Xenios AG DELTASTREAM HC Instructions For Use Manual

INSTRUCTIONS FOR USE

DELTASTREAM HC

2

MARKING AND SYMBOLS

MARKING AND SYMBOLS

Catalog number

Batch code

Manufacturer

Date of manufacture

Temperature limit 10-40 °C (50-104 °F)

Keep away from sunlight

Keep dry

Do not use if package is damaged

Consult instructions for use

Non sterile

Separate collection of
electrical and electronic equipment

3

INTRODUCTION

COPYRIGHT

The copyright to these instructions for use is held by
medos Medizintechnik AG. All rights reserved, including
for translation. No part of this information may be repro­duced or electronically processed, copied, translated or
disseminated in any form (printed, photocopy, microfilm
or by a dierent process) either in whole or in part with­out the written permission of medos Medizintechnik AG.
All violations involving copyright can result in legal action.

DISTRIBUTOR

Xenios AG
Im Zukunspark 1
74076 Heilbronn
Germany

Phone [phone]
Fax [phone]
[e-mail]
www.xenios-ag.com

MANUFACTURER

medos Medizintechnik AG
Obere Steinfurt 8-10
52222 Stolberg
Germany

Phone [phone]
Fax [phone]
[e-mail]
www.xenios-ag.com

PUBLICATION DATE

March 2018

Soware version 1.02

IFU Version:
EN_003_2018_03

Item number:
MEDPHC0016

VALID FOR

ME DPHC 0001 Deltastream HC, 230V

ME DPHC 0002 Deltastream HC, 115V

AVAILABLE LANGUAGES

The following languages are available as hard copies:

These andall otherproduct-specificlanguage versionsare
available as PDF downloads at www.xenios-campus.
com.

4

INTRODUCTION

INTRODUCTION

These instructions for use are intended to familiarize the
user with the unit. They provide an insight into its setup,
function and operation. Read these instructions for use

carefully, and make sure that you have understood them!
Follow the instructions to ensure safe operation.

EXPLANATION OF SYMBOLS AND NOTICES

DANGER This symbol indicates an immediate

danger. The patient’s life and health are
at risk if it is ignored.

CAUTION This symbol indicates a possible danger.

There is a risk of damage to the unit or
of personal injury if it is ignored. The
patient’s life and health could also be at
risk.

The following symbols are used in the text in order to
clarify instructions:

• Identifies lists

Ö Means »action to be performed««

■

Means »important statement/information««

WARNING This symbol indicates a possibly harm-

ful situation. The unit will be damaged
or destroyed if it is not prevented.

This symbol refers you to more informa­tion or tips from practical use.

DIMENSIONS

All dimensions are given in millimeters »mm«. Other units
of measurement are highlighted.

ILLUSTRATIONS

The shown product images in the following operating
instructions comply with the current state of printing.
Individual illustrations might dier from the delivery state.

5

TABLE OF CONTENTS

TABLE OF CONTENTS

1 Information on the Instruction manual 7

1.1 Limitation of liability 7

2 Safety instructions 8

2.1 Proper use 8

2.2 Requirements of personnel 8

2.3 Sources of risk 9

2.3.1 Risk of unintended heating or cooling 9

2.4 General safety instructions 9

3 Transport and packaging 10

3.1 Delivery contents and transport inspection 10

3.2 Unpacking 10

3.3 Disposal of packaging 10

4 Initial operation 11

4.1 Set up 11

4.1.1 Requirements at the place of use 11

4.1.2 Setting up with the deltastream Trolley 11

4.2 Water quality 12

4.3 Connecting the deltastream heater cooler 12

4.3.1 Filling the system with water 12

4.3.2 Connecting the oxygenator 13

4.3.3 Electrical connection 14

5 Design and function 15

5.1 Unit views, controls and displays 15

5.2 Safety devices 16

5.2.1 Sensors 16

5.3 Type plate 16

5.4 Function 16

5.4.1 Basics 16

5.4.2 Indications/contra-indications/side-effects 17

6 Use and operation 17

6.1 Before switching on 17

6.1.1 Checking the unity 17

6.1.2 oxygenator 18

6.2 Operation 18

6.2.1 Switching on 18

6.2.2 Function test 19

6.2.3 Setting the temperature 19

6.2.4 Temperature regulation mode 20

6.2.5 Duties during operation 20

6

TABLE OF CONTENTS

LIST OF FIGURES

Figure 1: Filling the system with water 12
Figure 2: Connecting the device side 13
Figure 3: Front view 15
Figure 4: Rear view (section) of unit with ventilation slots, microfuse and mains socket 15
Figure 5: Typeplate 16

6.2.6 Operating language 21

6.3 Alarms 21

6.3.1 General information 21

6.3.2 Low-priority alarms 22

6.3.3 High-priority alarms 23

6.3.4 Power failure alarm 24

7 Cleaning and disinfection 25

7.1 Unit 25

7.1.1 Surface cleaning and disinfection 25

7.1.2 Changing water and disinfecting the water circuit 26

7.1.3 Disinfection 27

8 Maintenance and safety-related checks 28

8.1 Maintenance 28

8.1.1 Unit 28

8.1.2 Hose couplings 28

8.2 Safety-related check 29

9 Repairs 30

9.1 Causes of faults and actions to take 30

10 Disposal of the old unit 31

11 Technical data and accessories 32

11.1 Technical data and accessories – deltastream hc 32

11.2 Accessories 33

12 Guidelines and manufacturer’s declaration 34

13 Quick Guide 38

7

1

INFORMATION ON THE INSTRUCTION MANUAL

1 INFORMATION ON THE INSTRUCTION MANUAL

This instruction manual is part of the deltastream heater
cooler (referred to below as the “unit”) and provides
important information on the initial operation, safety,
correct usage, care and servicing of the unit.

All illustrations and drawings in this instruction manual
are for general information only and not definitive in their
design details.

The full instruction manual should ideally be kept close to
the unit. It must be read and used by each person tasked
with the

• initial operation,

• use,

• cleaning,

• care,

• servicing and

• repair

of the unit.

Make sure that you have read the instructions for use
completely and have understood the content! Follow the
directions and notes in these instructions for use carefully
and conscientiously!

1.1 LIMITATION OF LIABILITY

In this instruction manual, all technical information, data
and instructions for installation, operation, care and
servicing correspond to the state of the art at the time of
printing, are based on previous experience and corre­spond to the best of our knowledge and good manufac­turing practice.

No claims may be derived from the details, illustrations
and descriptions in this manual.

Warranty and liability claims for personal injuries and
property damage shall be excluded if they are the result
of one or more of the following:

• Ignoring the instructions in the manual in relation
to transport, storage, installation, initial operation,
use and servicing of the unit

• Improper use of the unit

• Incorrect initial operation, use and servicing of the
unit

• Unauthorized structural and technical modifica­tions to the unit

• Use of non-approved spare parts

• Incorrectly performed repairs and servicing

8

2

SAFETY INSTRUCTIONS

2 SAFETY INSTRUCTIONS

2.1 PROPER USE

The unit is intended exclusively for cooling or heating
the water that is pumped during use of the unit through
an attached oxygenator to regulate the temperature of
the patient’s blood. Any other form of use is regarded as
improper.

The unit must only be operated with its associated
components and a oxygenator in accordance with the
instruction manual.

