or clip. All
signal states which the Docon 7 shows on its display are transferred as an optical signal to
the light.
Figure 4: Docon 7 status indicator

Docon®7
Product description
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Docon 7 sealing option –sealing handle
The sealing handle is an automated sealing unit used to seal PVC tubes, particularly the
blood removal tube directly attached tothe donor. This ensures greater safety when sealing
the tube. The sealing procedure can be documented in the data set.
Various PVC tubes with different diameters and wall thicknesses can be sealed. The seal-
ing time is automatically adjusted for the tubes specified. The sealing process is indicated
by a LED on the sealing handle (see Sealing procedure on page 20).
The sealing handle corresponds to the electrical safety requirements of a type
B applied part as per EN 60601.
Only the original sealing handle may be connected to the Docon 7.
Only position the designated object between the electrodes of the Docon 7
sealing handle. See Technical data (page 62)
To achieve an optimal sealing result, only use tubes and bag systems which
have been approved by the device manufacturer.
Figure 5: Sealing Handle for Docon 7
3.5.5.1 Sealing of blood removal tubes
The integrated sealing unit emits electromagnetic radiation during sealing.
Incorrect use or direct contact between the sealing handle electrodes and tis-
sue can result in tissue burns.

Docon®7
Product description
Page 20 of 74
Make sure that the surface of the tube, at the point where the seal is to be
made, is dry and free of dirt.
Sealing stops immediately when you release the sealing handle lever!
The tube must not be subjected to mechanical loading during sealing.
If a tube is sealed in several places, there must be a minimum distance of
10 mm between each sealed point.
Check the quality of the seals visually and periodically.
Sealing procedure
1. Place the tube in the recess on the sealing handle.
2. Press the sealing handle lever as far as it will go. The LED lights up and sealing
starts automatically.
3. Sealing is complete once the LED on the sealing handle starts flashing.
4. Now open the sealing handle lever and remove the tube.
3.5.5.2 Cleaning the sealing handle
To rule out any risk to the user, pull the connecting cable out of the sealing
handle before cleaning.
When cleaning, the user should wear appropriate protective clothing for his
own protection.
Sterilisation methods such as autoclaving and ethylene oxide sterilisation ren-
der the Docon 7 sealing handle unusable.
Make sure that no liquids flow into the electronic components of the sealing
handle.
Do not use sharp objects for cleaning.
To guarantee the functionality and safety of the sealing handle, it must be cleaned regularly.
You will find a list of products tested for cleaning on page 58.
The Docon 7 sealing handle must always be cleaned after it has come in direct
contact with blood.
The Docon 7 sealing handle should be cleaned thoroughly once per month.