cep10014 - market review: intravenous fluid warming devices

Market review

Intravenous fluid warming devices CEP10014

March 2010

Contents 2

CEP10014: March 2010

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

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.

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 rateStandard 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.

Market review 5


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.

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.

Market review 7


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:

No flow or empty cartridge Low temperature or probe fault No heat, check connection Over temperature Over current

Market review 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:

Moderate to high flow: 42.5ºC for 2 minutes, or ≥ 48ºC for 2.5 seconds 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:

100ml/min for crystalloid fluid with input temperature 20ºC 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.

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.

Market review 10


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.

Market review 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.

Market review 12


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:

run/standby switch temperature selection keys (only operational during standby) 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.

Market review 13


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:

run/standby switch temperature selection keys (only operational during standby) 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.

Market review 14


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.

Market review 15


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.

Market review 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 Medi-Temp 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:

run/standby switch setpoint switch digital selected temperature display remove from use indicator 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.

Market review 17


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 user-selected 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.

Market review 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 non-metallic 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:

Controller: digital fluid temperature (ºC)

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.

Market review 19


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.

Market review 20


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:

Controller: digital fluid temperature (ºC)

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

Market review 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.

Market review 22


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.


Fluid warmer: o digital cylinder temperature (ºC) o on/off o alarms: over or under temperature. o 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.

Market review 23


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.

Market review 24


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.

Market review 25


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.

Market review 26


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.


Fluid warmer: o Digital recirculating fluid temperature (ºC) o alarm tests o automatic operation o alarms: check disposables, add recirculating solutions, over

temperature.

Air detector: o automatic operation o alarms: check tubing, air detected

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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).

Market review 28


Smiths Hotline blood and fluid warmer General features

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.


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

IV Fluid

Recirculating fluid, up

Recirculating fluid, down

Figure 1. Cross section of triple lumen tubing

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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).

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:

start/standby buttons temperature adjustment buttons digital temperature display for measured and set temperature 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.

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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.

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.


start/standby buttons temperature adjustment buttons digital temperature display for measured and set temperature 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.

Market review 33


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.

202224262830323436384042

0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 95100

Tem

pera

ture

°C

Flow Rate ml/minTemperature Adjustment 41°C, Liquid Start Temperature 10°C

Performance curves

AP220S

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: Set temperature (ºC) End temperature compared to set temperature (using a ‘control thermometer’

display). Flow in (ml/min) Total volume (l) Total operating time (hrs) ‘Maintenance required’ indicator ‘Replace heating lamp’ indicator ‘Insert / remove cassette’ indicator Tilt alarm ‘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:

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.

Market review 36


How to use the market review tables Table 1. Key to market review tables 2- 4 Notation used Warming Warming method – coil, plate, induction, heated tube or circulating fluid Use with blood may be used to heat blood may not be used to heat blood Use with IV fluids may be used to heat IV fluids may not be used to heat IV fluids Additional components Administration set Requires proprietary or standard administration set Other consumables Size (cm) Dimensions of main unit Weight (kg) Weight in kilograms of the main unit Power (W) Power in Watts,

List price for device List price in GBP excluding VAT March 2010. Discounts may be available. Leasing arrangements may be available.

List price for consumable

List price in GBP excluding VAT March 2010 for example administration set.

Warranty Length of manufacturer warranty Supplier UK supplier of this product at publication date

Gravity fluid flow gravity driven Pressure fluid flow may be pressurised to give rapid flow Pump device incorporates pump

Flow control Flow is controlled by roller clamp on the administration set or through the device

Flow rate (ml/min) Specified flow rates. KVO = keep vein open (for temperature) Temperature achieved at specified flow rates Adjustable The set temperature is user adjustable Target (ºC) Set temperature Steps (ºC) Set temperature increments Warm up Time taken from switching on to achieve set temperature

Bubble trap device includes a bubble trap Alarms – high temp (ºC) Temperature which triggers the high temperature alarm - low temp (ºC) Temperature which triggers the low temperature alarm Blood filter Device contains an integral blood filter Thermal safety features Any thermal safety features in addition to alarms