Proper use also includes following all the instructions in
this manual and performing all inspection and servicing
work in due time.

Claims of any kind relating to damage resulting from
improper use shall be excluded.

The risk shall be borne exclusively by the operator.

CAUTION Danger due to improper use!

Improper use and/or any other type of
use could put the patient and/or user at
risk.

2.2 REQUIREMENTS OF PERSONNEL

WARNING • To ensure patient safety, the unit

should be monitored continuously
during operation.

• The product may only be used on
the instructions of a doctor, under
medical supervision and only by
medically-trained personnel (e.g. car­diovascular technician/doctor/critical
care sta).

• Only persons whose training and
qualifications entitle them to do so
should work on/with the unit. They
must also be instructed to do so by
the operator.

• Personnel being trained, taught or
instructed, or taking part in a course
of general training, may only operate
the unit under the supervision of an
experienced person.

WARNING • Persons under the influence of drugs,

alcohol or medication aecting the
response capacity must not use this
device.

• The device may cause dangers if used
improperly by untrained sta.

• In addition to the instructions for use,
the general legal and other contractu­al regulations for accident prevention
and environmental protection as
well as essential health and safety
requirements must be observed.
The operator must instruct the sta
accordingly.

9

2

SAFETY INSTRUCTIONS

2.3 SOURCES OF RISK

2.3.1 RISK OF UNINTENDED HEATING OR COOLING

CAUTION There is a risk that the patient’s

blood could be heated or cooled
excessively.

• The patient’s body temperature must
be continuously monitored when the
unit is used with the oxygenator/on
the patient.

2.4 GENERAL SAFETY INSTRUCTIONS

WARNING For safe handling of the unit, observe

the following general safety instruc­tions:

• Before initial operation, make sure
the unit (mains cable, housing,
connections, hoses, etc.) and the
oxygenator are in proper order.

• Make sure there are no kinks in the
hoses to the oxygenator.

• Check that the hoses are connected
correctly to the oxygenator.

• Do not touch the hoses with pointed
or sharp items.

• Fill the unit tank with sterile water.

• Operate the unit only with the screw­cap on the tank closed.

• Position the unit for operation so that
it is level. The slope of the supporting
surface must be ≤ 3%.

• The height dierence between the
unit and oxygenator must be <75cm.

• Do not cover the unit. There are
ventilation openings at the sides,
underneath and at the rear.

WARNING • Pay attention to the automatic func-

tion test when switching on the unit.

• Perform the automatic function test
manually at least once a day if the
unit is in continuous operation.

• During operation, check the water
flow and level at regular intervals.

• Operate the unit only with suicient
water in it (see MIN mark).

• Observe the specified ambient tem­perature (10-39 °C)

• We recommend only operating the
unit with Medos oxygenators and
their original accessories.

• Do not operate the unit in the pres­ence of flammable gases.

• Do not use the unit in heating/cool­ing mode in conjunction with other
sources of heat.

• Do not operate the unit in the vicinity
of heat sources (beams of light, heat­ers/radiators, direct sunlight, etc.).

• Perform servicing and safety-relat­ed checks in accordance with this
instruction manual.

• Allow only authorized personnel to
operate the unit.

• The patient’s body temperature must
be continuously monitored separate­ly from the system.

10

3

TRANSPORT AND PACKAGING

CAUTION Do not use unfilterd and unsterilized

main water!

• Main water must be filtered with sterile
filter with pore size ≤ 0.22 μm and sub­sequently sterilized to avoid a germ
borne contamination.

3

TRANSPORT AND PACKAGING

3.1 DELIVERY CONTENTS AND TRANSPORT INSPECTION

The delivery contents for the deltastream heater cooler
include:

• deltastream heater cooler unit

• Mains cable

• Instruction manual

• Two hoses with Hansen couplings

• deltastream Trolley (optional with order)

• Disinfectant (optional with order)

Check the contents of the delivery for
completeness and visible damage.

If items are missing or if there is damage
resulting from unsatisfactory packaging
or transport, report this immediately to
the shipper, insurance company and the
supplier.

3.2 UNPACKING

To unpack the unit:

• Take the unit out of the box and remove the packaging
material.

• Place the unit om a sturdy, level and horizontal
surface.

CAUTION The unit weights approximately 17 kg.

Use two people to transport, unpack and
set up the unit.

3.3 DISPOSAL OF PACKAGING

The packaging protects the unit from
transport damage. The packaging mate­rials have been chosen for their environ­mental compatibility and are recyclable.

Returning the packaging to the material
cycle saves raw materials and reduces
the amount of waste generated. Dispose
of packaging materials that are no lon­ger needed at an appropriate collection
point..

Where possible, keep the original packag­ing for the duration of the unit’s warranty
period so it can be repacked correctly in
the event of a warranty claim.

11

4

INITIAL OPERATION

4 INITIAL OPERATION

CAUTION Personal injury or material damage

can occur during initial operation.

Follow the safety instructions in order to
avoid risks.

• The unit weights approximately
17kg.

• Use two people to transport, unpack
and set up the unit.

4.1 SET UP

4.1.1 REQUIREMENTS AT THE PLACE OF USE

For safe and problem-free operation of the unit, the place
of use must

• Be sturdy (when filled, the unit weighs approxi­mately 17 kg)

• Be level

• Be horizontal (≤ 3% angle)

• Provide 20 cm of space on all sides of the unit

• Guarantee suicient ventilation on all sides of the
unit

• Be located no more than 75 cm below or above
the oxygenator

• Be free from devices with strong magnetic fields in
the vicinity.

For safety reasons, the unit must not be operated on the
floor.

The deltastream Trolley which is avail­able as an accessory, meets all these
requirements.

• If the unit is not horizontal, the water
indicator at the front will show the
incorrect water level.

• If the unit is well below the level of
the oxygenator, water can flow back
from the oxygenator into the unit and
cause the tank to overflow when the
filler stopper is opened and the unit
switched o.

4.1.2 SETTING UP WITH THE DELTASTREAM TROLLEY

By means of the deltastream Trolley, which is available as
an accessory for the deltastream console, the deltastream
heater cooler, which was designed as a standing unit, can
also be used as a mobile standing unit.

Set up the unit with the deltastream Trolley as follows:

Put the deltastream Trolley together as shown in its
assembly manual.

There is a locking screw in the support plate of the deltas­tream Trolley. Place the deltastream heater cooler on the
plate so that the screw and thread align in the base of the
unit.

12

4

INITIAL OPERATION

4.2 WATER QUALITY

• Do not use unfilterd and unsterilized main water!
Main water must be filtered with sterile filter with pore
size ≤ 0.22 μm and subsequently sterilized to avoid a
germ borne contamination.

• For filling the system, approx. 1 liter of sterile water is
necessary.

4.3 CONNECTING THE DELTASTREAM HEATER COOLER

CAUTION Risk due to water coming into

contact with electricity.

Do not connect the unit to the mains
until it has been filled with water.

CAUTION Risk due to water coming into con-

tact with electricity.

Water can conduct electricity.

If the water overflows when the unit is
being filled, it must be dried thoroughly
and be completely dry before it is con­nected to the mains and switched on.

When filling the unit for the first time,
please follow the instructions on disinfect­ing (see “Maybe some of the listed prod­ucts are not available in your country. Take
care about the availability!” on page 27).

