Stihler Electronic ASTOTHERMplus User guide

REF

AP220

REF

AP220S

REF

AP260

REF

AP260S

Order No. 0450.7200.12 Rev. 03 10/2017

10/2013

Instructions for use

®

ASTOTHERM

plus

Warmer for Blood, Intravenous

Fluids and Irrigation Fluids

STIHLER ELECTRONIC GmbH • 70597 Stuttgart • Germany

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: [email protected]

© 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 .................................................................................................................... 11

3.4 Notices ....................................................................................................................... 12

4 Specification of application .......................................................................................... 13

4.1 Intended use .............................................................................................................. 13

4.2 Intended medical indication ....................................................................................... 13

4.3 Contraindications ....................................................................................................... 13

4.4 Possible adverse effects ................................................................ ............................ 13

4.5 Intended patient population ....................................................................................... 13

4.6 Intended user profile .................................................................................................. 13

4.7 Intended use/operation environment ......................................................................... 13

4.8 Intended part of the body/type of tissue ..................................................................... 14

5 Symbols ......................................................................................................................... 15

6 Product description ....................................................................................................... 17

6.1 Introduction ................................................................................................................ 17

6.2 Technical description ................................................................................................. 17

6.3 Components of the ASTOTHERM PLUS ................................................................... 21

6.4 Applied part ASTOLINE ............................................................................................. 22

6.5 Control panel ............................................................................................................. 23

7 Operating states ............................................................................................................ 25

7.1 Standby mode ........................................................................................................... 25

7.2 On mode .................................................................................................................... 26

7.3 Heating mode ............................................................................................................ 27

7.4 Increasing/Decreasing the setpoint temperature ....................................................... 28

7.5 ASTOLINE* On mode ................................................................................................ 29

7.6 ASTOLINE* Off mode ................................................................................................ 29

8 Installation ..................................................................................................................... 30

8.1 Initial start-up ............................................................................................................. 30

8.2 Installation of the warmer ........................................................................................... 30

9 Getting started ............................................................................................................... 31

9.1 Preparation for use .................................................................................................... 31

9.2 Inserting the infusion line, priming and starting the infusion ...................................... 34

9.3 After use .................................................................................................................... 38

9.4 Cleaning and disinfecting ........................................................................................... 39

10 Alarms and troubleshooting ...................................................................................... 41

10.1 Low temperature alarm ........................................................................................... 42

10.2 Overheating alarm ................................................................................................... 43

10.3 Cable break alarm ................................................................................................... 44

10.4 ASTOLINE alarm (“S” models only) ........................................................................ 45

10.5 Processor alarm ...................................................................................................... 46

10.6 Standby mode - failure ............................................................................................ 47

11 Brief overview of operating states and alarms ......................................................... 48

11.1 Overview of operating states ................................................................................... 48

11.2 Overview of alarms ................................................................................................. 49

12 Maintenance ................................................................................................................ 50

12.1 Recurrent tests ........................................................................................................ 50

12.2 Set up for electrical tests ......................................................................................... 57

12.3 Test protocol ........................................................................................................... 58

13 Technical data ............................................................................................................. 60

14 Compliance with international standards ................................................................. 61

15 Ordering information, accessories and consumables ............................................ 62

16 Guidelines and manufacturer’s declaration ............................................................. 63

1 Information about these Instructions

ASTOTHERM PLUS Instructions for Use

 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.

1 Information about these Instructions

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.

5

ASTOTHERM PLUS Instructions for Use

2 General information

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.

Follow the national regulations on the disposal of medical products.

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.

2.5 Service information

For service or technical support, please contact your local sales point or the
following:

STIHLER ELECTRONIC GmbH Tel. [phone]
Julius-Hoelder-Strasse 36 Fax [phone]
70597 Stuttgart www.stihlerelectronic.de
GERMANY E-Mail: [email protected]

6

3 Important safety information

ASTOTHERM PLUS Instructions for Use

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.

DANGER

Risk of explosion!

Do not use the ASTOTHERM PLUS in an environment at risk of explosion or in
the presence of flammable anesthetics.

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.

3 Important safety information

These Instructions for Use indicate and define the following safety information:

3.1 Dangers

3.2 Warnings

7

ASTOTHERM PLUS Instructions for Use

3 Important safety information

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, plugs, or connecting socket.

- 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 ASTOLINE („S“-models only), e.g. caused by clamps, scissors or
improper handling or storage.

- Damaged or missing markings/safety signs/warnings on the warmer and/or
ASTOLINE.

 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.

8

3 Important safety information

ASTOTHERM PLUS Instructions for Use

WARNING

Risk of overheating!

 ASTOLINE („S“-models only) must hang freely while in use. Do not kink,

cover (not even partially), clamp (for example, with a surgical clamp) or roll
ASTOLINE.

 Do not place ASTOLINE under or directly beside the patient. Heat build-up

can occur and/or the infusion extension can be squeezed off.

 Do not kink or clamp ASTOLINE during storage, to avoid internal damage.

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.

9

ASTOTHERM PLUS Instructions for Use

3 Important safety information

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 and the

ASTOLINE are undamaged.

 The mains plug must be removed from the socket to fully disconnect the

ASTOTHERM PLUS from the mains. 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.

10

3 Important safety information

ASTOTHERM PLUS Instructions for Use

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).

Damage to ASTOLINE can cause overheating, therefore follow the instructions
below:

 Only disinfect ASTOLINE with alcohol-based agents or an approved

disinfectant.

 Do not use solutions containing hypochlorite (bleach) for disinfecting

ASTOLINE.

 Do not kink or pull excessively ASTOLINE.
 Do not use any clamps or sharp instruments on ASTOLINE as damage to

ASTOLINE or the infusion line inside may result.

 Use narrow plaster strips or other narrow, soft fixation methods (for example

cannula fixation, tube holder or Velcro®) to fix ASTOLINE.

 Do not use cleaning and disinfection procedures which differ from the

procedure described.

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 and, if applicable, in the entire length
of ASTOLINE.

 The temperatur 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.

3.3 Cautions

11

ASTOTHERM PLUS Instructions for Use

3 Important safety information

CAUTION

Risk of needle dislodgement!

The weight of ASTOLINE („S“-models only) pulls on the patient’s infusion line.
Carefully secure the patient’s access against pulling. Attach the ASTOLINE by

suitable methods (e.g. tape, plaster or Velcro®).

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.

NOTICE

 To avoid damage to the warmer:

- Do not immerse the warmer or ASTOLINE 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.

 To avoid damaging during storage, place ASTOLINE loosely around the

warmer and do not kink or clamp it. Use narrow plaster strips or other narrow,
soft fixation methods (for example cannula fixation, tube holder or Velcro®) to
fix ASTOLINE.

 The customer is responsible for the proper packaging and labelling of returns.
 Only the active insulation ASTOLINE must be connected to the appliance

socket of the “S” models.

3.4 Notices

12

4 Specification of application

ASTOTHERM PLUS Instructions for Use

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

When the ASTOTHERM PLUS is used as a warmer for return blood flow in a
haemofiltration, haemodialysis or haemodiafiltration device, it must be ensured
that the entire system meets the following:
The highest set temperature (43°C) must be used with care when operating at
low effluent flow rates (below 500 ml/h) for patients who weigh less than 30 kg.
Global positive heat balance and net patient warming may occur. If necessary,
operate the warmer at a reduced temperature setting.

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.

13

ASTOTHERM PLUS Instructions for Use

4 Specification of application

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).
The optional applied part ASTOLINE may have skin contact.

14

5 Symbols

ASTOTHERM PLUS Instructions for Use

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

“ASTOLINE” button for switching On/Off the active insulation

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

Prohibition: Do not cover the active insulation ASTOLINE – risk
of overheating!

Prohibition: Do not clamp the active insulation ASTOLINE – risk
of damage and possible overheating!

