Professional Documents
Culture Documents
for
Bagmatic SL
Blood collection monitor
Version 20.0
May 2015
SW Revision V100102.LC.20141118
www.lmb.de
info@lmb.de
User Manual – Bagmatic SL
Table of contents
1. General purpose
This manual describes the optimal way how to operate this device and gives basic
instructions for handling, possible errors or operation failures.
Before you start using the BAGMATIC please read this manual carefully to avoid
mistakes.
The BAGMATIC blood taking monitor is used to monitor blood donation in the
appropriate blood bags, independent of type or manufacturer of the used bag set.
The BAGMATIC is designed for both mobile and stationary use. The device
registers the blood flow velocity, is mixing the collected blood with the blood
stabilizer by constant rocking of the collection bag, records interruptions or
failures and is used to control the previously defined sampling volume. The
BAGMATIC is providing all collected donor data, the data-collection period, the
donation process and the collected user data of the medical staff. The BAGMATIC
monitors the whole donation process according to the medical requirements and
after expiration of the donation process the extraction is finished automatically
when the selected donor final volume is achieved.
2. Warranty
All units are produced and checked with the utmost care by the manufacturer.
However, if unit show a malfunction, we give each Bagmatic a warranty period of
twelve months from date of sale. Warranty is valid only if the user complies with
the following rules:
Technologie GmbH
Möslstr. 17
D-85445 Schwaig
Germany
Tel.: +49-8122-88096-0
Fax: +49-8122-88096-60
www.lmb.de info@lmb.de
3. Safety advices
to connect the bar code reader up or down during the operation of the
Bagmatic
to let the bar code reader connected with the cable during the data
selection! This might destroy the exit.
Dangers- of mechanic kind or caused by electric power- have not to be
feared if the device is used properly. In the following we give you notes
for the save use of the device.
Dangers caused mechanically or electrically don’t need to be feared if you
operate in an appropriate way.
According to that, we give you some instructions for the safe operation of
the device:
In the case of injuries due to inappropriate handling or operation, any
liability and guarantee claim will expire.
Please use only the delivered battery charger. For further information see
Chapter 6: delivery contents and Chapter 7: technical data.
Mechanical dangers can appear at the moving tube clamp device and at
the tilting mechanism. That’s why you should never grasp into the
moving mechanical parts.
Please follow also the instructions written on the unit itself.
connect only devices and accessories to the ports of the BAGMATIC that
fulfil the regulations of SELV-circuits.
The unit is not responsible for the sealing and welding of the blood bag
tube. We explicitly point out that the demanded medical protection for
closing or clamping the blood bag tube fall under the responsibility of the
unit that is responsible for this special action.
Avoid constant extreme humidity and condensation. Protect the device
from water and chemicals.
Don’t try to repair the electrical and mechanical systems on your own.
Only instructed technicians are allowed to open the device. For this
purpose please contact the service of Lmb.
Put the device in a suitable position. Make sure that it is placed horizontally. Make
sure that the place of the device is not directly exposed to sunlight or any other
high intensity source of light. Also, this place must not be under influence of
vibration, high temperature and humidity.
The user need to have access from front side and from left and right for best
access to the device. The device is designed for transportable use and can be
placed directly on the transportation case.
The user should have always best view to the display as well. The user approach
to the device needs to be always from up front. The user needs to be able to
interfere and to check and react on all occasions and processes.
Different use as intended and described in this manual may lead into problems
listed below:
- Caused by drop of the device lead into serious damage of electronic balance,
mechanical and inner components. The device can resist shock only as long it
is well packed in its transportation case.
- Caused by incorrect use of the device. The device is able of being checked and
activated beside the intended use. In such case it is possible, if you are
careless, to clamp hand and fingers by activating the clamp-swing-mechanism.
