Instructions for Use

Barkey
Version 3 GB
Issue 2014-03-31

Manufactured by:
Barkey GmbH & Co. KG
Gewerbestrasse 8
33818 Leopoldshoehe
Germany
Instructions for Use
Barkey S-line Contents

Contents
1  Introduction ..................................... 4 
1.1  Symbols used in the text ........................................................................... 4 
1.2  Target group ............................................................................................... 4 
1.3  What you must observe ............................................................................. 5 
1.4  Conformities ............................................................................................... 5 
1.5  Copyright..................................................................................................... 5 

2  Device description ............................... 6 

2.1  Components of the Barkey S-line ............................................................. 7 
2.2  Components of the display and control panel ........................................ 8 
2.3  Technology description ............................................................................. 9 
2.4  Symbols on adhesive labels.................................................................... 11 
2.5  Earthing stud ............................................................................................ 12 
2.6  Use for the intended purpose.................................................................. 13 
2.7  Contraindication ....................................................................................... 13 
2.8  Safety features .......................................................................................... 13 
2.9  Cooling the control unit ........................................................................... 14 
2.10  Overtemperature protector ...................................................................... 14 
2.11  Fault signal................................................................................................ 14 

3  Safety information .............................. 16 

3.1  Safety information for using the device ................................................. 16 
3.2  Safety information for handling the device............................................ 18 
3.3  Safety information for environmental influences .................................. 19 
3.4  Electromagnetic properties / safe clearances ....................................... 20 
3.4.1  Electromagnetic emission......................................................................... 20 
3.4.2  Immunity against electromagnetic interference ........................................ 21 
3.4.3  Recommended safe clearances ............................................................... 24 

4  Installation / start-up ......................... 25 

4.1  Location..................................................................................................... 25 
4.2  Starting installation / start-up.................................................................. 25 
4.2.1  Fitting the device ...................................................................................... 26 
4.2.2  Connecting the mains cable ..................................................................... 29 
4.2.3  Switching on ............................................................................................. 30 
4.2.4  Switching off ............................................................................................. 30 

Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Telephone: + 49 (5202) 9801-0
Service department: + 49 (5202) 9801-30 - Fax: + 49 (5202) 9801-99 - E-mail: [email protected]
 4.2.5  Inserting the infusion line ......................................................................... 31 

5  Cleaning and care ............................... 33 

6  Maintenance ..................................... 34 

6.2 Overtemperature protection control ............................................................ 34 
6.2 Accidental activation of the overtemperature protection control ............. 36 

7  Guarantee and disclaimer of liability ........... 37 

8  Service department .............................. 38 

9  Technical data .................................. 40 

Device master sheet - specimen

Declaration of conformity
Certificates

Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Telephone: + 49 (5202) 9801-0
Service department: + 49 (5202) 9801-30 - Fax: + 49 (5202) 9801-99 - E-mail: [email protected]
Instructions for Use
Barkey S-line

1 Introduction

We would like to congratulate you on your decision to use the Barkey S-line to warm in-
fusion lines. You have decided on a high-quality, durable product.
These instructions for use contain all the information on the functions, commissioning
and use of the Barkey S-line.
1.1 Symbols used in the text
In these instructions for use warnings and special information are designated by the fol-
lowing symbols:

On non-compliance: danger for persons.

WARNING
On non-compliance: danger for property,
ATTENTION the device or elementary device functions.
Additional useful pointers and information.
INFORMATION ("i" stands for "information".)

You will see the following symbol in instructions for using the device:

Instruction step.
Carry out this step as shown.

INFORMATION
The symbols related to the control elements and device displays and the symbols
on device adhesive labels are explained in chapter 2 of these instructions for use.

1.2 Target group

These instructions for use are directed at:
 Medical specialists in hospitals who can show proof of a recognised vocational quali-
fication in a human medicine occupation.

WARNING
Only persons who satisfy these requirements may operate this device.