Prohibition: Do not disinfect the active insulation ASTOLINE
with Hypochlorite solution – risk of damage and possible
overheating!

5 Symbols

15

ASTOTHERM PLUS Instructions for Use

5 Symbols

Symbol at the connector for potential equalization according
IEC/EN 60601-1

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.

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

16

6 Product description

ASTOTHERM PLUS Instructions for Use

6 Product description

6.1 Introduction

ASTOTHERM PLUS consists of a stand-alone Warmer and optionally of the
additional active insulation ASTOLINE („S“-models).

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 warm­ing 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 figures 1 to 4.

In the case of low flow rates, the re-cooling of the heated fluid on the way from
the warmer to the patient is limited by using the active insulation ASTOLINE („S“
models only). The heated flexible silicone body surrounds the infusion extension
on the way to the patient, ensuring that the part of the infusion line which would
otherwise be exposed to cool ambient air is insulated and heated. Its special
shape also enables infusions and transfusions to be observed all the way to the
patient.

The active insulation ASTOLINE and the infusion extension ASTOTUBE are
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

The heat protection sleeve (option) protects infusions from the effects of external
cold (e.g. air condition) and prevents heat being given off into the room.

17

ASTOTHERM PLUS Instructions for Use

6 Product description

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 and, if applicable, in the entire length
of ASTOLINE.

 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.

18

6 Product description

ASTOTHERM PLUS Instructions for Use

32

34

36

38

40

42

44

0 10 20 30 40 50 60 70 80 90 100

Temperature [°C]

Flow [ml/min]

SET: 37°C

39°C

41°C

43°C

32

34

36

38

40

42

44

0 10 20 30 40 50 60 70 80 90 100

Temperature [°C]

Flow [ml/min]

43°C

41°C

SET: 39°C

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

Typical temperature curves are shown in the following figures.

Fig. 1: Fluid outlet temperature (device outlet) at 10°C inlet temperature

model AP220 without ASTOLINE

Fig. 2: Fluid outlet temperature (patient connection) at 20°C inlet temperature

model AP220S with ASTOLINE

19

ASTOTHERM PLUS Instructions for Use

6 Product description

32

34

36

38

40

42

44

0 10 20 30 40 50 60 70 80 90 100

Temperature [°C]

Flow [ml/min]

43°C

41°C

39°C

SET: 37°C

32

34

36

38

40

42

44

0 10 20 30 40 50 60 70 80 90 100

Temperature [°C]

Flow [ml/min]

43°C

41°C

SET: 39°C

Fig. 3: Fluid outlet temperature (device outlet) at 20°C inlet temperature

Fig. 4: Fluid outlet temperature (patient connection) at 20°C inlet temperature

20

model AP260 without ASTOLINE

model AP260S with ASTOLINE

6 Product description

ASTOTHERM PLUS Instructions for Use

#

Item

Description

1

Control Panel

Control buttons and displays.
(s. chapter 6.5 Control panel)

2

Bracket*

Fixes ASTOLINE*

3

ASTOLINE*

Active insulation of the infusion extension up to the
patient (s. a. figure 6).

4

Heat Protection Sleeve**

Reduces the effect of environment and minimizes the
radiation of heat.

5

Screw with Star Grip

For adapting the attachment device to infusion stands
of different diameters.

6

Universal Attachment
Device

Attaches the warmer to infusion stands (Ø 12 to
35 mm) or medical rails.

7

Appliance socket*

Electrical connection of the active insulation
ASTOLINE.

8

Tube holder rear

Fixes the infusion extension at the entry point (from
the liquid container).

9

Sleeve grips

To open / close the heat protection sleeve**

10

Heat exchanger

(under sleeve)

Transfers heat from the internal heating element
through the inserted infusion extension to the medium
to be heated.

11

Tube holder front

Fixes the infusion extension at the exit point (to the
patient or to ASTOLINE*).

7 6 5

8 9 10

11 1 2

3 4 12

13

6.3 Components of the ASTOTHERM PLUS

Fig. 5: ASTOTHERM PLUS (AP220S)

21

ASTOTHERM PLUS Instructions for Use

6 Product description

#

Item

Description

12

Connector for Potential
Equalization**

The purpose of additional potential equalization is to
equalize potentials between different metal parts that
can be touched simultaneously, or to reduce
differences of potential which can occur during
operation between the body, the medical electrical
devices and conductive parts of other objects.
The connection is made by green-yellow insulated
leads (min. 4 mm²) to standardized plug connectors
and receptacles.
When connecting/combining medical electrical
equipment together to a medical electrical system, the
requirements of IEC/EN 60601-1 must be observed.

13

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.

#

Item

Description

1

Adapter

Connection between silicone jacket and cable.

2

Appliance plug

For electrical connection of ASTOLINE* to the Warmer
ASTOTHERM PLUS.

3

Flexible silicone jacket

Molded groove takes the infusion extension up to a
length of 130 cm and protects the heated liquid from
cooling on its way from the warmer to the patient.

*„S“ models only, **optional

6.4 Applied part ASTOLINE

Fig. 6: Active insulation ASTOLINE*

*„S“ models only

22

6 Product description

ASTOTHERM PLUS Instructions for Use

#

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.

8

LCD Display

Informs the user about temperatures, test and fault conditions.

9

Actual
Temperature

Displays the current temperature of the heat exchanger.

„S“models only

6.5 Control panel

Fig. 7: Control panel

23

ASTOTHERM PLUS Instructions for Use

6 Product description

#

Item

Description

10

Setpoint
Temperatures

Shows the three possible setpoint temperatures. The frame
indicates the selected temperature.

11*

“ASTOLINE“
button

Switches ASTOLINE on / off when the warmer is in On Mode.

12*

“ASTOLINE“
LED

Illuminates green, when ASTOLINE is switched on.

13

“Alarm“ LED

Lights yellow if an alarm condition exists.

*„S“ models only

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.

24

7 Operating states

ASTOTHERM PLUS Instructions for Use

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 and

“ASTOLINE” 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

13

12

1

7 Operating states

*„S“ models only

25

ASTOTHERM PLUS Instructions for Use

7 Operating states

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 13

26

7 Operating states

ASTOTHERM PLUS Instructions for Use

7.3 Heating mode

Control Panel

Action

Press the “Start” button at least for one second to switch
the warmer from On Mode to Heating Mode.

Device response

 While the button is pressed, a self-test is performed.

During this test the safety cut offs are activated to verify
their safe function. The brief clicking of the relay can be
heard.

 “Start” LED turns on.
 Acoustic alarm signal stops.

 The heater is activated until the setpoint temperature

(indicated by the frame) is reached.

 The display shows the increasing current

temperature of the heat exchanger (e.g. 39.4°C).

 “Alarm” LED lights until the setpoint temperature has

exceeded (during heating up) the tripping limit of the Low
Temperature Alarm (see chapter 10.1 Low temperature
alarm).

 If the “Start” button“ is not pressed long enough, the

self-test cannot be completed and the warmer will not
start. Then repeat the procedure and press the “Start”

button for at least one second.

 After a short power failure (< 5 seconds), and after return

of the power supply, the warmer resumes operation again
to the setpoint temperature which was previously
selected.

4

5

10

8

9

13

4

27

ASTOTHERM PLUS Instructions for Use

7 Operating states

7.4 Increasing/Decreasing the setpoint temperature

Control Panel
Action

1. Briefly press the “Increase” button or “Decrease”
button , while the device is turned on (On Mode) or

started (Heating Mode) to change the setpoint
temperature within the three indicated temperatures.

2. Confirm the new setpoint temperature within 5 seconds by
pressing the “Start” button .

Device response

 The flashing frame indicates the selected setpoint

temperature .

 “Start” LED flashes green until to the confirmation with

the “Start” button .

 After confirmation the “Start” LED lights green and the

frame marks the currently selected setpoint
temperature .

