Users Manual
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USER’S MANUAL HEATER-COOLER UNIT HCU 20
Table of Contents 1 General... 3 2 Preparation for operation... 11 3 Operation... 13 4 Display and error messages... 25 5 Maintenance... 27 6 Technical data... 29
HCU 20, User's Manual English version 1.10
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1. General General Description of function The Maquet Heater-Cooler Unit HCU 20 supplies temperature-controlled water for blood heat exchangers in extracorporeal circulation and for blankets with which patients can be warmed or cooled. The water temperature is adjustable from 3°C to 41°C. A 33 litre tank of ca. 3°C cold water assures quick cooling of the patient. Two external water circuits can be attached, each with their own waterflow adjustment system (but with a common temperature control). A safety system monitors the regulation in order to prevent the temperature from rising above 42°C. The HCU 20-602 and the HCU 20-603 have a UV-lamp in the water tank to prevent the growth of algae, fungus, mould, bacteria and other microbes. The HCU 20-600 and the HCU 20-601 are prepared for a UV-lamp. The differences between the HCU 20-600 and the HCU 20-602 versus the HCU 20-601 and the HCU 20-603 are the circulation method, the flow capacity and the maximum pressure (see page 29). The remote control unit RCU 20-610 is optional.
Patient mode To prevent a too abrubt heating or cooling, the water temperature is only allowed to deviate from the temperature of the patient by certain values, gradients, in “patient mode”. This provides a more physiologically optimised heating and/or cooling than the direct setting of the water temperature.
Note: Use an independent power supply, protected by a 20 A automatic thermic fuse.
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1. General Safety Explanations of symbols on the HCU 20 Important! Observe the warnings and safety precautions given in the accompanying documents Observe the instructions in the User’s Manual IEC 60601-1 classification: Type B applied part
Special instructions These special instructions are contained in the User’s Manual. Please bear them in mind. WARNING! Risk of serious personal injury! This is an instruction or procedure which must be observed to avoid injury to the user, patient or other persons.
Alternating current
CAUTION: Risk of damage to device!
Separate collection of electric and electronic devices in accordance with Directive 2002/96/EC: Do not dispose of the device with normal domestic waste. Keep separate from domestic waste and dispose of in an environmentally safe way in compliance with local regulations.
This is an instruction or procedure which must be observed to avoid the device being damaged. Notice This is important or explanatory information.
Protection type in accordance with IEC 60529: Protection against ingress of solid foreign objects larger than 1 mm and dripping water when tilted up to 15° Equipotential bonding
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HCU 20, User’s Manual English version 1.11
1. General Precautions Note: Before use, read the User's Manual thoroughly! CAUTION: Dry-running damages the circulation pump. The HCU 20 must never be laid on its side. If accidentally put in another position, it must stand upright for at least 24 hours before operation. If a switched on unit is connected to the power supply, the fuse might blow.
WARNING! The radiation from the UV-lamp in the water tank is instantly injurious to the eye. Never look down the funnel of the water tank. Keep the lid on whenever possible. Never risk exposure during disassembly.
WARNINGS! • Use the system and the accessories according to the User's Manual and proven medical practices. It is the responsibility of a qualified perfusionist to ensure that the system is used, tested and maintained according to all updates of the product description and the User's Manual. • Use only fully functioning machines during an operation. • The system may only be operated by a qualified perfusionist who has experience in operating the Maquet Heater-Cooler Unit or similar systems. • Use the system under supervision. The safety of the patient requires that the system is continuously monitored by a qualified operator. Clinical processes and methods are the responsibility of the physician. • When the unit is used together with other medical machines the total of the leakage currents must be checked. • The system must not be used in the presence of leaking combustible or inflammable gases.
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1. General Front view of the HCU 20
1. 2. 3. 4. 5.
Funnel for the water tank Front panel Mains switch Fuses Stopcock for the right circulation (open in vertical position) 6. Stopcock for the left circulation (open in vertical position) 7. Inlet (suction side) of the left circulation 8. Outlet (pressure side) of the left circulation 9. Opening for tank overflow 10. Outlet (pressure side) of the right circulation 11. Inlet (suction side) of the right circulation 12. Wheels with foot-lever operated brake 13. Cover for service Note: Keep the lid of the fuse box closed during normal operation.
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HCU 20, User's Manual English version 1.10
1. General Fuses
FUSES INSIDE
1.
2.
Press the screws and turn them 1/4 turn counter-clockwise to open the lid over the automatic fuses. Normal fuse positions Compressor:
pressed in
3.
Pump:
pressed in
4.
Heater:
to the right
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1. General Rear view of the HCU 20
1. 2. 3. 4. 5. 6. 7. 8.
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Funnel for the water tank Mains cable holder Socket for remote control and service terminal Automatic fuse for the mains circuit Connection for potential equalization Type label Mains cable Drain cock for the water tank
HCU 20, User's Manual English version 1.10
1. General Front panel of the HCU 20
1. 2.
3. 4. 5. 6.
7.
8.
