Intravenous fluid warming devices
Market review
Intravenous fluid warming devices
CEP10014
March 2010
Contents
2
Introduction ............................................................................................. 3 Market review........................................................................................ 12 Acknowledgements ............................................................................... 50 References .............................................................................................51
Appendix 1: Supplier contact details ..................................................... 52
Appendix 2: Additional price information ............................................... 54
Author and report information................................................................ 60
CEP10014: March 2010
Introduction
3
CEP market reviews provide comparative product specifications for healthcare
products available to the UK market within a defined category. They supplement CEP
buyers’ guides, which offer more general advice on the technical, operational, and
economic considerations to be taken into account when selecting an appropriate
product. Readers are encouraged to check CEP’s web site for updates.
Scope
This market review should be read in conjunction with CEP’s Intravenous fluid
warming devices buyers’ guide [1]. Intravenous (IV) fluid warming is a method of
raising the temperature of fluids administered to a patient. It may be used in many
different situations including during surgical operations to avoid inadvertent
perioperative hypothermia. Hypothermia is defined as a drop in core body
temperature below 36ºC and is associated with poor outcomes for patients [2]. IV
fluid warming devices are mainly used in operating theatres and recovery rooms or
the critical care environment. The clinical staff that use IV fluid warming devices are
those who care for patients in these settings, including nurses, operating department
practitioners, anaesthetic assistants and anaesthetists.
This market review includes intravenous (IV) fluid warming devices that:
•
•
are routinely used in operating theatres, post anaesthetic recovery rooms,
Intensive care units and the emergency unit
are available in the UK and are CE marked.
Devices for warming blood are included in the report. Warming cabinets are
excluded.
IV fluid warming devices
IV fluid warming devices comprise a heater unit and a disposable set that connects
the bag of fluid to a cannula inserted into the patient’s vein.
The devices may include safety features to prevent air bubbles reaching the patient,
and warning alarms to notify the user if the fluid temperature is too high or too low or
if there are other fault conditions.
The design of the devices is very variable, which can influence the performance of
the device. More information on different types of warming devices is given in the
Intravenous fluid warming devices buyers’ guide [1]. Purchasers should pay
particular attention to the specified maximum flow rate at which the device will warm
the fluid to the required temperature [3].
Information is as provided by manufacturers. No further testing has been carried out.
CEP10014: March 2010
Market review
4
Arizant Ranger® model 245 Blood/Fluid Warming System
General features
The Ranger blood and fluid warming system is a plate
warming system used with a range of disposable
device specific administration sets. The cassette within
the disposable set acts as the heat exchanger. The
warmer has a single target temperature of 41º C ±1°C,
which is monitored 4 times a second. If required, the
disposable set may be transferred from one Ranger
unit to another Ranger unit using a correct procedure.
The Ranger system has no active control of fluid flow
but fluid will flow through the disposable set under gravity. Arizant also supply as a
separate item, a Ranger Pressure Infuser plus its specific power pack. The pressure
infuser applies a pressure to the bag of fluid of 300mmHg.
Safety
The warming system has an audiovisual over and under-temperature alarm which
activates at 43ºC and 33ºC. The system also has an independent back-up safety
alarm which triggers at either 46ºC or 44ºC, depending on the revision of Ranger
warming device. When the safety alarm sounds the warming device interrupts power
to the heating plates. The temperature is measured at the fluid pathway inside the
warming plate. The standard and paediatric administration sets include a bubble trap
which sits in a holder on the warming unit. The high flow set includes a self-venting
bubble trap, capable of venting 3000cc of air per minute, without impeding flow.
Performance
The Ranger warming system will heat fluid to a target temperature of 41ºC ±1ºC
within two minutes and is designed to maintain this plate temperature of 41 ºC at a
wide range of flow rates and input temperatures. Ranger systems disposable sets
provide the following flow rates
Disposable set
Flow rate
Standard flow set:
KVO -150ml/min
High flow set
KVO - 500ml/min
Paediatric/neonate flow set KVO - 100ml/min
Cleaning and maintenance
The Ranger warming unit must not be immersed in fluids and the exterior should be
cleaned by wiping with a slightly damp cloth and a nonabrasive cleaning solution.
CEP10014: March 2010
Market review
The interior may be cleaned using a specific cleaning tool (supplied by Arizant)
soaked in a nonabrasive cleaning solution.
The operating temperature and alarm settings should be tested every six months or
in accordance to the hospital protocol.
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Market review
6
Arizant Bair Hugger® 241™
General features
The BairHugger 241 is an accessory product to the
BairHugger series of forced air warming devices1 and
can only be used with a BairHugger forced air warmer.
The Bair Hugger 241 is a disposable fluid warming coil
which is inserted into the Bair Hugger hose-end. The
Bair Hugger warming unit has three temperature
settings: 32ºC, 38ºC & 43ºC. The infusion fluid within
the coil is warmed by the warm air passing through
the Bair Hugger tubing and over the fluid coil.
The BairHugger 241 is used either with a disposable forced air blanket (used for
warming the patient), or with a reusable hose cap to seal the hose end if no blanket
is used.
The BairHugger 241 has an inline liquid crystal temperature display on the fluid outlet
tubing to indicate the fluid temperature.
Safety
The Bair Hugger warming units are fitted with an over temperature alarm set at
53°C±3°C for a series 500 warming unit and 53°C±1.5°C for a series 700 warming
unit.
1
These are used to apply heat to the patient’s skin. An electric blower blows warm air over the skin via
an inflatable, perforated blanket. See CEP reports 09034, 09035 and 09036.
CEP10014: March 2010
Market review
Belmont Buddy
General features
The Belmont Buddy is an induction warming device
comprising a controller unit, a warming unit and
disposable cassettes. The controller provides power to
the warming unit, which is located close to the patient,
with only a short distance of tubing for heated fluid to
travel through, reducing heat loss. The device has a
single temperature setting; the user does not make a
temperature selection. The warming unit contains two
heating plates and sensors on the heater boards to
measure the fluid temperature.
The Buddy does not regulate flow rate, the user controls flow rate by adjusting a
roller clamp on the disposable set. Flow of fluid is gravity driven.
The controller has an alphanumeric display of:
•
power status
•
output fluid temperature
•
alarms.
The device has a single temperature setting of 38ºC±3ºC. The cassette contains
microporous membranes to vent out-gassed air from the fluid, a blood filter and also
a pressure regulating valve to protect the cassette from high fluid pressure. The use
of pressure infusers with the Belmont Buddy is contraindicated. The cassette has a
small clamp on the fluid infusion line to secure the cassette and warmer close to the
patient when in use.
Safety
The Belmont Buddy has an independent safety circuit. The controller has the
following safety alarms:
ƒ
No flow or empty cartridge
ƒ
Low temperature or probe fault
ƒ
No heat, check connection
ƒ
Over temperature
ƒ
Over current
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Market review
ƒ
8
System reset.
The over temperature alarm is audiovisual. When the over temperature alarm
sounds, the device stops heating the fluid. The fluid temperature at which the alarm
triggers varies with flow rate:
ƒ
Moderate to high flow: 42.5ºC for 2 minutes, or ≥ 48ºC for 2.5 seconds
ƒ
Low flow: >42ºC for 2.5 sec or ≥ 44ºC for 1 second.
The temperature alarm also sounds if the warming plate reaches a temperature of
50.5ºC. The under temperature alert is visual only and alerts the user when the fluid
temperature is below 31ºC for 10 seconds.
In cases of prolonged use condensation may accumulate on the warming device and
does not constitute a malfunction.
Performance
The Belmont Buddy heats fluid to 38ºC±3ºC at flow rates up to:
ƒ
100ml/min for crystalloid fluid with input temperature 20ºC
ƒ
50 ml/min @ input fluid temperature 10ºC
Belmont advise that if a fluid extension line is added to the fluid exit side of the
cassette, this should be no longer than 6 inches to prevent significant cooling of fluid.
Cleaning and maintenance
The Belmont Buddy can be cleaned by wiping with 10% bleach solution. Following
cleaning a visual inspection of wiring and connections for wear is recommended.
CEP10014: March 2010
Market review
9
Belmont Rapid Infuser FMS2000
General features
The Belmont rapid infuser is an induction warmer,
used only with disposable Belmont rapid infuser
disposable administration sets. The administration
set contains a cassette which is inserted into the
warmer unit during use. Heat is transferred by
induction. The FMS 2000 is suitable for warming
blood, blood products and IV fluids.