 The displayed actual temperature rises or falls

according to the selection.

 If the newly selected setpoint temperature is not confirmed

within 5 seconds by pressing the “Start” button , the
temperature regulation continues working with the initial
setpoint temperature.

 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.

7 6 4

10

5 4 5

10

9

4

28

7 Operating states

ASTOTHERM PLUS Instructions for Use

7.5 ASTOLINE* On mode

Control Panel

Action

Briefly press the “ASTOLINE” button while the device is
in On Mode or Heating Mode.

Device response

 “ASTOLINE” LED turns on green.
 The active insulation ASTOLINE slowly warms up.

If no heat is taken away from the Warmer (e.g. at high
ambient temperature and stagnant liquid or low flow or when
lowering the setpoint temperature) the heating element of
ASTOLINE is switched off automatically after appr. 4.5
minutes, and ASTOLINE cools down.

The “ASTOLINE” LED continues lighting. With recurrent
heat demand ASTOLINE is reconnected automatically.

7.6 ASTOLINE* Off mode

Control Panel

Action

Briefly press the “ASTOLINE” button while the device is
in ASTOLINE On Mode.

Device response

 “ASTOLINE” LED turns off.
 The active insulation ASTOLINE cools down slowly.

Turning off the Warmer with the “Standby” button
automatically causes the shutdown of ASTOLINE.

11

12

12

11

12

*„S“ models only

29

ASTOTHERM PLUS Instructions for Use

8 Installation

8 Installation

8.1 Initial start-up

Prior to first use, perfom the following inspections:

 Visual inspection (s. chapter 12.1 Recurrent tests)
 Check the mains voltage (compare the details on the type label with the

available mains voltage.) An incorrect mains voltage may destroy the

National regulations may require different inspections for the initial start-up. If
additional tests are required for electrical safety, these must be carried out
according to chapter 12.1 Recurrent tests, 12.2 Set up for electrical tests and

12.3 Test protocol.

8.2 Installation of the warmer

For safe installation, the warmer is equipped with a universal attachment device.
With this, the device can be securely attached to infusion stands as well as to
medical standard rails.

8.2.1 Attachment to infusion stands/rods

1. Turn the handwheel counterclockwise to open the attachment device.

2. Select a maximum height of 165 cm (ASTOSTAND: 180 cm) at the infusion

3. Turn the handwheel clockwise to lock the attachment device to the infusion

4. Check that the warmer is firmly fixed.

8.2.2 Attachment to medical rails

1. Unscrew the small knurled screw on the bottom of the attachment device.

2. Hang the warmer obliquely from above with the attachment device into the

3. Fix the heater by tightening the small knurled screw to the standard rail.

4. Check that the warmer is firmly fixed.

equipment.

stand and place the open clamping area of the attachment device on the
infusion stand.

stand.

standard rail.

30

9 Getting started

ASTOTHERM PLUS Instructions for Use

CAUTION

Risk of injury!

Use only approved infusion sets / infusion extensions.

ASTOTUBE

Order No.

Description

Suitable for model

IFT 30460

Sterile infusion extension made from PVC,
outer diameter Ø 4 mm, length 575 cm.
Filling volume approx. 40 ml

AP220

AP220S

IFT 30410

Sterile infusion extension made from PVC,
outer diameter Ø 6.8 mm, length 490 cm.
Filling volume approx. 89 ml

AP260

AP260S

WARNING

Risk of injury!

Do not use the ASTOTHERM PLUS until the following error conditions have
been remedied through appropriate corrective action:

- Damaged or worn cables, plugs, or connecting socket.

- 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 ASTOLINE („S“-models only), e.g. caused by clamps, scissors or
improper handling or storage.

- Damaged or missing markings/safety signs/warnings on the warmer and/or
ASTOLINE.

 To achieve the greatest possible benefit, ASTOTHERM PLUS should

be set up close enough to the patient so that the end of the active
insulation ASTOLINE* reaches up to the point of injection.

 ASTOTHERM PLUS and ASTOLINE* should be switched on before

use so that ASTOLINE* has time to heat up.

 Do not position the device in a manner that is difficult to disconnect it

from mains by the mains plug.

*„S“ models only

9 Getting started

Getting started is grouped into 4 sections. Read through each section before
performing a procedure.

ASTOTUBE is the original CE-marked accessory for ASTOTHERM PLUS.

9.1 Preparation for use

31

ASTOTHERM PLUS Instructions for Use

9 Getting started

WARNING

Risk of injury!

 Use of the ASTOTHERM PLUS must be carried out under the supervision of

a physician.

 The mains cable should not touch the patient and should not hinder the

treating personnel.

CAUTION

Risk of injury!

When fixing the Warmer to a mounting device (e.g. IV pole) pay attention to the
max. safe working load and tipping stability. Using normal infusion stands
ASTOTHERM PLUS may be mounted at a height of up to165 cm. If you use
the robust IV pole ASTOSTAND, the device can be mounted up to 180 cm.

WARNING

Risk of injury!

If the yellow "Alarm” LED and the acoustic alarm are not activated automatic­ally when the device turns on by pressing the “Standby” button, remove the
device from service immediately.

1. Attach ASTOTHERM PLUS to an IV pole or to a medical standard rail using
the attachment device according to chapter 8.2 Installation of the warmer.

2. Plug the mains plug into a socket.

 The blue “Standby” LED turns on, the device is in Standby Mode.

3. Press the “Standby” button to switch ASTOTHERM PLUS to On Mode.

 The blue “Standby” LED turns off and the green “On” LED turns on.

4. Check the audible and visual indicators and the display:

 The acoustic alarm signal beeps and the “Alarm” LED lights yellow.
 The „Start” LED flashes green and the display shows the actual

temperature of the heat exchanger and the available setpoint temperatures.

5. Press the “Increase” button or the “Decrease” button to select a
different setpoint temperature, if necessary.

32

9 Getting started

ASTOTHERM PLUS Instructions for Use

 Any change of the setpoint temperature must be confirmed within 5

seconds by pressing the „Start” button, otherwise the warmer uses the
previously selected setpoint temperature.

 As long as the temperature of the heat exchanger is below 15°C, the

display shows “- - -“.

 As long as the actual temperature is below the trigger temperature of

the low temperature alarm (4°C lower than the selected setpoint
temperature), the “Alarm” LED lights yellow.

 The setpoint temperature can be changed during operation at any time

following chapter 7.4 Increasing/Decreasing the setpoint

temperature.

NOTICE

 Only the active insulation ASTOLINE must be connected to the appliance

socket of the „S“ models.

 Do not rotate the angled connector housing of ASTOLINE in the inserted

state. This can cause damage to appliance plug and/or socket.

Fig. 8: Connection of

ASTOLINE

6. Press the “Start” button for at least one second to switch ASTOTHERM
PLUS to Heating Mode.

 While the button is pressed, the clicking of the self-test can be heard.
 The “Start” LED illuminates green.

,

Only for „S“ models:

7. Connect the plug of ASTOLINE to the appliance socket on
the rear housing part (the correct alignment is marked with
arrows, s. fig 8).

8. Press the “ASTOLINE” button to switch on
ASTOLINE.

 The “ASTOLINE” LED illuminates green and ASTOLINE

heats up slowly.

33

ASTOTHERM PLUS Instructions for Use

9 Getting started

WARNING

Risk of air embolism!

 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

treatment.

 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.

 When fluids are warmed up, it is possible that gas may evolve (bubble form).
 Do not warm infusions containing soluted gas (e.g. bicarbonate).
 Extreme care should always be taken to ensure that a bolus of air does not

pass to the patient.

WARNING

Risk of infection!

Use aseptic procedures.

WARNING

Risk of haemolysis!

Make sure that the infusion line is not kinked.

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 and, if applicable, in the entire length
of ASTOLINE.

 The temperatur 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.

Pressure losses can occur when infusion extensions are used
(depending on tube dimensions and flow rate).