4 Instructions for Use Barkey S-line - V3 GB - ae-100-EW-0000-05 - 2014-03-31

Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Telephone: + 49 (5202) 9801-0
Service department: + 49 (5202) 9801-30 - Fax: + 49 (5202) 9801-99 - E-mail: [email protected]
 Instructions for Use
Barkey S-line

1.3 What you must observe

The operating conditions and safety information described in these instructions for use
must be observed when the device is used. This guarantees that there is no improper han-
dling that could endanger patients or operators of the devices and/or lead to damage to the
devices.
Barkey GmbH & Co. KG does not assume any liability for damage caused by non-
compliance with these instructions for use.

WARNING
These instructions for use are a part of the product. They must be kept throughout
the whole of the product's service life and handed over to subsequent owners or
operators. Make sure that supplements to these instructions for use are kept to-
gether with these instructions for use.
Read these instructions for use carefully before starting the device.
It is essential to observe the information on the intended purpose in chapter 2.6 and
the safety information in chapter 3. To understand this chapter it is helpful to get to
know the device's basic functions in chapter 2.
Please observe as well the requirements for the qualification of the device operators
that are indicated in chapter 1.2.
Medical electrical devices are subject to special safety measures with regard to the
EMC (electromagnetic compatibility). Always make sure that the device is in-
stalled and operated in accordance with the EMC information contained in these
instructions for use.
1.4 Conformities
Please read the declaration of conformity in the annex to these instructions for use.

1.5 Copyright
These instructions for use, including all the illustrations they contain, are protected by
copyright. Translating, copying, reprinting, removing illustrations, reproducing photos
technically and storing and producing in electronic systems, even in the form of extracts
only, and every amendment, require the written approval of Barkey GmbH & Co. KG.
All further use beyond the use of the described contents in connection with the product
acquired is prohibited.
Third-party products, protected names, etc., are always referred to without a reference to
the registration or the protection. Existing patent rights and registered names are ex-
pressly acknowledged.
Misprints and errors excepted; we reserve the right to make changes that serve technical
progress or that become necessary through amendments to regulations.

Instructions for Use Barkey S-line - V3 GB - ae-100-EW-0000-05 - 2014-03-31 5

Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Telephone: + 49 (5202) 9801-0
Service department: + 49 (5202) 9801-30 - Fax: + 49 (5202) 9801-99 - E-mail: [email protected]
Instructions for Use
Barkey S-line

2 Device description

Fig. 1: Barkey S-line

The Barkey S-line can be used to warm fluids that are administered to the patient through
infusion lines.
The temperature of the warming section is factory-set.
The Barkey S-line is available in the following versions:
Infusion tube diameter Heating profile length Temperature setting
4-5mm 1500mm 37°C
4-5mm 1500mm 39°C
4-5mm 1200mm 37°C
6-7mm 1500mm 39°C

The Barkey S-line is operated using a button for switching the device on and off.
The device's status is shown by a display, a luminous ring and an acoustic sensor.

6 Instructions for Use Barkey S-line - V3 GB - ae-100-EW-0000-05 - 2014-03-31

Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Telephone: + 49 (5202) 9801-0
Service department: + 49 (5202) 9801-30 - Fax: + 49 (5202) 9801-99 - E-mail: [email protected]
 Instructions for Use
Barkey S-line

2.1 Components of the Barkey S-line

1. Control unit Controls the temperature in the warm-

ing section.
2. Warming The flexible warming section holds the
section infusion tube and transmits the heat to
the flowing fluid.
3. Warming The warming section can be placed at
section its head and end in the holder pro-
holder vided. This prevents unintentional con-
tact with the floor.
4. Fastening The fastening clamp fixed to the back
clamp of the housing is used to fasten the
Barkey S-line to an infusion stand.
5. Power cable Transmits electricity from the socket to
the warming device.

Instructions for Use Barkey S-line - V3 GB - ae-100-EW-0000-05 - 2014-03-31 7

Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Telephone: + 49 (5202) 9801-0
Service department: + 49 (5202) 9801-30 - Fax: + 49 (5202) 9801-99 - E-mail: [email protected]
Instructions for Use
Barkey S-line

3
1
4

2 5

Fig. 2: Barkey S-line

2.2 Components of the display and control panel

The Barkey S-line has a control panel on the front of the control unit. The control panel is
shown below and contains:
 a display for showing the temperature of the current actual value of the warming
section
 a touch panel for switching on and off
 a luminous ring for showing the device's status.