The FMS 2000 uses a roller pump to regulate flow
rate. The user controls flow rate by menus on the
operating panel, including the option of a bolus,
battery operated backup for transport and manual
operation in case of a power failure.
The FMS2000 has a touch screen display on the
warmer device with touch screen keys to drive the
menu options.
The normal display is:
•
Flow rate in ml/min
•
Volume infused
•
Infusate temperature in ºC
•
Pressure in the fluid line in mm Hg
•
Bolus Volume (when infusion of a fixed bolus of fluid is desired)
In operation the user can select:
Flow rate of 10 – 750 ml/min in 10ml/min steps. Bolus of 100 to 500 ml. The default
amount is defined by the operator during set up, but can also be altered during
infusion. Flow rate of 2.5 or 5 ml/min for maintaining the vein open. There is no
heating when this option is chosen.
Quick single touch 500ml/minute flow rate button
Temperature setting of 37.5ºC for low rates greater than 60ml/min, or 39ºC for slower
flow rates, to allow for cooling between unit and patient.
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Safety
The disposable warming set includes two separate ultrasonic air detectors. One is
prior to heating to detectwhen the fluid supply stops, the other is after heating in the
patient infusion line. There is an automatic air purge after 500ml of fluid is infused.
A pressure sensor ensures that pressure is less than the value selected by the user.
If pressure rises, or spikes, then the unit will lower the flow rate to avoid patient
trauma. If the rise is rapid or exceeds 300 mmHg then there is an alarm and the
pump stops.
There are infra-red temperature sensors at the input and output of the heat
exchanger to monitor temperature. The over temperature alarm operates at 42ºC
Performance
Fluids are warmed at flow rates of 10 – 750 ml/min, with the temperature measured
at the output of the heat exchanger.
Cleaning and maintenance
The warmer unit exterior and inside the door should be cleaned with water or
isopropyl alcohol. To disinfect the pump clean with hydrogen peroxide or a mild
bleach solution and dry. It is recommended to inspect the power cord, fan guard and
seals around the unit and check the instrument door as part of routine maintenance.
CEP10014: March 2010
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11
Belmont Buddy lite
General features
The Belmont Buddy lite is a portable in-line fluid
warming device comprising a Buddy lite
disposable set, heater unit and battery pack. The
disposable set locks into the heater unit, which
contains warming plates and temperature
sensors. The Buddy lite is suitable for warming
blood and fluids when the flow rate is 80ml/min
and less.
There are no user adjustments to the heater unit which is gravity fed via a standard
administration set that attaches by luer connection to the Buddy lite disposable. The
unit can be placed close to the patient, minimising heat loss.
Safety
Air venting occurs through microporous membranes in the disposable set. Audible
alarms accompanied by flashing LEDs warn of over temperature, no heat, if there is
a malfunction at start-up or when there is air in the fluid path. The temperature
sensors are located on the heater board and measure the temperature of the
warming plates. When using the device with blood a filter must be included in the
standard administration set as there is no additional filtering in the Buddy lite
disposable unit.
Performance
The Buddy lite is an in-line fluid heater that can warm IV fluids to physiological
temperatures at flow rates up to 80ml/min for crystalloids at 20 ºC and 50 ml/min for
packed red cells at 10 ºC.
Cleaning and maintenance
The battery pack and heater unit may be cleaned by wiping with a soft cloth
moistened with water or 10% bleach solution.
The battery pack must be charged prior to use. This takes approximately 2.5 hours
from fully discharged to fully charged. A visual inspection of wiring and connections is
recommended. If the red LED on the battery charger flashes it is necessary to
recalibrate the battery fuel gauge.
CEP10014: March 2010
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Biegler Protherm II
General features
The Biegler Protherm II is a plate warmer, used only with
Biegler disposable warming sets. Heat is transferred by
conduction; through contact of the cassette with six metal
plates inside, three on each side of the administration set.
The fluid flows through the administration set in a convoluted
pathway (as illustrated), allowing time and surface area for
fluid exposure to the heating plates.
The Protherm II does not regulate flow rate, the user controls
flow rate by adjusting a roller clamp on the disposable set.
Flow of fluid may be gravity driven or higher flow rates can be achieved by using a
generic pressure cuff (up to a maximum of 300mmHg pressure).
The warmer unit display panel comprises:
ƒ
run/standby switch
ƒ
temperature selection keys (only operational during standby)
ƒ
temperature display
In operation the user selects a desired fluid temperature of 37ºC-41ºC, selectable in
0.5ºC increments. Adjustment can only be made during standby.
Safety
The disposable warming set includes a drip chamber, filter and an air trap. There is a
low temperature alarm when the mean temperature of all the plates is lower than
36.5ºC. An audible alarm starts after 60 seconds. The warmer unit contains an
audiovisual alarm that operates if the temperature in any one of the plates exceeds
42ºC. When the alarm is triggered all the heating plates are switched off.
Performance
The published information for this device does not include the flow rates and
temperatures at those rates that can be achieved. It is described as being suitable for
normal and massive infusions up to 18 l/hr.
Other features
An interface is provided that can be used to output data from each of the heating
plates to a PC with terminal software.
Cleaning and maintenance
The warmer unit exterior should be cleaned with water based non-abrasive cleaning
solution. Disinfection is with any commercial alcohol based spray. An annual routine
inspection is recommended.
CEP10014: March 2010
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Biegler BW 685 / 685 S
General features
The Biegler BW 685 and 685S blood and infusion warmers
are drum warmers using a heated cylinder around which a
standard administration line can be wrapped.
The Biegler BW 685 and 685S do not regulate flow rate.
The user controls flow rate by adjusting a roller clamp on
the disposable set. Flow of fluid may be gravity driven or
higher flow rates can be achieved by using a generic
pressure cuff (up to a maximum of 300mmHg pressure).
The warmer unit display panel comprises:
ƒ run/standby switch
ƒ
temperature selection keys (only operational during standby)
ƒ
temperature display
In operation the user selects a desired fluid temperature of 37ºC-41ºC, selectable in
0.5ºC increments. Adjustment can only be made during standby.
The BS 685S has an optional accessory, the Tubeflow, of an actively heated silicone
tube to prevent the fluid from cooling between the patient and the warmer. It has a
separate control unit and has a set temperature of 39 ºC.
Safety
A bubble trap may be included in the administration set.
An under temperature alarm is activated when the mean temperature of all the plates
is lower than 36.5ºC. An audible alarm starts after 60 seconds. The warmer unit
contains an audiovisual alarm that operates if the temperature in any one of the
plates exceeds 42ºC. When the alarm is triggered all the heating plates are switched
off.
Performance
The published information for this device does not include the flow rates and
temperatures at those rates that can be achieved.
Cleaning and maintenance
The warmer unit exterior should be cleaned with water based non-abrasive cleaning
solution. Disinfection is with a ready-made alcohol based spray. An annual routine
inspection is recommended.
CEP10014: March 2010
Market review
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Estill Medical Technologies, Inc. Thermal Angel
General features
The Thermal Angel is a disposable, single patient
use, battery powered warming device that can be
used with any standard administration set. The IV
fluid or blood passes directly through a sterile
stainless steel serpentine fluid path. This fluid
path is heated by electrical resistance and
contains temperature sensors embedded on the
inside of the fluid path to directly measure and
control fluid temperature.
The Thermal Angel does not regulate flow rate. The user controls flow rate by
adjusting a roller clamp on the disposable set. Flow of fluid may be gravity driven or a
pump may be used.
The warmer unit does not have a display panel. It has a green LED at the input
connection which is on to indicate that the warmer is functioning correctly. It blinks
and indicates an error code if there is a malfunction, or the input fluid is too hot or
cold.
Power is supplied from a battery pack that is recharged from the mains. The battery
cannot be in use and charged at the same time, so there must be a system for
ensuring that batteries are kept charged. The battery can be recharged
approximately 150 times. The battery life depends on the flow rate and input fluid
temperature. A fully charged battery will warm approximately:
Three to five litres of fluid at 20°C
One to three units (0.45 to 1.35 litres) of blood at 10°C.
If warming is required for a long period, then back up batteries may be required.
•
•
Safety
The warmer unit contains a backup system that is independent of the main
temperature controller, and which will interrupt power to the warmer if input or output
fluid temperature exceeds 47ºC.
