Maquet Hu 35 User manual

HU 35, User's Manual 1

English version

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User’s Manual

Heater Unit HU 35

2HU 35, User's Manual

English version

2.00

HU 35, User's Manual 1

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

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HU 35, User's Manual 3

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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 if necessary.

7. Press the enable key “>38°C” 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.

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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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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

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HU 35, User's Manual 7

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3. General Description

Figures.......................................................................................... 8

Product Description................................................................... 10

Intended Purpose / Indications ................................................. 10

Side Effects / Contraindications ............................................... 10

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3. General Description

Figures

Figure 1: Front

1 Water filler neck with screw cap

2 Actual temperature display

3 Status and error messages display

4 “Performance Test” key

5 “Alarm Off” key

6 “Increase Temperature Setpoint” arrow key

7 “Temperature Setpoint greater than 38°C” enable key

8 “Decrease Temperature Setpoint” arrow key

9 Temperature setpoint display (33 - 39°C)

10 Water flow display for right coupling pair

11 Power switch O/I

12 Right coupling pair for connecting the tubes to the oxygenator

13 Blind plugs in left coupling pair

14 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

1

2

3

4

5

14A

6

7

8

9

10

11

12

17

16

15

14B

13

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3. General Description

Figure 2: Rear

1 Water outflow point with screw cap

2 Clamp mounting (accessories)

3 Line fuses (2 x T 3.15 A)

4 Connector plug for power cord

1

2

3

4

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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.

HU 35, User's Manual 11

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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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Figure 3

Figure 4

Figure 5

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

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

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

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).

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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).

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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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Maquet HU 35 User manual

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