The system is a closed circuit and the
water line should not be disconnected
in the operating room. Ensure that the
connection of the hose to the oxygenator
has already taken place before the system
is placed in the operating room.

4.3.1 FILLING THE SYSTEM WITH WATER

• Unsrew the cap on the water filler (2) without con­taminating the interior of the unit.
Wear gloves when doing so.

• Be careful not to lose the seal on the cap.

• Add sterile water, for example by placing a funnel
in the water tank.

• We recommend using a sieve to prevent foreign
material entering the water circuit.

• Watch the water level gage (5) during filling. The
water level should be just under the MAX mark
aer filling.

• Screw the cap on the water filler tightly until it is
sealed.

Figure 1:

5

2

Filling the system with water

13

4

INITIAL OPERATION

4.3.2 CONNECTING THE OXYGENATOR

• Attach the hose couplings to the couplings on the
unit. The couplings are connected correctly if the
coupling on the hose coupling locks into place in the
coupling on the unit such that it cannot come loose.

• Undo the couplings by pressing on the metal plate on
the hose coupling and pulling out the hose.

• An adapter is used to connect the hose to the Hansen
coupling on the oxygenator. Hansen couplings are
couplings that can be connected to all Medos oxy­genators. The couplings are connected correctly if the
coupling on the hose locks into the coupling on the
unit such that it cannot come loose.

• The connections between the unit and
the oxygenator are correct if the water
flow meter rotates when the unit is
switched on.

• Before use, check that the hoses are
connected correctly to the oxygenator

• The oxygenator can also be discon­nected while the unit is on.

• There will be a slight drip when the
couplings are undone. This is normal
and not a sign of a leak or defect.

• In heating mode: Lower the target
temperature before disconnecting
the oxygenator. Otherwise, the water
in the unit’s circuit will briefly heat
up above the target temperature and
trigger the alarm TEMP.DIFF > 1 °C
(depending on the time lapse).

Figure 2: Connecting the device side

Further instructions for the oxygenator
can be found in its instruction manual.

14

4

INITIAL OPERATION

4.3.3 ELECTRICAL CONNECTION

WARNING Risk due to electrical current

Faulty mains cables and/or plugs can
result in a fatal electric shock.

• Check that the unit’s mains cable and
plug are in perfect condition before
switching on the unit.

To ensure safe and problem-free operation of the unit, fol­low the instructions below when connecting the power:

• Before switching on the unit, compare the connec­tion details (voltage and frequency) on the type
plate with those of your mains electricity. They
must be the same to prevent damage to the unit. If
in doubt, ask your qualified electrician.

• The socket must be protected by a 16 A fuse.

• Use the mains cable supplied to connect the unit
to the mains. The plug is located on the back of
the unit (see “5.1 Unit views, controls and displays”
on page 15).

15

5

DESIGN AND FUNCTION

5 DESIGN AND FUNCTION

5.1 UNIT VIEWS, CONTROLS AND DISPLAYS

Figure 3:

10

11

8

7

16

15

13

6

5

4

3

2

1

12

14

9

Front view

1. Handles

2. Water filler with screw cap

3. Temperature display for actual value

4. Fault indicator

5. Water level gage

6. Temperature display for target value

7. Water flow rate indicator

8. Mains switch

9. Hose couplings

10. Thread for locking screw (in base plate)

11. Display for status and fault messages

12. Function test

13. Alarm o

14. Increase target value

15. Confirm button <35 °C / >38 °C

16. Decrease target value

Figure 4: Rear view (section) of unit with ventilation

slots, microfuse and mains socket

16

5

DESIGN AND FUNCTION

5.2 SAFETY DEVICES

5.2.1 SENSORS

The deltastream heater cooler monitors the following
during operation:

• The water level in the unit

• Whether the water temperature in the circuit corre­sponds to the set target value

• Whether there is mains voltage

• Whether its own functional safety is in order

and triggers an alarm if there is a fault (see “6.3 Alarms”
on page 21).

5.3 TYPE PLATE

The type plate (here an example) featuring the connec­tion and output data is located on the back of the unit:

Figure 5: Typeplate

5.4 FUNCTION

5.4.1 BASICS

The deltastream heater cooler unit are used to heat or
cool the patient’s blood between 15 °C and 39 °C with the
aid of a oxygenator.

The temperature line between the patient’s blood and
the water circuit runs via a membrane in the oxygenator.
Because of its high thermal capacity and good heat-con­duction properties, water is an ideal transfer medium for
this application.

The water is cooled or heated in a water tank in the unit
using thermo electric elements and, when operated with
a oxygenator, is continuously fed to a rotary pump.

The correct operation of the unit is shown by various indi­cators on the front of the unit. Its electronic controls can
accurately set the temperature transfer to the patient’s
blood while simultaneously ensuring the unit is operating
safely.

17

6

USE AND OPERATION

5.4.2 INDICATIONS/CONTRA-INDICATIONS/SIDE-EFFECTS

The unit is used for the following:

• Heat transfer during inter-operative or post-opera­tive hypothermia

• Heat supply or removal to stabilize the patient’s
temperature (normothermia)

• Heat removal in the case of malignant
hyperthermia

During cold transfer and associated deliberate lower­ing of the patient’s temperature (therapeutic hypo­thermia), the following side-eects may occur:

• Autonomous reactions (incl. shivering),

• Electrolyte shi,

• Hyperglycemia,

• Reduced oxygen intake,

• Reduced coagulation activity,

• Changed solubility of blood gases/narcosis,

• Changed pH value,

• Lower heart rate,

• Lower anesthesia requirements.

Disadvantages of therapeutic hypothermia include:

• Extended bypass time from cooling to heating,

• Increased blood viscosity,

with increasing degree and duration of organ damage
and tendency to bleed

6 USE AND OPERATION

6.1 BEFORE SWITCHING ON

6.1.1 CHECKING THE UNITY

The system is a closed circuit. The water lines should not
be connected or disconnected in the operating room.
Ensure that the water connections to the oxygenator have
already been connected before the system is placed in
the operating room.

Check the unit for external damage.

Aer switching on the unit, check the water level every
time before and aer connecting a oxygenator.

The water level must be between both marks on the
gage, preferably just below the maximum mark. The fill
dierence between the minimum and maximum marks is
about 0.5 liters.

Top up with sterile water if the level is below the mini­mum mark.

18

6

USE AND OPERATION

6.1.2 OXYGENATOR

We recommend using Meods oxygenators.

• We recommend using Medos oxygenators.

Before connecting, check the oxygenator for damage.
Only use undamaged oxygenators. Follow the directions
in the oxygenator manual.

WARNING Only use oxygenators than can sustain a

water pressure of 0.15 bar.

Oxygenators can be connected or disconnected with the
unit on or o.

Disconnecting oxygenators during
operation

• In heating mode:

Reduce the target temperature before
disconnecting the oxygenator. Otherwise,
the water in the unit’s circuit will briefly
rise above the target temperature and
may trigger the alarm TEMP.DIFF > 1°C
(depending on the time lapse).

• In cooling mode:

Increase the target temperature before
disconnecting the oxygenator. Otherwise,
the water in the unit’s circuit will briefly
fall below the target temperature and
may trigger the alarm TEMP.DIFF > 1°C
(depending on the time lapse).

6.2 OPERATION

6.2.1 SWITCHING ON

Fill the water tank (see „4.3.1 Filling the system with
water“ on page 12) to the MAX mark with sterile water.