Performance
The manufacturer states that the Thermal Angel strives to achieve 38 °C ± 3°C.at
rates of 2 to 150 ml/min, with a fluid input temperature of 20°C and a fully charged
battery.
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Cleaning and maintenance
There is no maintenance, cleaning or calibration for the Thermal Angel warmer since
it is a disposable item. The batteries should be kept fully charged and ready for use.
Other features
The Thermal Angel can be transferred with the patient between different services if
necessary, for instance from ambulance to theatres. This is facilitated if each service
has their own battery packs.
CEP10014: March 2010
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16
Gaymar Medi-Temp III REF FW600 Series Blood/Fluid Warmer
General features
The Gaymar Medi-Temp III REF FW600 Series
Blood/Fluid Warmer is a plate warmer used only with
disposable Gaymar D25000 series disposable warming
sets. The warming set contains a cassette which is
inserted into the warmer unit during use. The MediTemp III is suitable for warming blood, blood products
and IV fluids.
The Medi-Temp III does not regulate flow rate. The user
controls flow rate by adjusting a roller clamp on the
disposable set. Flow of fluid may be gravity driven or higher flow rates can be
achieved by using a generic pressure cuff (up to a maximum of 300mmHg pressure).
The warmer unit display panel comprises:
ƒ
run/standby switch
ƒ
setpoint switch
ƒ
digital selected temperature display
ƒ
remove from use indicator
ƒ
standby indicator.
In operation the user selects a desired fluid temperature of 38ºC-43ºC, selectable in
1ºC increments.
Safety
The disposable warming set includes a simple bubble trap which the user must
ensure is kept upright, and does not go below ¼ full of fluid. Air may be removed
from the bubble trap via a syringe port.
The warmer unit contains a backup system that is independent of the main
temperature controller, and which will interrupt power to the heaters if fluid
temperature exceeds 45ºC. If an over temperature situation is due to a fault, the
‘remove from use’ indicator alerts the user and the device shuts down. The warmer
unit performs self test at start up and periodically during use. The warmer has an
under temperature alarm, triggered at a fluid temperature of 34ºC.
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Performance
Refrigerated fluids may be warmed to a user-selected temperature of 38ºC-43ºC at
flow rates up to 300ml/min. Room temperature fluids can be warmed to a userselected temperature of 38ºC-43ºC at flow rates up to 500ml/min. The reference
point for temperature is the end of the patient line.
Cleaning and maintenance
The warmer unit exterior should be cleaned with non-abrasive cleaning solution. The
interior slot which accepts the cassette should be cleaned with 10% chlorine bleach
solution and using a Gaymar cleaning kit (P/N 78350-000). An annual functional
check and safety inspection is recommended.
CEP10014: March 2010
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18
GE Healthcare enFlow
General features
The Vital Signs enFlow IV Fluid/Blood
Warming System is an induction
warming system comprising the enFlow
warmer, the enFlow controller and
enFlow disposable cassettes.The
controller provides power to the
warmer, or an optional battery is also
available.
During use, the user connects the
small cassette to any standard IV fluid
giving set with Luer connections. The
user inserts the cassette into the
warmer. The cassette contains a metal plate which makes contact with the nonmetallic surface in the warmer and which is heated by induction. The infusion fluid
passes over the other side of the metal plate and is heated by direct contact. The
device has a single temperature setting of 40ºC.
The enFlow system does not regulate flow rate. The user controls flow rate by
adjusting a roller clamp on the disposable set.
The warmer unit display panel always reads ‘right way up’ permitting different
placement options. The device’s display features are:
ƒ
Controller: digital fluid temperature (ºC)
ƒ
Warmer: 2 LEDs indicate power status and fluid temperature of <33ºC, 33-35
ºC, 35-42ºC, >42ºC.
Safety
The user must use a standard disposable fluid administration set to provide a bubble
trap. The enFlow has no feasible means of attaching a bubble trap between the heat
source and the patient.
The warming device has redundant temperature sensors and a microprocessor to
monitor and control fluid temperature. The controller has an audio-visual over
temperature alarm system, triggered at 43ºC. At 45ºC an audiovisual alarm indicates
that the user must shut the device down and remove it from use.
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The warming device contains electromagnets and should not be placed within 15 cm
of a cardiac pacemaker. The device and cartridge may become hot when heating
cold fluids at high flow rates.
Performance
The operators’ manual states that the device can deliver fluid heated from 20ºC to
between 38ºC and 42ºC at flow rates of up to 200 ml/min.
Cleaning and maintenance
In most instances the device need only be wiped clean. Both the warmer and
controller are chemically resistant to most common hospital grade instrument
cleaning solutions and non-caustic detergents (a full list of solutions is provided in the
operators’ manual).The warmer may also beimmersed in cleaning fluid. An annual
performance check and safety inspection is recommended.
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JMW Medical Ltd Thermofluid TF251
General features
The Thermofluid TF251 warming system is a plate
warmer that can be used with a standard
administration set for low flow rates (up to
100ml/min), or with a device specific
administrations set for higher flow rates.
The device has two warming plates. Four
millimeter outside diameter tubing can be placed in
a serpentine groove in the heating plate on the
door. The device specific set is placed on the flat
warming plate. This design allows the following
heating options:
Standard administration set in serpentine
groove for low flow
•
•
Device specific administration set in second
plate for high flow
•
Use both sets, one after the other, for additional heating
•
Use each set for separate fluids eg. Blood in second plate, irrigation fluid in
groove.
The device has a single temperature setting of 39ºC±0.4°C.
The TF 251 does not regulate flow rate. The user controls flow rate by adjusting a
roller clamp on the disposable set, flow of fluid is gravity driven. The warmer unit
display panel comprises:
The device’s display features are:
ƒ
Controller: digital fluid temperature (ºC)
ƒ
Power and alarm LEDs.
Safety
The device specific administrations set contains a bubble trap.
There are two independent circuits, one to control plate temperature and the other to
prevent overheating. An audiovisual alarm is triggered if the plate temperature
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21
exceeds 41 ºC. This also disconnects power to the heating elements. A low
temperature alarm sounds if the plate temperature is less than 10 ºC.
Performance
The device can deliver fluid at flow rates of up to 200 ml/min, depending on the
administration set used and initial temperature.
Cleaning and maintenance
The Thermofluid 251 can be cleaned with soap and water or a mild detergent. It can
be disinfected and sterilised using formaldehyde, chloramine or cidex.
Calibration is required at six monthly intervals and requires a test jig.
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Nuova GmbH, Nuova/05, Nuova/05plus and Nuova/05plus W/0
General features
The Nuova/05 blood and fluid warmer
is a drum warmer with a heated
cylinder around which a standard
administration line can be wrapped. It
allows 13 turns of a single line.
Alternatively 10 turns can heat an IV
fluid, and 3 for an irrigation fluid, or two
irrigation fluids can be warmed using 6
or 7 turns each.
The Nuova series do not regulate flow
rate. The user controls flow rate by
adjusting a roller clamp on the
disposable set.
The device can be set between 37 ºC
to 41 ºC in 0.5 ºC steps. The temperature measured and displayed is in all cases the
heating cylinder, not the IV fluid.
The Nuova/05 has an insulating silicon sleeve that reduces cooling between the
patient and the warming device. The Nuova/05 plus uses an actively heated silicon
sleeve to prevent cooling between the warming device and the patient. In the
Nuova/05 plus W/O the heated sleeve can be added as an option at a later point.
The device’s display features are:
ƒ
Fluid warmer:
o
o
o
o
digital cylinder temperature (ºC)
on/off
alarms: over or under temperature.
temperature adjust buttons
Safety
Three independent temperature measurements are taken across the cylinder. The
sensors are located on the surface of the aluminium cylinder to ensure that they are
close to the fluid temperature. The over temperature alarm is set at 43 ºC; this is an
audiovisual alarm and the device shuts down. There is a visual only low temperature
alarm if the measured temperature is less than 2 ºC below the temperature set.
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Performance
The flow rate is up to 100 ml/min, dependent on the temperature of the fluid being
administered.
Cleaning and maintenance
The device may be wiped clean with mild detergent or plastic-cleaner, with particular
attention to the aluminium grooves on the cylinder.
This device is mainly maintenance free. The safety cut-out, warm up time and
temperature display should be checked annually.
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Sarstedt Sahara Inline
General features
The Sahara Inline blood and infusion warming device
is a drum heater with a heated conical cylinder around
which a standard administration line can be wrapped.