9.2 Inserting the infusion line, priming and starting the infusion

34

9 Getting started

ASTOTHERM PLUS Instructions for Use

Fig. 9: Inserting the infusion extension (start)

Fig. 9: Inserting of the infusion extension (continuation)

9-A

9-B

9-C

1. Detach the heat protection sleeve (optional) by gently pulling apart the two
grips.

2. Clip the IV end of the infusion extension (female Luer Lock) into the rear tube
holder (fig. 9-A).

3. Starting from the back, wind and insert the infusion extension in a counter
clockwise direction up and around into the circumferential groove of the heat
exchanger (fig. 9-B). Gently pulling makes it easier to insert and improves the
seating of the infusion extension.

4. After leaving the last circulation, clip the infusion extension into the front tube
holder (fig. 9-C).

35

ASTOTHERM PLUS Instructions for Use

9 Getting started

Fig. 10: The use of ASTOLINE

To facilitate insertion of the infusion extension into ASTOLINE,
ASTOLINE can be dusted with usual in trade powder or talcum powder.

Fig. 11: Fixing of ASTOLINE

10-A

10-B

10-C

Additionally for „S“ models:

5. Starting from the patient side, place the end of the infusion extension with
3 to 5 cm overlap into ASTOLINE (fig. 10-A) and insert it with the thumb into

the groove of ASTOLINE (fig. 10-B).

6. Clip ASTOLINE together with the inserted infusion extension into the bracket
(fig. 10-C).

7. Check the correct position of the infusion extension:
a. Infusion extension is fully in the groove

b. Infusion extension „skips“ no circulation
c. Infusion extension is not kinked or twisted in itself

8. Connect the infusion extension with infusion set of the liquid container.

9. Prime the infusion system: allow fluid to flow until no air is observed in the
infusion lines and the lines are completely filled with fluid.

10. Place the heat protection sleeve (optional) around the heat exchanger, align
the grips upwards and let the latches snap into place by squeezing.

11. Connect the patient side end of the infusion extension to the patient cannula
and ensure a good fixation (e.g. with tape), especially when ASTOLINE is
used (fig. 11).

36

9 Getting started

ASTOTHERM PLUS Instructions for Use

Fig. 12: ASTOTHERM PLUS prepared with
ASTOLINE and heat protection sleeve

Fig. 13: ASTOTHERM PLUS prepared
(without ASTOLINE and without heat
protection sleeve)

WARNING

Risk of overheating!

 ASTOLINE („S“-models only) must hang freely while in use. Do not kink,

cover (not even partially), clamp (for example, with a surgical clamp) or roll
ASTOLINE.

 Do not place ASTOLINE under or directly beside the patient. Heat build-up

can occur and/or the infusion extension can be squeezed off.

CAUTION

Risk of needle dislodgement!

The weight of ASTOLINE („S“-models only) pulls on the patient’s infusion line.
Carefully secure the patient’s access against pulling. Attach the ASTOLINE by

suitable methods (e.g. tape, plaster or Velcro®).

from the liquid container

to the patient

to the patient
from the liquid container

The infusion extension is now free hanging with ASTOLINE (fig. 12) or without
ASTOLINE (fig.13) between the patient and ASTOTHERM PLUS and the
treatment can be started.

37

ASTOTHERM PLUS Instructions for Use

9 Getting started

To disconnect ASTOTHERM PLUS from the mains, it is necessary to
completely pull out the plug.

ASTOLINE does not have to be disconnected from its socket after use.
When not in use, ASTOLINE can be hung around the back of the
device.

NOTICE

 If ASTOLINE is disconnected from ASTOTHERM PLUS, the appliance socket

should be covered with the protective cap. This prevents the contacts to
become polluted.

 To avoid damaging during storage, place ASTOLINE loosely around the

warmer and do not kink or clamp it. Use narrow plaster strips or other narrow,
soft fixation methods (for example cannula fixation, tube holder or Velcro®) to
fix ASTOLINE.

9.3 After use

1. Discontinue infusion.

2. Press the “Standby” button for one second to switch off ASTOTHERM
PLUS and ASTOLINE („S“ models only).

 All indicators turn off, the LED “Standby” turns on blue.

3. Disconnect the infusion extension from the cannula.

Only for „S“ models:

4. Pull the infusion line out of the ASTOLINE heating profile.

5. Detach the heat protection sleeve (optional).

6. Wrap the infusion extension out from the circumferential groove of the heat
exchanger.

7. Clean and disinfect ASTOTHERM PLUS and ASTOLINE after each treatment
and if required.

38

9 Getting started

ASTOTHERM PLUS Instructions for Use

NOTICE

To avoid damage to the warmer and ASTOLINE:

- Do not immerse the warmer or ASTOLINE 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.

CAUTION

Risk of injury!

Damage to ASTOLINE can cause overheating, therefore follow the instructions
below:

 Only disinfect ASTOLINE with alcohol-based agents or an approved

disinfectant.

 Do not use solutions containing hypochlorite (bleach) for disinfecting

ASTOLINE.

 Do not kink or pull excessively ASTOLINE.
 Do not use any clamps or sharp instruments on ASTOLINE as damage to

ASTOLINE or the infusion line inside may result.

 Use narrow plaster strips or other narrow, soft fixation methods (for example

cannula fixation, tube holder or Velcro®) to fix ASTOLINE.

 Do not use cleaning and disinfection procedures which differ from the

procedure described.

9.4 Cleaning and disinfecting

ASTOTHERM PLUS

Clean and wipe-disinfect ASTOTHERM PLUS in accordance with the procedure
below:

1. Disconnect the mains plug from the socket.

2. Clean all surfaces with a soft cloth/cotton swab and mild soap-and-water
solution.

3. Disinfect ASTOTHERM PLUS with either:

 An approved disinfectant
 An alcohol-based disinfectant with a low content of aldehydes (< 0.2%)
 A mild bleach solution (max. 0.25 % hypochlorite)

39

ASTOTHERM PLUS Instructions for Use

9 Getting started

To facilitate insertion of the infusion extension, ASTOLINE can be
dusted with usual in trade powder or talcum powder.

 Meliseptol®

 Clinell Alcohol Wipes

 Biguamed® Perfekt N

 Incidin® Plus

 Mikrozid® Liquid

 HyPro medical 3% H2O2

 Bacillol® Plus

 Aniosurf

 Mikrobac® forte

 Oxivir Tb

 ClearSurf®

 Diosol 3% H2O2 PURE

 Clinell Universal Sanitising Wipes

 Virox5 RTU

ASTOLINE

Clean and wipe-disinfect ASTOLINE in accordance with the procedure below:

1. Clean all surfaces of the heating profile including the groove with a soft cloth/
cotton swab and a mild soap-and-water solution or with water only.

2. Disinfect the ASTOLINE only with approved disinfectants or with disinfectants
based on alcohol with a low content of aldehyds (< 0.2 %).

Do not disinfect ASTOLINE with disinfectants containing hypochlorite
(bleach).

In doing so follow the contact time of the disinfectant given in the specific
instructions for use of the disinfectant! After this time dry ASTOLINE.

3. Residuals of disinfectants cause a sticky surface, it is strongly recommended
to rinse with water after about 5 disinfections or once a week.

List of approved disinfectants*:

*In the United States please use only disinfectants which are registered by EPA
(U.S. Environmental Protection Agency) or cleared by FDA (U.S. Food and Drug Administration).

40

10 Alarms and troubleshooting

ASTOTHERM PLUS Instructions for Use

Alarm signal

Characteristics

visible

yellow LED lights constantently

audible

Sound pulse, all 17 sec.

10 Alarms and troubleshooting

In the event of device failure, two independent monitoring systems ensure the
safety against overheating. Except for the low temperature alarm, all alarms
switch off immediately the heating function. Thus, the overheating of the heated
liquid is surely prevented.

