STIHLER ELECTRONIC ASTOTHERM plus User manual

Instructions for use
ASTOTHERM®plus
Warmer for Blood, Intravenous
Fluids and Irrigation Fluids
REF
AP220
STIHLER ELECTRONIC GmbH • 70597 Stuttgart • Germany
Order No. 0550.7200.12 Rev. 06 10/2017 10/2013

To be filled in by the user:
Serial number
Registration number
Device location
Start-up date
Manufacturer:
STIHLER ELECTRONIC GmbH
Julius-Hoelder-Strasse 36
70597 Stuttgart
GERMANY
Tel. [phone]
Fax [phone]
www.stihlerelectronic.de
E-Mail: [e-mail]
© 2017 STIHLER ELECTRONIC GmbH
STIHLER ELECTRONIC GmbH, Stuttgart, declares in sole responsibility that this
product (230 –240 VAC models only) conforms to EC Directive 93/42/EEC on
medical devices.
Notified body: DEKRA Certification GmbH, registration number 0124.

Contents
1 Information about these Instructions............................................................................5
2 General information ........................................................................................................5
2.1 Guarantee conditions...................................................................................................5
2.2 Liability.........................................................................................................................5
2.3 Disposal of the equipment...........................................................................................6
2.4 Return of a used product .............................................................................................6
2.5 Service information......................................................................................................6
3 Important safety information..........................................................................................7
3.1 Dangers.......................................................................................................................7
3.2 Warnings .....................................................................................................................7
3.3 Cautions ....................................................................................................................10
3.4 Notices.......................................................................................................................11
4 Specification of application..........................................................................................12
4.1 Intended use..............................................................................................................12
4.2 Intended medical indication .......................................................................................12
4.3 Contraindications.......................................................................................................12
4.4 Possible adverse effects............................................................................................12
4.5 Intended patient population .......................................................................................12
4.6 Intended user profile..................................................................................................12
4.7 Intended use/operation environment .........................................................................12
4.8 Intended part of the body/type of tissue.....................................................................12
5 Symbols .........................................................................................................................13
6 Product description.......................................................................................................15
6.1 Introduction................................................................................................................15
6.2 Technical description.................................................................................................15
6.3 Components of the ASTOTHERM PLUS...................................................................17
6.4 Control panel .............................................................................................................18
7 Operating states............................................................................................................19
7.1 Standby mode ...........................................................................................................19
7.2 On mode....................................................................................................................20
7.3 Heating mode ............................................................................................................21
7.4 Increasing/Decreasing the setpoint temperature .......................................................22
8 Installation .....................................................................................................................23
8.1 Initial start-up.............................................................................................................23
8.2 Installation of the warmer...........................................................................................23
8.2.1 Attachment to infusion stands/rods.........................................................................23
8.2.2 Attachment to medical rails.....................................................................................23
9 Getting started...............................................................................................................24
9.1 Preparation for use....................................................................................................24
9.2 Inserting the infusion line, priming and starting the infusion ......................................26
9.3 After use....................................................................................................................28
9.4 Cleaning and disinfecting...........................................................................................29
10 Alarms and troubleshooting.......................................................................................30
10.1 Low temperature alarm............................................................................................31
10.2 Overheating alarm...................................................................................................32
10.3 Cable break alarm ...................................................................................................33
10.4 Processor alarm.......................................................................................................34
10.5 Standby mode - failure.............................................................................................35

11 Brief overview of operating states and alarms.........................................................36
12 Maintenance.................................................................................................................38
12.1 Recurrent tests ........................................................................................................39
12.2 Set up for electrical tests..........................................................................................44
12.3 Test protocol............................................................................................................45
13 Technical data..............................................................................................................47
14 Compliance with international standards..................................................................48
15 Ordering information, accessories and consumables.............................................49
16 Guidelines and manufacturer’s declaration ..............................................................50

