Bagmatic SL

Blood collection monitor

User Manual
Version 10.1 / September 2012.

SW Revision 9.0.34.3

Lmb Technologie GmbH

Möslstr. 17
D-85445 Schwaig

+49 - 8122 - 880 96 - 0

+49 - 8122 - 880 96 - 60

www.lmb.de
info@lmb.de
technical-service@lmb.de
 User Manual Bagmatic SL

Table of content

1. General purpose ............................................................................................. 4

2. Warranty ........................................................................................................ 5
3. Safety advices ................................................................................................ 6
3.1 General safety advices ............................................................................. 6
3.2 Description for proper workspace ............................................................... 6
3.3 Warning notes regarding incorrect use ....................................................... 7
3.3.1 Device damage .............................................................................. 7
3.3.2 Risk to user ................................................................................... 7
3.3.3 Quality Problems ............................................................................ 7
3.3.4 Blood preservation damage ............................................................. 7
3.4 Installation details ................................................................................... 7
3.5 Remaining risks ....................................................................................... 8
3.6 Restriction to guarantee secureness in following occasions ............................ 8
3.6.1 Installation secureness ................................................................... 8
3.6.2 De-installation secureness............................................................... 8
3.6.3 Shut-off condition secureness .......................................................... 8
3.6.4 Out-of-order condition secureness ................................................... 8
3.6.5 Maintenance and Service secureness ................................................ 8
3.6.6 Transportation secureness .............................................................. 8
3.7 Safety instructions for transport and storage ............................................... 8
3.8 Procedure recommended in case of emergency or casualty ........................... 9
3.9 Safety measures for installation and maintenance ........................................ 9
3.10 Electromagnetic interference resistance ...................................................... 9
4. General instructions ..................................................................................... 10
4.1 Service interval ..................................................................................... 10
4.2 Cleaning instructions .............................................................................. 10
5. Declaration of conformity ............................................................................. 10
6. Scope of supply ............................................................................................ 11
7. Technical data .............................................................................................. 12
7.1 Ports .................................................................................................... 14
7.2 Block diagram ....................................................................................... 15
7.3 Swing & Clamp Mechanism ..................................................................... 16
8. Beginning of operation ................................................................................. 17
8.1 Installation ........................................................................................... 17
8.2 Connect and work with the barcode reader ............................................... 18
8.3 Working with the data reading option ....................................................... 18
8.4 Blood donation ...................................................................................... 19
8.5 Withdrawal and/or exchange of the batteries ............................................ 20

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9. Supervisor menu valid from Software revision V9.0.34.3 ............................ 21

9.1 Menu option ‘LANGUAGE’ ........................................................................ 21
9.2 Menu option ‘BLOOD TAKING PROCESS’ ................................................... 22
9.3 Menu option ‘PARAMETER SETTINGS’ ....................................................... 23
9.4 Menu option ‘READ DATA’ ....................................................................... 24
9.5 Menu option ‘DATA SUCCESSION’ ............................................................ 26
10. User menu ................................................................................................. 27
10.1 General information to the user menu ...................................................... 27
10.2 Menu option ‘CALIBRATION‘ .................................................................... 27
10.3 Menu option ‘BLOOD TAKING‘ .................................................................. 29
11. Troubleshooting ........................................................................................ 32
12. Explanation of symbols ............................................................................. 33

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1. General purpose

Congratulations! You purchased one of the highly advanced BAGMATIC devices. It is the
result of intense research and development. We, Lmb, guarantee for the highest quality in
development, manufacturing and service of this product.

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.

The following list shows an overview of all single functions:

Single function Description of function

Receiving the blood collection bag set by the bag tray mounted on the weighing
and swing system
Receiving the tube in an automatic clamp By clamp mechanism on the front side of
for control, starting and stopping of the the device
blood flow
Weighing and swing system for control of By microprocessor-controlled swing
the extraction volume and for mixing of mechanism and attached calibratable
the blood bag to avoid clot formation weighing system
Monitoring of blood flow By electronic time and volume recording
Data entry By barcode reader or optional keyboard
Data output By transmission via RS232 port via cable
or radio (optional)
Extraction parameter setting By parameter setting of the Supervisor
menu
Alarm in the case of too low or too high By changing display and red signal lights
blood flow, weight problems or absence of the front of the device
the tube
Weight and donation process display By large, clear and backlit front display
Rechargeable battery for continuous By integrated or option rechargeable
mobile use batteries capable of changing

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2. Warranty

All units are produced and checked with the utmost care by the manufacturer. However,
should a 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:

 Defective Bagmatic must be sent to LMB or to the nearest authorized service facility
in the original packaging only.
Damages to units sent without original packaging will not be covered by
warranty.