Market review 37


Table 2. General Features

Arizant Arizant Belmont

Ranger Model 245 BairHugger 241 Buddy Warming Plate Coil Plate Use with blood Use with IV fluids

Additional components

Ranger Pressure Infuser and power pack

BairHugger forced air warming device Reusable Hose Cap (permits fluid warming without a BairHugger blanket)

Administration set Proprietary Proprietary

Other consumables

Filter accessory high-flow disposable set. Cleaning tool accessory

Size (cm) 11 x 19 x 25 22.5 16 x 29 x 8 Weight (kg) 3.4 Not stated 4.4

Power (W) 900 Power source is forced air warmer 150

List price for device

BairHugger forced air warmer costs £1950-£2000 £1,395

List price for consumable £12.50 per set

Warranty Two Year Single-Use disposable Not stated

Supplier Arizant UK Arizant UK Genesys Medical Solutions

Market review 38


Belmont Belmont Biegler

Rapid Infuser FMS2000 Buddy lite Protherm IIWarming Induction Plate Plate Use with blood Use with IV fluids Additional components None

battery and battery charger

Administration set Proprietary Proprietary Proprietary

Other consumables

Special 3 litre reservoir Dual Patient Line

heating bag complete with filters (large) and air trap

Size (cm) 34 x 30 x 19 4 x 13 x 2 39 x 28 x 10 Weight (kg) 11.8 1.7 lb 5 Power (W) 1440 1200 List price for device £12,500 £1,400 £2995 List price for consumable

£98 per set £87 per reservoir (3l) £14

Warranty 2 years

Supplier Genesys Medical Solutions Genesys Medical Solutions

Central Medical Supplies

Market review 39


Biegler Estill Medical,

Technologies Inc.

Gaymar

BW 685 / 685 S Thermal Angel Medi-Temp III REF FW600

Warming coil Heated tube Plate Use with blood Use with IV fluids


Tubeflow, to keep fluid warm between the patient and warmer.

battery pack, battery charger None

Administration set Standard Standard Proprietary Other consumables

Extension sets with/without bubble trap

Warmer unit is disposable. High flow set

Size (cm) 23 x 23 x 13 23 x 7 x 2 22 x 29 x 12 Weight (kg) 1.2 0.26 2.7 Power (W) 280 216 1000 List price for device £2095 List price for consumable £1.29 N/A Warranty 2 years One year Not stated

Supplier Central Medical Supplies

Fenton Pharmaceutical Inc (UK) Vital Signs UK

Market review 40


GE Healthcare JMW Medical Ltd Nuova GmbH

(supplied in UK by QED Scientific Ltd)

enFlow Thermofluid TD251 Nuova/05

Warming Induction Plate coil Use with blood Use with IV fluids Additional components None None

Administration set Proprietary

Standard 4mm OD or proprietary (with different flow rates) Standard

Other consumables Optional extension set Optional extension sets

Size (cm) 24 x 17 x 10 36.5 x 23 x 12.5 25 x 19 x 17

Weight (kg) 1.8 5 2.5 Power (W) 300 280-290

List price for device £1981

£1650- £1995 Also leasing, maintenance and consumable contracts available

List price for consumable

£5.23 per item Volume discount available

ET 460 £2.79 per item

Warranty Not stated 2 years from shipment, optional 3 years

Supplier Vital Signs UK JMW Medical Ltd QED Scientific Ltd.

Market review 41


Sarstedt AG & Co Smiths Smiths

Sahara Inline

Level 1 H1200 Fast flow fluid warmer

Hotline blood and fluid warmer

Warming coil circulating fluid circulating fluid Use with blood Use with IV fluids


RS 232 Interface module

Older versions can be updated with air detector and clamp

Administration set Standard Proprietary Proprietary Other consumables 5m Extension Line None Size (cm) 23 x 29 x 17 170 x 51 x 51 24 x 21 x 18 Weight (kg) 3 28.5 3.6 Power (W) 300 1449 345 List price for device Not Supplied £13,268 £3,226 List price for consumable Not Supplied