Follow the instructions on disinfecting (see “7.2.2 Chang­ing water and disinfecting the water circuit” on page 27).

• Switch on the unit using the push button (8).
The push button at the front of the unit remains
pushed in while the unit is on.

• Allow the unit to run until the air is eliminated
from the unit and the hoses. For this pupose posi­tion the hoses level with the unit or lower.

• Check the water level on the gage (5). If necessary,
switch the unit o, disconnect the power and top
up with sterile water.

• Connect the oxygenator to the unit. Check the
water level on the gage (5), especially if you have
connected an empty oxygenator.

• The height dierence between oxygenator and
unit must not exceed 75 cm.

• Reconnect the unit to the power supply, switch
it on and allow it to run for about two minutes to
remove air from the circuit.

• Check the water level on the gage (5) again. If nec­essary, switch the unit o, disconnect the power
and top up the water.

Please note that the tank contents may
leak out if there is a fault. For this reason,
be prepared in advance to take corrective
action

19

6

USE AND OPERATION

6.2.2 FUNCTION TEST

The unit performs a function test aer being switched
on. Watch during the test to see whether the indicators
behave as described below:

• A short audible alarm indicates that the unit is
ready for a possible mains failure alarm.

The unit now checks its own safety devices::

• Temperatures (3) and (6) on the display (11) read

.

• The red fault indicator (4) comes on.

• The audible alarm sounds.

• The display (11) shows FUNCTION TEST.

If the function test is successful, the display shows the
message FUNCTION TEST OK and the unit automatically
starts normal operation.

This test lasts a few seconds.

WARNING If the function test is not successful,

the unit is not safe for operation.

The unit cannot be operated if:

• No beep indicating the mains
failure alarm sounds aer the unit
is switched on.

• The automatic function test
switches the unit o automatical­ly because it detects a fault in its
own safety devices.

• One or more indicators are faulty.

In these cases, have the unit checked by
a Medos-approved customer service.

6.2.3 SETTING THE TEMPERATURE

• Use the two arrow keys (14)
and (16) to set the target value
for the water temperature. The
temperature can be adjusted
in increments of 0.1 °C from 15
to 39 °C.

• The temperature display (6)
shows the set target value.

• For target temperature values
above 38 °C, press and hold
the Confirm button (15) while
pressing the arrow key (14) at
the same time.

• For target temperature values
below 35 °C, press and hold
the Confirm button (15) while
pressing the arrow key (16) at
the same time.

WARNING • A considerable amount of heat will

be removed from the patient’s blood
at a temperature below 35 °C.

• A considerable amount of heat will
be added to the patient’s blood at a
temperature above 38 °C

The addition or removal of heat by the Medos oxygenator
to/from the patient’s blood only occurs if the temperature
of the water in the oxygenator is higher or lower that the
patient’s blood temperature.

The amount of heat transfer is directly proportional to the
temperature dierence between the blood and the water
in the oxygenator.

20

6

USE AND OPERATION

6.2.4 TEMPERATURE REGULATION MODE

If the target temperature value is between
35 °C and 38 °C, the unit starts operating
automatically aer being switched on and
the function test, and adjusts the water
temperature in the circuit to the set value.

If the set target value is higher than 38 °C or
lower than 35 °C, the unit sounds an alarm
and the display (11) shows the following
message: “TARGET VALUE <35 / >38 °C!”,
“CONFIRM BUTTON”. In this case, check
whether the target value is correct, then
press the Confirm button (15). The unit
starts temperature regulation mode and
the display (11) shows “HEATING ACTIVE” or
“COOLING ACTIVE”

CAUTION There is a risk that the patient’s

blood could be heated or cooled
excessively.

The patient’s body temperature must
be continuously monitored if the unit is
used on the patient with a oxygenator.

6.2.5 DUTIES DURING OPERATION

Checking the water flow rate

Check the water flow in the unit and oxygenator at regular
intervals. There is an impeller in the viewing window of
the water flow rate indicator (7). The individual impellers
cannot be seen at the optimum water flow rate.

Monitoring patient temperature

During operation, check the patient’s body temperature
at regular intervals.

Performing a function test

If the unit is in use for an extended period,
check the separate safety devices manually
at least once a day. To do this, press the
Function test key (12) during operation.

The unit now tests its safety electronics:

• The alarm sounds,

• Temperatures (3) and (6) on the display
(11) read

,

• The red fault indicator (4) comes on,

• The display (11) shows FUNCTION TEST.

If the test is successful, the display shows
the message FUNCTION TEST OK. The unit
then resumes operation automatically.

CAUTION If the test is not successful, the unit is

not safe for operation. In this case,

• do not continue to use the unit
on the oxygenator/patient.

• have the unit checked by a
medos Medizintechnik AG-approved
customer service..

21

6

USE AND OPERATION

6.2.6 OPERATING LANGUAGE

The status and fault messages can be shown on the
display (11) in German, English, French, Spanish,
Nederlands and Italian.

Set the display language as follows:

• Switch on the unit.

• Press and hold the “Alarm o” button
(13) for about 4 seconds. The last select­ed language appears on the display.

• Use the arrow key (14) to select the
desired language.

• About 10 seconds aer the last input,
the unit automatically returns to the
original operating mode. The last select­ed language is now active.

6.3 ALARMS

6.3.1 GENERAL INFORMATION

The unit always displays a visual alarm and sounds an au­dible alarm if there is a fault. This means that the operator
is quickly informed of any faults, thereby increasing the
operating safety of the system. The fault condition that
triggered the alarm is shown on the display (11) (with the
exception of power failure alarms).

n the case of low priority alarms (see
“6.3.2 Low-priority alarms” on page 22),
pressing the “Alarm o” button (13) cancels
the audible alarm for 10 minutes. The fault
message on the display (11) is deleted,
and the fault indicator (4) stays on for the
duration of the alarm condition.

In the case of high-priority alarms (see
“6.3.3 High-priority alarms” on page 23),
the unit switches all functions o. The
audible alarm cannot be canceled. Use
the mains switch (8) to switch the unit o.
Use the mains switch (8) to switch the unit
o. Take it out of service and, if necessary,
have it checked by an authorized service
technician.

22

6

USE AND OPERATION

6.3.2 LOW-PRIORITY ALARMS

TEMP.DIFF > 1 °C

The unit triggers this alarm if the water temperature
during operation varies by more than 1 °C from the set
target temperature value.

The display shows “TEMP.DIFF > 1 °C”, the red fault indica­tor (4) flashes and a beep sounds

• Press the “Alarm o” button (13) to can­cel the audible alarm for 10 minutes.

• Connecting or disconnecting a oxy­genator during operation can cause a
temperature dierence which triggers
the alarm.

• In cooling mode, the alarm can be
triggered at high room temperatures
because the target value (e.g. 15 °C)
cannot be reached. Increase the target
value until the unit is able to reliably
control the temperature.

• Aer the unit has been switched on
and aer a change in the target tem­perature value, this alarm function is
suppressed for a set time.

WATER LEVEL!?

The unit triggers this alarm if the water level during oper­ation falls below the MIN mark on the water level gage (5).
The display shows “WATER LEVEL!?”, the red fault indica­tor (4) comes on and a beep sounds.

• Press the “Alarm o” button (13) to
cancel the audible alarm for 10 min­utes.