 The purchase invoice should be included, along with a detailed description of the
defect.

Damages resulting from operating errors, misuse, manipulation, carelessness, or any

intervention unauthorized by LMB are not subject to warranty. LMB can grant a
perfect operation only if Bagmatic is used with the original power supplier specifically
designed for this instrument.

Warranty does not include the rechargeable batteries and the necessary labour for
their replacement because they are considered consumable parts.

For further information concerning warranty please contact LMB Technologie GmbH.

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3. Safety advices

3.1 General safety advices

For safe handling with the BAGMATIC device

Pay attention! Please avoid in any case

 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 fulfill 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.

3.2 Description for proper workspace

The workspace need to be according to standards for blood transfusion centres and
environmental recommendations by domestic health care administration.

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.

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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.

3.3 Warning notes regarding incorrect use

Different use as intended and described in this manual may lead into problems listed below:

3.3.1 Device damage

- 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.

3.3.2 Risk to user

- 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.

3.3.3 Quality Problems

- caused by incorrect settings or wrong programs selected by mistake or improper

prepared blood bags. Besides the taken precautions of limited access to the device and
procedure parameters a mess-up of settings is always possible. That can have very bad
influence of the quality and quantity of the estimated results of blood donation. The
operator must be aware that consequences.

3.3.4 Blood preservation damage

- 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.

3.4 Installation details

All details are stated in chapter 8. The installation can only be done by trained personnel
with full application training received from Lmb and its partners.
Special requirements of the operating personnel are not necessary.

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3.5 Remaining risks

The Lmb Company has taken care in production and design to eliminate all risk potential.
Some possible 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.

3.6 Restriction to guarantee secureness in following occasions

3.6.1 Installation secureness

The device must not be installed to other power sources and as described on the S/N Label
and in chapter 8.

3.6.2 De-installation secureness

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.).

3.6.3 Shut-off condition secureness

The device can be switched off via menu or switches off if unused for 1 – 30 minutes
automatically 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.

3.6.4 Out-of-order condition secureness

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.

3.6.5 Maintenance and Service secureness

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.

3.6.6 Transportation secureness

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.

3.7 Safety instructions for transport and storage

The device weight is 5.1Kg (365x190x135 mm) + 5kg for all accessories. Transportation
has to be done in proper box secured against shock and moisture. The balance tray can be
placed upside down on top of the device. The device should be stored in controlled
environment. To guaranty full functionality of the device over longer period of storage the
room temperature must in between 10°C – 30°C and the replaceable batteries should be

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removed. In case of higher or lower temperature during transport the device need to be
brought to standard environmental area 2h before use.

3.8 Procedure recommended in case of emergency or casualty

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.

3.9 Safety measures for installation and maintenance

 Please use only the delivered battery charger

 Connect only accessories tested from Lmb
 Avoid constant extreme humidity and condensation.
 Protect the device from water and chemicals.
 Only instructed technicians are allowed to open the device.

3.10 Electromagnetic interference resistance

According to IEC 61000-4-2 the device tolerates static discharges and/or voltage flashovers
of +/- 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%.

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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.

The device cannot be used for invitro or invivo analysis purposes.

4.1 Service interval

Once a year is a precautionary maintenance to make at the device.

4.2 Cleaning instructions

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.