DI65HL £63.80

L70 NI £20.79

Warranty 12 Months One Year One Year Supplier Sarstedt Ltd Smiths Medical Smiths Medical

Market review 42


Stihler Electronic GmbH


TSCI

Astoflo plus Astotherm plus 220/ 220S/ 260/ 260S Fluido

Warming Tube sleeve coil Infrared Use with blood Use with IV fluids


Astoline (AP220S & AP260S), heat protection sleeve

Fluido Airguard Fluido pressure chambers Fluido compressor Fluido IV pole

Administration set Standard Astotube Proprietary Other consumables Size (cm) 28 x 12 x17.5 14 x 13 x 29 39 x 22 x 25 Weight (kg) 3 2.9 9.5 Power (W) 90 450 1400 List price for device £2210-£2280 £2200-£3000 List price for consumable N/A

£2.08 for AP220/S £3.96 for AP260/S

Warranty Two years One year

Supplier Elgin Medical Ltd Elgin Medical Ltd Cardiac Services Group

Market review 43


Table 3. Performance features Arizant Arizant Belmont Ranger Model 245 BairHugger 241 Buddy Gravity Pressure Pump Flow control Roller clamp Roller clamp Roller clamp Flow rate (ml/min) KVO - 500 KVO - 50

100 50

(for temperature) Not stated Not stated 20 ºC 10ºC

Adjustable Target (ºC) 41±1 None 38ºC Steps (ºC) N/A N/A Warm up <2minutes Not stated Not stated


Rapid Infuser FMS2000

Buddy lite Protherm II Gravity Pressure Pump Flow control device Roller clamp Roller clamp Flow rate (ml/min) 10 - 750 80 300 (for temperature) Not stated 20ºC Not stated Adjustable

Target (ºC)

37.5ºC if flow ≥ 60ml/min 39ºC if flow ≤ 50ml/min 38°C ± 2°C 37°C to 41°C

Steps (ºC) N/A 0.5°C Warm up Not required 40 seconds

Market review 44


Biegler Estill Medical Technologies, Inc.

Gaymar


Gravity Pressure Pump Flow control Roller clamp Roller clamp Roller clamp Flow rate (ml/min) Not stated 2 - 150 KVO - 300

(for temperature) 4 - 38°C Refrigerated or room temperature

Adjustable Target (°C) 37 - 41 38± 3 38 - 43 Steps (°C) 0.5 N/A 1.0 Warm up 45 seconds 45 seconds Not stated



enFlow Thermofluid TF 251 Nuova/05

Gravity Pressure Pump

Flow control Roller clamp Roller clamp Roller clamp on extension sets

Flow rate (ml/min) KVO - 200 KVO - 200

Up to 6 litres per hour for 20°C fluids

(for temperature) 20ºC Up to 3.5 litres per hour for 10°C bloods

Adjustable Target (°C) 40 39 37 - 41 Steps (°C) N/A N/A 0.5

Warm up Less than 10 seconds at 20°C Approximately 1 min

60 sec to 38°C 25 sec to 30°C, from 10°C

Market review 45


Sarstedt AG & Co

Smiths Smiths

Sahara Inline



Gravity Pressure Pump Flow control Roller clamp Roller clamp Roller clamp Flow rate (ml/min) 8 - 83 40 - 1400 0.8 - 83 (for temperature) Not stated Not stated Not stated Adjustable Target (°C) 37 - 42 41.7 ± 0.3 41.9 ± 0.1 Steps (°C) 0.5 N/A N/A

Warm up 1-2mins Not stated Recirculating fluid rises from ambient to 37°C in 4 minutes

Market review 46




TSCI

Astoflo plus

Astotherm plus 220/ 220S/ 260/ 260S Fluido

Gravity Pressure Pump Flow control Roller clamp Roller clamp Roller clamp Flow rate (ml/min) 0-22 5-65

Water: 31-270 Blood: 18-172

(for temperature) 35-40 35-40 Not stated Adjustable Max 43±1.5ºC Target (°C) 33 - 43 39, 41 and 43 Steps (°C) 0.5 2.0 30 - 39 Warm up less than 2 mins Within 30 seconds

Market review 47


Table 4. Safety features

Arizant Arizant Belmont Ranger Model 245 BairHugger 241 Buddy Bubble trap Alarms – high temp (ºC)

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.