Any standard administration line of a suitable length
with an inner diameter 3mm and outer diameter
4.1mm can be used.
The Sahara Inline does not regulate flow rate. The
user controls flow rate by adjusting a roller clamp on
the disposable set. Flow of fluid may be gravity driven
or higher flow rates can be achieved by using a
generic pressure cuff (up to a maximum of 300mmHg
pressure).
The warming unit display panel has adjustable
brightness. It shows the actual temperature of the
warmer and the target temperature.
•
On/off
•
Temperature adjust
•
Actual temperature
•
Target temperature
•
Temperature unit
•
Test
The user can select a desired fluid temperature of 37ºC-42ºC, selectable in 0.5ºC
increments. Adjustment can only be made during standby.
Safety
There is a high temperature alarm and cut out at 43.5°C, with an additional cut out
also set to 43.5°C. There is also a low temperature alarm and cut out.
Performance
The flow rates are not stated for this device.
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Market review
Other features
A module printer can be connected via an interface module to document a system
test.
Cleaning and maintenance
Use alcohol based cleaners with a soft cloth, with particular attention to the
aluminium grooves on the cylinder.
The function should be checked by the integrated safety test on purchase, after
repair and every 3 months.
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Smiths Level 1® H1200 Fast Flow Fluid Warmer
General features
The Smiths Level 1 H1200 Fast Flow fluid
warming device is a recirculating fluid warming
device comprising a fluid warmer, two pressure
chambers, air detector, iv pole and bag hanger
and device specific disposable administration set.
The administration set includes a heat exchanger.
The IV fluid or blood passes through thin bore
tubing wrapped around a large bore cylinder
through which warm fluid is recirculated. The
recirculating fluid is held in a reservoir within the
fluid warmer and its temperature is regulated.
The flow rate is not regulated other than by roller
clamps, however the pressure chambers can
provide a pressure of 300mmHg to give a rapid
flow of fluid.
The administration set includes a gas vent and
filter which should be changed every 3 hours.
The device has a single temperature setting of
41.7ºC. The temperature measured and displayed
is in all cases the recirculating fluid, not the IV
fluid.
The device’s display features are:
ƒ
Fluid warmer:
o Digital recirculating fluid temperature (ºC)
o alarm tests
o automatic operation
o alarms: check disposables, add recirculating solutions, over
temperature.
ƒ
Air detector:
o automatic operation
o alarms: check tubing, air detected
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Market review
ƒ
27
Pressure chambers:
o pressure gauge
o pressurised or un-pressurised.
Safety
The H-1200 includes an air detector and automatic clamp. When air is present an
ultrasonic signal is interrupted, the line is clamped and an audiovisual alarm
activated. The user can then remove air from the device and restart flow without
disconnecting from the patient. This feature requires power to function.
An modification to the gas vent / filter in the administration set is to be released soon.
This will include an additional air detector that functions even if the power is off. If
there is a large volume of air a valve shuts, preventing the air from being circulated to
the patient.
The over temperature alarm is triggered when the recirculating fluid temperature is
greater than 43.9°C ± 0.1°C. An audiovisual alarm is activated and warming of the
recirculating fluid then stops. The device must be turned off to clear the alarm.
Alarms also indicate if the administration set is incorrectly located in the fluid warmer
or air detector.
Performance
The operators’ manual states that the device can deliver fluid heated from 10ºC to
41.7 ºC at flow rates of up to 650 ml/min, or from 20ºC to 41.7 ºC at flow rates of up
to 1150 ml/min. The figure is dependent on the administration set chosen.
Cleaning and maintenance
The device may be wiped clean with mild detergent or disinfected with 10% bleach
solution.
The recirculating fluid must be changed regularly. This is every 30 days if distilled
water is used or every year in the case of 0.3% hydrogen peroxide. The reservoir
should be disinfected every 12 months.
There are accessible o rings which should be lubricated every 30 days. Minor routine
maintenance is required annually (change of o rings, clean fan filter, check clamp).
CEP10014: March 2010
Market review
28
Smiths Hotline blood and fluid warmer
General features
Figure 1. Cross section of triple lumen tubing
Recirculating
fluid, down
IV
Fluid
Recirculating
fluid, up
The Smiths Hotline is a recirculating fluid warming device, comprising a fluid warmer
and device specific disposable administration set. The IV fluid or blood passes
through inner tubing, while a heated fluid circulates through an outer tube, warming
the IV fluid or blood (figure 1). The recirculating fluid is held in a reservoir within the
fluid warmer and its temperature is regulated.
The flow rate of the blood or IV fluid is not regulated other than by roller clamps.
The device has a single temperature setting of 41.9ºC. The temperature measured
and displayed is in all cases the recirculating fluid, not the IV fluid.
The device’s display features are:
ƒ
Fluid warmer:
o digital recirculating fluid temperature (ºC)
o on indicator
o alarms : check disposables, add recirculating solutions, over
temperature.
o Alarm test buttons
o Reservoir level is visible
CEP10014: March 2010
Market review
29
Safety
There is a gas vent that can be added to the administration set.
The recirculating fluid is normally regulated to be lower than 42°C, if this fails a
second temperature alarm is triggered when the recirculating fluid temperature is
greater than 43.1°C ± 0.1°C. An audiovisual alarm is activated and warming of the
recirculating fluid then stops. The device must be turned off to clear the alarm.
Alarms also indicate if the administration set is incorrectly located in the fluid warmer.
Performance
The operators’ manual states that the device can deliver a normothermic flow rate of
up to 83 ml/min. The IV fluid is heated all the way to the patient to avoid cooling.
Cleaning and maintenance
The device may be wiped clean with mild detergent or disinfected with 10% bleach
solution.
The recirculating fluid must be changed regularly. This is every 30 days if distilled
water is used or every year in the case of 0.3% hydrogen peroxide. The reservoir
should be disinfected every 12 months.
There are accessible o rings which should be lubricated every 30 days. Minor routine
maintenance is required annually (change of o rings, clean fan filter, check clamp).
CEP10014: March 2010
Market review
30
Stihler Electronic GmbH Astoflo plus
General features
The Astoflo plus is an IV fluid and blood warming device
comprising an electrically heated sleeve that fits around
the infusion line between the device and the patient. The
sleeve has a C shaped profile, so that the infusion line can
be slotted into it and remains visible during operation. The
temperature is measured at three points along the heated
sleeve and is controlled at the device. A standard
administration set is used, and the sleeve is available in
two width sizes to accommodate sets between 4 and 7mm
external diameter. Different length options are also
available.
The Astoflo plus does not regulate flow rate. The user
controls flow rate by adjusting a roller clamp on the
disposable set.
The warmer unit display panel comprises:
ƒ
start/standby buttons
ƒ
temperature adjustment buttons
ƒ
digital temperature display for measured and set temperature
ƒ
temperature alarm
In operation the user selects a desired fluid temperature of 33ºC-43ºC, selectable in
0.5 ºC increments.
Safety
A bubble trap may be included in the administration set.
The warmer unit has two independent high temperature alarms and a cut off is
activated if the measured temperature exceeds 45ºC ±1 ºC. There is a low
temperature alarm at of 33ºC±1 ºC
Performance
The Astoflo plus is suitable for heating fluids from ambient temperature to between
40 and 35 at 0-22 ml/min. It is also suitable for keeping pre-warmed fluid at the
correct temperature as it is delivered to the patient, even at fast flow rates.
CEP10014: March 2010
Market review
31
Cleaning and Maintenance
Cleaning should be with mild soap and water solution. Disinfection can be with ½%
bleach solution or a recommended disinfectant spray.
An annual performance check and safety inspection is recommended
A safety check should be carried out annually consisting of a visual check,
temperature and display accuracy and alarm tests.
CEP10014: March 2010
Market review
32
Stihler Electronic GmbH Astotherm plus AP 220/ 220S/ 260/ 260S
General features
The Astotherm plus is a heated drum IV fluid and
blood warming device around which an
administration set can be wrapped. It is designed
to be used with a device specific administration
set. The standard version AP220/S allows 11
turns of a single line. The AP260 and AP260S
are for a wider infusion line, with 9 turns. All
versions allow two separate lines to be warmed
simultaneously.
The Astotherm plus does not regulate flow rate.
The user controls flow rate by adjusting a roller
clamp on the disposable set.
The device can be set at three temperatures:
39°C, 41°C or 43°C.
A heated sleeve is available to prevent cooling
between the warmer and the patient. The sleeve
is included with the AP220S and the AP260S.
