HU 35 HEATER UNIT Users Manual Ver 2.0

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HU 35, User's Manual English version 2.00

Table of Contents 1 Brief Instructions... 3 2 Safety Instructions ... 5 3 General Description ... 7 4 Putting into Operation... 11 5 Instructions for Use... 19 6 Cleaning and Disinfection... 25 7 Maintenance and Safety Checks ... 27 8 Troubleshooting ... 31 9 Technical Data and Accessories ... 33 10 Warranty and Liability Limitations ... 39

HU 35, User's Manual English version 2.00

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HU 35, User's Manual English version 2.00

1. Brief Instructions 1.

Connect the unit to the power supply.

2.

Attach the oxygenator to the unit via the tubes.

3.

Check the unit’s water level.

4.

Switch on the unit using the power switch (0/I) and observe the automatic performance test.

5.

If the temperature setpoint is > 38°C when switching on the unit, the alarm is disabled and the unit is put into operation by pressing the enable key “>38°C”.

6.

Set the temperature using the arrow keys

7.

Press the enable key “>38°C”

if necessary.

and the arrow key

simultaneously

for temperatures in excess of 38°C. 8.

Monitor the patient’s body temperature.

9.

Monitor the unit’s water level and water flow.

10. If the unit is used continuously, carry out the performance test manually by pressing the “Performance Test” key

once daily.

11. Second priority acoustic alarms can be disabled by pressing the “Alarm Off” key.

12. First priority alarms can be disabled by switching the unit off. HU 35, User's Manual English version 2.00

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1. Brief Instructions Note: re. 12: If a first priority alarm is sounded, all the unit’s functions are automatically shut down. The unit must therefore be switched off in order to switch off the alarm signal. The unit must no longer be used and should be sent to a service technician for inspection and, if required, restoration of operational safety (see Chapter 5 “Alarm Signals” and Chapter 8). The unit must not be used if: -

the display is not functioning;

-

the display is faulty (missing segments of numbers could result in misinterpretation of values);

-

the red alarm LED is either continuously lit or does not light up at all (performance test);

-

the signal horn either sounds continuously or does not sound at all (performance test);

-

the unit fails to react when the keys are actuated;

-

the unit does not react as described in the User’s Manual when it is switched on or the performance test is carried out.

These brief instructions do not free the user from his obligation to observe the User’s Manual and instructions for use for the respective oxygenator!

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HU 35, User's Manual English version 2.00

2. Safety Instructions •

Before putting into operation, the user must ensure that both the unit (power cord, housing, couplings etc.) and the applied part (oxygenator) are in proper working order.

•

Fill the tank with tap water only.

•

Before opening the water tank’s screw cap, the unit must be disconnected from the power supply. The unit must NOT be operated without the screw cap.

•

The unit must only be operated in a horizontal position away from heat sources (spotlights, direct sunlight, heating elements, radiant heaters etc.).

•

Do not cover the ventilation slots on the bottom and rear of the unit.

•

The difference in height between the unit and the oxygenator must not be more than one meter (1 m).

•

Observe the automatic performance test when switching on the unit and, if the unit is used continuously, perform the test manually at least once daily.

•

When in use, the unit’s water flow and water level must be checked regularly.

•

The unit must only be operated with a sufficient water level.

•

Do not kink the tubes.

•

Observe the ambient temperature range (10 - 30°C) and the storage temperature range (10 - 40°C).

•

Only operate the unit with the MAQUET PLS oxygenator or other oxygenators and their respective original accessories as part of extracorporeal circuits.

•

The unit must not be used in the presence of flammable gases.

•

Carry out maintenance work and safety checks in accordance with the User’s Manual.

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2. Safety Instructions ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... 6

HU 35, User's Manual English version 2.00

3. General Description Figures... 8 Product Description... 10 Intended Purpose / Indications ... 10 Side Effects / Contraindications ... 10

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3. General Description Figures

1

2 3 17 16

4 5 14A

15

6 7 8 9

14B 10

11 12 13

Figure 1: Front 1 2 3 4 5 6 7 8 9 10 11 12 13 14

Water filler neck with screw cap Actual temperature display Status and error messages display “Performance Test” key “Alarm Off” key “Increase Temperature Setpoint” arrow key “Temperature Setpoint greater than 38°C” enable key “Decrease Temperature Setpoint” arrow key Temperature setpoint display (33 - 39°C) Water flow display for right coupling pair Power switch O/I Right coupling pair for connecting the tubes to the oxygenator Blind plugs in left coupling pair A. Threaded holes (fastening screws on housing) for tubing holder B. Threaded holes for clamp mounting (accessories) 15 Water level display: min. water level 16 Fault display lamp 17 Water level display: max. water level