Applied harmonized standards:

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

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6. Scope of supply

Basic Version:

 basic hardware BAGMATIC SL

 Bag tray
 power pack FRIWO FW 7118M/12
 12V 2AH lead battery type WP1250
 User manual

Optional:

 bar code scanner OPTICON SENSORS OPR-2001-RS232C+stand

 basic hardware including LCD display [standard]
 basic hardware including radio transmission card
 Basic unit with changeable battery [standard]
 Data transfer software BagWin®
 radio transmission unit
 transport case

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7. Technical data

 13-14 V charge voltage

 12 V power supply
by internal lead battery
 LCD display (programmable freely)
 LCD display with LED back lighting
 12 V direct current motors with gearing for clamp and swing mechanism
 foil keys for operating
 8 Bit controller card with interface for serial/parallel port, display

Power supply unit:

Producer: Friemann & Wolf GmbH

Type: FW 7118M/12

Supply: 230V AC / 50 HZ / 10 W

Charge voltage: 8,5V...14V DC

Battery current: 500 mA

Power output: 7 VA

Internal device data:

Power supply 12V DC

by internal lead changeable battery (WP1250)
optional external medical power supply

Consumption 0,25 A / 0,35 A

3 VA when LCD is lighted

Battery charge Up to 12 hours

duration External by charger with charge control

Fuse micro-fuse T 0.800A ; 250 V

Programming By front-side foil keys

Optional by barcode reader

Storage of data In internal RAM

In external data carrier

over RS 232 interface

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Internal interfaces:

Bar code Optional

scanner
Opticon Sensors OPR 2100-BK-RS 232+Stand
over RS 232 on the back side of the unit (3pin connection)

Radio card Optional

Over miniature antenna

External interface:

RS 232: For connection of external EDP systems

Baud rate: 9600; 8 Bit; No parity;
2 Stop bits

Radio: Industrial radio transfer

on the basis of RS-232

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:

Weighing procedure: accuracy +/- 3 %

see chapter 4: General instructions

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

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7.1 Ports

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7.2 Block diagram

External 12 Volt voltage

Power supply battery regulation

Program Tube clamp

control mechanism

Swing
motor

Display

Input / Output
Unit

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7.3 Swing & Clamp Mechanism

Swing mechanics with mounting for the blood bag tray

Tube clamp mechanism with tube detection when tube is inserted

Caution!
Moving parts. Don’t touch!

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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.

Instruction:

If the LCD display is situated in insert mode und no user input happens within 5 minutes,
the BAGMATIC executes its auto-off function. The auto-off time is determined ex works, but
can be changed (see chapter 9.3 of this manual - Menu option “Parameter settings” sleep
timer).

8.1 Installation

1. Remove the BAGMATIC from the transport crate.

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.

7. If the battery voltage is sufficient you have to continue as follows: Choose the option
blood donation and press the “Start” button again.
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).

11. Battery charge procedure

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)

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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.

8.2 Connect and work with the barcode reader

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 “Start” to activate 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.

8.3 Working with the data reading option

While doing so first switch off the device and then

 Plug the serial 0-modem cable into the backside port RS 232 of the BAGMATIC, connect
the opposite side of the cable with a PC for the data transfer and start the data transfer
program BagWin®.

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8.4 Blood donation

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. Choose the
kind of the blood donation – normal or own blood donation.

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.

If activated, please read the necessary bar codes with the barcode scanner.

During the steps:

When appears:
“PLACE BAG ON TRAY THEN START”
put the bag onto the blood bag tray and lead the connection tube
‘through’ the clamp. The tube must be inserted with about 15-20
cm of the blood bag until the tube clamps.

Now a tare follows. Please take care, that there are no objects in 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 about 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.

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8.5 Withdrawal and/or exchange of the batteries

1. The battery must be pressed easily inward, so that the clip

inside of the machine is relieved (fig. 1).

fig. 1

2. During pressing the battery, the release button over the

appropriate battery can be activated (fig. 2)

fig. 2
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.

3. Now the pressure on the battery can be solved (fig. 3). The
battery slips out and can be removed from the device.
The battery tray is designed polarized.

fig. 3

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9. Supervisor menu valid from Software revision V9.0.34.3

Abbreviations

[UP] button with direction arrow upwards

[DOWN] button with direction arrow downwards
[START] Start button
[STOP] Stop button

Meaning

[UP] navigation | select menu options

[DOWN] navigation | select menu options
[START] choose menu | scroll through menu
[STOP] leave menu

Access to the supervisor menu

[STOP] [UP] [UP] [DOWN] [START]

Now the display indicates:

SUPERVISOR MENU

LANGUAGE
BLOOD TAKING PROCEDURE
PARAMETER SETTING
READ DATA
DATA-SEQUENCE
SET DATE/TIME
CONFIGURATION

9.1 Menu option ‘LANGUAGE’

The display shows:

SPRACHE
SPRACHE: DEUTSCH
LANGUE: FRANCAIS

select options [UP]

[DOWN]
Leave menu without changes: [STOP]
Choose option und leave: [START]

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9.2 Menu option ‘BLOOD TAKING PROCESS’

The display shows now

BLOOD TAKING PROCESS

These inputs will be
extensively explained
on the following pages.