1 Information about these Instructions
ASTOTHERM PLUS Instructions for Use
5
1 Information about these Instructions
Carefully read the entire instructions for use before using the
device.
Correct and safe operation can only be guaranteed if the
instructions for use are observed.
Incorrect use can result in damage to the product or to other
property and/or personal injury.
Keep the instructions for use for future reference.
Only use the device for the intended purpose as described in
these instructions for use. Refer to chapter
4 Specification of application.
2 General information
2.1 Guarantee conditions
The guarantee period is 12 months. During this guarantee period the manufacturer
will repair or replace free of charge all defects caused as a result of material or
manufacturing errors.
Other damage is not subject to this guarantee. The guarantee does not include
cases of misuse or incorrect handling, use of force, or damage caused by normal
wear and tear. This applies also to changes undertaken by persons who are not
authorised by the manufacturer and to modifications to the original condition.
If the equipment is damaged during the guarantee period, send the cleaned
equipment to the nearest sales point or directly to STIHLER ELECTRONIC GmbH.
The sender is responsible for any transport and packaging costs.
2.2 Liability
The manufacturer is only liable for the safety, reliability and performance of the
equipment
if all operating, servicing, and calibration procedures have been carried out by
trained and qualified persons according to the procedures published by the
manufacturer;
if only original spare parts have been used to replace components as needed;
if assembly and repairs are only carried out by authorised personnel or an
authorised service centre;
if the electrical installations satisfy the locally applicable regulations and the
IEC/EN requirements and
if the equipment is used for its intended purpose and at a suitable location in
accordance with the instructions for use.

ASTOTHERM PLUS Instructions for Use
2 General information
6
2.3 Disposal of the equipment
Electrical devices are recoverable waste and should not be disposed of in
domestic waste at the end of their service life. Please follow the local rules for the
disposal of used products, or send the cleaned and disinfected equipment with a
corresponding note to STIHLER ELECTRONIC GmbH or your closest sales point.
This will ensure the most cost efficient and proper disposal of your old equipment.
2.4 Return of a used product
A report must be sent together with the equipment, detailing the precise reasons,
circumstances, and, if known, the cause of the return. To prevent transportation
damage, the equipment should be shipped either in the original packaging or in
other, well-protected packaging.
WARNING
Risk of infection!
Clean and disinfect the equipment after every use and before you return the
equipment for repairs.
NOTICE
The customer is responsible for the proper packaging and labelling of returns.
2.5 Service information
For service or technical support, please contact your local sales point or the
following:
Terumo BCT Europe N.V
Ikaroslaan 41
1930 Zaventem
Belgium
Phone: [phone]
Fax: [phone]
Terumo BCT, Inc.
10811 W. Collins Avenue
Lakewood, Colorado 80215
USA
Phone: [phone]
877.339.4228
Fax: [phone]
www.terumobct.com
Follow the national regulations on the disposal of medical products.

3 Important safety information
ASTOTHERM PLUS Instructions for Use
7
3 Important safety information
These Instructions for Use indicate and define the following safety information:
DANGER
DANGER indicates a hazardous situation which, if not avoided, will result in
death or serious injury.
WARNING
WARNING indicates a hazardous situation which, if not avoided, could result in
death or serious injury.
CAUTION
CAUTION indicates a hazardous situation which, if not avoided, may result in
minor or moderate injury.
NOTICE
NOTICE indicates a property damage message.
3.1 Dangers
DANGER
Risk of explosion!
Do not use the ASTOTHERM PLUS in an environment at risk of explosion or in
the presence of flammable anesthetics.
3.2 Warnings
WARNING
Risk of injury!
Use of the ASTOTHERM PLUS must be carried out under the supervision of
a physician.
Read and observe all instructions, stickers, and accompanying document-
ation enclosed with the medical device. Failure to observe the instructions,
including warnings and safety information, can result in incorrect handling,
patient injury, injury to users or medical personnel, damage to the device, or
material damage.
Operate and service this equipment only in accordance with the procedures
described in these instructions and with the applicable standards, rules, and
guidelines. The manufacturer shall not be responsible for the safety of users
or patients if any actions/procedures other than those published are carried
out during operation, servicing, or recurrent tests.

