KEEWELL FT2800 User manual

Blood and Infusion Warmer
FT2800
Operator’s Manual
( E di t io n : 0 6 /2 0 20/ E n )
K E E W E L L M E D I C A L T E C H N O L O G Y C O . , LT D
0482

IMPORTANT:
•These instructions are an essential part of the device.
•They must be kept in a suitable place near the device and should accompany the device if it is
transferred to other users.
•For proper and safe use of this device it is essential that the warnings and safety instructions, as
well as the instructions for use are read and carefully observed by all users before first using
the device.
•It is the responsibility of those using the device to fully acquaint themselves with its proper use
and operation.
•If a malfunction is suspected, the device is to be taken out of service immediately and sent to
the supplier for examine and repair.

CONTENT
Description 1
Contraindication 5
Warnings 6
Safety instructions 8
Appearance and panel 10
Safety characteristics 14
Installation &operation procedure 20
Maintenance 25
Periodic inspections 26
Trouble shoot 28
Manufacturer declaration 31
EMC declaration 32
Symbols 39
Technical data 42
Operating and storage conditions 44
Manufacturer liability 45
Warranty conditions 46

Operator’s Manual FT2800 KEEWELL
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DESCRIPTION
•The Blood and Infusion Warmer FT2800 can be used in all applications in which
hypothermia of the patient through cold transfusions and infusion solutions is to be
prevented. It is consisted of the main body, 2 flexible warming profiles, fastening unit and
power cable. The main body has two independent symmetrical control units. During the
operation, the infusion tube is inserted into the warming profile. The intelligent
micro-computer processing control system works separately and automatically to heat up
the two profiles homogeneously and continually adjusts heating state. At the same time,
the heat is transferred into the flowing liquid in the tubing placed in the profile, to rise the
temperature of the liquid. It is equipped with double independent temperature protection
systems to ensure the safety of use.
•The temperature of warming profile can be set between 33°C and 41°C in steps of 0.1°C
and is displayed on the LED screen. The device can memorize the last set temperature
automatically.
•The alarm and self-test functions for over-temperature and under-temperature
incorporated into the device assures safe operation.
•A standard infusion tubing (5.0mm in O.D and 1.4m in length) may be used in

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conjunction with the FT2800.
•The temperature shown in the display corresponds to the temperature of the warming
profile.
•The temperature of the fluid to be heated that is reached at the end of the warming section
depends on various factors, such as, the fluid's input temperature, the flow rate, the set
temperature, the ambient temperature, etc.
The following graph shows a typical initial temperature curve
(Initial temperature Fluid and ambient temperature: 20℃)
infusion rate
（ml/min）
1
5
10
15
20
25
30
35
40
45
50
55
60
65
70
75
One profile
（℃）
41
37.6
35.3
33.3
32
30.7
Dual profile
（℃）
41
41
40.8
39.3
38.2
37.2
36
34.8
33.8
33.2
32.8
32.3
31.7
31
30.5
30

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Fig. 1: Typical starting temperature of the fluid that has passed through at different flow rates
41
37.6
35.3 33.3 32 30.7
41 41 40.8 39.3 38.2 37.2 36 34.8 33.8 33.2 32.8 32.3 31.7 31 30.5 30
20
25
30
35
40
45
1 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75
Flowrate ml/min
Output temp
One Profile Dual Profile

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Applied part
The warming profile which is applied part of the medical device is type "BF". The electrical
conductors in the warming profile have been insulated from the other parts of the medical
device to such a degree that no current higher than the allowable PATIENT LEAKAGE
CURRENT flows if an unintended voltage originating from an external source is connected to
the PATIENT, and thereby applied between the PATIENT CONNECTION and earth.
The warming profile is defibrillation-protected and supplied with safety extra-low voltage.

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CONTRAINDICATION
It is forbidden to be used on the severe cardiopulmonary dysfunction patients.
The device may not be used to warm living organisms, objects.
It is forbidden to use for heating the drug liquid which the normal effect would be influenced
after heating.

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WARNINGS
▪If the over-temperature alarm is triggered, the supply of liquid to the patient must be
immediately stopped by disconnecting the connection tube to the patient. The medium
being used in the device must no longer be administered to the patient.
▪In the event of any suspected malfunction while in operation, the supply of liquid to the
patient must be immediately stopped by disconnecting the connection tube to the patient.
The medium being used in the device must no longer be administered to the patient.
Switch off the heating or unplug the mains plug.
▪The device must not be used in rooms subject to explosion hazard.
▪The device may only be fastened to infusion stands or tripods which are suitable due to
their stability and load capacity.
▪The device must not be immersed in liquids or sterilized with steam or by thermochemical
methods.
▪All extraneous influences such as radiation, electromagnetic interference or high
temperature are to be kept to minimum.

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▪Do not bend, fold, cut or stick pointed objects into the warming profile.
▪Keep the warming profile in the open air. Do not cover it with decorations, cloths,
bedding or warm-air blankets. Do not expose it to direct sunlight or heat radiation and do
not lead it in or through incubators.
▪Do not cool or warm the warming profile from outside.
▪Do not cover or seal the ventilation slots on the back of the main body.
▪The overheating of the infusion fluid may be caused if the infusion flow is stopped while
the warming profile is on heating.
▪Only sterile consumable materials may be used in conjunction with the FT2800.
▪Repairs and modifications to the device may only be carried out by persons or service
centers authorized by Keewell.
▪The device is equipped with an POTENTIAL EQUALIZATION CONDUCTOR,
it is intended solely for connecting with other devices in equipotential. The terminal
shall not be used for a PROTECTIVE EARTH CONNECTION.
▪The device must be disconnected from the mains before the housing is opened.