- low temp (ºC) 33 31

Blood filter

Only on High flow disposable set: filtration to 150microns None

Thermal safety features

Independent safety alarm with heater shut down on activation None

Independent safety circuit


Rapid Infuser FMS2000

Buddy lite Protherm II

Bubble trap

two ultrasonic air detectors, and automatic venting every 500 ml.

large venting membrane, flow control valve to prevent air entrapment

Alarms – high temp (ºC)

Not stated

check for air over temp no heat probe fault

42

- low temp (ºC) Not stated 36.5 Blood filter Yes (large heating bag) Thermal safety features Thermal cut out

Independent shut down at 42ºC

Market review 48


Biegler Estill Medical Technologies Inc

Gaymar


Bubble trap Optional Alarms – high temp (ºC) 42

not stated 45

- low temp (ºC) 36.5 Not stated 34 Blood filter


Independent shut down at 42ºC

Primary control to 38ºC, secondary Independent shut down at 47ºC

Thermal safety system independent of main temperature controller



enFlow Thermofluid 251 Nuova/05

Bubble trap on proprietary set

included on ET460 extension sets

Alarms – high temp (ºC) 45 40

43°C. Audible and visual warnings

-low temp (ºC)

None 10

2°C below set temperature. Audible warning

Blood filter Not stated


2 independent over heating protectors 2 independent circuits

3 independent measurement points. Safety cut off at 43°C

Sarstedt AG & Co Smiths Smiths

Sahara Inline



Bubble trap Alarms – high temp (ºC) 43.5 43.9

43.1

-low temp (ºC) 2°C below target temperature None

Blood filter


Thermal cut-out at 43.5 ºC

Heater shut down on alarm activation.

Primary temperature control to 42ºC, secondary alarm at 43.1ºC

Market review 49




TSCI

Astoflo plus

Astotherm plus 220/ 220S/ 260/ 260S Fluido

Bubble trap Alarms – high temp (ºC)

45 ± 1

Threeway independent overheat safety switch off. 45.5°C (± 1°C) 46.0°C (± 1°C) 65.0°C (± 5°C) Heating element

45

-low temp (ºC)

33± 1

Under temperature alarm4°C (± 1°C) below control temperature

Blood filter


Two independent alarms and cut off at 45 ºC

Threeway independent overheat safety switch off. Under temperature alarm

Backflow valve in cassette

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

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

Appendix 1: Supplier contact details 52


Supplier Address Contact details Arizant UK Limited

Calder Island Way Wakefield West Yorkshire WF2 7AW

Tel 01924 200550 www.arizant.co.uk

Cardiac Services Group The Acumen Centre First Avenue Poynton Manchester SK12 1FJ

Tel 01625 878999 www.cardiac-services.com

Central Medical Supplies Central Medical Supplies Ltd. Basford Lane Leek Staffordshire ST13 7DT

Tel 01538 399541 www.centralmedical.co.uk

Elgin Medical Elgin MEDICAL 1 Dryden Loan Loanhead Bilston Glen Ind. Estate Midlothian EH20 9HR

Tel 0131 440 6500 www.elginmedical.co.uk

Fenton Pharmaceutical Ltd (UK) Fenton Pharmaceuticals Ltd 4J Portman Mansions Chiltern Street London England W1U 6NS

Tel 020 7224 1388 www.thermalangel.com

Genesys Medical Solutions Genesys Medical Solutions (UK) Ltd Gibbs House Kennel Ride Ascot Berks SL57NT

Tel 0870 6009940 www.genesysmedicalsolutions.com

JMW Medical JMW Medical Ltd Pentland Industrial Estate Loanhead Midlothian EH20 9QH

Tel 0131 448 0205 www.jmw-group.co.uk

Appendix 1: Supplier contact details 53


QED Scientific QED Scientific Ltd, Ringstones Industrial Estate, Whaley Bridge, High Peak SK23 7PD