The operator must be aware that beside the taken precautions of clamp force
limitation that hand and fingers can be pressed strongly when put into the
moving parts
- Caused by incorrect blood bag handling. The device cannot check condition of
the blood preservations itself. All blood units will be handled as fully intact and
properly prepared. Damaged blood bags or tubes will stay unnoticed. The
operator must check the blood bag conditions and result of preparation
always. Any damage on the bag or incorrect placement can lead in total
destruction of the bag and loss of the product with all effects of blood
contamination. The product must be disposed then.
All details are stated in chapter 8. The installation can only be done by certified
technicians with full installation training received from Lmb and its partners.
Special requirements of the operating personnel are not necessary.
The Lmb Company has taken care in production and design to eliminate all risk
potential. Some risks remain because of exposed items such as balance parts and
the clamp mechanism. The balance parts and clamp are highly necessary for the
function.
The device must not be installed to other power sources and as described on the
S/N Label and in chapter 8.
The device can be unplugged from power and switched off and all batteries (SL-
model only) can be ejected after freeing of the device (remove bags etc.).
The device can be switched off via menu or switches off if unused for more than 5
min time until the START or STOP button is pressed again. The rechargeable
batteries prevent immediate power loss. The voltage of the main power source is
12VDC.
If the device is declared to be out of order and prohibited for use than unit need
to be shut down by switching off and replaceable batteries must be ejected and
the charger has to be unplugged.
The special maintenance menu allows to use and to maintain the device in full
operation mode and when power is present. Only service personal authorized by
Lmb and its partners is allowed to do so. Users need to be informed about current
device status and in case instructed by the service technician in charge.
Special care during transport is necessary. Take the balance tray and accessories
away before lifting. Do never carry the device on the balance plate. Lift and
transport the device only with 2 hands or in the appropriate transportation case.
According to the most SOP for blood transfusion centers, in case of any
emergency or malfunction, the device need to be declared as out-of-order and
taken out of operation until status of device is going to be changed by higher
authorization. Service contractor or Lmb partner need to informed about the
device conditions and about condition of last processed blood unit and result.
It is highly advisable to notify all seen problems and occasions and to share this
information with next person in charge and the service technician. That
cooperation can help to identify the problematic and to have the unit as quick as
possible back in operation.
Our level of conformity according to IEC 61000-4-2 accounts for +/- 3 KV. Please
make sure that the device is not subject to static discharge higher than 3KV.
Floor should be consistent of wood or concrete or ceramic flagstones. If the floor
is made of synthetic material, relative air humidity must account for at least 30%.
4. General instructions
The BAGMATIC is a blood taking monitor. The weight recorded by the BAGMATIC
doesn’t meet the calibration standards of the EU directive 90/384/EWG. For more
exact weight results you should use a scale meeting the requirements of these
calibration standards.
For cleaning of parts of the housing and all other parts that are accessible from
outside, please use an alcoholic area-wide disinfectant as it is used in clinics. For
harmless contamination even spirit can be utilised.
Attention: Please avoid necessarily that fluids reach the interior of the device.
5. Declaration of conformity
The Blood Taking Monitor “BAGMATIC” applies the directive 93/42/EEC for
Medical Devices with amendment 2007/47/EEC.
EN 980:2010
EN 1041:2010
EN ISO 10993-1:2009/AC: 2010
EN ISO 13485:2003/AC: 2009
EN ISO 14971:2009
EN 60601-1:2005
EN 60601-1-2:2001
EN 62304:2006
6. Scope of supply
Basic Version:
Optional:
7. Technical data
12 V power supply
supplied by internal lead battery
12 V direct current motors with gearing for clamp and swing mechanism
Type: FW 7118M/12
Supply: 100-240V AC / 50 HZ / 25 VA
Power output: 12 VA
Internal interfaces:
Special Note:
Connect only peripheral devices to the interface of BAGMATIC which fulfils the
requirements for SELV circuits subject to EN 60950 or equivalent.
General data:
ambient 10 - 30 °C
temperature:
atmospheric maximum 85 %
humidity:
dimensions: Length x Width x Height
365mm x 190mm x 135 mm
Weight: about 5 kg
7.1 Ports
Swing
motor
Display
Input / Output
Unit
Caution!
