Xenios DELTASTREAM HC User 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 repro-
duced 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 with-
out 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]
[email protected]om
www.xenios-ag.com
MANUFACTURER
medos Medizintechnik AG
Obere Steinfurt 8-10
52222 Stolberg
Germany
Phone [phone]
Fax [phone]
[email protected]om
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.
INTRODUCTION

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
ÖMeans »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 informa-
tion 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 corre-
spond to the best of our knowledge and good manufac-
turing 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 modifica-
tions 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. car-
diovascular 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 contractu-
al 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 instruc-
tions:
• 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 screw-
cap 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 tem-
perature (10-39 °C)
• We recommend only operating the
unit with Medos oxygenators and
their original accessories.
• Do not operate the unit in the pres-
ence of flammable gases.
• Do not use the unit in heating/cool-
ing mode in conjunction with other
sources of heat.
• Do not operate the unit in the vicinity
of heat sources (beams of light, heat-
ers/radiators, direct sunlight, etc.).
• Perform servicing and safety-relat-
ed checks in accordance with this
instruction manual.
• Allow only authorized personnel to
operate the unit.
• The patient’s body temperature must
be continuously monitored separate-
ly 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 sub-
sequently 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 mate-
rials have been chosen for their environ-
mental 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 lon-
ger needed at an appropriate collection
point..
Where possible, keep the original packag-
ing 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 approxi-
mately 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 avail-
able 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 deltas-
tream 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 con-
nected to the mains and switched on.
When filling the unit for the first time,
please follow the instructions on disinfect-
ing (see “Maybe some of the listed prod-
ucts 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 con-
taminating 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 oxy-
genators. 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 discon-
nected 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, fol-
low the instructions below when connecting the power:
• Before switching on the unit, compare the connec-
tion 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 corre-
sponds 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 connec-
tion 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-con-
duction 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 indi-
cators 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-opera-
tive 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 lower-
ing of the patient’s temperature (therapeutic hypo-
thermia), 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 mini-
mum 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 Chang-
ing 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 posi-
tion 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 nec-
essary, 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 automatical-
ly 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..