8 Instructions for Use Barkey S-line - V3 GB - ae-100-EW-0000-05 - 2014-03-31

Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Telephone: + 49 (5202) 9801-0
Service department: + 49 (5202) 9801-30 - Fax: + 49 (5202) 9801-99 - E-mail: [email protected]
 Instructions for Use
Barkey S-line

Fig. 3: Display and control panel

The display and control elements are marked by symbols, which are explained in the fol-
lowing table:

Touch panel for switching the device on and off.

If the luminous ring around the touch panel shows green the device is
switched on and ready for use.

This symbol means that the Barkey S-line is ready for use if the luminous
ring shows green.

If the luminous ring around the touch panel shows yellow, the device has a
fault and is not ready for use.

This symbol means that there is a fault in the Barkey S-line and an acoustic
alarm is heard, if the luminous ring shows yellow.

This symbol shows that the heater of the warming section is switched on.
The symbol appears in the top left of the display.
This symbol indicates that the overtemperature test has been activated. The
symbol appears in the bottom left of the display. The Barkey S-line must not
be used for heating fluids in this status.

2.3 Technology description

When the Barkey S-line is switched on and ready for operation, the heating profile is
heated to the fixed setpoint temperature ± 2°C by internal heating elements.
The heating profile is designed so that standard commercial infusion tubes can easily be
inserted into the groove.

Instructions for Use Barkey S-line - V3 GB - ae-100-EW-0000-05 - 2014-03-31 9

Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Telephone: + 49 (5202) 9801-0
Service department: + 49 (5202) 9801-30 - Fax: + 49 (5202) 9801-99 - E-mail: [email protected]
Instructions for Use
Barkey S-line

An independent overtemperature protector monitors the temperature in the warming sec-

tion. In case of a fault the operator is informed by the yellow luminous ring showing and
by an acoustic signal.

NOTE
Pay attention to the data on infusion tube diameters and lengths in chapter 2. Your
Barkey S-line is designed for a specific diameter and a specific length of infusion
tube. Optimum fluid heating is only achieved when using an appropriate infusion
tube.
An independent overtemperature protection system monitors the temperature in the heat-
ing profile. If there is any fault, the user is informed by the light ring lighting up yellow
and by an acoustic signal.

INFORMATION
In case of a fault the device's heating process is interrupted.
The temperature shown in the display corresponds to the temperature of the warm-
ing section. The temperature of the fluid to be heated that is reached at the end of
the warming section depends on various factors, such as the fluid's input tempera-
ture, the flow rate, the ambient temperature, etc.
The following graph shows a typical initial temperature curve (outlet):
(Inlet fluid temperature: 20°C and ambient temperature: 20°C, diameter 5 mm, length 1,500 mm,
temperature setting 39°C)

Outlet temperature

Flow rate ml / min

Fig. 4: Typical starting temperature of the fluid that has passed through at different flow rates

10 Instructions for Use Barkey S-line - V3 GB - ae-100-EW-0000-05 - 2014-03-31

Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Telephone: + 49 (5202) 9801-0
Service department: + 49 (5202) 9801-30 - Fax: + 49 (5202) 9801-99 - E-mail: [email protected]
 Instructions for Use
Barkey S-line

2.4 Symbols on adhesive labels

The following symbols can be seen on the adhesive labels on the Barkey S-line:

This symbol explains the device's conformity with EU Directive

93/42/EEC of 14 June 1993 for medical devices. The four-digit number
designates the notified body (TÜV SUED Product Service GmbH) that
monitors the manufacturer's quality assurance system.

This symbol states that the device is protected in the planned operating
IP X2 conditions against water drops falling up to 15° from the vertical in ac-
cordance with IEC 601-1.