ASTOTHERM PLUS Instructions for Use
3 Important safety information
8
WARNING
Risk of injury!
This device may only be operated by appropriately trained and medically
qualified healthcare professionals.
The service personnel must be appropriately trained and qualified.
Do not use the ASTOTHERM PLUS until the following error conditions have
been remedied through appropriate corrective action:
- Damaged or worn cables or plugs.
- Damaged housing, damaged or loose control panel.
- Device has been exposed to mechanical impact / exposed to severe shock
or exposed to liquid.
- Alarm without knowing the cause.
- Damaged or missing markings/safety signs/warnings on the warmer.
If the yellow “Alarm” LED and the acoustic alarm signal are not activated
automatically, when the device turns on by pressing the “Standby” Button,
remove the device from service immediately.
In the event of an overheating alarm proceed as outlined below:
1. Ensure that the ASTOTHERM PLUS safety system has deactivated the
heating function and that the temperature is dropping below 43°C. If the
temperature is not dropping, stop the treatment to prevent fluid from
returning to the patient. Remove the applicable tubing immediately from
the heat exchanger. Further evaluation should be carried out by
qualified medical personnel such as a physician before blood in the line
can be reinfused.
2. Consider the possible reasons for the alarm. For further information see
chapter 10 Alarms and troubleshooting. If in doubt, do not continue
using the warmer.
The mains cable should not touch the patient and should not hinder the
treating personnel.
The ASTOTHERM PLUS does not contain any parts the user can repair.
Therefore, do not attempt to repair the ASTOTHERM PLUS yourself.
Contact your local sales point.
Any repairs (such as, but not limited to, changing the power supply cord) to
the equipment may only be carried out by persons authorized and qualified
by the manufacturer.
Modifications to the device are not permitted.

3 Important safety information
ASTOTHERM PLUS Instructions for Use
9
WARNING
Risk of haemolysis!
Make sure that the infusion line is not kinked.
WARNING
Risk of air embolism!
When fluids are warmed up, it is possible that gas may evolve (bubble form).
Be aware of the potential for air emboli when using a blood and fluid warmer.
Therefore prime all filters, lines and disposable sets before starting a treat-
ment.
Make sure all connections of the complete fluid stream are fixed tightly to
prevent fluid leakages and inadvertent infusion of air into the fluid stream.
Do not warm infusions containing soluted gas (e.g. bicarbonate).
Extreme care should always be taken to ensure that a bolus o fair does not
pass to the patient.
WARNING
Risk of infection!
Use aseptic procedures.
Clean and disinfect the warmer after every use and before you return the
warmer for repairs.
WARNING
Risk of electric shock!
To avoid the risk of electric shock, this equipment must only be connected to
a supply mains with protective earth.
Do not use mains adapters that interrupt the earth conductor.
Do not open the ASTOTHERM PLUS housing.
If several pieces of equipment are combined or connected together (e.g., in
multiple socket outlets), the total leakage currents must not exceed the
allowable limits (refer to the respective national regulations). Observe the
requirements as stipulated in IEC/EN 60601-1 regarding medical electrical
systems.
All electrical installations must conform to the applicable electrical standards
and the specifications defined by the manufacturer.
Before every use, check to make sure that the ASTOTHERM PLUS is
undamaged.
The mains plug must be removed from the socket to fully disconnect the
ASTOTHERM PLUS from the mains.

ASTOTHERM PLUS Instructions for Use
3 Important safety information
10
WARNING
Risk of radio interference!
Use of this equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is
necessary, this equipment and the other equipment should be observed to
verify that they are operating normally.
Use of accessories, other than those specified or provided by the manufact-
urer of this equipment could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and result in improper
operation.
Portable RF communications equipment (including peripherals such as
antenna cables and external antennas) should be used no closer than 30 cm
(12 inches) to any part of the ASTOTHERM PLUS, including cables specified
by the manufacturer. Otherwise, degradation of the performance of this
equipment could result.
3.3 Cautions
CAUTION
Risk of injury!
Federal law (USA) restricts this device to sale by or on the order of a
physician.
When fixing the warmer to a mounting device, pay attention to the max. load
to avoid tilting. Using normal infusion stands ASTOTHERM PLUS may be
mounted at a height of up to 165 cm. If you use the robust IV pole
ASTOSTAND, the device can be mounted up to 180 cm.
Use only approved infusion sets / infusion extensions (e. g. ASTOTUBE, see
chapter 15 Ordering information, accessories and consumables).
CAUTION
Risk of hypothermia!
When ASTOTHERM PLUS is used, the patient’s body temperature must be
montitored at regular intervals.
The specified heating performance will only achieved by inserting the infusion
extension into the entire heat exchanger.
The temperatur control of the ASTOTHERM PLUS controls and monitors the
current temperature of the heat exchanger, but not the patient’s body temp-
erature.
If the ASTOTHERM PLUS cannot be started or if the patient's temperature
balance is insufficient, consider the use of alternative warming methods in
order to avoid or reduce hypothermia or to improve the patient's well-being.