Tel 01663 735494 www.qedscientific.co.uk

Sarstedt SARSTEDT Ltd. 68 Boston Road Beaumont Leys Leicester LE4 1AW United Kingdom

Tel 01162 359 023 www.sarstedt.com

Smiths Medical International Colonial Way Watford Herts WD24 4LG

Tel 01923 246434 www.smiths-medical.com/uk

Vital signs UK (GE healthcare group)

Vital Signs Ltd 13-14 Eldon Way Lineside Industrial Estate Littlehampton West Sussex BN17 7HE UK

Tel 08456 444955 www.vital-signs.co.uk

Appendix 2: Additional price information 54


Arizant UK Limited

Item Product code

Price Number in pack

Ranger Model 245 24507 Not stated 1 24200 Standard flow disposable set, including IV injection port, bubble trap and 76cm patient line. KVO to 150 ml/min flow rate

24200 Not stated 10

24250 Standard flow disposable set, including 2 IV injection ports, bubble trap and 152cm patient line. KVO to 150 ml/min flow rate.

24250 Not stated 10

24355 High flow disposable set, including 2 IV spikes, standard and needless injection port and auto-venting bubble trap. 100 – 500 ml/min flow rate. Replaceable 150 micron filter.

24355 Not stated 10

24365 High flow disposable set, with auto-venting bubble trap. 100 - 500 ml/min flow rate.

24365 Not stated 10

24370 High flow disposable set, with auto-venting bubble trap and 122cm patient line. 100 – 500 ml/min flow rate.

24370 Not stated 10

Bair Hugger 241 warming set. KVO – 50 ml/min flow rate

24110 Not stated 10

Reusable hose cap 90026 Not stated 12 Belmont

Item Product code


FMS2000 System including IV pole, reservoir holders and support housing assy

BE90300001 £12,500.00 1

FMS2000 3 spike disposable set BE90300006 £1,176.00 12 3 litre reservoir for FMS2000 BE90300018 £522.00 6 Dual patient line BE90300004 £152.00 18 Buddy blood and fluid warmer complete

BE90500001 £1,395.00 1

Disposable sets for buddy blood and fluid warmer

BE90500010 £300.00 24

Buddy lite system BE90500018 £1,400.00 1



Biegler

Item Product code


Biegler 685 Blood / I.V. Fluid Warmer BIEG160 £2,095.00 1 Biegler 685S Blood / I.V. Fluid Warmer (use with

BIEG165 £2,195.00 1

Biegler Tubeflow BIEG170 £595.00 1 Biegler Protherm 2 Rapid Warmer BIEG200 £2,995.00 1 Biegler Emergency Fluid Warmer BIEG700 £995.00 1 3.5m Extension Set BIEG101 £129.40 100 3.5m Extension Set BIEG101B £129.40 100 4.6m Extension Set + Injection Port BIEG107 £135.00 100 4.6m Extension Set + Bubble Trap + Injection Port

BIEG108 £253.20 100

4.6m Extension Set + Bubble Trap + 3-Way Tap

BIEG115 £275.00 100

5.3m Extension Set BIEG120 £175.00 100 5.6m Extension Set with Bubble Trap BIEG125 £275.00 100 Protherm II Heating Bag (Large) BIEG201 £310.00 20 Protherm II Heating Bag (Small) BIEG202 £275.00 25 Estill Medical Technologies, Inc

Item Product code


Thermal Angel Not stated Gaymar

Item Product code


Meditemp III Not stated Not stated Standard disposable set D25340CE Not stated Not stated Standard disposable set with 48" extension

D25310CE Not stated Not stated

Standard disposable set with 60" extension


Pediatric disposable set with 30" extension


High Flow disposable set with 48" extension




GE Healthcare

Item Product code


enFlow IV Blood/Fluid Warmer 980100 Not stated Not stated

enFlow Controller Power Unit 980121

Not stated Not stated

enFlow Disposable Sterile Cartridges 980200 Not stated 30 JMW Medical Ltd

Item Product code


TF251 Thermofluid TF251 £1981.00 1 TF251 Manual £ 52.50 1 Disposable bag inserts TFinsert/std £ 52.25 10 Box of Disposable Bags with 3-way tap Tfinsert/3wt £ 57.68 10 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 T1000, T2500,T3000 & T5000

