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Easymix V3.es - en
Easymix V3.es - en
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Operator's Manual
Fenwal
Easymix V3
Blood Mixer
RDR7438C
LBL-07195262ES(A) RDR7438C-OPM-06-06
Index
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5. APPENDICES ................................................. .................................................. ............................... twenty
5.1 Appendix A: Table of symbols ........................................... ............................................ twenty
5.2 Appendix B: Technical characteristics ........................................... ................................. twenty-one
Oficina de ventas
5.2Appendix C: Commercial Offices.................................................. ..................................22
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Warning!HeEasymixused in accordance with all
specifications and operating procedures listed in this manual
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1.GENERALITIES
Gripper
tube guide
balance plate
Screen
Baxter Easymix
Numeric keyboard
Indicators
Figure 1
1.1 Presentation
HeEasymixIt is a Blood Mixer. It has been designed to offer flexibility and safety during manual
harvesting.
The objective pursued is to mix all the blood collected with the anticoagulant contained in the blood
bag and control the volume collected. When the desired volume is reached, the machine clamps the
donor tube closed.
This machine has been designed with quality in mind. When theEasymixis turned on, various self-
control procedures are initialized. If a breakdown is detected, the machine informs the operator and
the harvesting ends.
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1.3 Unpacking instructions
EachEasymix(Product code RDR 7438C) is delivered fully assembled in the bag. Inspect the unit
immediately upon receipt and report any defects, damage or missing accessories to the shipping
company within 24 hours and to your local sales representative.Fenwal.
- 1 operator's manual
- 1 carrying bag
- 1 wire
HeEasymixworks with battery and 110 V current∼/220V∼,so it can be used as a portable device.
Next to the plug (left side) there is a voltage selector and two fuses. Selector allows switching
between 110-115 V∼and 220-240V∼
Warning! Check the position of the selector before connecting the Easymix to the
power
Note! + When the Easymix is connected to the power, the value on the LCD display is
not the actual battery voltage.
Note! + In the event of a power failure, the Easymix continues to work without
problems with the battery.
Note! + When connected to the mains, the Easymix simultaneously recharges its internal
battery (see 1.4.2)
A battery reaches full capacity after 3 charge/discharge cycles. Therefore, charge it for 1 night before
using it for the first time.
With a fully charged new battery, the Easymix can run for over 12 hours, with 4 pickups per hour; In
other words: a day and a half of work. This is an estimate and may vary from battery to battery.
This period is reduced from one cycle to the next. The life of a battery is given by the number of cycles,
which depends on the way it is charged and discharged. At the end of its life, the battery will have lost 60%
of its initial capacity.
The battery is automatically tested before collection. If it is not charged enough, the Easymix
indicates to the operator that it is not possible to start harvesting.
If the battery voltage becomes insufficient during a harvest, the lettersB.T.would appear
intermittently in the upper right corner of the screen. The collection in progress can continue, but it is
necessary to connect the Easymix to the power to charge the battery before starting a new collection.
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For your information, when theEasymixis turned on, its serial number and version appear on the
screen, as well as the battery level.
To charge the battery, simply connect the Easymix to power. Meanwhile, the Easymix will be able to
work, but it is necessary to disconnect it to check the real battery voltage.
It takes 10 to 12 hours to fully charge the battery.
In this example, if 400ml is to be taken, press the keyF2. If the key is pressedF5(cont.), the program
goes to another menu.
The red indicator lights up intermittently when an alarm situation occurs and intervention is
necessary.
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2.EMAKE A COLLECTION
When theEasymixis on, the message «Initialization in progress »appears on the screen, the clamp
closes and the motor runs. During this phase, the machine examines itself to ensure that it is ready
to operate.
Warning! Since theEasymixWeigh your scale pan during the initialization phase, check that
the pan is empty before turning on the machine and do not touch the scale pan
during the entire testing phase.
If heEasymixdoes not pass the test, the following message will appear on the screen.
The appearance of this message does not necessarily imply that theEasymixIt is not calibrated. There
may be something on the scale plate or the balance may have moved.Easymixduring the testing
phase. Repeat calibration testF1. If the message "The device is not calibrated» persists, contact your
local service center.Fenwal.
If heEasymixpasses the test, the following message will appear on the screen:
Then pressF5(forGO OUT) to begin harvesting. The message described in §2.2 appears on the screen.