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HU 35, User's Manual English version 2.00

3. General Description

1

2

3

4

Figure 2: Rear

1 2 3 4

Water outflow point with screw cap Clamp mounting (accessories) Line fuses (2 x T 3.15 A) Connector plug for power cord

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3. General Description Product Description The Heater Unit HU 35 works on the principle of heat dissipation via a thick membrane to the blood stream with an oxygenator. A heating element heats up the water in the unit’s water tank, this water is electronically controlled and pumped continuously. The Heater Unit HU 35 is characterized by its compact design, simple and safe handling and reliability. The Heater Unit HU 35’s main features are its efficient and precise heat transfer and its outstanding operational safety. The various displays on the front of the unit provide information on the proper functioning of the device at all times. Operation is both simple and intuitive. The temperature on the unit can be set between 33°C and 39°C, which enables body temperature to be maintained.

Intended Purpose / Indications The Heater Unit HU 35 acts as a heat supply in order to maintain the patient’s body temperature via a MAQUET PLS oxygenator or other oxygenators as part of extracorporeal circuits.

Side Effects / Contraindications There are no side effects and no known contraindications when the Heater Unit HU 35 is used for the intended purpose.

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4. Putting into Operation Setting up the Unit ... 12 Language... 13 Water Level... 14 Oxygenator... 15 Putting into Operation ... 16

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4. Putting into Operation Setting up the Unit a) Table top unit The Heater Unit HU 35 hyperthermia system unit is designed for use on table tops, i.e., it can be placed on all types of flat, horizontal, hard and load-bearing surfaces. For safety reasons, the unit must not be operated on the floor. b) Mobile floor-mounted unit

Figure 3

Together with the SPRINTER Cart as an optional accessory and the respective clamp mounting, the unit can be used as a mobile floor-mounted appliance. The clamp mounting for the SPRINTER Cart is secured on the left side of the unit (see Figure 3) using two screws. The unit is secured to the slide rail of the SPRINTER Cart using the star screw on the clamp mounting. c) Wall mounting on slide rails

Figure 4

The unit can be attached to the standard slide rails (25 x 10 mm) found in hospitals. To this end, the clamp mounting, which is available as an accessory, is ideally secured to the rear of the unit using two screws. The unit is secured to the rail using the star screw on the clamp mounting (see Figure 4). d) Tubing holder

Figure 5

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If necessary, the tubing holder, which is available as an accessory, can be attached to the right-hand side of the unit using the knurled screws located there (see Figure 5).

HU 35, User's Manual English version 2.00

4. Putting into Operation The following must be observed when setting up the unit: When setting up the unit it must be ensured that the ventilation slots on the bottom and rear of the unit are not covered. When in operation, the unit must be in a horizontal position (max. incline of 2°) as otherwise the water level display on the front of the unit displays an incorrect value. Furthermore, it is also recommended that the unit is positioned level or slightly higher than the oxygenator (max. height difference 1 m) due to the water pressure conditions in the circulation system. Moreover, when opening the water filler neck when the unit is switched off, water from the tubes and oxygenator can flow back into the unit causing the water tank to overflow.

Language The language in the display (Fig. 1 point 3) on the front of the unit, which provides information on the status and error messages, can be changed by the user. The following languages are available: German, English, French, Spanish, Italian. The language is set, with the unit switched on, as follows: 1.) Keep the “Alarm Off” key (Fig. 1 point 5) depressed (4 seconds) until the language appears in the display. 2.) Pressing the “Increase Setpoint” key (Fig. 1 point 6) serves to display and activate the languages in the following order: German, English, French, Spanish, Italian, German etc.. 3.) The selection option automatically ends 10 seconds after the last entry.