This symbol indicates that the warming devices connected to the Barkey
S-line are approved for use on the human body. The device's so-called
"application parts" are type BF (body floating). In addition, all devices
in the Barkey S-line are defibrillation protected.

The four-digit number in this symbol shows the year of manufacture.

2009
This symbol indicates that the device must not be disposed of with
household waste. It must be handed to a waste disposal company or re-
turned to the manufacturer for disposal. (EU Directive 2002/96/EC on
waste electrical and electronic equipment, WEEE)

Instructions for Use Barkey S-line - V3 GB - ae-100-EW-0000-05 - 2014-03-31 11

Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Telephone: + 49 (5202) 9801-0
Service department: + 49 (5202) 9801-30 - Fax: + 49 (5202) 9801-99 - E-mail: [email protected]
Instructions for Use
Barkey S-line

This symbol indicates that the mains plug must be withdrawn from the
socket before the device housing is opened.

This symbol advises you that you must comply with the user manual
supplied.

This symbol indicates that the device complies with safety standards for
electromagnetic devices for the USA and Canada. . This symbol is only
employed on devices which are used for sale in North America.

2.5 Earthing stud

ATTENTION
The Barkey S-line is fitted with an earthing stud. The earthing stud is intended solely for
connecting a test conductor for an electrical safety check. Equipotential bonding conduc-
tors must not be connected to this earthing stud.

12 Instructions for Use Barkey S-line - V3 GB - ae-100-EW-0000-05 - 2014-03-31

Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Telephone: + 49 (5202) 9801-0
Service department: + 49 (5202) 9801-30 - Fax: + 49 (5202) 9801-99 - E-mail: [email protected]
 Instructions for Use
Barkey S-line

2.6 Use for the intended purpose

The Barkey S-line is an active medical warming device that warms an infusion line and
can be used in combination with the blood return line ofhaemodialysis devices to protect
patients from hypothermia.
The infusion tubes that are to be warmed are placed in the warming section of the Barkey
S-line and enclosed by the warming section.
The Barkey S-line can be used in all cases in which hypothermia of the patient through
cold transfusions and infusion solutions is to be prevented.
This summary of information on the use of the device for its intended purpose will be
supplemented in these instructions for use in each chapter. Please read these chapters
carefully for information on how to use the device in detail.
2.7 Contraindication
The device may not be used to warm living organisms, objects or fluids of any kind with
the exception of those described in the intended purpose.
The device may not be used to fasten, pull or lift loads.
Contraindications on warming blood and blood products are not known.
2.8 Safety features
- Easy to use (ON or OFF) through permanently preset temperature.
- Easy-to-read layout and marking of the display and control elements.
- Integrated overtemperature protector in the warming section (see chapter 2.10).
- Automatic warming and sensor fracture monitoring.
- Optical and acoustic signals in case of fault.
- Monitoring of the temperature in the control unit.
- Temperature-dependent ventilator controller in the control unit
- Suitable for permanent operation.
- Homogeneous temperature distribution in the warming section, no hot spots.
- No mechanical obstructions for the flow of the fluid.
- No denaturation of blood or blood products.
- Safety extra-low voltage at the warming section (application part).
- Defibrillation protection of the whole device.
- Control unit protected from water drops up to 15° inclination (IPX2).
- Corrosion-free plastic housing.

Instructions for Use Barkey S-line - V3 GB - ae-100-EW-0000-05 - 2014-03-31 13

Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Telephone: + 49 (5202) 9801-0
Service department: + 49 (5202) 9801-30 - Fax: + 49 (5202) 9801-99 - E-mail: [email protected]
Instructions for Use
Barkey S-line

2.9 Cooling the control unit

The control unit is fitted with ventilation slots on the back.