Before selecting the volume to be taken, place the bag on the scale plate and insert the tube into the
slot of the clamp and then into the tube guide (if the bag is facing to the left you should use the left
tube guide). Then press the key corresponding to the volume to be taken (e.g.F2for400ml).
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If the desired volume does not appear on the screen, pressF5(forcont.). The following message will appear
on the screen.
By pressingF1(eitherF2), the volume displayed on the screen decreases (or increases) from 5 ml to 5
ml. When the desired volume appears on the screen, pressF3(forGATHER).F5(for ABANDON) returns
to the previous menu (the desired volume is saved in memory until the machine is turned off).
2.3 Self-calibration
Once the volume to be taken is selected, the battery is tested and the machine self-calibrates. During
self-calibration, theEasymixchecks that there is a bag on the scale pan and asks the operator to place
the bag if the scale pan is empty. The following message appears on the screen:
Once the bag is in place, pressF1(forokay), the machine will self-calibrate and you can begin
harvesting.
HeEasymixIt also checks that the bag placed on the scale plate is empty. If not, the machine informs
the operator with the following message:
In this case, the machine assumes that there is already blood in the bag. Therefore, when you pressF1(forokay),
the program returns to the first menu.
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2.4. Start collection
Insert the needle into the donor vein and pressF1(forSTART). The clamp opens and agitation begins.
The blood flows through the tube and then enters the bag, where it mixes with the anticoagulant.
It is extremely important to insert the tube into the collet slot. In fact, if the tube is not in place, the
EasymixIt cannot prevent blood from flowing and entering the bag when an accident occurs or at
the end of the collection. For this reason theEasymixincorporates a tube detection system.
When blood begins to flow into the bag, the clamp closes and theEasymixCheck that no more blood
enters the bag. The clamp is then opened and blood continues to flow.
If blood continues to flow when the clamp is closed, theEasymixIt assumes that the tube has not been
inserted into the collet slot. The machine emits a high-pitched sound and the following message appears
on the screen.
Once the tube is inserted into the clamp slot, pressF5(forokay). Check once again that the tube has
been inserted and collection continues.
2.6. Harvest
Throughout the collection, the machine indicates the duration, the actual volume of blood collected, the
programmed volume (in parentheses) and the blood flow in ml/mn.
Labels should be attached to the bags only after blood has entered the bags. By pressingF5(forLABEL
), the engine stops and the following message appears on the screen:
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Paste label (25s left)
CONTINUE
F1 F2 F3 F4 F5
A period of 25 seconds is given to paste the labels. Once this period has elapsed, the engine starts
working again. However, if the labels are affixed before this period expires, it is possible to restart the
engine by pressingF1(forCONTINUE).
Labels can be attached up to 5 minutes after the start of collection. After this time, the message '
LABEL' disappears and the mixing process cannot be interrupted. He Easymixdetects that the label
has not been attached and stores this information as an incident.
During collection, two flow incidents can occur: «Flow too low »either "Flow too high ». These
incidents must last longer than 3 seconds to be reported. When an incident of "Flow too high », is
notified on the screen. If the flow is too large for 15 seconds, theEasymixemits a high-pitched sound,
the clamp closes. When an incident of "Flow too low », is notified on the screen.If the flow is too
low for 15 seconds, theEasymixemits a high-pitched sound until the flow returns to normal.
The operator must pressF5(forVALIDATE) to verify that the collected volume is correct before
pressingF1(for the end).
By pressingF1(forEND) the operator is asked to remove the needle from the donor vein.
The operator must pressF2(forWHISTLE) to eliminate the Easymix beeping when the collected
volume is equal to the programmed amount.
Warning!: Something may have fallen onto the scale pan (for example, a pen). HeEasymix
will weigh this object and the collection will continue. In this case, remove the
unwanted object and press F5 (to VALIDATE) to complete the collection.
Disconnect donor
okay
F1 F2 F3 F4 F5
By pressingF1(forokay) again, the clamp opens and the first menu appears on the screen. He
Easymix is ready to start a new collection.
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2.10 End a collection manually
For any reason, it may be necessary to interrupt a collection. Harvesting can be interrupted by
pressingF1(forSTOP). The motor stops working, the clamp closes, the incident is stored in the device
and the following message appears on the screen:
Stop required
END INFO CONTINUE QUANTITY
F1 F2 F3 F4 F5
By pressingF1(forEND) again, the collection is actually interrupted and theEasymixasks that the needle be
removed from the donor's vein.