The device’s display features are:
ƒ
start/standby buttons
ƒ
temperature adjustment buttons
ƒ
digital temperature display for measured and set temperature
ƒ
high and low temperature alarms
Safety
Three independent temperature measurements are taken across the cylinder, any of
which can trigger the over temperature alarm at 45.5 ºC. This is an audiovisual alarm
and the device shuts down.
There is also a low temperature alarm if the warmer does not reach set temperature
within 2 minutes of start up.
Performance
The following performance curves were provided by the manufacturer.
CEP10014: March 2010
Market review
33
Temperature °C
Performance curves
42
40
38
36
34
32
30
28
26
24
22
20
AP220S
0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 95100
Flow Rate ml/min
Temperature Adjustment 41°C, Liquid Start Temperature 10°C
Cleaning and maintenance
The Astotherm plus should be cleaned regularly with a soft cloth and soap solution.
For disinfection alcohol based sprays with less than 0.2% aldehydes are
recommended. Periodic performance tests should be carried out at least every two
years.
CEP10014: March 2010
Market review
34
TSCI Fluido
General features
The Fluido is an infrared blood and fluid warmer, providing heat
using five halogen lamps. The Fluido uses only Fluido integrated
warming cassette/fluid sets. The infrared energy heats the fluid
without heating the disposable cassette itself.
The user controls flow rate by adjusting a roller clamp on the
disposable set. Flow of fluid may be gravity driven or higher flow
rates can be achieved by using a generic pressure cuff with a
pressure gauge (up to a maximum of 300mmHg pressure).
Fluido display panel shows:
ƒ
Set temperature (ºC)
ƒ
End temperature compared to set temperature (using a ‘control thermometer’
display).
ƒ
Flow in (ml/min)
ƒ
Total volume (l)
ƒ
Total operating time (hrs)
ƒ
‘Maintenance required’ indicator
ƒ
‘Replace heating lamp’ indicator
ƒ
‘Insert / remove cassette’ indicator
ƒ
Tilt alarm
ƒ
‘Malfunction’ indicator / alarm code.
Safety
The disposable warming set includes a simple bubble trap which the user should
keep ¾ full of fluid. Accumulated air may be removed from a syringe port.
The Fluido has a redundant temperature sensor which is used to trigger alarms. The
over temperature alarm threshold is 45ºC.
Performance
The Fluido delivers fluid to the end of the fluid line at the temperature selected and
indicated on the display panel (30ºC to 39ºC). The associated flow rates for water
and blood at different cannula sizes are:
CEP10014: March 2010
Market review
35
IV cannula gauge
22
20
18
17
16
14
Internal diameter (mm)
0.6
0.8
1.0
1.2
1.4
1.7
Flow rate, water (ml/min)
31
54
80
125
180
270
Flow rate, blood (ml/min)
18
31
45
76
118
172
The temperature reaching the patient will be cooler than indicated if extension lines
are added to the Fluido set. Without a cannula the Fluido can deliver fluid at the
selected temperature up to 800ml/min.
Cleaning and maintenance
The Fluido should be cleaned after each use with a moist cloth, standard cleaning
agents or alcohol wipes.
The Fluido has no parts that can be maintained by the user. The TSCI service centre
should service the appliance at least once a year.
CEP10014: March 2010
Market review
36
How to use the market review tables
Table 1. Key to market review tables 2- 4
Notation used
Warming method – coil, plate, induction, heated tube or circulating fluid
9may be used to heat blood 8 may not be used to heat blood
9may be used to heat IV fluids 8 may not be used to heat IV fluids
Warming
Use with blood
Use with IV fluids
Additional
components
Administration set
Other consumables
Size (cm)
Weight (kg)
Power (W)
Requires proprietary or standard administration set
Dimensions of main unit
Weight in kilograms of the main unit
Power in Watts,
List price in GBP excluding VAT March 2010. Discounts may be
available. Leasing arrangements may be available.
List price for device
List price for
consumable
Warranty
Supplier
List price in GBP excluding VAT March 2010 for example administration
set.
Length of manufacturer warranty
UK supplier of this product at publication date
Gravity
Pressure
Pump
9 fluid flow gravity driven
9 fluid flow may be pressurised to give rapid flow
9 device incorporates pump
Flow control
Flow rate (ml/min)
(for temperature)
Adjustable
Target (ºC)
Steps (ºC)
Warm up
Flow is controlled by roller clamp on the administration set or through the
device
Specified flow rates. KVO = keep vein open
Temperature achieved at specified flow rates
9 The set temperature is user adjustable
Set temperature
Set temperature increments
Time taken from switching on to achieve set temperature
Bubble trap
Alarms – high temp (ºC)
- low temp (ºC)
Blood filter
Thermal safety features
CEP10014: March 2010
9 device includes a bubble trap
Temperature which triggers the high temperature alarm
Temperature which triggers the low temperature alarm
9 Device contains an integral blood filter
Any thermal safety features in addition to alarms
Market review
37
Table 2. General Features
Warming
Use with blood
Use with IV fluids
Additional
components
Administration set
Arizant
Arizant
Ranger Model 245
BairHugger 241
Buddy
Plate
Coil
Plate
9
9
9
9
9
9
Other
consumables
Size (cm)
Weight (kg)
Ranger Pressure Infuser and
power pack
Proprietary
Filter accessory high-flow
disposable set.
Cleaning tool accessory
11 x 19 x 25
3.4
Power (W)
900
List price for
device
List price for
consumable
Belmont
BairHugger forced
air warming device
Reusable Hose Cap
(permits fluid
warming without a
BairHugger blanket)
Proprietary
22.5
Not stated
Power source is
forced air warmer
BairHugger forced
air warmer costs
£1950-£2000
16 x 29 x 8
4.4
150
£1,395
£12.50 per set
Warranty
Two Year
Single-Use
disposable
Supplier
Arizant UK
Arizant UK
CEP10014: March 2010
Not stated
Genesys Medical
Solutions
Market review
38
Belmont
Belmont
Biegler
Rapid Infuser FMS2000
Buddy lite
Protherm II
Warming
Use with blood
Use with IV fluids
Additional
components
Administration set
Induction
Plate
Plate
9
9
9
9
9
9
None
Proprietary
battery and battery
charger
Proprietary
Other
consumables
Size (cm)
Weight (kg)
Power (W)
List price for
device
List price for
consumable
Warranty
Special 3 litre reservoir
Dual Patient Line
34 x 30 x 19
11.8
1440
Supplier
Genesys Medical Solutions
£12,500
4 x 13 x 2
1.7 lb
£1,400
£2995
Genesys Medical
Solutions
£14
2 years
Central Medical
Supplies
£98 per set
£87 per reservoir (3l)
CEP10014: March 2010
Proprietary
heating bag
complete with filters
(large) and air trap
39 x 28 x 10
5
1200
Market review
Biegler
Warming
Use with blood
Use with IV fluids
Additional
components
Administration set
Other
consumables
Size (cm)
Weight (kg)
Power (W)
List price for
device
List price for
consumable
Warranty
Supplier
39
Estill Medical,
Technologies
Inc.
Gaymar
BW 685 / 685 S
Thermal Angel
Medi-Temp III
REF FW600
coil
Heated tube
Plate
9
9
9
9
9
9
Tubeflow, to keep fluid warm
between the patient and
warmer.
Standard
battery pack, battery
charger
Standard
None
Proprietary
Extension sets with/without
bubble trap
23 x 23 x 13
1.2
280
Warmer unit is
disposable.
23 x 7 x 2
0.26
216
High flow set
22 x 29 x 12
2.7
1000
£2095
£1.29
2 years
Central Medical Supplies
CEP10014: March 2010
N/A
One year
Fenton
Pharmaceutical Inc
(UK)
Not stated
Vital Signs UK
Market review
Warming
Use with blood
Use with IV fluids
Additional
components
Administration
set
Other
consumables
Size (cm)
Weight (kg)
Power (W)
GE Healthcare
JMW Medical Ltd
enFlow
Thermofluid
TD251
Nuova/05
Induction
Plate
coil
9
9
9
9
9
9
None
None
Standard 4mm OD or
proprietary (with
different flow rates)
Standard
Proprietary
Optional extension set
24 x 17 x 10
1.8
300
List price for
device
Not stated
Vital Signs UK
CEP10014: March 2010
Nuova GmbH
(supplied in UK by
QED Scientific Ltd)
Optional extension sets
36.5 x 23 x 12.5
5
£1981
£5.23 per item
Volume discount
available
List price for
consumable
Warranty
Supplier
40
JMW Medical Ltd
25 x 19 x 17
2.5
280-290
£1650- £1995
Also leasing,
maintenance and
consumable contracts
available
ET 460
£2.79 per item
2 years from shipment,
optional 3 years
QED Scientific Ltd.