• Top up with sterile water immediately
until the level is just below the MAX
mark (see “4.3.1 Filling the system with
water” on page 12).

If the water is not topped up, a high-prior­ity alarm, ”WATER LOW”, is triggered (see
“6.3.3 High-priority alarms” on page 23).

WARNING • If the level is too low, there may not

be adequate water circulation.

• Too little water can damage com­ponents and cause the unit to fail.

23

6

USE AND OPERATION

6.3.3 HIGH-PRIORITY ALARMS

WATER LOW!?

The unit triggers this alarm if operating safety is compro­mised by a low water level. The display shows “WATER
LOW!?”, the red fault indicator (4) comes on and a beep
sounds. The unit switches o the heater and pump.

The audible alarm can be canceled with the “Alarm o”
button (13).

• Switch o the unit at the mains switch (8).

• Leave it o for 30 minutes.

• Then, top up with sterile water until the level is
just below the MAX mark (5) (see “4.3.1 Filling the
system with water” on page 12).

• Switch the unit on again.

WARNING Follow the sequence of steps described

in this manual. Otherwise, the unit may
be damaged.

If the unit continues to sound an alarm, take it out of
service and have it checked by an authorized service
technician.

ALARM TEST FAILED  CUSTOMER SERVICE

The unit triggers this alarm if it detects a fault during the
automatic or manual function test, or finds that the sepa­rate safety devices are not responding. The display shows
“ALARM TEST FAILED” and → “CUSTOMER SERVICE”, the
red fault indicator (4) comes on and a beep sounds.

The audible alarm can be canceled with the “Alarm o”
button (13).

• Switch o the unit at the mains switch (8).

• Leave it o for about 2 hours.

• Switch the unit on again.

If the unit continues to sound an alarm, take it out of
service and have it checked by an authorized service
technician.

24

6

USE AND OPERATION

LOW TEMPERATURE CHECK UNIT

The unit triggers this alarm if the water tank temperature
is below the measurement range (about 9 °C). The display
shows “LOW TEMPERATURE” and “CHECK UNIT”.

The red fault indicator (4) comes on and a beep sounds.

The temperature gage showst

.

The audible alarm can be canceled with the “Alarm o”
button (13).

• Switch o the unit at the mains switch (8).

• Move the unit to a warmer environment and leave
it o for about 2 hours.

• Switch the unit on again.

WARNING • Store the unit only in the approved

temperature range of 10 °C-40 °C.
Otherwise, it could be damaged.

• Operate the unit only in the ap­proved ambient temperature range
of 10°C-30°C. Otherwise, it is not
safe to use and could be damaged.

If the unit continues to sound an alarm, take it out of
service and have it checked by an authorized service
technician.

CHECK UNIT  CUSTOMER SERVICE

The unit triggers this alarm if a variety of faults occur.

The display shows “CHECK UNIT” and “CUSTOMER
SERVICE”, the red fault indicator (4) comes on and a beep
sounds.

The audible alarm can be canceled with the “Alarm o”
button (13).

• Switch o the unit at the mains switch (8).

Take the unit out of service and have it checked by an
authorized service technician.

6.3.4 POWER FAILURE ALARM

The unit triggers this alarm if the power fails while it is
in operation. The red fault indicator (4) comes on and a
beep sounds. All other indicators are inactive.

The power supply in the unit will maintain the alarm for at
least 10 minutes without mains power.

• Switch o the unit at the mains switch (8).

The alarm ceases automatically when the
power is restored.

25

7

CLEANING AND DISINFECTION

7 CLEANING AND DISINFECTION

CAUTION During the water change or the

disinfection, no oxygenator may be
connected to the water circuit.

Pay attention to hygienic handling when
cleaning the device!

WARNING Read the safety instructions below

before starting to clean the unit:

• The system is a closed circuit. The water line
should not be disconnected in the operating area.
Do not perform water changes and disinfection in
the operating area.

• Carry out water changes and disinfection only in
hygienically clean surroundings.

• Pay attention to hygienically clean work processes.
(Disposable gloves, protective mask, hood).

• Make sure you and your sta are aware of myco­bacteria and their eects.

• Regularly check the system for microbial contam­ination. We recommend to test the water quality
once a month, nevertheless the system is in use or
stored.

• Disconnect the mains plug before starting to clean
and disinfect the unit.

• For all surfaces and parts use only disinfectants
based on aldehydes, ammonium components or
alcohols that do not attack ABS plastic, PVC or PU.
As far as possible, do not use disinfectants based
on phenol derivatives because they shorten the life
of plastics. Please note the list of surface disinfec­tants on this page 26.

• Make sure no liquid enters the unit (e.g. through
the ventilation slots).

• Only switch on the device if neither the surface is
wetted nor if liquid is inside the device outside the
tank.

• Only use sterile water for disinfecting the device!

• Fill sterile water into the tank only with auxiliaries
that have been previously disinfected.

7.1 UNIT

7.1.1 SURFACE CLEANING AND DISINFECTION

Surface

• Aer each water change, carry out a surface disin­fection (device housing, hose set and connectors).

• If the device is contaminated by contact with body
fluids, disinfect the surface and, if necessary, the
watercarrying parts.

• Make sure that aer surface disinfection no resi­dues of the cleaning agent are le on the surface
and the housing resp. interior of the device is dry
before use.

• For disinfecting the surface of the device, please

note the list of surface disinfectants on this page

26. When using the disinfectant, observe the man­ufacturer’s instructions.

• Also clean and disinfect the screw thread of the
filler neck.

• Do not switch the unit on again until the disinfec­tant has evaporated fully.

26

7

CLEANING AND DISINFECTION

Ventilation slots

Check the ventilation slots on the sides of the unit for dirt
regularly, but at least every six months. Do not open the
device yourself.

Dust deposits in the unit will reduce the eiciency of the
system. Have any inside dirt removed by an authorized
service technician.

Company Product name Actve substance

Isopropanol Isopropanol (70%)

Bode Chemie GmbH Kohrsolin

TM

Sterilium

TM

Bacilol Plus

TM

Aldehyde
Propanol
Propanol

Ecolab Healthcare

GmbH

Incidin Schaum

TM

Incidin Spray Liquid

TM

Propanol/Ethanol
Propanol/Ethanol

B.Braun Melsungen AG Meliseptol

TM

Propanol

Clorox Company USA Clorox Healthcare

Bleach Germicidal
Wipes

TM

Hypochlorid

Schülke&Mayr Mikrozid Liquid AF Propanol/Ethanol

Metrex Cavi Wipes Isopropanol/Butox

yethanol

PDI Super Sani Cloth Isopropanol

Maybe some of the listed products are not available in
your country. Take care about the availability!

7.1.2 CHANGING WATER AND DISINFECTING THE WATER CIRCUIT

We recommend changing the water with the subsequent
disinfection of the water cycle as follows in order to kill
water-borne pathogens (including non-tuberculous my­cobacteria) and other germs:

• Aer each therapy,

• As part of the initial commissioning,

• at latest 30 days aer the start of therapy,

• in case of storage and / or prolonged non-use

• generally aer 30 days, also with stored devices

• every 12 months as part of the safety inspection.

• Replace hose set and couplings every 12 months.

Filling the device during initial operation and recommissioning:

• Fill approximately 1 liter of sterile water, e.g. with
the help of a disinfected funnel into the water tank
of the device.

• Make sure that no foreign objects enter the water
tank.