By pressingF2(forINFO), the previous message (time, volume and flow) will appear on the
screen. By pressingF3(forCONTINUE), harvesting begins again.
By pressingF4(forAMOUNT) the operator has the opportunity to change the scheduled collection
quantity. (For example in case of biomedical incident)
The following message appears:
PressedF1(eitherF2) the displayed amount decreases (or increases) in steps of 5 ml. When the new
desired amount appears on the screen, pressF3(forGATHER) and return to the previous menu.
If heEasymixNot used for 20 minutes, it turns off automatically. However, it is possible to turn off the
Easymixpressing twiceF5(to cont.) in the main menu. The following message appears on the screen:
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3.AJUST THEANDASYMIX
By pressingF3(forCLOCK), it is possible to check and adjust the internal clock. The following message will
appear on the screen.
Hedía flashes. This means that it can be modified by pressingF2(for-) eitherF4(for+). To select another
date (Mis,Year,hpray,Minuto,Yessecond) use the arrows (F1andF5).
Check that the scale pan is empty and pressF1(forCALIB), the following message will appear on the
screen.
F1 F2 F3 F4 F5
During this phase, it is very important not to touch the scale plate. After a few seconds the following
message will appear on the screen.
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Place the reference weight on the scale pan and pressF1(forokay). The following message will appear
on the screen:
F1 F2 F3 F4 F5
After a few seconds, theEasymixIt will tell you if it is ready to work or not calibrated. If heEasymixis
not calibrated, please contact your local technical service.Fenwal.
The operator has the opportunity to program the periodicity of the Easymix calibration test
By pressingF1(forDAY) the Day flashes. It means that the calibration test will be done automatically
once a day.
By pressingF2(forWEEK) the Week flashes. It means that the calibration test will be done
automatically once a week.
By pressingF3(forMONTH) the Month flashes. It means that the calibration test will be done
automatically once a month.
By pressingF4(forYEAR) the Year flashes. It means that the calibration test will be done automatically
once a year.
By pressingF5(ForABANDON) the selected information is stored and you return to the main menu.
When pressingF2(forBAT), the battery voltage will appear on the screen as follows:
Note: When the Easymix is connected to the power, the value on the LCD display is not the actual value of
the battery voltage.
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4.VARYANS
HeEasymixIt does not need special cleaning. However, clean the device periodically (for example,
every three months) with a classic disinfectant (isopropanol 70%...). Be careful not to use solvents
(such as acetone, trichlorethylene...) that may damage the plastic case.
If blood spatter occurs, the unit must be removed from operation, cleaned and disinfected before
returning to service.
To clean the caliper you can use a swab or a stiff bristle brush with a cleaner.
The scale plate can be removed for washing. Place both hands under the plate and remove it by
grabbing the base tray and sliding the plate at the same time (from right to left when we are in front
of the machine).
Warning: Turn off and unplug theEasymixof the current before performing the
cleaning procedure.
4.2 Maintenance
To guarantee an accurate measurement it is recommended that the calibration test be carried out
about once a week (see §3.3).
If heEasymixindicates that it is not calibrated, contact your local service representative. Fenwal.
4.3 Transport
-
Warning!: HeEasymixIt is a very sensitive measuring device. Its bag has been designed to
protect it during transport. Therefore, theEasymixIt must be transported in its
bag. Keep the bag in a position that ensures the stability of the machine.
4.4 Warranty
FenwalHealthcare
Baxter Europe sprl, in Mont-Saint-Guibert warrants that the equipment will be free from defects
Corporation,FenwalDivision
in material and workmanship when delivered to the original purchaser. Fenwal's sole obligation shall
be limited to repairing or replacing the defective part or unit for a period of one (1) year from the
date of delivery, at the option ofFenwal, who will bear the costs.
The warranty covers the original purchaser only, is not assignable or transferable, and will not affect
ancillary equipment or available accessories.
Fenwalguarantees that the equipment is suitable to fulfill the purposes and indications described on
the labeling when used in accordance with the instructions for use. Unless the equipment is used in
accordance with such instructions, this warranty is void and void. There are no other warranties
expressed or implied, including the warranty of merchantability or fitness for a particular purpose.
The only obligation ofFenwaland a buyer's sole remedy for breach of warranty shall be limited to
repair or replacement at the option of Fenwal.Fenwalwill not be liable for immediate, incidental or
indirect damages. Any modification, alteration, recalibration or mistreatment of the device and the
intervention of any person other than an authorized representative ofFenwalThey could void the
warranty.