ASTOTHERM PLUS does not require continuous supervision by the operator, but
it must be checked at regular intervals (depending on the condition of the patient

status). Then the intended operator’s position is directly in front of the control

panel.
In case of failure of the equipment, possible injury to the patient is delayed and
the operator has sufficient time to provide alternative warming methods.

According to IEC/EN 60601-1-8 the alarms are defined as “Low Priority Alarms”.
The alarms are only triggered by technical alarm conditions (equipment faults).

The alarm signal is given visually and acoustically.

41

ASTOTHERM PLUS Instructions for Use

10 Alarms and troubleshooting

10.1 Low temperature alarm

Control panel

Device response

 The display shows an actual temperature , which

is more than 4°C below the setpoint temperature .

 The green “On” LED lights.
 The green “Start” LED lights.

 The “Alarm” LED lights yellow.
 The acoustic alarm signal is activated with a 2 minute

delay.

 The heating element is not switched off.

Alarm condition

The current temperature of the heat exchanger is more
than 4°C below the setpoint temperature during Heating
Mode.

Possible reason(s)

►Required

action(s)

Inlet temperature of the liquid is too low and the flow rate is
too high.

►Reduce flow rate.

Warmer is defective.

►Return ASTOTHERM PLUS to local sales office.

Possible actions to
clear

None, the alarm is automatically disabled if the alarm
condition is eliminated.

During warm up phase, as long as the actual temperature
is 4°C below the selected setpoint temperature, low
temperature alarm is displayed (visual alarm signal only).

8

9

10

3

5

13

42

10 Alarms and troubleshooting

ASTOTHERM PLUS Instructions for Use

10.2 Overheating alarm

Control panel

Device response

 The display shows the current temperature ,

which drops slowly after the alarm was activated.

 The selection frame flashes.
 The green “On” LED lights.
 The “Start” LED flashes green.

 The “Alarm” LED lights yellow.
 The acoustic alarm signal sounds every 17 seconds.
 The heating element is switched off.
 ASTOLINE („S“-models only) is switched off.

Alarm condition

The temperature of the heat exchanger rises to the alarm
limit of 45.5C  1.0C.

Possible reason(s)

►Required

action(s)
Effect of external heat source, such as sunlight or radiator.

►Eliminate the heat source and/or select cooler location.

Ambient temperature too high.

►Eliminate heat source and/or select cooler location.

Warmer is defective.

►Return ASTOTHERM PLUS to local sales office.

Possible actions to
clear

Press the “Start” button to switch the device back to
Heating Mode (after cooling down).

Press the “Standby” button to switch the device to
Standby Mode.

 As long as the actual temperature is above the alarm

limit, the warmer cannot be switched to the Heating
Mode.

 In order to prevent potential overheating due to a

possible failure of the temperature control system, the
ASTOTHERM PLUS possesses two independent
excessive temperature cut offs.

8

9

10

3

5

13

4

2

43

ASTOTHERM PLUS Instructions for Use

10 Alarms and troubleshooting

10.3 Cable break alarm

Control panel
Device response

 The display shows „- - -„.
 The selection frame flashes.

 The green “On” LED lights.
 The “Start” LED flashes green.

 The “Alarm” LED lights yellow.
 The acoustic alarm signal sounds every 17 seconds.
 The heating element is switched off.

Alarm condition

A defect of the cable break detection or a temperature
sensor break has been detected.

Possible reason(s)

►Required

action(s)

Warmer is defective.

►Return ASTOTHERM PLUS to local sales office.

Possible actions to
clear

Press the “Standby” button to switch the device to

Standby Mode.

8

10

3

5

13

2

44

10 Alarms and troubleshooting

ASTOTHERM PLUS Instructions for Use

10.4 ASTOLINE alarm (“S” models only)

Control panel

Device response

 The display shows the current temperature ,

which drops slowly after the alarm was activated.

 The selection frame flashes.
 The green “On” LED lights.

 The green “ASTOLINE” LED lights.
 The “Start” LED flashes green.

 The “Alarm” LED lights yellow.
 The acoustic alarm signal sounds every 17 seconds.
 The heating element is switched off.

Alarm condition

The power supply of ASTOLINE is open or shorted.

Possible reason(s)

►Required

action(s)

ASTOLINE is not connected and it was tried to switch on

ASTOLINE with the “ASTOLINE” button .

►Connect ASTOLINE and repeat procedure.

ASTOLINE is defective.

► Return ASTOLINE to local sales office.

Possible actions to
clear

1. Press the “ASTOLINE” button to switch off
ASTOLINE.

2. Press the “Start” button to switch the device to
Heating Mode.

In the case of a defective ASTOLINE, ASTOTHERM PLUS
can be used with deactivated ASTOLINE.

8

9

10

3

12 5 13

11

11

4

45

ASTOTHERM PLUS Instructions for Use

10 Alarms and troubleshooting

10.5 Processor alarm

Control panel

Device response

Even when you plug in the power cord ….

 the “Alarm” LED lights yellow.
 the acoustic alarm signal sounds every 17 seconds.
 none of the buttons can cause a device reaction.

Alarm condition

Program fault.

Possible
reason(s)

►Required

action(s)

Temporary program fault.

►Alarm reset (see below).

Permanent program fault caused by defect data file.

►Return ASTOTHERM PLUS to local sales office.

Possible actions
to clear

1. Press the “Increase” button and the “Decrease” button

at the same time until the device switches to Standby

Mode.

2. Unplug the power cord and wait one minute.

3. Plug in again the power cord.

13

7

6

46

10 Alarms and troubleshooting

ASTOTHERM PLUS Instructions for Use

10.6 Standby mode - failure

Control panel

Device response

The “Standby” LED is off and the device cannot be
switched to On Mode by pressing the “Standby” button .

Possible
reason(s)

►Required

action(s)
Power supply problem or no power.

►Check plugs and fuses compare mains voltage with rating

plate.

Warmer not plugged in.

►

1. Plug the warmer into functioning socket.

2. Press the “Standby” button .

3. Press then the “Start” button to switch the device

to Heating Mode.

Warmer is defective.

►Return ASTOTHERM PLUS to local sales office.

1 2 2

4

47

ASTOTHERM PLUS Instructions for Use

11 Brief overview of operating states and alarms

11.1 Overview of operating states

Operating
state

Display

“Standby“

LED

“ASTOLINE“

LED

“Alarm“ LED

“Start“ LED

“On“ LED

Acoustic alarm

signal

Possible
reason(s)

blue green

yellow

green

green

Standby Mode

OFF

-

On Mode

---

T

Act

≤ 15°C

or
T

Act

≥ 50°C

T

Act

-

Heating Mode

---

or

T

Act

≤ 15°C

T

Act

or

-

T

Act

„Start” button
has been pres­sed too short.
Otherwise
device defect.

T

Act

Defective
ASTOLINE or
not connected

T

act

= Actual Temperature (current temperature of heat exchanger)

T

set

= Setpoint Temperature (selected temperature, marked by a frame)

=

LED is off

=

LED lights

=

LED flashes

8 1 12

13 5 3

11 Brief overview of operating states and alarms

48

11 Brief overview of operating states and alarms

ASTOTHERM PLUS Instructions for Use

11.2 Overview of alarms

Alarm

Display

“Standby“

LED

“ASTOLINE“

LED

“Alarm“ LED

“Start“ LED

“On“ LED

Acoustic alarm

signal

Possible
reason(s)

blue

green

yellow

green

green

Low
Temperature
Alarm

T

act

or

sounds
every 2
min.