• Observe the water level indicator during filling.
The water level should be slightly below the MAX
mark aer filling.

• Aer filling, screw the screw cap of the water filler
neck back in until the screw cap seals.

• Check the microbial contamination regularly.
We recommend to test the water quality once a
month, nevertheless the system is in use or stored.

Emptying the device:

• Disconnect the device from the mains.

• Place a container (bucket, bowl, etc.) under the device
or place it on a drain (e.g. sink).

• Unscrew the cap of the water filler neck in sterile
condition.

• Drain the tank contents into the collector via the
connected hoses. To do this, remove the adapter
between the Hansen couplings. Make sure that the
hoses are also completely emptied aerwards.

27

7

CLEANING AND DISINFECTION

7.1.3 DISINFECTION

• Empty the system as described.

• Insert the adapter between the Hansen couplings.

• Fill the device again with the chosen H

2O2

solution

until the tank is completely filled.

• Leave the fuel cap open during the cleaning process,
as overpressure may occur.

• Switch on the device and allow the disinfectant solu­tion to circulate at 35 °C. Ventilate the hose set.

• Complete this process aer a total of 30 minutes and
drain the used disinfectant solution from the water
circuit as described.

• Refill with sterile water

• Take the device for 5 min. in operation and then drain
the water from the water cycle. Repeat this procedure
several times with fresh sterile water.

• The water cycle must be flushed until a suitable detec­tion medium (e.g. test strips „Sanosil and pH test“) no
longer detects disinfectant residues.

• If the device continues to operate, recharge it with
sterile water until it is slightly below the MAX mark on
the level gauge.

• Stored devices must be disinfected every 30 days to
prevent the formation of a biofilm.

• If a biofilm has formed, all water-bearing parts must
be replaced.

• Liquids should never penetrate the inside of the
device outside of water-bearing parts. medos Mediz­intechnik AG recommends removing devices whose
internal parts have come into contact with foreign
fluids from the surgical area and to disinfect them
aerwards. Contaminated devices may only be used
again once disinfection and maintenance have taken
place.

For the disinfection of the water cycle a H2O2 ­containing solution is recommended.
Concentration of H2O2 should be between 3%

- 7.5%.
For a 3% H2O2 solution of Sanosil™ S015 mix
400 ml of Sanosil™ S015 with 600 ml of sterile
water.
Sanosil™ S015 is not available in every region!
Please make sure that a suitable product is
approved in your region! (e.g., Amity™ 75).

28

8

MAINTENANCE AND SAFETY-RELATED CHECKS

8 MAINTENANCE AND SAFETY-RELATED CHECKS

8.1 MAINTENANCE

We recommend concluding a service contract with Medos
Medizintechnik AG. By concluding a service contract, you
will meet the requirements of the following:

• The BetrSichV (German Ordinance on Industrial

Safety and Health) BGV A2 (German employers’
liability association regulations) (VBG 4 [German
Industrial Association Specification]) – new BGV
A3,

• The Medical Devices Directive 93/42/EEC,

• and the MPBetreibV (German Medical Device

Operator Ordinance),

all of which call for regular technical checks of devices.
The unit must be fully serviced at least every 12 months.
Servicing by our experts also guarantees the maximum
operating safety and long life of the unit.

WARNING Do not use methods for cleaning and de-

contamination other than those recom­mended by Medos Medizintechnik AG.

Check with Medos Medizintechnik AG
before introducing new processes.

That is the only way to ensure that these
processes will not damage the unit.

Please use the disinfection protocol as described in
chapter 7.

8.1.1 UNIT

• Check the ventilation slots on the sides of the unit

for dirt at least every six months. Dust deposits in
the unit will reduce the eiciency of the system.
Have a service technician (Xenios Customer Ser­vice) remove any dirt inside the unit.

• Do not open the unit yourself.

• Have Xenios Customer Service advise you of the
servicing and safety-related check intervals.

8.1.2 HOSE COUPLINGS

The seals (O-rings) on all couplings age and become dry
and brittle. Apply a thin film of silicon paste or grease (e.g.
Vaseline) at least every six months.

29

8

MAINTENANCE AND SAFETY-RELATED CHECKS

8.2 SAFETY-RELATED CHECK

To guarantee conformity with the Medical Devices Direc­tive 93/42/EEC (Annex 1, item 13.6.d) and the MPBetreibV
(German Medical Devices Operator Ordinance) (Section 6
(1)), the unit must undergo a safety-related check every 12
months.

The operator is responsible for the performing the
safety-related check properly. The MPBetreibV (Section
6 (4) 1. + 3.) states that the safety-related check can only
be performed by Medos Medizintechnik AG or a qualified
person. The safety-related check must include at least the
following:

• Checking the unit and the operating parts for
external damage, wear, aging and legibility of the
displays and lettering;

• Measuring the protective conductor resistance
and the earth current in accordance with the test
equipment and the manufacturer’s data;

• Checking all functions as per the instruction
manual;

• Checking all safety functions as per the manufac­turer’s data;

• Checking the sensors as per the manufacturer’s
data (Medos Medizintechnik AG provides a service

manual for authorized persons).

To ensure conformity with the legal safety
guidelines, we recommend concluding a
safety-related check contract with Medos
Medizintechnik AG. We will then carry out
the annual safety-related check.

In the case of very dirty units or accesso­ries sent for servicing where there is the
suspicion of contamination, we reserve
the right to refuse these for safety reasons
or to subject them to a technical examina­tion or damage analysis aer discussing
this additional process. Any additional
costs incurred shall be borne by the
customer.

30

9

REPAIRS

9 REPAIRS

WARNING • Repairs to electrical equipment may

only be performed by specialists
trained by the manufacturer.

• Improper repairs can result in consid­erable risks for the user and damage
to the unit.

The opening of the unit by unauthorized
persons will void warranty and guarantee
claims

9.1 CAUSES OF FAULTS AND ACTIONS TO TAKE

Fault Possible causes Actions to take

No or low water circulation

1. Hoses kinked

2. Couplings not firmly connected

3. Unit is positioned much lower than
the oxygenator

4. Pump worn/defective

5. Air in system

1. Ensure correct routing and posi­tioning

2. Insert couplings firmly into each
other

3. Position the unit higher or the
oxygenator lower

4. Customer Service*

5. Remove air from system

Couplings sti

O-ring dry and brittle Lubricate O-ring, e.g. with silicone

paste or Vaseline

Coupling connection drips
constantly

Outer, visible O-ring damaged or missing Replace O-ring*

Valve on unconnected coupling
drips constantly

1. Inner O-ring damaged

2. Inner O-ring dirty

1. Customer Service*

2. Insert and remove coupling
several times or contact Customer
Service

Alarm + display message:
“ALARM TEST FAILED”
“-> CUSTOMER SERVICE”

1. Separate protective devices defective

2. Pump has electrical fault

Customer Service*

Alarm + display message:
“TEMP.DIFF .>1 °C”

1. Oxygenator is connected or discon­nected during operation

2. Cooling output insuicient

3. Cooling elements or pump faulty

4. Bypass interrupted

1. Cancel alarm using “Alarm o”
button

2. See next fault

3. Customer Service*

4. Customer Service*

Target cooling value not
achieved

Cooling output insuicient because:

1. Ambient temperature too high and/
or

2. Target value too low

Both of these causes have negative
eects on the other, so at least one
cause must be eliminated.