Label options description

SET CLAMP YES/NO closing of the tube clamp during tapping the donor

DISPLAY IN ml/g display indication of the blood flow in millilitres (ml) or grams
(g)

TONE ALARM FOR FLOW YES/NO warning alarm when blood flow exceeds limit

BAG TARE ALWAYS: YES/NO YES:

measures the bag weight
In the beginning of every donation und subtracts it from the
total weight

NO:
measures the bag weight only immediately after the switching
on and uses this for further donations

TOTAL WEIGHT YES/NO Bag weight is indicated

ACCU BAR YES/NO Indication of the battery capacitance before the donation

DONOR AFTER DONOR YES/NO If YES: the device changes directly after one donation to the
next donor. (displayed message: the step to the menu is let
out.

BLOODVOLUME AT MENU YES/NO Setting of the volume is already possible in the main menu

TOO FAST FLOW YES/NO When torrent flow donation is activated, the device alarm
beeps a warning sign at a flow of more than 20 ml per second.
STOP: Cancel the donation
START: Resume donation after correction

FAULTY PROCEDURE YES/NO registration of errors in the display

ALARM STOP YES/NO Alarm is to be verified with STOP.
START / STOP CODES = YES/NO start-/stop codes are red in addition
urgent advice: choose YES -

CALIBRATION PROGRAM YES/NO choice if a daily weight control shall be used or not.
if yes: choice between manual and automatic check
CALIBRATION SETTING MAN/AUT Choice between manual and automatic weight check.
automatical: daily demand for control, before this no donation
can be taken manual: weight check is effected via menu
Pay attention!
donations can be taken here even without check in advance!
TUBE ID YES/NO With NO the hard ware tube recording is switched off by the
soft ware.

OPERATION MODE BLOOD At body weight, the weight of the donor has to be feeded, the
AMOUNT/ device converts automatically.
BODY
WEIGHT
SHOW DATE/TIME YES/NO Will show it on Display or not

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9.3 Menu option ‘PARAMETER SETTINGS’

The display shows now

PARAMETER SETTING

Label options description

FLOW LIMITS (mini) 5-50 alarm sounds when blood flow falls below limit
ml/min
FLOW LIMITS (maxi) 50-200 alarm sounds when blood flow exceeds limit
l/min
SLEEP TIMER (mini) 1-30 min auto-off function: turns device off while idling (battery saving)

CALIBRATION WEIGHT 250-750 g weight of calibration weight

CAL. WEIGHT TOLERANCE 1-10 % tolerance in standardizing weights

(e.g. when 1% und 500 g calibration weight are selected you
can use a calibration weight of 495 - 505 g)

MAX. DURATION (mini) 1-20 min maximum donation dura-tion, when exceeded an alarm will be
activated and the donation will be cancelled

MAX. INTERRUPTION (sec) 1-300 sec Selection of the maximal general break, which can be
triggered by STOP during a donation. Here general
interruptions of the blood flow are considered, too.
When exceeded, the donation will be cancelled.

DURATION NORMAL TIME 1-20 min If this time limit is exceeded, an alarm beep will be heard, but
[min] the donation continues until the maximum donation duration is
reached (see 2 steps behind)

BLOOD VOLUME [g/ml] 1-600 g Blood amount which repeatedly shall be taken

NO. OF BARCODE LABELS 1-16 Maximum number of bar codes which shall be read

NO. OF BAGS 1-6 Number of blood bags per donation

NO. OF TUBES 1-6 Number of tubes used during donation

PC PORT USED RADIO/ Port which is used for data transfer to a PC

COM/
CARD

EXTERNAL DISPLAY YES/NO if used

DATE FORM dd-mm- 3 different ways at display
yyyy
START TILTING AT 1-500 ml Amount of blood which is the lower limit for starting the titling
procedure
1. FLOW 1-4 Tilting speed 1

2. LIMIT OF VOLUME (ml) 1-600 ml Limit value up to tilting speed 2

2. FLOW 1-4 Tilting speed 2

3. LIMIT OF VOLUME (ml) 1-600 ml Limit value up to tilting speed 3

3. FLOW 1-4 Tilting speed 3

4. LIMIT OF VOLUME (ml) 1-600 ml Limit value up to tilting speed 4

4. FLOW 1-4 Tilting speed 4

STOP TIME (s) 0 - 99 sec Motor stops after this duration. So the final position of the tray
is adjusted.