Low temperature
(T

act

≤ T

set

- 4°C)
because of cold
liquid/high flow
rate or device
defective

Excessive
Temperature
Alarm

T

act

or

T

act

> 45.5°C

± 1°C

Cable Break
Alarm

---

or

Temperature
sensor(s) or
associated
circuit(s)
interrupted

ASTOLINE
Alarm

T

act

Defective
ASTOLINE or
not connected

Processor
Alarm

OFF

Program failure

Manual
Excessive
Temperature
Alarm
Test 1

alternating

with T

act

„Start” button
has been
pressed for
longer than 3
seconds

Manual
Excessive
Temperature
Alarm
Test 2

alternating

with T

act

„Increase” button
has been
pressed for
longer than 3
seconds

Manual Low
Temperature
Alarm
Test 3

Alternating

with T

act

after
cooling to
T

act

≤

T

set

– 4°C

„Decrease”

button has been
pressed for
longer than 3
seconds

T

act

= Actual Temperature (current temperature of heat exchanger)

T

set

= Setpoint Temperature (selected temperature, marked by a frame)

=

LED is off

=

LED lights

=

LED flashes

8 1 12

13 5 3

49

ASTOTHERM PLUS Instructions for Use

12 Maintenance

No service or maintenance shall be carried out while in use with a
patient.

WARNING

 Risk of injury!
 The service personnel must be appropriately trained and qualified.

 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 authorised and qualified
by the manufacturer.

 Modifications to the device are not permitted.

12 Maintenance

ASTOTHERM PLUS does not require preventive maintenance (e.g. replacement
of liquids or components). Recurrent tests shall be performed according to
chapter 12.1.

The accessories specified in chapter 15 Ordering information, accessories
and consumables may be replaced without restriction by the operating or
maintenance personnel.

On request, STIHLER ELECTRONIC GmbH will provide service instructions that
will allow properly trained and qualified persons to repair the parts of the
equipment that the manufacturer has designated as repairable.
Provision of technical documents and/or spare parts is not an authorisation from
the manufacturer to open or repair the equipment.

12.1 Recurrent tests

12.1.1 Warmer ASTOTHERM PLUS (ASTOLINE see 12.1.2)

A recurrent test must be carried out on the ASTOTHERM PLUS warmer at least
every 24 months to ensure the safe operation of the warmer.
Please ensure that all the applicable national directives (e.g. IEC/EN 62353) for
checking the safety of medical equipment are observed additionally and that the
test equipment is calibrated.

Necessary test equipment:

 Standard medical electrical safety tester
 Digital clinical thermometer (max. diameter of probe tip 3.5 mm and

accuracy ± 0.1°C)

50

12 Maintenance

ASTOTHERM PLUS Instructions for Use

Test 1

Visual inspection

Required
Actions

Check the following items:

 Complete and legible labeling.
 No damage to the housing.
 Control panel in good condition. (Since the front foil prevents

fluid from entering the unit, it is important that its full surface
adheres securely to the housing.)

 No defects in the power supply cord and mains connector

insulation, with clean and non-corroded contacts.

Test 2

Protective earth resistance

Required
Actions

Measure the resistance between the earth pin on the power plug
and the connector for potential equalization, located on the rear
side of the housing.
For detailed information performing this test see chapter 12.2
Set up for electrical tests.

Result

The test is successful when the limits are met in accordance with
the test protocol.

Test 3

Insulation resistance

Required
Actions

Measure the resistance of the insulation between the live parts
and the parts which are connected to earth.
For detailed information performing this test see chapter 12.2
Set up for electrical tests.

Result

The test is successful when the limits are met in accordance with
the test protocol.

The following sections describe how the tests are to be performed. The attached
test protocol (see chapter 12.3 Test protocol) can be used.

51

ASTOTHERM PLUS Instructions for Use

12 Maintenance

Test 4.1

Optional to test 4.2

Equipment leakage current (alternative method)

Required
Actions

Measure the current flowing from protective earthed conductor
to the two (shorted) power supply connections.
For detailed information performing this test see chapter 12.2
Set up for electrical tests.

Result

The test is successful when the limits are met in accordance with
the test protocol.

Test 4.2

Optional to test 4.1

Earth leakage current (direct method)

Required
Actions

Measure the maximum earth leakage current (PE open)*.
Measure all combinations of line polarity with neutral open
(single fault condition) and closed (normal condition).
For detailed information performing this test see chapter 12.2
Set up for electrical tests.

Result

The test is successful when the limits are met in accordance with
the test protocol.

or alternatively:

*is usually done automatically by the safety tester

52

12 Maintenance

ASTOTHERM PLUS Instructions for Use

Test 5

Temperature control and display

Required
Actions

1. Insert the clinical thermometer
into the rear measuring bore on
the side of the heat exchanger.

2. Plug the mains plug into a socket.

3. Press the “Standby” button (On Mode).

4. Select a temperature of maximum 41°C (if necessary press
the “Decrease” button or the „Increase” button .

5. Press the “Start” button for at least one second (Heating
Mode).

6. Wait about 5 minutes until the actual temperature is equal to
the setpoint temperature.

7. Start the measurement on the clinical thermometer and
measure the actual temperature of the heat exchanger.

8. Compare the measured temperature with the displayed
temperature and the selected setpoint temperature of the
Warmer.

Result

The test is successful when the limits are met in accordance with
the test protocol (chapter 12.3 Test protocol)

 This test is used to check the essential performance.
 Absolutely avoid during this measurement influences from the

environment (drafts, heat radiation of other heat sources, etc).
Use if available the heat protection sleeve (slightly rotated so
that the measuring bore is freely accessible).

 Clinical thermometers are designed as „immersion sensors“. In

order to achieve a sufficiently accurate measurement result,
the thermometer must be immersed deep enough (depending
on manufacturer and type). Because here only the metal tip of
the thermometer is used, usually the measured temperature is
slightly lower than the real temperature.

Fig. 14: Temperature measurement

53

ASTOTHERM PLUS Instructions for Use

12 Maintenance

Test 6

Manual excessive temperature cut off 1

Required
Actions

1. Operate the Warmer with the middle setpoint temperature.

2. Hold down the “Start” button at least for 3 seconds, to
start the test.

Result

The test is successful, when:

 The display alternately indicates t1 and the actual temperature

and after a short time

- the “Start” LED flashes green,

- the “Alarm” LED lights yellow,

- the acoustic alarm signal sounds.

The test is not successful if any of the following conditions
occurs:

 The display does not indicate t1.
 The “Start” LED does not flash.

 The “Alarm” LED does not light.
 The acoustic alarm does not beep.

For the continuation of the tests, press the “Start” button to
switch the Warmer back to the Heating Mode.

Test 7

Manual excessive temperature cut off 2

Required
Actions

1. Operate the Warmer with the highest setpoint temperature.

2. Hold down the “Increase” button at least for 3 seconds, to
start the test.

Result

The test is successful, when:

 The display alternately indicates t2 and the actual temperature

and after a short time

- the “Start” LED flashes green,

- the “Alarm” LED lights yellow,

- the acoustic alarm signal sounds.

The test is not successful if any of the following conditions
occurs:

 The display does not indicate t2.
 The “Start” LED does not flash.

 The “Alarm” LED does not light.
 The acoustic alarm does not beep.

For the continuation of the tests, press the “Start” button to
switch the Warmer back to the Heating Mode.

54

12 Maintenance

ASTOTHERM PLUS Instructions for Use

Test 8

Manual low temperature alarm

Required
Actions

1. Operate the Warmer with the lowest setpoint temperature.

2. Hold down the “Decrease” button at least for 3 seconds, to
start the test.

Result

The test is successful, when:

 The display alternately indicates t3 and the actual

temperature.

 The actual temperature slowly decreases, and after cooling to

T

Act

= T

Set

– 4°C

- the “Alarm” LED flashes yellow and

- after another 2 minutes, the acoustic alarm signal sounds.

The test is not successful if any of the following conditions
occurs:

 The display does not indicate t3.
 The “Alarm” LED does not light after cooling.

 The acoustic alarm signal does not beep after another 2

minutes waiting time.

 Without heat protection sleeve the Warmer cools down faster

in this test.