Alarm + display message:
“WATER LEVEL!? “
Cancel alarm for 10 minutes
using “Alarm o” button

1. Water level too low

2. Unit is not horizontal

3. Sensor variation

1. Top up water

2. Make sure unit is horizontal

3. Customer Service*

*Switch o the unit immediately

31

10

DISPOSAL OF THE OLD UNIT

Fault Possible causes Actions to take

Alarm + display message:
“CHECK UNIT”
“-> CUSTOMER SERVICE”

1. Water tank empty

2. Sensor T1 broken/closed

3. Various faults

1. Top up water*

2. Customer Service*

3. Customer Service*

Alarm + display message:
“CHECK UNIT”
“LOW TEMPERATURE”

1. Unit too cold (< 9 °C)

2. Sensor T2 broken

3. Water tank frozen

1. Allow unit to warm up for a while
at room temperature*

2. Customer Service*

3. Allow unit to defrost*; check unit
for frost damage
(is water running out of the unit?)
→ Customer Service

Unit completely inoperative
and extra audible alarm

1. Power failure

2. Mains plug not making contact

3. Faulty fuse

4. Faulty unit

1. Switch o unit until power is
reinstated

2. Check plug is seated correctly in
socket

3. Customer Service*

4. Customer Service*

*Switch o the unit immediately

10 DISPOSAL OF THE OLD UNIT

Old electrical and electronic equipment
contains a number of valuable materials.
It also contains hazardous materials
needed for its operation and safety.

If handled incorrectly in residual waste,
these pose a risk to human health and
the environment. This unit must not be
disposed of with general industrial or
domestic waste.

In accordance with product responsi­bility as per Section 22 of the Kreislauf­wirtschas- und Abfallgesetz (German
Closed Substance Cycle and Waste
Management Act) and the Elektro- und
Elektronikgesetz (German Electrical
and Electronic Equipment Act) Section
2(1), no. 8, this unit must be taken to an
appropriate communal collection point or
returned to the manufacturer.

32

11

TECHNICAL DATA AND ACCESSORIES

11 TECHNICAL DATA AND ACCESSORIES

11.1 TECHNICAL DATA AND ACCESSORIES – DELTASTREAM HC

Item no. (REF)

ME DPHC 0001; ME DPHC 0002

Rated voltage

230 VAC, 50/60 Hz – 115 VAC, 50/60 Hz – 220 VAC, 50/60 Hz

Power consumption

320 W max.

Current draw

Approx. 1.5 A (220/230 V) - 3 A (115 V)

Target value range

15 °C - 39 °C

Safety cut-o

42.1 °C - 42.5 °C

Measurement range

Approx. 9 °C - 50 °C

Measurement variation

≤ ±0.1 °C (water temperature gage)

Correction value

0.5 °C (water temperature temperature gage)

Sensor element

2 × NTC 5K

Pump output

Max. 5.5 l/min., max. 0.15 bar

Heat output

Approx. 750 W max. (at 27 °C)

Cold output

Approx. 500 W max. (at 27 °C)

Heat-up time

Approx. 5-10 min. (20 °C - 37 °C)

Cool-down time

Approx. 5-10 min. (20 °C - 15 °C)

Fuse rating

2 × T 3, 15 L 250 V (220/230 V); 2 × T 5A, L 250 V (115 V)

Protection class/type

I, BF

IP rating

IPX1 (drip-proof)

Risk class (93/42/EEC)

II b

Ambient temperature

10 °C - 40 °C

Relative humidity

Approx. 30 - 70%

Storage temperature

10 °C - 40 °C

Tank contents

Approx. 0.5 l/1.0 l (MIN/MAX)

Permitted height dierence

Max. 0.75 m (unit/oxygenator)

Dimensions W×H×D

Approx. 200 × 290 × 440 mm

Weight

Approx. 17 kg (filled)

Noise level

Approx. 45 dB(A) (1 m)

Alarm level

> 55 dB(A) (3 m)

Test basics

Medical Device Directive 93/42/EEC, EN 60601-1, EN 60601-1-2, 80601-2-35

Subject to technical modifications.

The level of electrical protection for parts in use corresponds to TYPE BF.

33

11

TECHNICAL DATA AND ACCESSORIES

11.2 ACCESSORIES

Item Item no

Water connection adapter with Hansen nipple, m/m
hilite 7000 (exp.)

ME ZW02 0002

Water connection adapter with Hansen nipple, m/m
hilite child and newborn oxygenator

ME ZW05 0002

Water connection adapter for hollow fiber oxygenator
hilite 7000 (exp.); hose nozzle, HC 90° coupling

ME ZW02 0008

Water connection adapter for hollow fiber oxygenator
hilite 7000 (exp.), metal nozzle 1/4", straight

ME ZW02 0010

Water connection for hollow fiber oxygenator
hilite 2800, 2400 LT, 1000, 800 LT (children and newborns),
HC coupling

ME ZW05 0009

Water connection for hollow fiber oxygenator
hilite 2800, 2400 LT, 1000, 800 LT (children and newborns),
HC 90° coupling

ME ZW05 0010

Water connection for hollow fiber oxygenator
hilite 2800, 2400 LT, 1000, 800 LT (children and newborns),
metal nozzle, 1/4", straight

ME ZW05 0011

Disinfectant ME DPHC 0014

pH litmus paper ME DPHC 0005

deltastream Trolley ME DP 100321

We recommend the use of oxygenators from the Medos
hilite series. The deltastream heater cooler can be used
with the deltastream Trolley available as an accessory.

Additional information on Medos hilite oxygenators and
deltastream Trolley can be found in the relevant bro­chures and price lists.

34

12

GUIDELINES AND MANUFACTURER’S DECLARATION

12 GUIDELINES AND MANUFACTURER’S DECLARATION

Guidelines and manufacturer’s declaration – electromagnetic interference

The deltastream heater cooler is designed for operation in an electromagnetic environment as described below. The
customer or user of the deltastream heater cooler should ensure that it is operated in this type of environment.

Interference measurements Compliance Electromagnetic environment

guidelines

HF emissions as per CISPR11 Group 1

The deltastream heater cooler units use
HF power exclusively for their internal
functions. Its HF emissions are there­fore very low, and are unlikely to aect
nearby electronic equipment.

HF emissions as per CISPR11 Class B The deltastream heater cooler units

are suitable for use in places other
than living areas and such like that are
directly connected to the public supply
mains that also supply buildings used
for residential purposes.

Emission of harmonics as per
IEC 61000-3-2

Class A

Emission of surges/flickers as per
IEC 61000-3-3

Not applicable

35

12

GUIDELINES AND MANUFACTURER’S DECLARATION

Guidelines and manufacturer’s declaration – electromagnetic interference immunity

The units of the deltastream heater cooler are intended for operation in the electromagnetic environment described
below. The customer or user of the units should ensure that they are used in such an environment.

Interference immunity
testing

IEC 60601 test level Compliance level Electromagnetic environment

guidelines

Static electricity
discharge as per
IEC 61000-4-2

±6 kV contact discharge

±8 kV air discharge

±6 kV contact discharge

±8 kV air discharge

Flooring should be made of wood or
concrete or covered in ceramic tiles. If
the floor is covered in synthetic mate­rial, the relative humidity must be at
least 30%.