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9.4 Menu option ‘READ DATA’

The display shows now:

DATA INPUT

DATA PER DAY

DATA AT START
DATA DURING BLOODTAK.
DATA AT THE END
SAME DATA

Label description

DATA PER DAY Data will be requested once a day (preset data)

DATA AT START Data will be requested once a donation

in the beginning (donor specific data)

DATA DURING BLOOD Data will be requested once a donation

TAKING during donation (donor specific data)

DATA AT THE END Data will be requested once a donation

in the end (donor specific data)

COMPARISATION OF DATA This data will be checked for equality – if not equal an alarm signal will be
heard

Because all the five sub menus contain the same fields, the description is only one time
explained on the following pages.

These sub menus can differ from those of your Bagmatic-blood taking monitor, because
they are adjusted specifically for the customer.

Label Options Description

PLACE OF DONATION YES/NO Bar code reading

ENTER TEAM NUMBER ? YES/NO Bar code reading

MEDICAL / DOCTOR YES/NO Bar code reading

NURSE CODE 1 YES/NO Bar code reading

NURSE CODE 2 YES/NO Bar code reading

BLOOD AMOUNT YES/NO Bar code reading

or select using keys

BAG TYPE YES/NO Bar code reading

or selection using keys

NUMBER OF BAGS YES/NO Bar code reading

or selection using keys

NUMBER OF TUBES YES/NO Bar code reading

or select using keys

BLOOD GROUP YES/NO Bar code reading

or selection by keys

RH FACTOR YES/NO Bar code reading

or selection by keys

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Label Options Description

HEMOGLOBIN YES/NO Bar code reading

or selection by keys

BAG PR. CODE YES/NO Bar code reading

DONATION NUMBER YES/NO Bar code reading

TUBE CODE YES/NO Bar code reading

DONOR ID. YES/NO Bar code reading

DONATION CODE YES/NO Bar code reading

ADD ON CODE YES/NO Bar code reading

here 3 codes are optionally
available

ERROR STATUS YES/NO Bar code reading

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9.5 Menu option ‘DATA SUCCESSION’

The display now shows

DATA

DATA PER DAY

DATA IN THE BEGINNING
DATA WITHIN
DATA IN THE END
IDENTICAL DATA

Here you can select in which sequence the data

shall be requested:

Label description

DATA PER DAY Data will be requested once a day (preset data)

DATA IN THE BEGINNING Data will be requested once a donation

in the beginning (donor specific data)

DATA DURING Data will be requested once a donation

during donation (donor specific data)

DATA IN THE END Data will be requested once a donation

in the end (donor specific data)

IDENTICAL DATA This data will be checked for equality – if not equal am alarm signal will be
heard

 Selection priority [UP] and/or [DOWN]

 Leave without
[STOP]
changes:
browse and save while
[START]
leaving:

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10. User menu

The user menu is the menu which is displayed when the Bagmatic is switched in by the
START-key and which is operated by the user during the blood taking.

10.1 General information to the user menu

The expressions [UP], [DOWN], [START] and [STOP] relate to the plastic film buttons of
the BAGMATIC.

[UP] = button with direction arrow upwards

[DOWN] = button with direction arrow downwards [START] = START-button
[STOP] = STOP-button

These functions can be simulated or replaced by bar codes.

Display of 5 options: BAGMATIC

BLOOD TAKING
LAST RESULT
READ DATA
CALIBRATION
TURN OFF

Selecting the menu topic LAST RESULT you can review the last reading of the previous
donor.

Selecting the menu topic READ DATA, the whole saved data will be transferred to the new
memory device (ordinary serial to a PC).

10.2 Menu option ‘CALIBRATION‘

Selecting the menu topic CALIBRATION you can carry out the manual calibration.