 The cooling time depends in the initial temperature and the

ambient temperature.

 To exit the test, press the “Standby” button to switch the

Warmer to the Standby Mode.

55

ASTOTHERM PLUS Instructions for Use

12 Maintenance

Test 9

Manual ASTOLINE cut off („S“ models only)

Required
Actions

1. Operate the Warmer with any setpoint temperature.

2. Do not connect ASTOLINE to the designated appliance
socket or disconnect the plug of ASTOLINE.

3. Press the „ASTOLINE” button to switch the Warmer to
ASTOLINE On Mode.

Result

The test is successful, when:

 The “Start” LED flashes green.
 The “Alarm” LED flashes yellow.
 The acoustic alarm signal sounds.

The test is not successful if any of the following conditions
occurs:

 The “Start” LED does not flash.
 The “Alarm” LED does not flash.

 The acoustic alarm signal does not beep.

Test 10

Visual inspection

Required
actions

1. Clean ASTOLINE with an alcohol-based agent.

2. Dust ASTOLINE (groove and outer side) with talcum powder.

3. Pull the entire silicone jacket from ASTOLINE trough the hand
and pay attention to:

- unusual discolorations in the groove or on the outer

surface of the profile

- damages, scratches, cuts or open areas in the silicone

profile

4. Check marking and the safety signs.

Result

The test is successful, when

 No discolorations are visible
 No damages are present
 The safety signs are complete and legible

12.1.2 Active insulation ASTOLINE

In order to ensure the safe operating condition, the recurrent test of ASTOLINE
must be carried out at least every 24 months.

56

12 Maintenance

ASTOTHERM PLUS Instructions for Use

Test 11

Functional test

Required
actions

Operate ASTOLINE together with the warmer ASTOTHERM
PLUS.

Result

The test is successful, when

 ASTOLINE can be switchen on with the “ASTOLINE” button

 The “ASTOLINE” LED illuminates green
 No alarm is indicated.

Test

Measurement (True RMS)

(see also IEC/EN 62353)

Use connection to
electrical safety analyzer

2

Protective earth resistance

Connection 1 and 2

3

Insulation resistance

Connection 1

4.1

optional to 4.2

Equipment leakage current
(alternative method)

Connection 1

(and possibly connection 2,
depending on the used safety
analyzer)

4.2

optional to 4.1

Earth leakage current N.C.
(direct method)

Connection 1
Earth leakage current S.F.C

(direct method, N open)

In order to achieve a sufficient accurate measurement result, during the
measurement of the protective earth resistance, good electrical contact
with the metal of the heat exchanger must be established.
On the top of the heat exchanger (backside) is a small bare spot to
make the contact with the probe. At this point the (insulating) anodic
coating of the heat exchanger is penetrated by the manufacturer’s test.

Connection 1:
Mains plug

Connection 2:
Probe to heat exchanger
(=touchable and conductive)

12.2 Set up for electrical tests

For measuring the protective earth resistance, the insulation resistance and the
equipment/earth leakage current, the following test set up can be used:

Abb. 15: Test set up for measuring

57

ASTOTHERM PLUS Instructions for Use

12 Maintenance

ASTOTHERM

PLUS

ASTOLINE

Test equipment

Type

Type

SN

SN

Date of
calibration

Test 1: Visual inspection

P/F

Labeling and markings on ASTOTHERM PLUS

Control panel (front foil)

Housing

Power supply cord

Attachment device

Test 2: Protective earth resistance

Value [Ω]

Max [Ω]

P/F/NA

Protective earth resistance

0.3

Resistance potential equilization (optional)

0.3

Test 3: Insulation resistance

Value [MΩ]

Min [MΩ]

P/F

Insulation resistance

100

Test 4: Leakage current test either to 4.1 or 4.2

 4.1 Equipment leakage current (alternative method)

Alternative test for measurement the earth leakage current using the direct method (Test 4.2)

Value [mA]

Max [mA]

P/F

Equipment leakage current

1.0

 4.2 Earth leakage current (direct method)

Alternative test for measurement the equipment leakage current using the alternative method
(Test 4.1)
PE (Protective ground) open. Measure all combinations of line polarity.

Value [mA]

Max [mA]

P/F

Earth leakage current N.C

0.5

Earth leakage current S.F.C (N open)

1.0

12.3 Test protocol

58

12 Maintenance

ASTOTHERM PLUS Instructions for Use

Test 5: Temperature control and display

Value [°C]

Min [°C]

Max [°C]

P/F

Selected setpoint temperature T

(max. 41°C)

Temperature measurement TT

(with clinical thermometer)

T – 0.5

T + 0.5

Actual temperature (displayed) TD

T – 0.3

T + 0.3

Manual tests

P/F/NA

Test 6: Manual excessive temperature cut off 1 (t1)

Test 7: Manual excessive temperature cut off 2 (t2)

Test 8: Manual low temperature alarm (t3)

Test 9: Manual ASTOLINE cut off

ASTOLINE

P/F/NA

Test 10: Visual inspection ASTOLINE

Test 11: Functional test

Overall assessment

Please mark where applicable

No safety or functional deficiencies were detected



No direct risk, deficiencies detected may be corrected on short term



Equipment shall be taken out of operation until deficiencies are corrected



Equipment does not comply – Modification / Exchange of components / Taking
out of service - is recommended



Comments

Date

Signature

59

ASTOTHERM PLUS Instructions for Use

13 Technical data

ASTOTHERM PLUS
REF AP220..
AP220S..
AP260..
AP260S..

..AU
..CH
..CN

..DK

..EU

..UK

..NA

..JA

Electrical connection

230 - 240 VAC

50 – 60 Hz

100 - 115 VAC

50 – 60 Hz

Fuses primary

(F1 F2)

T4AH 250 V (5 x 20 mm)

Fuses secondary

(F3 F4)

T0630AL 250 V (TR5 type)

Power consumption

max. 450 W

Classification

(IEC/EN 60601-1)

Class I, Type B

applied part is defibrillation proof

Classification

(IEC/EN 60529) IPX4

Classification

(MDD 93/42/EEC)

Class IIb

Code UMDNS

10-447

Code GMDN

47616

Regulatory class as per FDA

II

Dimensions

(excl. ASTOLINE)
Height
Width
Depth

(incl. attachment device)

max.
145 mm
135 mm
295 mm

Weight

(excl. ASTOLINE) 2.9 kg

Operating mode

continuous operation

Permissible environmental
conditions

Humidity

Temperature

Pressure

in operation

10% to 90%

not condensing

+16°C to +32°C

700 hPa to

1060 hPa

In storage

10% to 90%

not condensing

-20°C to +60°C

500 hPa to

1060 hPa

Selectable setpoint temperatures

Standard setting by manufacturer, special
setpoint temperatures are possible in the
range from 36°C to 43°C

43°C

41°C

39°C

Essential performance acc. to
IEC/EN 60601-1

Regulation of the temperature of the heat

exchanger to a selectable Set-temperature between

37 °C to 43.5 °C +/- 0.5 °C

1.Excessive temperature cut off

2. Excessive temperature cut off

if max. T

Set

= 43°C

45.5°C (± 1°C)

46.0°C (± 1°C)

if max. T

Set

= 41°C

42.5°C (± 0.5°C)

43.5°C (± 0.5°C)

Low temperature alarm

T

Setpoint

– 4°C (± 0.5°C)

Heating up time (22°C to 40°C)

approx. 1 minute

Self-start
after power interruption up to

5 seconds

ASTOLINE

8 W rated power

supplied with 22 VDC from ASTOTHERM PLUS

13 Technical data

60

14 Compliance with international standards

ASTOTHERM PLUS Instructions for Use

Standard

Title

IEC/EN 60601-1
ANSI/AAMI ES 60601-1

CAN/CSA C22.2 No.
60601-1

Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance

IEC/EN 60601-1-2

Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance ­Collateral standard: Electromagnetic compatibility –
Requirements and tests

IEC/EN 60601-1-8

Medical electrical equipment - Part 1-8: General
requirements for basic safety and essential performance

- Collateral Standard: General requirements, tests and
guidance for alarm systems in medical electrical
equipment and medical electrical systems.