Quick, transient electrical
disturbances/bursts as
per IEC 61000-4-4

±2 kV for mains cables

±1 kV for input and out­put cables

±2 kV for mains cables

±1 kV for input and out­put cables

The quality of the supply voltage
should be suitable for a typical com­mercial or hospital environment.

Surges as per
IEC 61000-4-5

±1 kV external conductor

- external conductor

±2 kV external conductor

- earth

±1 kV

±2 kV

The quality of the supply voltage
should be suitable for a typical com­mercial or hospital environment.

Voltage dips, short inter­ruptions and variations
in the supply voltage as
per IEC 61000-4-11

<5% UT (> 95% dip in UT)
for 1/2 period

40% UT (60% dip in UT)
for 5 periods

70% UT (60% dip in UT)
for 25 periods

<5% UT (> 95% dip in UT)
for 5 seconds

<5% UT (> 95% dip in
UT) for 1/2 period

40% UT (60% dip in UT)
for 5 periods

70% UT (60% dip in UT)
for 25 periods

<5% UT (> 95% dip in
UT) for 5 seconds

The quality of the supply voltage
should be suitable for a typical com­mercial or hospital environment. If
the user of the unit requires advanced
functions even when power supply in­terruptions occur, it is recommended
to supply the unit from an uninterrupt­ible power supply or a battery.

Magnetic field and sup­ply frequency (50/60 Hz)
as per IEC 61000-4-8

3 A/m 3 A/m Magnetic fields at mains frequencies

should correspond to the typical val­ues found in commercial and hospital
environments.

NOTE: UT is the mains AC voltage before applying the test level.

36

12

GUIDELINES AND MANUFACTURER’S DECLARATION

Guidelines and manufacturer’s declaration – electromagnetic interference immunity

The deltastream heater cooler is designed for operation in an electromagnetic environment as described below. The
customer or user of the deltastream heater cooler should ensure that it is operated in this type of environment.

Interference immunity
testing

IEC 60601 test level Compliance level Electromagnetic environment

guidelines

HF conducted
disturbances as per
IEC 61000-4-6

HF radiated
disturbances as per
IEC 61000-4-3

3 V

e

150 kHz to 80 MHz

3 V

e

80 MHz to 2,5 GHz

3 V

3 V/m

Portable and mobile telecommunica­tions equipment should not be used at
a closer distance from the unit, includ­ing the cable, than the recommended
safety distance calculated using the
equation that applies to the transmis­sion frequency.

Recommended safe distance:

d = 1.17 √P

d= 1.17 √P for 80 MHz to 800 MHz

d= 2.33 √P for 800 MHz to 2.5 GHz

with P as the maximum rated output of
the transmitter in watts (W) as per the
transmitter manufacturer’s data and d
as the recommended safe distance in
meters (m).

The field strength of stationary radio
transmitters should at all frequencies
be a) less than the compliance level as
per a test performed on site, and b)

no interference should be possible in
the vicinity of devices that display the
following sign.

Note 1 The higher frequency range applies to 80 MHz and 800 MHz.

Note 2 These guidelines may not apply in all cases. The spread of electromagnetism is influenced by the absorption and

reflection of buildings, objects and people.

a. The field strength of stationary transmitters such as base stations of mobile phones and land mobile radios, amateur radio stations, AM and FM

radio and TV transmitters cannot be precisely predetermined in theory. A study of the location should be considered in order to determine the
electromagnetic environment with regard to the stationary transmitters. If the measured field strength at the location where the unit is being
used exceeds the aforementioned conformity level, the unit should be observed in order to verify proper functioning. If unusual performance
characteristics are observed, additional measures may be necessary such as a dierent alignment or a dierent location for the unit.

b. The field strength should be less than 3 V/m above a frequency range of 150 kHz to 80 MHz.

37

12

GUIDELINES AND MANUFACTURER’S DECLARATION

Recommended safe distances between portable and mobile HF telecommunications devices and
the deltastream heater cooler

The deltastream heater cooler is intended for operation in electromagnetic environments where HF interference is
controlled. The customer or user of the deltastream heater cooler can therefore help to prevent electromagnetic
interference if they maintain the minimum distance between portable and mobile HF telecommunications equipment
(transmitters) and the unit depending on the power output of the communication device, as shown below.

Rated output of transmitter
[W]

Safe distance as a factor of transmission frequency in m

150 kHz to 80 MHz

d = 1.17 √P

80 MHz to 800 MHz

d = 1.17 √P

800 MHz to 2.5 GHz

d = 2.33 √P

0.01 0.12 m 0.12 m 0.24 m

0.1 0.37 m 0.37 m 0.74 m

1 1.17 m 1.17 m 2.34 m

10 3.69 m 3.69 m 7.38 m

100 11.67 m 11.67 m 23.34 m

In the case of transmitters whose maximum rated output is not given in the table above, the distance can be deter­mined using the equation for each column, where P is the maximum rated output of the transmitter in watts (W) in
accordance with the data from the transmitter manufacturer.

Note 1 The higher frequency range applies to 80 MHz and 800 MHz.

Note 2

These guidelines may not apply in all cases. The spread of electromagnetism is influenced by the absorp-

tion by and reflection of buildings, objects and people.

38

13

QUICK GUIDE

13 QUICK GUIDE

• Connect unit to mains.

• Connect oxygenator to unit.

• Check water level in unit.

• Main Switch (8) on unit using mains switch (0/I) and watch automatic function test.

• If target temperature value on start-up is < 35 °C or > 38 °C, an alarm will sound. Cancel
and start by pressing the Confirm button.

• Set temperature using arrow keys.

• Press and hold Confirm key for temperatures above 38 °C while pressing arrow keys at
the same time.

• Press and hold Confirm key for temperatures below 35 °C while pressing arrow keys at
the same time.

• Continuously monitor patient’s body temperature.

• Monitor water level and water flow through the unit.

• In continuous operation, run the function test manually once a day using the “Function
test” button.

• Low-priority audible alarms can be canceled using the “Alarm o” button.

• High-priority alarms cannot be canceled. Switch the unit o at the mains switch.

39

13

QUICK GUIDE

WARNING The quick guide does not absolve the

user of the need to follow the full instruc­tion manual.

The unit switches all functions o in the
case of high-priority alarms. Take it out
of service and hand it over to a service
technician to perform checks and restore
operating safety.

CAUTION There is a risk that the patient’s

blood could be heated or cooled
excessively.

Monitor the patient’s body temperature
if the unit is used on the patient with a
oxygenator.

WARNING Do not operate the unit if:

• The display has failed;

• Individual segments of the tempera­ture display have failed (temperature
can no longer be read clearly);

• The red fault indicator (4) stays on
or does not come on at all (function
test);

• The beep continues to sound or does
not sound at all (function test);

• The unit does not respond when
buttons are pressed;

• When the unit is switched on or
during the function test, the unit
does not react as described in the in­struction manual (see “6.2.2 Function
test” on page 19).

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www.xenios-ag.com

EN_003_2018_03

24/7 Xenios Clinical Support [phone]

Manufacturer

medos Medizintechnik AG



Obere Steinfurt 8-10



[phone]

52222 Stolberg



[phone]

GERMANY @ www.xenios-ag.com

[e-mail]

Distributor

Xenios AG



Im Zukunspark 1



[phone]

74076 Heilbronn



[phone]

GERMANY @ www.xenios-ag.com

[e-mail]