Set temperature (alphanumeric display) Water temperature, temperature of the cold water or water level (alphanumeric display) Patient temperature or error codes (alphanumeric display) Circulation on/off button (Lit when circulating). Local/remote button (Lit when remote control is on). Adjustment knob (Hold down the “Set Temp.” button and turn the adjustment knob to set a temperature). Audio off button (Flashes when the present acoustic alarm is switched off. The acoustic alarm returns with every new alarm condition). Cooling LED (Lit when cooling the water).
HCU 20, User's Manual English version 1.10
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Heating LED (Lit when warming the water). 10. Tank temperature button (Press to see the temperature in the cold water tank in the middle display. Press together with the “Set Temp.” button for three seconds to see the water level in the middle display). 11. Set temperature button (2.9°C to 41°C), ( Hold down this button and turn the adjustment knob to set a temperature. Press together with the “Audio off” button to alter the brightness of the displays in three grades).
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HCU 20, User's Manual English version 1.10
2. Preparation for operation Preparation for operation Filling an empty unit Fill a completely empty unit as follows, to avoid an airlock in the pump. 1. Prepare a length of tubing with a Walther type male ½" quick connector at one end and a connector suitable for your soft water supply at the other. 2. Connect the tubing between one outlet of the unit and the soft water supply. 3. Switch the unit on and press the “Set Temp.” and the “Tank Temp.” buttons simultaneously for three seconds to see the water level in the middle display. 4. Open the outlet stopcock of the unit and turn on the water supply. Fill to a level of 33 litres. 5. Turn off the water supply and close the outlet stopcock. Remove the tubing from the water supply. 6. Press the “Tank Temp.” button to leave the “level mode”.
De-airing the internal circulation 1.
2.
3.
4.
Prepare a short transparent tubing with a Walther type male ½" quick connector at both ends. Connect the tubing between one outlet and the corresponding inlet. Open the outlet stopcock. Switch the unit on and hold down the “Set Temp.” button and turn the adjustment knob to set the temperature to 2.9°C (“tank mode”). Wait till the display message “TANK” stops flashing. Press the circulation button. Circulate until no bubbles can be seen in the tubing and the water pump runs with an even, gentle sound. The internal circulation is now free of air.
Note: If the water tank is over-filled or if a maximum filled unit is moved the superfluous water is released through the overflow opening (above the left front wheel).
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2. Preparation for operation Connection of heat exchanger and blanket WARNING! Check the pressure limit given by the manufacturer of the blanket before connection. Don’t exceed the pressure limit. Use a pressure reducer, if needed. 1.
2. 3.
4.
Connect your heat exchanger to one circulation of the system and your blanket to the other circulation. Set the temperature to 2.9°C (“tank mode”). Open one outlet stopcock. Circulate to de-air the external system. Close the outlet stopcock. Open the other outlet stopcock. Circulate to de-air the external system.
Note: It is difficult to de-air the blanket circulation. Tap the blanket systematically with the palm of your hand to loosen the air in the chambers of the blanket. Notes: • The HCU 20-600 and the HCU 20-602 are optimized for 6 metre tube lengths from the unit to the heat exchanger or to the blanket. • The HCU 20-601 and the HCU 20-603 are optimized for 10 metre tube lengths from the unit to the heat exchanger or to the blanket. • Shorter lengths of tubing could, in case of error, result in the water temperature exceeding 41°C at the meeting point water/blood or blanket/patient.
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HCU 20, User's Manual English version 1.10
3. Operation Operation General The Heater-Cooler Unit can always remain in standby mode, i.e. even over night, to keep the cold water at 3°C. If the unit is switched off it must be switched on about one hour before use to cool the water to 3°C. The exact cooling time depends on the initial temperature of the water, but is about 50 minutes with an initial temperature of 20°C (see page 29). When the water is cooled the compressor only runs intermittently to keep the temperature. Check the water level after connecting the heat exchanger and the blanket. Fill soft water to a level of 31 to 33 litres through the funnel for the water tank. CAUTION: Only the RCU 20-610 or the HL 20 may be connected to the remote control socket of the HCU 20 by using the remote control cable RCC 20-611. Note: Protect the remote control socket with the protective cover when the RCC 20-611 is not connected.
Water mode The patient temperature is not measured in “water mode”. The patient temperature display shows “ ”. The water temperature is only controlled by the set temperature. In stand alone operation only the “water mode” is available because the HCU 20 cannot measure the patient temperature. In stand alone operation the patient temperature display always shows “ ”. Hold down the “Set Temp.” button and turn the adjustment knob to set a temperature. Press the circulation button to start the circulation.
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3. Operation Operation with the HL 20 Connection to the HL 20 Connect the remote control cable RCC 20-611 to the remote control socket at the rear side of the HCU 20. Connect the other end to the socket marked “SYS-COM” under the flap at the rear side of the HL 20. Ensure that the cable is firmly attached.
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HCU 20, User's Manual English version 1.10
3. Operation On the control panel of the HL 20
HCU 20, User's Manual English version 1.10
1. 2. 3.