Moving parts. Don’t touch!
8. Beginning of operation
Caution !
In the beginning of operation and while working with the Bagmatic please observe
absolutely the security instructions in chapter 3 of this manual.
8.1 Installation
2. Check the delivery content in accordance with delivery order and delivery
note (referring to chapter 6).
3. Verify the supply voltage of your house is 230 V AC in accordance with your
power supply of your charge unit.
4. Connect up the barcode reader (scanner). Please note, that it may only get
connected up or down while the device is switched out. see also chapter 8.2
Connect and work with the barcode reader
5. Press the key „Start” on the control panel in order to activate the
BAGMATIC.
6. If there’s no indication in the display after the input order Start, the battery
capacity is exhausted. In this case you proceed directly to point 11.
8. Choice of the kind of blood donation: Normal or own blood donation. Choose
by the arrow buttons and then press “Start”.
9. By pressing the „Start” button another time a factory set battery status
appears in the LCD display. If the voltage exceeds mare than 12 V, the
device is sufficiently charged for the further operation. (ignore point 11 and
12).
10. If the BAGMATIC is not to switch on with the “Start” command and no
damage in transit has occurred, you have to charge the internal battery by
the battery charge station, which is enclosed in the delivery parcel, possibly
for several hours externally (see point 11)
While the battery is charging, a red light appears at the charge device. This
goes out as soon as the battery is charged completely and went into green.
Please note, that the charging of the changeable battery is only externally
possible, not inside the BAGMATIC SL.
(Withdrawal and/or exchange of the batteries – see chapter 8.5 of the user
manual)
Plug the charge unit into the power connector und connect the outgoing plug
of the charge unit with the exchange battery. Please note that the connection
cable of the charge unit to the BAGMATIC is only 2 m long. The charge
procedure will take until to 12 hours, if the battery is empty. After this
charge procedure the BAGMATIC is ready for operation according to
regulations.
12. Put the tray on the swing mechanism. Pay attention that the pins on the
bottom of the tray snap in their counterparts in the swing mechanism.
According to supervisor menu of this manual (chapter 9) the user menu can now
be adjusted by an authorized person.
If the device is still running, turn it off using the option at the bottom of the user
menu.
Unpack barcode reader and connect the 3-pin-connector to the scanner port on
the back of the BAGMATIC.
Press the button of the barcode reader and approach to about 3 cm to the code
until a beep can be heard and the respective sign appears on the display.
Caution! While operating with an external power supply a fully charged battery
should remain in the battery tray in spite of this. Each 14 days this must be either
exchanged or get completely charged. The delivered external power supply is not
a main supply, but a charging device, which keeps the internal battery in full
charge. Therefore do not operate the device without inserted battery in any case!
Activate the menu option “Blood taking” on the display using the start button.
After the self-test press the start button again (the battery status beam briefly
appears), proceed according to chapter 10 User menu in correspondence to the
display text.
Choose the blood amount between 300-900ml by following message in the bottom
of the screen “press up/down to modify, then start or stop”
If activated, please read the necessary bar codes with the barcode scanner.
When appears:
“PLACE BAG ON TRAY THEN START”
put the bag onto the blood bag tray and lead the
connection tube ‘through’ the clamp.
Now a tare process follows. “TARATION DO NOT TOUCH THE TRAY” Please
take care, that there are no objects on the bag tray (as for instance the scanner
cable, the scanner and so on).
As soon as “ATTACH DONOR THEN START” appears, attach the donor. When 5
ml of blood are taken, the mixing of the blood starts.
When “STOP THEN REMOVE BAG” appears, seal the blood taking tube with a
lead seal.
Clamp or seal the blood taking tube possibly! Then press the arrow button
upwards in order to open the clamp. Take the tube out of the clamp, remove the
blood bag from the tray and put it away.
Press “START”.
If it is set, the weight will be displayed now.
For further steps continue according to chapter 10 User menu.
fig. 1
Important!!