Market review
41
Sarstedt AG & Co
Smiths
Smiths
Sahara Inline
Hotline
Level 1 H1200 Fast flow blood and
fluid warmer
fluid warmer
Warming
Use with blood
Use with IV fluids
coil
circulating fluid
circulating fluid
9
9
9
9
9
9
Additional
components
Administration set
Other
consumables
Size (cm)
Weight (kg)
Power (W)
List price for
device
List price for
consumable
Warranty
Supplier
RS 232 Interface
module
Standard
Older versions can be
updated with air detector and
clamp
Proprietary
Proprietary
5m Extension Line
23 x 29 x 17
3
300
170 x 51 x 51
28.5
1449
None
24 x 21 x 18
3.6
345
Not Supplied
£13,268
£3,226
Not Supplied
12 Months
Sarstedt Ltd
DI65HL
£63.80
One Year
Smiths Medical
L70 NI
£20.79
One Year
Smiths Medical
CEP10014: March 2010
Market review
Warming
Use with blood
Use with IV fluids
Additional
components
Administration set
Other
consumables
Size (cm)
Weight (kg)
Power (W)
List price for
device
List price for
consumable
Warranty
Supplier
42
Stihler Electronic
GmbH
Stihler Electronic
GmbH
Astoflo plus
Astotherm plus 220/
220S/ 260/ 260S
TSCI
Fluido
Tube sleeve
coil
Infrared
9
9
9
9
9
9
Standard
Astoline (AP220S & AP260S),
heat protection sleeve
Astotube
Fluido Airguard
Fluido pressure
chambers
Fluido
compressor
Fluido IV pole
Proprietary
28 x 12 x17.5
3
90
14 x 13 x 29
2.9
450
39 x 22 x 25
9.5
1400
£2210-£2280
£2200-£3000
N/A
£2.08 for AP220/S
£3.96 for AP260/S
Two years
Elgin Medical Ltd
CEP10014: March 2010
Elgin Medical Ltd
One year
Cardiac Services
Group
Market review
43
Table 3. Performance features
Gravity
Pressure
Pump
Flow control
Flow rate
(ml/min)
(for temperature)
Adjustable
Target (ºC)
Steps (ºC)
Warm up
Gravity
Pressure
Pump
Flow control
Flow rate (ml/min)
(for temperature)
Adjustable
Target (ºC)
Steps (ºC)
Warm up
Arizant
Ranger Model 245
9
9
8
Arizant
BairHugger 241
9
Belmont
Buddy
9
8
8
Roller clamp
Roller clamp
Roller clamp
KVO - 500
KVO - 50
Not stated
Not stated
100
50
20 ºC
10ºC
8
8
41±1
N/A
<2minutes
None
38ºC
N/A
Not stated
Not stated
Belmont
Belmont
Biegler
Rapid Infuser
FMS2000
8
8
9
Buddy lite
9
9
8
Protherm II
9
9
8
device
10 - 750
Not stated
Roller clamp
80
20ºC
Roller clamp
300
Not stated
9
9
9
37.5ºC if flow ≥
60ml/min
39ºC if flow ≤ 50ml/min
N/A
Not required
38°C ± 2°C
37°C to 41°C
0.5°C
40 seconds
CEP10014: March 2010
Market review
44
Biegler
Estill Medical
Technologies, Inc.
BW 685 / 685 S
9
9
8
Thermal Angel
9
9
8
Medi-Temp III REF
FW600
9
9
8
Roller clamp
Roller clamp
Roller clamp
Not stated
2 - 150
4 - 38°C
KVO - 300
Refrigerated or room
temperature
9
8
9
37 - 41
0.5
45 seconds
38± 3
N/A
45 seconds
38 - 43
1.0
Not stated
GE Healthcare
JMW Medical Ltd
Nuova GmbH
(supplied in UK by
QED Scientific Ltd)
enFlow
9
8
8
Thermofluid TF
251
9
8
8
Nuova/05
9
8
8
Flow control
Flow rate
(ml/min)
Roller clamp
Roller clamp
Roller clamp on
extension sets
KVO - 200
KVO - 200
(for temperature)
Adjustable
Target (°C)
Steps (°C)
20ºC
Gravity
Pressure
Pump
Flow control
Flow rate
(ml/min)
(for temperature)
Adjustable
Target (°C)
Steps (°C)
Warm up
Gravity
Pressure
Pump
Warm up
Gaymar
Up to 6 litres per hour
for 20°C fluids
Up to 3.5 litres per hour
for 10°C bloods
8
8
9
40
N/A
39
N/A
Less than 10 seconds at
20°C
Approximately 1 min
37 - 41
0.5
60 sec to 38°C
25 sec to 30°C, from
10°C
CEP10014: March 2010
Market review
Sarstedt AG &
Co
Gravity
Pressure
Pump
Flow control
Flow rate
(ml/min)
(for
temperature)
Adjustable
Target (°C)
Steps (°C)
Warm up
45
Smiths
Smiths
Sahara Inline
9
9
8
Level 1 H1200
Fast flow
fluid warmer
9
9
8
Hotline blood and fluid
warmer
9
8
8
Roller clamp
Roller clamp
Roller clamp
8 - 83
40 - 1400
0.8 - 83
Not stated
Not stated
Not stated
9
8
8
37 - 42
0.5
41.7 ± 0.3
N/A
1-2mins
Not stated
41.9 ± 0.1
N/A
Recirculating fluid rises from
ambient to 37°C in 4 minutes
CEP10014: March 2010
Market review
Stihler
Electronic
GmbH
Gravity
Pressure
Pump
Flow control
Flow rate
(ml/min)
(for temperature)
Adjustable
Target (°C)
Steps (°C)
Warm up
46
TSCI
Astoflo plus
9
8
8
Stihler
Electronic
GmbH
Astotherm plus
220/ 220S/ 260/
260S
9
8
8
Roller clamp
Roller clamp
Roller clamp
0-22
35-40
5-65
35-40
9
9
Water: 31-270
Blood: 18-172
Not stated
Max 43±1.5ºC
33 - 43
0.5
39, 41 and 43
2.0
less than 2 mins
Fluido
9
9
8
9
30 - 39
Within 30 seconds
CEP10014: March 2010
Market review
47
Table 4. Safety features
Bubble trap
Alarms – high
temp (ºC)
- low temp (ºC)
Arizant
Ranger Model 245
9
Arizant
BairHugger 241
8
Belmont
Buddy
9
43
53
Moderate to high flow:
42.5ºC for 2 minutes,
or ≥ 48ºC for 2.5
seconds. Low flow:
>42ºC for 2.5 sec or ≥
44 ºC for 1 second.
31
None
9
None
Independent safety
circuit
Belmont
Rapid Infuser
FMS2000
Belmont
Biegler
Buddy lite
Protherm II
two ultrasonic air
detectors, and
automatic venting
every 500 ml.
large venting
membrane, flow control
valve to prevent air
entrapment
check for air
over temp
no heat
probe fault
33
9Only on High flow
Blood filter
Thermal safety
features
Bubble trap
Alarms – high
temp (ºC)
- low temp (ºC)
Blood filter
Thermal safety
features
disposable set: filtration
to 150microns
Independent safety
alarm with heater shut
down on activation
Not stated
Not stated
9
42
36.5
Yes
9 (large heating bag)
Thermal cut out
Independent shut down
at 42ºC
CEP10014: March 2010
Market review
Bubble trap
Alarms – high
temp (ºC)
- low temp (ºC)
Blood filter
Thermal safety
features
Bubble trap
Alarms – high
temp (ºC)
-low temp (ºC)
Biegler
Estill Medical
Technologies Inc
BW 685 / 685 S
9Optional
Thermal Angel
8
Medi-Temp III REF
FW600
9
42
36.5
not stated
Not stated
45
34
8
8
8
Independent shut down
at 42ºC
Primary control to
38ºC, secondary
Independent shut down
at 47ºC
Thermal safety system
independent of main
temperature controller
GE Healthcare
JMW Medical Ltd
enFlow
Thermofluid 251
8
9 on proprietary set
45
40
None
10
Not stated
8
2 independent circuits
3 independent
measurement points.
