Stihler Astotherm Plus User manual

Operating Instructions

®

ASTOTHERM

Warmer for blood, infusion and irrigation solutions

Models AP220

AP220S
AP260
AP260S

plus

STIHLER ELECTRONIC GmbH • 70597 Stuttgart • Germany

Part-No.0450.7200.12, Rev. 1 – 06/2006

To be filled in by the user:

Serial number ______________________________________________

Stock number ______________________________________________

Appliance location ______________________________________________

Date of commissioning ______________________________________________

Manufacturer: Telephone: Telefax:

STIHLER ELECTRONIC GmbH Nat.: 0711/72067-0 Nat.: 0711/72067-57

Julius-Hölder-Str. 36 Int.: [phone] Int.: [phone]
70597 Stuttgart E-Mail: [e-mail]
Germany

STIHLER ELECTRONIC GmbH, Stuttgart takes sole responsibility for declaring that this
product (only 230-240 VAC models) complies with EC Council Directive 93/42/EEC pertaining
to medical products, dated 14th June 1993.

Appointed agency: DEKRA Certification GmbH, permit number 0124.

Year of approval for application of CE symbol: 2004

Operating Instructions ASTOTHERM

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CONTENTS

Section............................................................................................................Page

1 WARNINGS AND SAFETY INFORMATION ............................................................................4

2 EXPLANATIONS OF SYMBOLS .............................................................................................6

3 GENERAL TECHNICAL DATA ................................................................................................7

4 DESCRIPTION OF THE ASTOTHERM

5 DESCRIPTION OF ASTOLINE® (optional accessory) ...........................................................13

6 CONTROL PANEL.................................................................................................................14

7 INSTALLATION...................................................................................................................... 16

8 COMMISSIONING ................................................................................................................. 17

9 SWITCHING OFF THE APPLIANCE .....................................................................................19

10 CLEANING AND DISINFECTION........................................................................................... 20

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11 PERIODICALLY RECURRING TEST MEASURES................................................................ 21

12 REPAIRS AND CUSTOMER SERVICE .................................................................................23

13 WARRANTY TERMS..............................................................................................................24

14 RETURN AND DISPOSAL OF APPLIANCES ........................................................................ 24

15 EMC GUIDANCE AND MANUFACTURER’S DECLARATION.............................................. 25

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Operating Instructions ASTOTHERM

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1 WARNINGS AND SAFETY INFORMATION

Follow the operating instructions! Any handling of the appliance assumes
the accurate knowledge of and compliance with these instructions.

WARNINGS

• If the ASTOTHERM PLUS excessive temperature alarm is triggered, stop supply of fluid to
the patient immediately.

• When the ASTOTHERM PLUS is combined with other electrical medical devices, the

relevant standards must be observed (see EN 60601-1-1 Safety requirements for medical
systems).

• When the ASTOTHERM PLUS is used as a component in a haemofiltration,
haemodialysis or haemodiafiltration device, it must be ensured that the entire system
meets EN 60601-2-16. The temperature of the fluid may not exceed 41 °C. The
haemodialysis, haemofiltration or haemodiafiltration device must have an independent
overtemperature cut-out (41 °C) which at the very least must be checked before every
treatment.

• To ensure reliable disconnection from the mains, pull out the mains plug if required.

• Do not use the ASTOTHERM PLUS in areas at risk of explosion.

• In order to minimise the risk of electrical shock, do not remove the rear of the housing. Do

not use mains adapters or extensions which interrupt the earth wire.

• In order to ensure the safety of user/patient, the application and servicing measures
specified by the manufacturer must be carried out.

• The manufacturer will not be liable for user/patient safety if measures other than those
specified by the manufacturer are applied in use, servicing and safety checks.

• Persons performing such measures must be appropriately qualified and trained.

• Any servicing measures and modifications to the appliance may be carried out only by

qualified persons authorised by the manufacturer.

• Any electrical installations must comply with the national standards and regulations
applicable in each case (e.g. DIN VDE 0107).

• In the case of several appliances being combined and connected (e.g. at multiple
sockets), the sum of the leak currents must not exceed the permissible limit value.

• Only use sterile infusions extensions marked expressly as accessories for the
ASTOTHERM PLUS.

• All disposable sterile infusion systems are intended to be used only once.