3 Important safety information
ASTOTHERM PLUS Instructions for Use
11
CAUTION
Risk of radio interference!
The essential performance can be lost or degrated due to EM disturbances.
As a result, there is the possibility of hypothermia of the patient.
According to the standard IEC/EN 60601-1-2, medical electrical equipment
requires special precautions regarding electromagnetic compatibility (EMC)
and needs to be installed and put into service according the EMC information
provided.
This device/system may cause radio interference or may disrupt the operat-
ion of nearby devices. It may be necessary to take mitigation measures, such
as re-orienting or relocating of ASTOTHERM PLUS or shielding the location.
3.4 Notices
NOTICE
To avoid damage to the warmer:
- Do not immerse the warmer in liquid.
- Do not disinfect the warmer with these methods:
steam (autoclave)
hot air
thermo-chemical cleaning solutions.
- Refer to the specific instructions for use of the disinfectants.
The customer is responsible for the proper packaging and labelling of returns.

ASTOTHERM PLUS Instructions for Use
4 Specification of application
12
4 Specification of application
4.1 Intended use
ASTOTHERM PLUS is a warmer for Blood, Intravenous Fluids and Irrigation
Fluids. The application areas include blood transfusions, intravenous fluids,
dialysis, hemofiltration and apheresis.
4.2 Intended medical indication
The warming of medical fluids with ASTOTHERM PLUS supports the prevention
and therapy of hypothermia.
4.3 Contraindications
There are no known contraindications for warming blood, intravenous fluids and
irrigation fluids.
4.4 Possible adverse effects
There are no known side effects, which are causally attributed to the warming of
blood, intravenous fluids or irrigation fluids.
4.5 Intended patient population
There are no restrictions for the intended patient group.
4.6 Intended user profile
The ASTOTHERM PLUS Warmer is to be operated only by medically qualified
and trained healthcare professionals.
4.7 Intended use/operation environment
The warmer may only be used in professional healthcare facilities (e.g. hospital,
emergency care, dialysis, including HF surgical equipment, etc.).
The warmer is not intended for home healthcare environment.
The warmer is reusable, but requires cleaning / disinfection between the
applications.
Appropriate medical hygienic factors must be applied for the use of the warmer.
The warmer must not be used in an environment at risk of explosion or in the
present of flammable anesthetics.
4.8 Intended part of the body/type of tissue
The warmer is used to warm blood or other medical fluids supplied to the body.
The fluids are physically separated from the warmer by disposable parts (tubes).

5 Symbols
ASTOTHERM PLUS Instructions for Use
13
5 Symbols
Symbols, used on the Control Panel
Alarm condition if the yellow “Alarm” LED lights
“Standby” button.
The Warmer is in Standby Mode if the blue LED is on
“Start” button.
The Warmer is in Heating Mode, if the green LED is on
“Increase” button increases the setpoint temperature
“Decrease” button decreases the setpoint temperature
Where these symbols are applicable, they appear at the relevant point on the
device, the package, the rating plate or in the accompanying paperwork.
Defibrillation-proof type B applied part in accordance with
IEC/EN 60601-1
IPX 4
Splash proof in accordance to IEC/EN 60529
Refer to instructions for use! / Follow instructions for use!
Caution: Federal US law restricts this device to sale by or on
order of a physician.
General warning sign
Catalogue number
Serial number
Year of manufacture
Manufacturer
Electrical devices are valuable products and should not be
thrown in dustbin when the reach the end of their serviceable
life.
The device is conform to the MDD 93/42/EEC dated 14th June
1993 for medical devices. The Notified Body DEKRA
Certifications GmbH (Reg. No. 0124) monitors the quality
system of the manufacturer. The CE mark applies only to the
ASTOTHERM PLUS Warmer. Disposable parts (e.g. infusion
sets) suitable for use with this device have their own approvals.