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SAFETY INSTRUCTIONS
The device must only be used in areas in which the electrical installations are in
accordance with the rules and regulations in force. To avoid electrical shock, the
device must only be connected to a properly grounded power source.
The device must not be used in the following circumstances:
•If the device or the warming profile is damaged or one of the front film layers becomes
detached.
•If the device has been exposed to a hard physical shock (e.g. dropped, hit or shaken).
•If the device has been immersed in water.
•If the device has triggered an over - temperature alarm protection that was not caused by
external factors.
•If the device has triggered a sensor malfunction alarm.
•If the mains power cord or plug is damaged.
•If the device has given somebody an electric shock.

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•If the fixing clamp is damaged and no longer assure safe clamping to the infusion stand.
Should a malfunction be evident, suitable warning signs should be attached to
the device to ensure that it cannot be used before necessary service and repair
work has been carried out.

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Appearance and Control Panel
Fig. 2: General illustration
Connection Cable
LED Screen
Control Panel
Infusion Tubing
Warming Profile
Infusion Stand
Main Control Body

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Fig. 3: Illustration of LED screen(*The same indications for the symmetric unit on the left)
Light on: warming profile on heating
Flashing accompanied with acoustic alarm and
heating is switched off⇨sensor malfunction
Flashing accompanied with acoustic
alarm ⇨temperature lower than 32˚C
Set temperature
Actual temperature
Heating time
Flashing accompanied with acoustic alarm and heating is
switched off ⇨temperature higher than 42˚C

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Fig.4: Illustration of the control panel
(*The same indications for the symmetric units. The key and key for both uses.)
Key to set
temperature up
Key to set
temperature down
Key to switch between
Celsius and Fahrenheit
Key to choose
test mode
Key Standby/ Operating

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•The device can be fixed to the infusion stand or other support by using the clamp at
the back.
•Only use infusion stands or supports which be capable of supporting a minimum of ten
pounds (4.5 kg) and with a minimum 60cm diameter wheelbase.
•Make sure that they are sufficiently stable to against tipping over.
Warning: After the device be fixed stable, it cannot be pull or application of force any
way to avoid the infusion stands or supports tipping over. Failure to do so may result
in damage to the device, the device may drop down with the infusion line and prevent or
interrupt the infusion flow.

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SAFETY CHARACTERISTICS
Low temperature information signal
The low temperature information signal is activated when the temperature of the warming
profile drops below 32°C. In this event the under - temperature LED indicator lights up
accompanied with the acoustic signal.
The low temperature information signal is deactivated during the first 5 minutes after
switching on.
Over - temperature alarm
The over - temperature alarm is activated when the temperature of the warming profile
exceeds 42°C. In this event the over - temperature LED indicator lights up accompanied
with the acoustic signal and the heating is switched off.
To reset the device or switch off the alarm, the device must first be disconnected from the
power supply and the temperature drops below 42.0°C.

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Sensor malfunction alarm
In the event of sensor malfunction, the indicator will light up, the “HEAT TEMP”area
will display a “LL”code accompanied with acoustic alarm and the device will stop working.
Return it to the supplier or the manufacturer for a service.
This alarm can be triggered when the temperature of the warming profile is below
-5.0°C or above 45.0°C.
Attention:
The over –temperature alarm can also be triggered by exposure to sunlight,
extraneous heat, as well as the infusion fluid is pre-warmed to higher than 42˚C
before it is flowing through the warming profile. To reset the alarm, the mains plug
must be pulled out.
All alarms are alarms of “Low priority” according to EN 60601-1-8 “Collateral
standard: Alarm systems”

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The alarm system does not have to be verified. The alarm limits cannot be adjusted.
The risk management process has found that a shutdown of the alarms is not
meaningful, because it is desirable that the error (e.g. high temperature) is detected.
Resetting of the alarm is only possible through disconnection of the device from
mains. The operator station is in front of the device.
Attention:
The operation temperature is designed within a safe range of 33- 41℃. If the
temperature exceeds 42±1℃, 43±2℃ in faulty situations, the independent high temperature
protection incorporated into the device will cut off the heating power. Over-heating may cause
hemolysis and vessel hurt. Thus it is requested for the operator that in the event of any
suspected malfunction while in operation to stop the supply of liquid immediately by
disconnecting the tube to the patient. The medium being used in the device must no longer be
administered to patient.

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Alarm overview
Software high
temperature alarm
Hardware-high
temperature alarm
Sensor malfunction
alarm
Condition
The high temperature
alarm is triggered when
the temperature of the
warming profile exceeds
42°C (108℉). When the
temperature of the
warming profile exceeds
43°C, a “HH”code and the
target temperature will
display alternately. When
it reaches to 45°C, a “HH”
code is displayed.
The high temperature
alarm is triggered when
the warming profile
exceeds 43°C (110℉).
Self-test detects a
sensor malfunction.
Consequence
The heater is switched off.
The heater is switched
off.
The heater is
switched off.