• Use only CE-marked accessories marked expressly as accessories for the ASTOTHERM

PLUS (e.g. ASTOTUBE, see also Section 7).

• Only the ASTOLINE active insulation cover may be connected to the appliance socket of

the ASTOTHERM PLUS 220S or AP260S.

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Operating Instructions ASTOTHERM

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WARNINGS (observe when using the ASTOLINE)

• ASTOLINE may only be connected to the appliance socket provided for it on the
ASTOTHERM PLUS.

• The ASTOLINE may not be covered during use (cloths, emergency films etc.).

• Do not bend the ASTOLINE.

SAFETY INFORMATION

• All applications involving the use of an ASTOTHERM PLUS warmer must performed under
supervision of medically trained staff.

• When fluids are warmed up, it is possible that gas may evolve (bubbles form).

• Be aware of the potential for air emboli when using a blood and fluid warmer.

• Fully prime all filters, lines and disposable sets before starting an infusion.

• Make sure all connections of the complete fluid stream are fixed tightly to prevent

inadvertent infusion of air into the fluidstream.

• 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.

• In order to minimise the risk of injury to patients or users, or the risk of damage to
property, please notify your regional sales agent immediately of any of the following
events. In such cases, do not use the ASTOTHERM PLUS until the appropriate corrective
measures have been taken.

- Damaged or worn mains connecting cables or mains plug

- Damaged housing, damaged front panel, front panel with poor adhesion

- A system which has suffered a severe shaking, blow or fall

- An appliance whose electronic components have been exposed to the effects of fluids

- A system which has already given one person an electrical shock

- A system which seems to overheat

• When fitting the warmer to an infusion stand, follow the instructions of the infusion stand
manufacturer with regard to maximum load and the avoidance of tilting.

• ASTOTHERM PLUS is a medical electrical equipment. According to Medical Safety EMC
standard EN60601-1-2-2001 medical electrical equipment needs special precautions
regarding Electromagnetic Compatibility. Please follow the related notes in chapter 15.

• Portable and RF communication equipment (especially mobile phones) may interfere

medical electrical equipment (see chapter 15).

• High frequency surgical appliances may interfere medical electrical equipment (see

chapter 15).

CONTRAINDICATIONS

No contraindications are currently known apart from those which may generally occur
when infusions, transfusions or dialysis processes are used.

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Operating Instructions ASTOTHERM

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2 EXPLANATIONS OF SYMBOLS

Insofar as these symbols are applicable, they appear in the relevant place on the appliance,
in the packaging, on the rating plate or in the accompanying paperwork.

Symbol: this shows that the appliance is a Type B defibrillation-protected part
as per standards IEC 601-1 and VDE 0750 Part 1.

Symbol: protected from water splashes

Symbol: appears before the 4-figure year of manufacture of the appliance

Symbol: Indicates the manufacturer.

Symbol: indicates that an absolute prerequisite for operating the appliance

safely is accurate knowledge of the accompanying documents before using

the appliance

Symbol: certifies compliance with the requirements of Medical Products

Directive 93/42/EEC

Control lamp: excessive or inadequate temperature alarm

(look at temperature display)

Control lamp: stand-by mode

Key: "Appliance On/Off"

(keep depressed for at least 1 second to switch off)

Key: "ASTOLINE On/Off"; models AP220S, AP260S only

Key: "Start", confirms temperature selected and starts the warmer heating

process (keep depressed for approx. 1 second)

Key: "Increase" selected temperature

Key: "Decrease" selected temperature

Symbol: energy output values for ASTOLINE appliance socket

Symbol: equipotential bonding (optional)

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Operating Instructions ASTOTHERM

3 GENERAL TECHNICAL DATA

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ASTOTHERM PLUS 220 and
220S (with ASTOLINE)
ASTOTHERM PLUS 260 and
260S (with ASTOLINE)

Power supply cord Earthing-contact

Electrical connection 230-240 VAC ±10%

Impedance of protective earthing ≤ 0.2 Ω

Insulation resistance > 2 MΩ

Leakage current ≤ 0.2 mA

Primary fuses 2 x 4 A

Secondary fuses 2 x 0.63 A

Power consumption 450 W

Self-start after mains power failure 5 to 30 sec.