ASTM F 2172-02

Standard Specification for Blood/Intravenous
Fluid/Irrigation Fluid Warmers

14 Compliance with international standards

61

ASTOTHERM PLUS Instructions for Use

15 Ordering information, accessories and consumables

REF

(Order-No.)

Description

AP220xx

For 4 mm infusion line,
without ASTOLINE, Heat Protection Sleeve optional

AP220Sxx

For 4 mm infusion line,
with ASTOLINE AL222, with Heat Protection Sleeve

AP260xx

For 6.8 mm infusion line,
without ASTOLINE, with Heat Protection Sleeve

AP260Sxx

For 6.8 mm infusion line,
with ASTOLINE AL260, with Heat Protection Sleeve

xx =

EU 230 - 240 VAC, CEE 7/7 (Schuko) Plug

CH 230 - 240 VAC, Swiss Plug

DK 230 - 240 VAC, Danish Plug

CN 230 - 240 VAC, China Plug

UK 230 - 240 VAC, BS Plug incl. 13A fuse

AU 230 - 240 VAC, Australian Plug

NA 100 - 115 VAC, Hospital Grade Plug

JA 100 - 115 VAC, Hospital Grade Plug

REF

(Order-No.)

Description

AL222

ASTOLINE suitable for infusion lines Ø 4 mm,
length: 130 cm

AL260

ASTOLINE suitable for infusion lines Ø 6.8 mm,
length: 130 cm

WM226

Heat Protection Sleeve suitable for all models

REF

(Order-No.)

Description

IFT30460

ASTOTUBE, sterile infusion extension made from PVC,

outer diameter Ø 4 mm (suitable for AP220/220S),
filling volume approx. 40 ml

IFT30410

ASTOTUBE, sterile infusion extension made from PVC,

outer diameter Ø 6.8 mm (suitable for AP260/260S),
filling volume approx. 89 ml

15 Ordering information, accessories and consumables

You can order an ASTOTHERM PLUS Warmer using the following order
numbers:

Accessory:

Suitable Consumables:

We reserve the right to modify design and technical data without notice.

62

16 Guidelines and manufacturer’s declaration

ASTOTHERM PLUS Instructions for Use

Guidance and manufacturer's declaration - electromagnetic emissions

ASTOTHERM PLUS is intended for use in the electromagnetic environment specified below. The customer or user of the
ASTOTHERM PLUS should assure that it is used in such an environment.

Emission test

Compliance

Electromagnetic environment - guidance

RF emissions
CISPR 11/EN 55011

Group 1

ASTOTHERM PLUS uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are not
likely to cause interference in nearby electronic equipment.

RF emissions
CISPR 11/EN 55011

Class A

The emissions characteristics of this equipment make it
suitable for use in industrial areas and hospitals (CISPR 11
class A). If it is used in a residential environment (for which
CISPR 11 class B is normally required) this equipment might
not offer adequate protection to radio-frequency communicat­ion services. The user might need to take mitigation measure­es, such as relocating or re-orienting the equipment.

Harmonic emissions IEC/EN
61000-3-2

Class A

Voltage fluctuations / flicker
emissions
IEC/EN 61000-3-3

Complies

Guidance and manufacturer's declaration - electromagnetic immunity

The ASTOTHERM PLUS is intended for use in the electromagnetic environment specified below.
The customer or user of the ASTOTHERM PLUS should assure that it is used in such an environment.

Immunity test

Test level

Compliance
level

Electromagnetic environment ­guidance

Electrostatic
discharge (ESD)
IEC/EN 61000-4-2

± 8 kV contact
± 2 kV, ± 4 kV, ± 8
kV, ± 15 kV air

in compliance

Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.

Electrical fast
transient/bursts
IEC/EN 61000-4-4

± 2 kV
100 kHz repetition
frequency

in compliance

Mains power quality should be that of a
typical commercial or hospital
environment.

Surge
IEC/EN 61000-4-5

± 0.5 kV, ± 1 kV
Line-to-line
± 0.5 kV, ± 1 kV, ±
2 kV
Line- to-ground

in compliance

Mains power quality should be that of a
typical commercial or hospital
environment.

Voltage dips
IEC/EN 61000-4-11

0 % UT; 0.5 cycle
At 0°, 45°, 90°, 135°,
180°, 225°, 270° and
315°

0 % UT; 1 cycle
and

70 % UT; 25/30
cycles
Single phase: at 0°

in compliance

Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the
ASTOTHERM PLUS requires continued
operation during power mains
interruptions, it is recommended that the
ASTOTHERM PLUS be powered from an
uninterruptible power supply or a battery.

Voltage interruptions
IEC/EN 61000-4-11

0 % UT; 250/300
cycle

in compliance

Rated power
frequency
magnetic fields
IEC/EN 61000-4-8

30 A/m
50 Hz or 60 Hz

in compliance

Power frequency magnetic fields should
be at levels characteristic of a typical
commercial or hospital environment.

NOTE UT is the AC mains voltage prior to application of the test level.

16 Guidelines and manufacturer’s declaration

63

ASTOTHERM PLUS Instructions for Use

16 Guidelines and manufacturer’s declaration

Guidance and manufacturer's declaration - electromagnetic immunity

The ASTOTHERM PLUS is intended for use in the electromagnetic environment specified below.
The customer or user of the ASTOTHERM PLUS should assure that it is used in such an environment.

Immunity test

Test level

Compliance
level

Electromagnetic environment – guidance
Recommended separation distance

Conducted
disturbances induced
by RF fields
IEC/EN 61000-4-6

3 Vrms

0.15 MHz to 80 MHz
6 Vrms in ISM bands

between 0.15 MHz
and 80 MHz
80 % AM at 1 kHz

in compliance

Pd 2.1

Radiated RF EM
fields
IEC/EN 61000-4-3

3 V/m
80 MHz to 2.7 GHz
80 % AM at 1 kHz

in compliance

Pd 2.1

80 MHz to 800 MHz

Pd 3.2

800 MHz to 2.7 GHz

Portable and mobile RF communications equipment should be used no closer to any part of the ASTOTHERM PLUS,
including cables, than the recommended separation distance calculated from the equation applicable to frequency of the
transmitter.

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and
"d" is the recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the
compliance level in each frequency range b.
Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE1. At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE2. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.

a

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To
assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the ASTOTHERM PLUS is used exceeds the applicable
RF compliance level above, the ASTOTHERM PLUS should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as reorienting or relocating the ASTOTHERM
PLUS.

b

Over the frequency range 150 kHz to 80 MHz, field strength should be less than 3 V/m.

Recommended separation distances between

Portable and mobile RF communications equipment and the ASTOTHERM PLUS

The ASTOTHERM PLUS is intended for use in the electromagnetic environment in which radiated RF disturbances are
controlled. The customer or user of the ASTOTHERM PLUS can help prevent electromagnetic interference by maintaining
a minimum distance between portable and mobile RF communications equipment (transmitters) and the ASTOTHERM
PLUS as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output
power of transmitter
(W)

Separation distance according to frequency of transmitter (m)

150 kHz to 80 MHz

Pd 2.1

80 MHz to 800 MHz

Pd 2.1

800 MHz to 2.7 GHz

Pd 3.2

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

For transmitters rated at maximum output power not listed above, the recommended separation distance d in
meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in Watts (W) according to the transmitter manufacturer.

NOTE 1: The compliance level between 80 MHz and 2.7 GHz is intended to decrease the likelihood that mobile/portable
communication equipment could cause interference if it is inadvertently brought into patient areas. For this reason, an
additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in this frequency
range.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.

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