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Contact the Division's Technical ServiceFenwalfor information on service and repair of all
instrumentsEasymix.
In (country) : . . . . . . . . . . . Spain........................
call : . . . . . . . . . . . Baxter SA Technical Service, Fenwal Division, Valencia......
Phone : . . . . . . . . . . . 96-3860804.................
Fax: . . . . . . . . . . . 96-3702697.................
Shipping costs for all units returned toFenwalwill be borne by the client. The unit must be packaged
in its original packaging or other packaging approved byFenwalto adequately protect it during its
shipment. To guarantee immediate shipment, the breakdown must be notified to a representative of
the Division's Technical Service.Fenwalprior to shipping a unit for repair. When you call the Technical
Service DivisionFenwalPlease be ready to provide us with the code number and serial number of the
unit. A repair request number will be assigned and must appear on all correspondence. When an
instrument is sent for repair, a brief report of the problem must be attached.
The divisionFenwalwill not be responsible for unauthorized returns or units damaged in transit due
to incorrect packaging.
After warranty periodFenwal, the Technical Service of the DivisionFenwalwill continue to carry out
the technical service of theEasymix.
If the instrument was purchased by the user, you can choose between carrying out the technical service on your
own or entrusting it to the Division's Technical Service.Fenwal.
If the user wishes to take charge of the technical service on their own, the Technical Service Division
Fenwalwill make available, if requested, the maintenance manual that includes circuit diagrams, a list
of the parts that make up the device, descriptions, calibration instructions, a periodic preventive
maintenance guide, or any other information that may be helpful to the user. suitably qualified
technical personnel of the customer to repair parts of the equipment that the manufacturer
considers repairable.
User maintenance is limited to replacing the power cord and fuses. The following information covers
the most common problems and offers solutions.
1. Replacing fuses
- Turn off the Easymix and disconnect the power cable, the fuses are located in holders on the
rear panel.
- Press down and twist the protective cap on the fuse holder to access the fuse.
- Replace the defective fuse and replace the protective cap in reverse order.
Warning: Replacement fuses must be of the same type and class as the
indicated on the Easymix plate.
Note: Always check why the fuses blow. If the fuse blows again, send the unit for repair
2. power cord
- Turn off the power switch and disconnect the cable.
- Replace the power cord with the same model or an equivalent one
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4.6 Glossary (on-screen messages)
MESSAGE MEANING
BAT Battery
VOLUME Volume
INFO Information
Vol Volume
flj Flow
CONTINUE Continue
CALIB Calibration
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4.7. Troubleshooting and repair guide
Some of the errors listed below do not prevent the program from working. Some may even be
considered mere information and simply indicate what has happened. The following table shows the
meaning of the errors and how they can be solved.
16
17
18
19 Date and/or time Real Time Clock Failure User / Set the Real Time Clock
impossible Technical
twenty Real time clock not Real Time Clock Failure User / Set the Real Time Clock
working Technical
-
-
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Battery voltage
twenty-one The battery is almost User Recharge the battery
reaching threshold discharged
alarm.
22 There was no The label was not attached - -
pause during the during collection
harvest
23 Check balance - -
24 -
26 Software version Easymix not reset after Technical Reset the Easymix
incorrect Eprom replacement
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5.AAPPENDICES
5.1--- -
-
0123 This mark reflects compliance with Council Directive 93/42/EEC on Medical Devices
START Indication near the switch (right side of theOptimix) to indicate that the power
switch is ON and not OFF.
Note: The circuit used to recharge the battery is connected to power when
the power cord is plugged in. The “START” switch has no control over the
circuit used to recharge the battery.
Power/Charging Indication near the power light. When the indicator light is on, the power supply is
connected to the mains, and the battery charger is charging the battery
continuously.
Remove the power cable from the case to disconnect theEasymixof the network.
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5.2 Appendix B: Technical characteristics
Parameter Value/Description
When the battery becomes defective or when the useful life limit of the
EASYMIX is reached, remove and discard the battery by placing it in an
appropriate recycling container located in your geographic area.
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5.2. Appendix C: Sales Office
Fenwal and Fenwal Blood Technologies (trade name and design) are trademarks or registered trademarks of
Fenwal Inc. in the United States and other countries.