The activating of the release button is only
allowed, if pressure is put on the back of the
battery. Otherwise the ejection automatic can
be damaged. fig. 2
fig. 3
9. Configuration menu
9.1 Configuration
If you need to change parameter, you have to create an file on SD_Card with the
name "Config.cfg" .
Structure:
N //0 Donor ID
n //1 Temperature[C]
n //2 Donation code
n //3 Lot number
n //4 Hemoglobin
n //5 Number of Bags
n //6 Bags of Labels
n //7 Number of Tubes
n //8 Tubes Labels
n //9 Bloodgrup
n //10 RH factor
n //11 Product Number
n //12 Place of donation
n //13 Team ID
n //14 Doctor ID
n //15 Nurse ID 1
n //16 Nurse ID 2
y //17 Free prg information 1
y //18 Free prg information 2
y //19 Free prg information 3
n //20 Error code
y //21 Measured the minimum speed [ml/min]
y //22 Measured the maximum speed [ml/min]
y //23 Set the minimum speed [ml/min]
y //24 Set the maximum speed [ml/min]
y //25 Maximum processing time
N //26 Measured weight calibration
y //27 Fast Flow (>200ml/min)
y //28 Time datas
Y //29 Max-Min excess speed signal.
n //30 Speech enable
455 //Progr. amount of blood [ml]
20 //Set the minimum speed [ml/min]
130 //Set the maximum speed [ml/min]
15 //Maximum processing time [min]
120 //Maximum interrpting time [min]
Free prg text 1
Free prg text 2
Sign „Y” and Sign „N” activate follow function or deaktivate it in the basic setting.
With „Free prg text” is it possible to insert 3 datafields with variable name.
„Speech enable” does not work with Version LC!.
Access: PRESS
[STOP]
[UP]
[UP]
[UP]
SERVICE SETTING
Measurement Setting
Device Setting
Device Test Appeared.
Choose submenu by up/down key and START!
Measurement Setting
Weight Calibration
Put 500g weight on tray, wait until it`s stable , save and leave press stop.
Clamp setting
Device Setting
Date/Time setting
Device Test
Memory Test
The user menu is the menu which is displayed when the Bagmatic is switched
either by Connect with battery or external power supply, or if it is switched of by
menu before by pressing START-key. This key is equal to an ENTER key and start
Menu function.
The expressions [UP], [DOWN], [START] and [STOP] relate to the plastic film
buttons of the BAGMATIC.
BLOOD TAKING
CALIBRATION
TURN OFF
Selecting the menu topic CALIBRATION you can carry out the manual calibration.
Step 1
Step 2
Step 3
Step 4
For a short time its weight will be displayed. If the weight is within the preset
tolerance, you will have finished the calibration with success; and the clamp closes
and opens as confirmation. If the weight is beyond the preset tolerance, it is
recommended to repeat the calibration; otherwise the message ‘Calibration not
checked’ will be displayed when taking a blood donation.
Selecting the menu topic TURN OFF, you can switch off the device whenever you
want. This is important if you want to connect another device to the serial port or
if you want to plug a cable in or out (e.g. plugging in/out the reading unit or a
serial cable) or if the charging unit has to be attached.
Main menu
1. Battery voltage
2. Blood amount
Stop to Abort
Taration
do not touch the Tray
Caution!
1. Don't touch in any case the bag tray during blood taking!
Press STOP
Press UP
THEN REMOVE BAG!
Blood Amount
START = CONTINUE
STOP = ABORT
UP = OPEN
DOWN = CLOSE
Here you can open and close the clamp. After the correction you can continue,
namely after the preset stop time.
30 LMB_DOC_MANUAL_BAGMATIC-SL – Revision status 14 / 05.15 – version 20.0 / May 2015
User Manual – Bagmatic SL
11. Troubleshooting
The following table shows possible errors and symptoms and possible correction
measures (troubleshooting).
Explanation:
The table contains correction measures of two different classes. Class A-
measures can be executed by the operator of the device, class B-measures shall
be executed by trained service technician.
set SN
replace radio or main board
Caution, advice
0123