SIMCAL5 £1050.00 1

Adapter cable for TF251 SIMCAL5C £ 80.00 1 Nuova GmbH

Item Product code


Nuova05 In line rapid warmer with insulated sheath

Nuova05 £1,650.00

1

Nuova05plus w/o In line rapid warmer with insulated silicon sheath, upgradeable

Nuova05plus w/o

£1,795.00 1

In line rapid warmer with heated silicon sheath

Nuova05plus £1,995.00 1

Upgrade / replacement heated silicon sheath for Nuova05plus models

£495.00 1

Replacement insulated silicon sheath for Nuova05

£42.00 1

Extension line, 460cm long with roller clamp & injection port.

ET460/0 £109.00 80

Extension line, 460cm long with bubble trap, roller clamp & injection port.

ET460 £204.00 80

Leasing prices per calander month, over 36 months. Prices can vary with



interest: Nuova05 £55.00 Nuova05plus w/o £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 clamp & injection port.

ET460/0 £176.00 80


ET460 £223.00 80

1 year contract for 3 boxes (80 units each) every quarter:Extension line, 460cm long with roller clamp & injection port.

ET460/0 £275.00 80


ET460 £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 Product code


Sahara Inline 97.8710.210 Not stated 1 Infusion tube extention 5m with clamp and luer lock connection

79.8710.205 Not stated 100

Transflow model RS, blood transfusion system with integrated 40 micron filter, tube length 600cm

79.8200.460 Not stated

100 Interface module RS 232, to connect protocol printer to Sahara inline.

79.8710.270 Not stated 1

Module protocol printer 97.8710.570 Not stated 1 Paper for protocol printer 97.8710.570 Not stated 10 Ink ribbon for protocol printer 97.8710.570 Not stated 1



Smiths Medical International

Item Product code


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.

Disposable administration set DI-60HL / 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

Gas vent / filter F-10 / F-50 £377.67 20

Hotline HL-90 UK-230 £3,226.00 Fluid warming set without injection port 2.4m

L-70 NI £20.79 30

T connector with injection port, 20.3cm PC-8 £4.72 40 Y connector with injection port, 20.3cm YC-8 £4.14 40 gas vent L-10 £190.74 40 Stihler Electronic GmbH

Item Product code


ASTOFLO plus, with 180cm length 4mm profile Blue

AFP200 (WP2418) £2,210.00 1

ASTOFLO plus, with 180cm length 6.7mm profile Grey

AFP200 (WP2618) £2,210.00 1

ASTOFLO plus, with 240cm length 4mm profile Blue

AFP200 (WP2424)

£2,280.00 1

ASTOFLO plus, with 240cm length 6.7mm profile Grey

AFP200 (WP2624)

£2,280.00 1

ASTOTHERM® plus 220 Blood and Infusion Warmer without heat protection sleeve selectable temperature settings 39/ 41/ 430 C

AP220

£2200.00 ASTOTHERM® plus 220S Blood and AP220S £2800.00 1



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

IFT30460

£104.00 50 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

AP260

£2400.00 1 ASTOTHERM® plus 260S Blood and Infusion Warmer with ASTOLINE® PCB and 1 active insulation ASTOLINE®

AP260S

£3000.00 1 ASTOTUBE® Infusion Extension Set, 490 cm long, PVC. Sets for ASTOTHERM® plus 260/ 260S

IFT30410

£99.00 25 The Surgical Company International (TSCI)

Item Product code


Fluido blood and fluid warmer Not stated 1 Fluido IV pole Not stated 1 Fluido air guard Not stated 1 Fluido pressure chambers (2) Not stated 1 Fluido compressor Not stated 1 Fluido standard set including air relief and 150cm patient line. Max flow 650 ml/min

671200 Not stated 40

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


Author and report information 60


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 - market review: intravenous fluid warming devices

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