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
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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 dierent 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 Zukunspark 1
74076 Heilbronn
Germany
Phone +49 7131 2706-0
Fax +49 7131 2706-299
info@xenios-ag.com
www.xenios-ag.com
MANUFACTURER
medos Medizintechnik AG
Obere Steinfurt 8-10
52222 Stolberg
Germany
Phone +49 7131 2706-300
Fax +49 7131 2706-498
info@xenios-ag.com
www.xenios-ag.com
PUBLICATION DATE
March 2018
Soware version 1.02
IFU Version:
EN_003_2018_03
Item number:
MEDPHC0016
VALID FOR
ME DPHC 0001 Deltastream HC, 230V
ME DPHC 0002 Deltastream HC, 115V
AVAILABLE LANGUAGES
The following languages are available as hard copies:
These andall otherproduct-specificlanguage versionsare
available as PDF downloads at www.xenios-campus.
com.
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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 dier from the delivery state.
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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
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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
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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
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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 aecting 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.
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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 dierence between the
unit and oxygenator must be <75cm.
• 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 suicient
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.
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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.
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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.
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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
17kg.
• 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 suicient 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.
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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
aer filling.
• Screw the cap on the water filler tightly until it is
sealed.
Figure 1:
5
2
Filling the system with water
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