Safety cut off at 43°C
Blood filter
8
Thermal safety
features
2 independent over
heating protectors
Sarstedt AG & Co
Bubble trap
Alarms – high
temp (ºC)
-low temp (ºC)
Blood filter
Thermal safety
features
48
Sahara Inline
8
Smiths
Level 1 H1200
Fast flow fluid
warmer
9
Gaymar
Nuova GmbH
(supplied in UK by
QED Scientific Ltd)
Nuova/05
8 included on
ET460 extension
sets
43°C. Audible and
visual warnings
2°C below set
temperature. Audible
warning
Smiths
Hotline blood and
fluid warmer
9
43.1
43.5
2°C below target
temperature
None
8
9
9
Heater shut down on
alarm activation.
Primary temperature
control to 42ºC,
secondary alarm at
43.1ºC
Thermal cut-out at
43.5 ºC
CEP10014: March 2010
43.9
Market review
Stihler Electronic
GmbH
Bubble trap
Alarms – high
temp (ºC)
Stihler Electronic
GmbH
Astotherm plus
220/ 220S/ 260/
260S
8
TSCI
Threeway independent
overheat safety switch
off. 45.5°C (± 1°C)
46.0°C (± 1°C)
65.0°C (± 5°C) Heating
element
Under temperature
alarm4°C (± 1°C) below
control temperature
45
8
8
8
Two independent
alarms and cut off at
45 ºC
Threeway independent
overheat safety switch
off. Under temperature
alarm
Backflow valve in
cassette
Astoflo plus
8
45 ± 1
-low temp (ºC)
33± 1
Blood filter
Thermal safety
features
49
CEP10014: March 2010
Fluido
9
Acknowledgements
50
We should like to thank the following for their contribution to this market review.
Peggy Edwards, Patient Safety Manager (South East Wales), National Patient Safety
Agency
Joanna Ford, Surgical Materials Testing Laboratory (SMTL)
Mark Harper, Consultant Anaesthetist, Royal Sussex County Hospital
Surgical Materials Testing Laboratory
Gavin, Hughes, Technical Manager, Surgical Materials Testing Laboratory (SMTL)
Richard Hughes, Consultant Anaesthetist, Cardiff and Vale University Health Board
Sherran Milton, Education Officer, Association for Perioperative Practice
Peter Phillips, Acting Director, Surgical Materials Testing Laboratory (SMTL)
Peter Robinson, Buyer, NHS Supply Chain
John Andrzejowski, Consultant Anaesthetist, The Royal Hallamshire Hospital
Nicole Small, Senior Medical Device Specialist, MHRA
CEP10014: March 2010
References
51
(1)
Centre for Evidence-based purchasing. Buyers' guide: Intravenous fluid
warming devices. NHS Purchasing and Supply Agency. 2010. CEP10013.
London.
(2)
National Institute for Health and Clinical Excellence. Clinical Guideline CG65:
The management of inadvertent perioperative hypothermia in adults. (2008).
Available online at:
http://www.nice.org.uk/guidance/index.jsp?action=byID&o=11962
Last accessed: 12/02/2010
(3)
Turner M, Hodzovic I and Mapleson WW. Simulated clinical evaluation of four
fluid warming devices. Anaesthesia 2006 61: 571-575
CEP10014: March 2010
Appendix 1: Supplier contact details
Supplier
Arizant UK Limited
Cardiac Services Group
Central Medical Supplies
Elgin Medical
Fenton Pharmaceutical Ltd (UK)
Genesys Medical Solutions
JMW Medical
CEP10014: March 2010
Address
Calder Island Way
Wakefield
West Yorkshire
WF2 7AW
The Acumen Centre
First Avenue
Poynton
Manchester
SK12 1FJ
Central Medical
Supplies Ltd.
Basford Lane
Leek
Staffordshire
ST13 7DT
Elgin MEDICAL
1 Dryden Loan
Loanhead
Bilston Glen Ind.
Estate
Midlothian EH20
9HR
Fenton
Pharmaceuticals Ltd
4J Portman
Mansions
Chiltern Street
London
England
W1U 6NS
Genesys Medical
Solutions (UK) Ltd
Gibbs House
Kennel Ride
Ascot
Berks
SL57NT
JMW Medical Ltd
Pentland Industrial
Estate
Loanhead
Midlothian
EH20 9QH
52
Contact details
Tel 01924 200550
www.arizant.co.uk
Tel 01625 878999
www.cardiac-services.com
Tel 01538 399541
www.centralmedical.co.uk
Tel 0131 440 6500
www.elginmedical.co.uk
Tel 020 7224 1388
www.thermalangel.com
Tel 0870 6009940
www.genesysmedicalsolution
s.com
Tel 0131 448 0205
www.jmw-group.co.uk
Appendix 1: Supplier contact details
QED Scientific
Sarstedt Smiths Medical International
Vital signs UK
(GE healthcare group)
CEP10014: March 2010
QED Scientific Ltd,
Ringstones Industrial
Estate, Whaley
Bridge, High Peak
SK23 7PD
SARSTEDT Ltd.
68 Boston Road
Beaumont Leys
Leicester LE4 1AW
United Kingdom
Colonial Way
Watford
Herts
WD24 4LG
Vital Signs Ltd
13-14 Eldon Way
Lineside Industrial
Estate
Littlehampton
West Sussex
BN17 7HE
UK
53
Tel 01663 735494
www.qedscientific.co.uk
Tel 01162 359 023
www.sarstedt.com
Tel 01923 246434
www.smiths-medical.com/uk
Tel 08456 444955
www.vital-signs.co.uk
Appendix 2: Additional price information
54
Arizant UK Limited
Item
Ranger Model 245
24200 Standard flow disposable set,
including IV injection port, bubble trap
and 76cm patient line. KVO to 150
ml/min flow rate
24250 Standard flow disposable set,
including 2 IV injection ports, bubble
trap and 152cm patient line. KVO to
150 ml/min flow rate.
24355 High flow disposable set,
including 2 IV spikes, standard and
needless injection port and autoventing bubble trap. 100 – 500 ml/min
flow rate. Replaceable 150 micron
filter.
24365 High flow disposable set, with
auto-venting bubble trap. 100 - 500
ml/min flow rate.
24370 High flow disposable set, with
auto-venting bubble trap and 122cm
patient line. 100 – 500 ml/min flow rate.