ASTOTHERM PLUS Instructions for Use
5 Symbols
14
75JA
MEDICAL –GENERAL MEDICAL EQUIPMENT AS TO
ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS
ONLY IN ACCORDANCE WITH standards
ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012),
C1:2009/(R)2012 and A2:2010/(R):2012
CAN/CSA-C22.2 No. 60601-1:2014.
Control No. 75JA
This symbol indicates additional information.
Indicates the temperature range within which the package must
be stored and handled.
Indicates the ambient humidity range within which the package
must be stored and handled.
Indicates the pressure range within the package must be stored
and handled.
Indicates the upright position of the package
The package must be kept in a dry environment.
The contents of the package are fragile and must therefore be
handled with care. Do not drop or throw.
Recyclable - Polystyrene (acc. GB 18455-2001)
CB
Recyclable - Cardboard (acc. GB 18455-2001)
Acoustic alarm signal
No acoustic alarm signal

6 Product description
ASTOTHERM PLUS Instructions for Use
15
6 Product description
6.1 Introduction
ASTOTHERM PLUS is a device for specific heating of blood and fluids which are
delivered to the patients by transfusion, infusion or irrigation. The warming of the
liquid supports the prevention and therapy of hypothermia during or after surgery;
during longer procedures such as dialysis, hemofiltration, or apheresis the warm-
ing leads to a well-being. The applications of the ASTOTHERM PLUS therefore
include transfusion, infusion, dialysis, hemofiltration and apheresis.
The ASTOTHERM PLUS Warmer can be used to warm fluids administered to a
patient at flow rates of 0 to 6000 ml/h (i.e. 0 to 100 ml/min), see figure 1.
The infusion extension ASTOTUBE is considered as applied part acc. to IEC/EN
60601-1.
6.2 Technical description
During operation of the Warmer heat is transferred from the internal heating
element to the heat exchanger. Infusion extensions can simply be inserted in the
circumferential groove. The heat from the heat exchanger is transferred through
the inserted infusion extension to the fluid to be warmed.
The temperature of the heat exchanger is monitored by a microprocessor
controlled temperature control system and by two independent alarm systems
designed to alert the operator to failure conditions and, if necessary, to switch off
the heating process automatically in the event of excessively high temperatures.
During operation, the mean temperature of the heat exchanger is displayed; this is
not equal to the temperature of the medium to be warmed. ASTOTHERM PLUS
neither regulates nor monitors/displays the current temperature of the medium to
be warmed. The temperature of the medium (fluid) depends on a variety of factors,
such as, but not limited to additional factors:
Room temperature and ventilation
Inlet temperature of the fluid (warmed-up or cold)
Flow rate

ASTOTHERM PLUS Instructions for Use
6 Product description
16
33
34
35
36
37
38
39
40
41
42
020 40 60 80 100
CAUTION
Risk of hypothermia!
When ASTOTHERM PLUS is used, the patient’s body temperature must be
montitored at regular intervals.
The temperature control of the ASTOTHERM PLUS controls and monitors
the current temperature of the heat exchanger, but not the patient’s body
temperature.
If the ASTOTHERM PLUS cannot be started or if the patient's temperature
balance is insufficient, consider the use of alternative warming methods in
order to avoid or reduce hypothermia or to improve the patient's well-being.
Typical temperature curves are shown in the following figures.
Fig. 1: Fluid outlet temperature at 20°C inlet temperature
10 ml/min = 0,6 l/h 60 ml/min = 3,6 l/h
20 ml/min = 1,2 l/h 70 ml/min = 4,2 l/h
30 ml/min = 1,8 l/h 80 ml/min = 4,8 l/h
40 ml/min = 2,4 l/h 90 ml/min = 5,4 l/h
50 ml/min = 3,0 l/h 100 ml/min = 6,0 l/h
Flow [ml/min]
Temperature [°C]
SET: 37°C
39°C
41°C