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4. Putting into Operation Water Level a) Checking Before switching the unit on and connecting the tube to the oxygenator, the water level must be checked. The water level display is located on the front of the unit, the display has a minimum (Fig. 1 point 15) and maximum (Fig. 1 point 17) permissible value. The water level must be between these two values, whereby the maximum value should be aimed for. The difference between the two values is 0.7 liters. Water must be refilled under the following conditions:

the water level is below the minimum value; the display shows “WATER LEVEL!?”; empty tubes and an oxygenator are connected and the water level is below the maximum value.

b) Filling / Refilling The water tank is filled with tap water. The unit is filled after it has been switched off and disconnected from the power supply. To pour in water, the screw cap (Fig. 1 point 1) of the water filler neck is removed (e.g., using a coin). After being filled, the water level should be slightly below the max. value on the display. Once the water has been poured in, the screw cap should be screwed on lightly. Operators should not use any cleaning or decontamination methods other than those recommended by the manufacturer without checking with the manufacturer beforehand whether the suggested methods could cause damage to the unit. If, when filling, water flows over the unit, this must be dried thoroughly. The unit must not be used again until it is completely dry. c) Changing the water The water must be changed every two weeks (see also Chapter 7 “Maintenance and Safety Checks”)

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4. Putting into Operation Oxygenator An oxygenator can be attached either before or after the unit is switched on. The tube couplings are simply connected to the right-hand coupling pair on the unit (Fig. 1 point 12). The couplings are correctly attached to each other when the lock on the tube coupling clicks into place in the unit’s coupling nipple and the connection can no longer accidentally become undone. On the oxygenator side, the tube is connected to the oxygenator via an adapter on a Hansen coupling. The used Hansen couplings can be connected with all current oxygenators. The connection is correct if the water flow display above the coupling pair on the unit rotates when the unit is switched on. The coupling is released by pressing on the small metal plate on the tube coupling. The couplings can be released when the unit is switched on. It must be ensured, however, that the adapter on the oxygenator side is decoupled as otherwise water will leak out. The system has been designed so that, after release, the coupling drips briefly; this is not a sign of a leakage or fault.

Tip
The black sealing rings on the couplings can become dry, brittle and stiff as a result of ageing. This can be remedied by applying a thin film of silicone grease, Vaseline or similar to the sealing ring.

The unit must only be operated with the MAQUET PLS oxygenator or other oxygenators as part of extracorporeal circuits.
The used oxygenators need to resist a pressure of a maximum of 0.34 Bar and to allow a maximum temperature of 40°C (independent safety shutdown).
For further information, please refer to the oxygenator’s instructions for use.
An oxygenator must not be connected when performing disinfection (also see Chapter 6 “Cleaning and Disinfection”).

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4. Putting into Operation Putting into Operation The unit can be connected to the power supply using the power plug, taking into account points “Setting up the Unit” – “Oxygenator”. Switching on (O/I) The power switch is designed as a push switch with the symbols O/I and is located on the front of the unit (Fig. 1 point 11). The unit is switched on when the power switch button is depressed into the recess and off when the button is flush with the front of the unit. Performance Test A short acoustic alarm sounds when the unit is switched off and on. This signals that the power failure alarm is ready. Shortly after switching the unit on, a performance test checks the independent safety device and the result is shown in the display. Furthermore, all the segments (88.8) of the temperature displays, the fault display lamp and the acoustic alarm are activated at the same time. This performance test takes just a few seconds, during this time the user must observe the activation of the above-named displays. Warm-up Phase
Once the performance test has been completed, the temperature control mode starts automatically if the temperature is set between 33 and 38°C.
If the set value is greater than 38°C, an acoustic alarm sounds and the following messages are displayed “SET VALUE >38°C”, “ENABLE KEY >”. The temperature control mode is started by pressing the enable key “>38°C” (Fig. 1 point 7). 16

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4. Putting into Operation Once the setpoint temperature has been reached, heat dissipation in watts (W) is shown in the display (also see Chapter 5 “Heat Dissipation”). The unit must be taken out of use in the following examples and inspected by the authorized customer service organization:
the short acoustic power failure alarm cannot be heard when switching the unit on and off;
the automatic performance test identifies a defect in the independent safety device and automatically switches the unit off;
the user notes a defect in the displays. The unit is not designed for continuous use without an oxygenator. If the unit is operated for an extended period (> 1h) without an oxygenator, various alarm messages may be given due to the lack of heat dissipation, in this case such messages do not point to a defect, but rather signal the proper functioning of the safety devices. The unit can be used again after a cooling down period. When used with an oxygenator, the patient’s body temperature should be monitored.

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4. Putting into Operation ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... 18

HU 35, User's Manual English version 2.00