Bair Hugger 241 warming set. KVO –
50 ml/min flow rate
Reusable hose cap
Product
code
24507
24200
Price
Not stated
Not stated
Number in
pack
1
10
24250
Not stated
10
24355
Not stated
10
24365
Not stated
10
24370
Not stated
10
24110
Not stated
10
90026
Not stated
12
Belmont
Item
FMS2000 System including IV pole,
reservoir holders and support housing
assy
FMS2000 3 spike disposable set
3 litre reservoir for FMS2000
Dual patient line
Buddy blood and fluid warmer
complete
Disposable sets for buddy blood and
fluid warmer
Buddy lite system
CEP10014: March 2010
Product
Price
Number in
code
pack
BE90300001 £12,500.00 1
BE90300006
BE90300018
BE90300004
BE90500001
£1,176.00
£522.00
£152.00
£1,395.00
12
6
18
1
BE90500010 £300.00
24
BE90500018 £1,400.00
1
Appendix 2: Additional price information
55
Biegler
Item
Biegler 685 Blood / I.V. Fluid Warmer
Biegler 685S Blood / I.V. Fluid Warmer
(use with
Biegler Tubeflow
Biegler Protherm 2 Rapid Warmer
Biegler Emergency Fluid Warmer
3.5m Extension Set
3.5m Extension Set
4.6m Extension Set + Injection Port
4.6m Extension Set + Bubble Trap +
Injection Port
4.6m Extension Set + Bubble Trap + 3Way Tap
5.3m Extension Set
5.6m Extension Set with Bubble Trap
Protherm II Heating Bag (Large)
Protherm II Heating Bag (Small)
Product
code
BIEG160
BIEG165
Price
£2,095.00
£2,195.00
Number in
pack
1
1
BIEG170
BIEG200
BIEG700
BIEG101
BIEG101B
BIEG107
BIEG108
£595.00
£2,995.00
£995.00
£129.40
£129.40
£135.00
£253.20
1
1
1
100
100
100
100
BIEG115
£275.00
100
BIEG120
BIEG125
BIEG201
BIEG202
£175.00
£275.00
£310.00
£275.00
100
100
20
25
Product
code
Price
Number in
pack
Estill Medical Technologies, Inc
Item
Thermal Angel
Not stated
Gaymar
Item
Meditemp III
Standard disposable set
Standard disposable set with 48"
extension
Standard disposable set with 60"
extension
Pediatric disposable set with 30"
extension
High Flow disposable set with 48"
extension
CEP10014: March 2010
Product
code
Price
D25340CE
D25310CE
Not stated
Not stated
Not stated
Number in
pack
Not stated
Not stated
Not stated
D25315CE
Not stated
Not stated
D25320CE
Not stated
Not stated
D25330CE
Not stated
Not stated
Appendix 2: Additional price information
56
GE Healthcare
Item
enFlow IV Blood/Fluid Warmer
enFlow Controller Power Unit
enFlow Disposable Sterile Cartridges
Product
code
980100
980121
Price
Not stated
Not stated
Number in
pack
Not stated
Not stated
980200
Not stated
30
Product
code
TF251
Price
Number in
pack
1
1
10
10
Product
code
Nuova05
Price
JMW Medical Ltd
Item
TF251 Thermofluid
£1981.00
TF251 Manual
£ 52.50
Disposable bag inserts
TFinsert/std £ 52.25
Box of Disposable Bags with 3-way tap Tfinsert/3wt
£ 57.68
Volume discounts are available on disposable bags
Thermofluid’s can also use an inexpensive 4mm external diameter extension tube
as an alternative to the disposable bag, which is only required to obtain the higher
flow rates
Test jig for Thermomat controllers
SIMCAL5
£1050.00
1
T1000, T2500,T3000 & T5000
Adapter cable for TF251
SIMCAL5C
£ 80.00
1
Nuova GmbH
Item
Number in
pack
1
Nuova05 In line rapid warmer with
£1,650.00
insulated sheath
Nuova05plus w/o In line rapid warmer
Nuova05plus £1,795.00 1
with insulated silicon sheath,
w/o
upgradeable
In line rapid warmer with heated silicon Nuova05plus £1,995.00 1
sheath
Upgrade / replacement heated silicon
£495.00
1
sheath for Nuova05plus models
Replacement insulated silicon sheath
£42.00
1
for Nuova05
Extension line, 460cm long with roller
ET460/0
£109.00
80
clamp & injection port.
Extension line, 460cm long with bubble ET460
£204.00
80
trap, roller clamp & injection port.
Leasing prices per calander month, over 36 months. Prices can vary with
CEP10014: March 2010
Appendix 2: Additional price information
interest:
Nuova05
Nuova05plus w/o
57
£55.00
£60.00
£67.00
Consumables scheme:
Nuova05plus
Free loan
2 year contract for 3 boxes (80 units each) every quarter:
Extension line, 460cm long with roller
ET460/0
clamp & injection port.
£176.00
80
Extension line, 460cm long with bubble ET460
trap, roller clamp & injection port.
£223.00
80
1 year contract for 3 boxes (80 units each) every quarter:
Extension line, 460cm long with roller
ET460/0
clamp & injection port.
£275.00
80
Extension line, 460cm long with bubble ET460
trap, roller clamp & injection port.
£322.00
80
Cost of extension sets reverts to standard purchase price after the agreed initial
contract period. QED Scientific Ltd retains ownership of the Nuova05plus warmer
during the contract period. Nuova05plus can be purchased at end of contract
period for a sum equal to one box of ET460 extension lines. Units damaged or
lost during the contract period will be charged for.
Sarstedt AG & Co
Item
Sahara Inline
Infusion tube extention 5m with clamp
and luer lock connection
Transflow model RS, blood transfusion
system with integrated 40 micron filter,
tube length 600cm
Interface module RS 232, to connect
protocol printer to Sahara inline.
Module protocol printer
Paper for protocol printer
Ink ribbon for protocol printer
CEP10014: March 2010
Product
code
97.8710.210
79.8710.205
Price
Not stated
Not stated
Number in
pack
1
100
79.8200.460
Not stated
100
79.8710.270
Not stated
97.8710.570
97.8710.570
97.8710.570
Not stated
Not stated
Not stated
1
1
10
1
Appendix 2: Additional price information
58
Smiths Medical International
Product
Price
Number in
code
pack
Level 1 H1200
EN-230_UK £13,268.00
A new gas vent / filter (F-50) is soon to be released, and will be included in the
Level 1 administration sets. The first part number is correct at publication, the
second part number is for the sets including the F-50.
DI-60HL /
Disposable administration set
DI-65HL
£63.80
10
Disposable administration set
DI-50 /
DI-75
£44.74
10
Disposable administration set
DI-100 /
DI-150
£105.28
10
Disposable administration set
DI-300 /
DI-350
£176,47
20
F-10 /
Gas vent / filter
F-50
£377.67
20
Item
Hotline HL-90
Fluid warming set without injection port
2.4m
T connector with injection port, 20.3cm
Y connector with injection port, 20.3cm
gas vent
UK-230
L-70 NI
PC-8
YC-8
L-10
£3,226.00
£20.79
£4.72
£4.14
£190.74
30
40
40
40
Price
Number in
pack
£2,210.00
1
£2,210.00
£2,280.00
1
Stihler Electronic GmbH
Item
ASTOFLO plus, with 180cm length
4mm profile Blue
ASTOFLO plus, with 180cm length
6.7mm profile Grey
ASTOFLO plus, with 240cm length
4mm profile Blue
ASTOFLO plus, with 240cm length
6.7mm profile Grey
ASTOTHERM® plus 220 Blood and
Infusion Warmer without heat
protection sleeve selectable
temperature settings 39/ 41/ 430 C
ASTOTHERM® plus 220S Blood and
CEP10014: March 2010
Product
code
AFP200
(WP2418)
AFP200
(WP2618)
AFP200
(WP2424)
AFP200
(WP2624)
1
£2,280.00
1
AP220
AP220S
£2200.00
£2800.00
1
Appendix 2: Additional price information
Infusion Warmer with heat protection
sleeve selectable temperature settings
39/ 41/ 430 C with ASTOLINE® PCB
and 1 active insulation ASTOLINE®
ASTOTUBE® Infusion Extension Set,
570 cm long, PVC. Sets for
ASTOTHERM® plus 220/220S
ASTOTHERM® plus 260 Blood and
Infusion Warmer with heat protection
sleeve selectable temperature settings
39/ 41/ 430 C for high infusions uses
6.8mm bore extension set
ASTOTHERM® plus 260S Blood and
Infusion Warmer with ASTOLINE®
PCB and 1 active insulation
ASTOLINE®
ASTOTUBE® Infusion Extension Set,
490 cm long, PVC. Sets for
ASTOTHERM® plus 260/ 260S
59
IFT30460
£104.00
50
£2400.00
1
£3000.00
1
£99.00
25
Price
671200
Not stated
Not stated
Not stated
Not stated
Not stated
Not stated
Number in
pack
1
1
1
1
1
40
671500
Not stated
30
671700
Not stated
30
AP260
AP260S
IFT30410
The Surgical Company International (TSCI)
Item
Fluido blood and fluid warmer
Fluido IV pole
Fluido air guard
Fluido pressure chambers (2)
Fluido compressor
Fluido standard set including air relief
and 150cm patient line. Max flow 650
ml/min
Fluido trauma set including air relief,
administration set, filter 200 microns
and 150cm patient line. Max flow
800ml/min
Fluido trauma plus set including air
relief, administration set, filter 200
microns and 200cm patient line. Max
flow 1100ml/min
CEP10014: March 2010
Product
code
Author and report information
Market review:
Intravenous fluid warming
devices
Andrew Cleves, Megan Dale, Grace
Carolan-Rees
Clinical Engineering Device
Assessment and Reporting (CEDAR)
Cardiff Medicentre
Cardiff
CF14 4UJ
Tel: 029 2068 2120
Email:[email protected]
www.cedar.wales.nhs.uk
About CEP
The Centre for Evidence-based
Purchasing (CEP) is part of the NHS
Purchasing and Supply Agency. We
underpin purchasing decisions by
providing objective evidence to support
the uptake of useful, safe and
innovative products and related
procedures in health and social care.
CEP publications since 2002 are
available from our website.
www.dh.gov.uk/cep
© Crown Copyright 2010
CEP10014: March 2010
60
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