6 Product description
ASTOTHERM PLUS Instructions for Use
17
6.3 Components of the ASTOTHERM PLUS
Fig. 2: ASTOTHERM PLUS AP220
#
Item
Description
1
Control Panel
Control buttons and displays.
(s. chapter 6.4 Control panel)
2
Heat exchanger
Transfers heat from the internal heating element
through the inserted infusion extension to the medium
to be heated.
3
Screw with Star Grip
For adapting the attachment device to infusion stands
of different diameters.
4
Universal Attachment
Device
Attaches the warmer to infusion stands (Ø 12 to
35 mm) or medical rails.
5
Tube holder rear
Fixes the infusion extension at the entry point (from
the liquid container).
6
Tube holder front
Fixes the infusion extension at the exit point (to the
patient).
7
Power Supply Cord with
Mains Plug
Conveys electricity from the wall power supply to the
device. Pull the mains plug to disconnect from supply
network.
5
6
1
2
4
3
7

ASTOTHERM PLUS Instructions for Use
6 Product description
18
6.4 Control panel
Fig. 3: Control panel
#
Item
Description
1
“Standby” LED
Illuminates blue when the warmer is in Standby Mode.
2
“Standby” button”
Turns the warmer from Standby Mode to On Mode.
Turns the warmer from any Mode to the Standby Mode.
3
“On”LED
Illuminates green when the warmer is in On Mode.
4
“Start” button
Starts the heating process while the device is in On Mode or
Alarm Mode.
Starts test 6 (see chapter 12.1 Recurrent tests), when the warmer is
operated with the middle setpoint temperature.
5
“Start” LED
Flashes green when the device is in On Mode (heating is not
yet started).
Illuminates green when the device is in Heating Mode (“Start”
button has been pressed).
6
“Decrease”button
Selection of the next lower setpoint temperature. The frame
indicates the selected temperature.
Starts test 8 (see chapter 12.1 Recurrent tests), when the warmer is
operated with the lowest setpoint temperature.
7
“Increase”button
Selection of the next higher setpoint temperature. The frame
indicates the selected temperature.
Starts test 7 (see chapter 12.1 Recurrent tests), when the warmer is
operated with the highest setpoint temperature.

7 Operating states
ASTOTHERM PLUS Instructions for Use
19
#
Item
Description
8
LCD Display
Informs the user about temperatures, test and fault conditions.
9
Actual Temperature
Displays the current temperature of the heat exchanger.
10
Setpoint
Temperatures
Shows the three possible setpoint temperatures. The frame
indicates the selected temperature.
11
“Alarm“ LED
Lights yellow if an alarm condition exists.
The following section provides further information about the operating states. This
includes a description of the actions of the user and the device responses of each
operating state.
7 Operating states
7.1 Standby mode
Control Panel
Action
When the mains cable is plugged into the socket, the device
is in Standby Mode.
Alternately, press the “Standby”button to switch the
device from any Mode to Standby Mode.
Device response
When plugging in the power cord briefly
all segments of the display and all LEDs
turn on, then
all segments of the display turn off .
“Start” LED , “On” LED , “Alarm” LED turn off.
“Standby” LED turns on.
After a prolonged power failure (> 5 sec), the device
automatically switches to Standby Mode.
In Standby Mode, only the electronic is disconnected
from the power supply. The Warmer remains connected to
the mains.
2
8
5
3
11
1

ASTOTHERM PLUS Instructions for Use
7 Operating states
20
7.2 On mode
Control Panel
Action
Press the “Standby” button to switch the device from
Standby Mode to On Mode.
Device response
“Standby” LED turns off.
“On” LED turns on.
The backlight of the display lights up.
The display shows the current temperature (eg.
22.4°C) of the heat exchanger and the available range of
setpoint temperatures . The selection frame is flashing.
“Start” LED flashes.
„Alarm” LED lights
Acoustic alarm signal beeps.
As long as the temperature of the heat exchanger is below
15°C, the display shows “- - -”.
2
1
3
8
8
9
10
5
11
●