Step 1

Choose the menu topic ‘CALIBRATION‘ using the arrow buttons.

Confirm with START.

Step 2

For a short time the display will indicate:

CALIBRATION CHECK

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Step 3

Now you have to place the first weight.

Place the weight on the tray or on its mounting. Press START.

Step 4

Place the second weight on the tray or its mounting. (preset

final weight)

Press START.

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.

If automatically calibration is selected, the calibration has to be successful; otherwise you

cannot carry out a blood taking. For that reason, you have to change the selection in the
supervisor menu (CALIBRATION AUT).

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.

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10.3 Menu option ‘BLOOD TAKING‘

Main menu

In the main menu choose the first option BLOOD

TAKING with the arrow buttons und press START

1. Kind of blood taking

Choose one of the two blood taking options:

- blood taking normal

- blood taking autolog

2. Battery voltage

The following test shows the voltage of the battery.

Press STOP to cancel the donation.

3. Data input

Now follows the input of the data determined in the

supervisor menu.

Use the arrow buttons or the barcode reader to enter the

data.

After entering the first bag code and presupposed the device is activated for the first time a
calibration of the tray is carried out.

The display indicates:

PLACE BAG ON
TRAY THEN START!

Press START; a calibration of the empty bag will be carried out.

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Caution, the tube has be put into the clamp in an appropriate way, because if this isn’t
carried out correctly the device will interrupt (because of the tube identification) and the
following message will be displayed:

INCORRECT BAG PLACEMENT

START = CONTINUE
STOP = ABORT

ATTACH DONOR
THEN START!

The tray moves into reserves and starts tilting after the first 5 ml: When certain volume
amounts are reached the tilting speed can change if selected. If the flow speed falls below
or exceeds the preset speed an alarm beep will be emitted and an indicator lamp will flash.
If the preset volume is reached the clamp will close the tube. It can also be closed in
intervals if selected.

Caution!

1. Don't touch in any case the bag tray during

blood taking!

2. Be sure that the scanner cable isn't situated

on the bag tray.

3. The distance between clamp and bag should be

15-20 cm, because a too short tube could
cause a wrong measurement result.

Not to respect these points leads

to wrong measurement results!

After completed donation the following message appears:

STOP
THEN REMOVE BAG

THEN If you want to correct a failure you can press STOP during the blood taking. For that
reason the clamp will close.

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.

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Display after donation:

TOTAL WEIGHT 624 g press STOP if the display doesn’t change to the next
input option

HEMOGLOBIN 20 read amount from 1 - 33 by bar code, then press START.

NURSE CODE read not more than 16 numbers

1. TUBE CODE read not more than 16 numbers

You are back in the main menu:

BAGMATIC

BLOOD TAKING
LAST RESULT
READ DATA
CALBRATION
TURN OFF

Now you may continue with the next blood taking!

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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.

Errors Class Troubleshooting

A Change battery
A Change charger
Turn on not possible A/B Change fuse
B Change start button
B Change main board
B Initialization failed
A No power
No display
B Display bad
B Main board bad
A No tube in clamp
B No tube detect
Donation start not possible A Wrong barcode reading
B Bad or no barcode reading (if selected)
A/B Bad or no taring possible
A Flow high or low, time override, interruption etc.
Errors during donation A Correct tube position, donor fault
B Adjust unit
Donation error at end under / A Operator problem, wrong placement etc.
overfilled, time over B Adjust unit
Clamps out of function, open
B Adjust unit
after close – no tube detection
Up/down continuous, no
B Adjust unit
position detection
Unit in calibration status wrong
B Adjust unit
or unstable weight system
Charge battery at start of A Replace battery, use charger
donation,
B Adjust, replace load cell or main board
voltage detect < 11 V
No shaking B Mechanics, motor, main board
Data usage: no data or B Electronics or bad data base
transfer available, radio 1. solution: read out by serial cable daily (loose
transmission not working maybe 1 day)
2. correct setup or initialize

set SN
replace radio or main board

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12. Explanation of symbols

Caution, advice

Caution, electrostatic sensitive device

European Union WEEE Directive Logo

according to Waste Electrical and
Electronic Equipment Directive
2002/96/EC

The system has CE mark.

0123 = number of Notified Body
0123

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