Set temperature (alphanumeric display) Water temperature (alphanumeric display) External reference selector button (Press to select one of the four temperature channels to be used for control in “patient mode”). 4. Cooling LED (Lit when cooling the water). 5. External mode (“patient mode”) button (Lit when working in “patient mode”). 6. Circulation on/off button (Lit when circulating). 7. Set temperature button (2.9°C to 41°C), (Hold down this button and turn the adjustment knob to set a temperature. Press together with the “Safety” button to see the temperature in the cold water tank in display 2). 8. Set +gradient button (5°C to 15°C), (Hold down this button and turn the adjustment knob to set the warming gradient). 9. Set –gradient button (5°C to 25°C), (Hold down this button and turn the adjustment knob to set the cooling gradient). 10. Selection LED (Indicates the temperature channel that can be used for control). 11. Heating LED (Lit when warming the water).
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3. Operation Beside the adjustment knob
1. 2. 3.
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Safety button Adjustment knob Audio off button
HCU 20, User's Manual English version 1.10
3. Operation Entering remote control Press the “local/remote” button on the HCU 20 for three seconds to enter the remote control mode. A longish acoustic signal sounds and the “local/remote” button lights up. The “HEATER-COOLER” field on the HL 20 control panel is activated. You can remotely control all functions except to see the water level. Note: The panel of the HCU 20 is now inactive and is only used as a display. If the connection is interrupted the HCU 20 stops the circulation pump and shows the error message “NO COM.” together with an acoustic alarm. Press the “local/remote” button to return to local mode. Note: If the connection is interrupted or if you switch off the remote control the circulation pump has to be restarted.
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3. Operation Patient mode Patient mode is available when the HCU 20 is controlled by the HL 20. Press the “Ext. ref. selector” button to select the temperature channel to be used for control. Note: The temperature channel must be selected before switching to patient mode. In patient mode it is not possible to change the selection. Press the “Safety” button together with the “External mode” button for three seconds to enter patient mode. If the chosen channel does not show a valid value (no sensor attached or value out of range) it is not possible to enter patient mode. Set the gradients by holding down the corresponding gradient button and turning the adjustment knob. Hold down the “Set Temp.” button and turn the adjustment knob to set a temperature. The patient will be warmed (or cooled) to the set temperature, but the water temperature Tw will not exceed (or fall below) the patient temperature Tp by more than the +gradient T+grad (or –gradient T–grad): Tw(max) = Tp + T+grad (warming) or Tw(min) = Tp – T–grad (cooling)
Example: You want to warm a patient who has a current temperature of 27°C to the normal temperature of 37°C. The +gradient is set at 8°C. The water temperature is calculated: 27°C + 5°C = 32°C. The water temperature now rises, keeping the gradient of +8°C constant, in relation to the patient temperature, until it reaches the pre-set upper limit of 41°C. The water now remains at this temperature until the patient has reached the set temperature of 37°C. 18
HCU 20, User's Manual English version 1.10
3. Operation Emptying the external circuit
Tank mode
Note: It is possible to empty the external water circuit with the HCU 20-600 and the HCU 20-602 (Pressure/suction pump) but not with the HCU 20-601 and the HCU 20-603 (Pressure pump only).
In tank mode all water is pumped to the water tank. It is used to de-air the internal and external circulation (the water is de-aired in the water tank) and to empty the external circulation of the HCU 20-600 and the HCU 20-602 (the water is pumped to the water tank). Set the temperature to 2.9°C to enter tank mode. The display message “TANK” flashes and the circulation pump stops. This is to avoid circulation until all water can be pumped to the water tank (unintentional heating of the water on the way through the heater is avoided). When the display message lights steady the pump can be started. This can take up to 60 seconds (if the temperature has been set from 41°C to 2.9°C). To start the circulation pump earlier, set the temperature to e.g. 3.0°C and start the pump.
1. 2.
3.
4.
5. 6.
Switch off the circulation and close both outlet stopcocks. Disconnect the tubing from the outlet of the HCU 20 of the external circuit to be emptied. Connect a loose Walther type female ½" quick connector to the male connector at the loose end of the tubing, so that the self-closing connector stays open. Set the temperature to 2.9°C (“tank mode”) and wait till the display message “TANK” stops flashing. Switch on the circulation. As soon as the external circuit is empty, switch off the circulation.
CAUTION: Dry-running damages the circulation pump. Switch off the circulation immediately after emptying the external circuit. Note: If the water tank is over-filled or if a maximum filled unit is moved the superfluous water is released through the overflow opening (above the left front wheel).
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3. Operation Operation via remote control Connection to the HL 15 or other machines Use the remote control unit RCU 20-610 when operating the HCU 20 with the Maquet Heart Lung machine HL 15 or machines made by other manufacturers. Connect the remote control cable RCC 20-611 to the remote control socket at the rear side of the HCU 20. Connect the other end to the socket at the underside of the remote control unit. A temperature sensor (of the YSI 400 series manufactured by Yellow Springs or other compatible sensor) may be connected to the temperature probe socket of the RCU 20-610. The remote control has a holder for mounting on round masts with a diameter of 28 to 38 mm.
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HCU 20, User's Manual English version 1.10