Protection class I

Protection level to IEC 601-1 Type B defibrillation-proof applied part

AP220 EU

AP220S EU

AP260 EU

AP260S EU

type plug

H 05 VVF

3 x 0,75

AP220 UK

AP220S UK

AP260 UK

AP260S UK

BS-plug incl.

13 A Fuse

H 05 VVF

3 x 1

50-60 Hz

AP220 CH

AP220S CH

AP260 CH

AP260S CH

Swiss plug

H 05 VVF

3 x 0,75

AP220 DK

AP220S DK

AP260 DK

AP260S DK

DK plug

DK2-Ia, DK2-5a

3 x 0,75

Signal output part
("S“ Models only)

Humidity protection IP X4

Classification as per Appendix IX IIb (Rule 9)

UMDNS Code 10-447

Dimensions (excl. ASTOLINE)
height x width x depth

Weight (excl. ASTOLINE) 2.9 kg

Heating-up time Approx. 1 min (20°C to 35°C)

Operating mode Continuous operation

Permissible environmental
conditions:

operation:

storage:

3 selectable control temperatures Standard: 39°C / 41°C / 43°C (± 0.5°C)

1st Safety temperature cut-off
2nd Safety temperature cut-off

Heating element bimetal switch 65.0°C (± 5°C)

DC 8 W, can only be used for ASTOLINE

145 mm x 135 mm x 295 mm

Humidity:

10% to 90%

10% to 100%

Optional: from 36°C to 43°C

45.5°C (± 1°C)

46.0°C (± 1°C)

Temperature:

0°C to 32°C

-20°C to 60°C

Pressure:

700 hPa to 1060 hPa
500 hPa to 1060 hPa

Inadequate temperature alarm 4°C (± 1°C) below control temperature

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Operating Instructions ASTOTHERM

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Permissible cleaning agents and disinfectants

• Bacillol plus (Bode Chemie, Hamburg)

• Meliseptol (B. Braun, Melsungen)

• Mikrozid Liquid (Schülke und Mayr, Hamburg)

• Mikrozid Pumpspray (Schülke und Mayr, Hamburg)

• or ¼%-strength sodium hypochlorite solution

Compliance with international standards:

EN 60601-1: 1990 + A1: 1993 + A2: 1995

Electrical medical equipment: Part 1: General requirements for safety

EN 60601-1-2: 2001

Electrical medical equipment: Part 1: Addition standard: Electromagnetic compatibility,
requirements and tests

ASTM F 2172-02:

Standard Specification for Blood, Fluid Warmers

Environmental information

By dispensing with the mains switch, it has been possible to considerably improve the
ecobalance of the ASTOTHERM PLUS. The raw materials and energy which would be
incurred in manufacturing the mains switch and cables are saved. Even 10 years' permanent
stand-by mode uses less energy (< 1 W) than that which would be used to manufacture the
switch and cables.

To save still more energy, we recommend disconnecting the mains plug when the appliance
is not in use.

We reserve the right to make modifications to the design and technical data without
prior notice.

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Operating Instructions ASTOTHERM

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4 DESCRIPTION OF THE ASTOTHERM®plus

220(S)/260(S)

Appliance socket for the

STOLINE (optional

ttachment device

Handwheel for
fixing/releasing the
attachment device

Heat protection sleeve

tion)

Tube holder, rear

Sleeve grips

Tube holder, front

ASTOLINE active
insulation cover

tion

Bracket for ASTOLINE

tion)

Applications

The ASTOTHERM PLUS can be used to heat fluids supplied to the patient either to avoid or
reduce hypothermia or to increase well-being.

Applications include transfusions, infusions, dialysis, haemofiltration and apheresis.

The warmer works in accordance with the principle of flow heating, in other words, the heat is
transferred from the heat exchanger via the sterile infusion extension to the fluid flowing
through it.

If the entire heating output is not required, it is possible also to insert two infusion extensions
in the first and second half of the heat exchanger. A check on heat exchanger temperature at
the inlet and outlet avoids the fluids overheating, even if they have different inlet
temperatures.

The patented heat protection sleeve insulates the heat exchanger cylinder and the infusion
extension against the effects of ambient cold (e.g. air-conditioning units) and thus increases
the degree of efficiency. There is a recess in the centre of the heat protection sleeve for using
a second infusion extension. Extensions can be put in or brought out at this point and secured
with the hand-grips.

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