ATTENTION
The ventilation slots must not be covered or closed.
There is a fan behind the lower ventilation slots that cools the electronics. The fan is con-
trolled in dependence on the temperature, i.e. it can be switched off fully at low tempera-
tures or run at full speed at high temperatures of the electronics.
The fan's noise level is very low, so that it does not create noticeable disturbance.
2.10 Overtemperature protector
An independent overtemperature protector monitors the temperature in the warming sec-
tion.
In case of a fault, if a temperature 43°C +/- 1°C is reached, the warming section's heater
is switched off, the luminous ring in the display and control panel shows yellow and an
acoustic signal is heard.
In this case switch the device off or pull the mains plug out and wait until the warming
section has cooled down. The cooling down process can take some minutes. After this
you can switch device on again. However, if the cause of the fault has not been elimi-
nated, the fault will occur again and the device must be inspected by a trained service
technician.

WARNING
On a fault signal the infusion of fluid to the patient must be stopped immediately
or the warming device removed from the patient.
The Barkey S-line may not be used in case of a device fault. Barkey GmbH & Co.
KG or authorised personnel must inspect the device.

The overtemperature cut-out on the various device versions is dependent on the factory-
set temperature:
Temperature setting Overtemperature cut-out
37°C 41°C +/-1°C
39°C 43°C +/-1°C

2.11 Fault signal

On a fault signal the luminous ring shows yellow and an acoustic signal is heard. The
fault signal occurs if
- the overtemperature protector has triggered (see chapter 2.10), or
- one of the warming conductors integrated in the section is defective, or
- a sensor or a sensor cable is broken, or
- the temperature of the electronics was found to be too high.

14 Instructions for Use Barkey S-line - V3 GB - ae-100-EW-0000-05 - 2014-03-31

Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Telephone: + 49 (5202) 9801-0
Service department: + 49 (5202) 9801-30 - Fax: + 49 (5202) 9801-99 - E-mail: [email protected]
 Instructions for Use
Barkey S-line

If a fault signal occurs, switch the device off or pull the mains plug out. Wait about 5
minutes until the warming section has cooled down. Switch the device on again. If the
fault occurs again, the device must be inspected by a trained service technician.

WARNING
On a fault signal the infusion of fluid to the patient must be stopped immediately or
the warming device removed from the patient.
The Barkey S-line may not be used in case of a device fault. Barkey GmbH & Co.
KG or authorised personnel must inspect the device.

Instructions for Use Barkey S-line - V3 GB - ae-100-EW-0000-05 - 2014-03-31 15

Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Telephone: + 49 (5202) 9801-0
Service department: + 49 (5202) 9801-30 - Fax: + 49 (5202) 9801-99 - E-mail: [email protected]
Instructions for Use
Barkey S-line

3 Safety information

3.1 Safety information for using the device

Check the device for damage before each use. Damaged de-
WARNING vices may not be used.
In order not to endanger the patient or the operator, do not use
the device if one of the following conditions is found:
- damaged or worn mains cable, mains plug, control lead
- damaged housing, damaged control panel
- device was dropped, or the internal electronic components
have become wet
- device does not warm correctly (shown by optical and
acoustic alarms)
- yellow alarm lamp or acoustic alarm is activated
All electrical installations must conform to the respective valid
regulations and standards and the specifications stipulated by
the manufacturer. The owner is responsible for the correct in-
stallation.
Read these instructions for use carefully before using the de-
vice.
The manufacturer does not assume any liability for the patient's
safety if the operating, maintenance and calibration procedures
for the system do not conform to the procedures in the instruc-
tions and in the service manual.
Take account of the requirements for the qualifications of the
device operators. The operating personnel must be suitably
trained and qualified.
It is imperative that you read the information on the use for the
intended purpose and the safety information in these instruc-
tions for use.
Use the device solely for the intended purpose and in confor-
mity with the procedures described in these instructions for
use.
Before being used the Barkey S-line must be acclimatised to
the ambient temperature at the location of use for at least one
hour.
If infusion solutions or medicines are warmed or kept warm,
the operator must ensure that they are suitable for the preset
temperature in the device and retain their efficacy.
Turn the device's fixing screw so tight that the holder is fixed
securely to the infusion stand. It must not be possible to shake

16 Instructions for Use Barkey S-line - V3 GB - ae-100-EW-0000-05 - 2014-03-31

Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Telephone: + 49 (5202) 9801-0
Service department: + 49 (5202) 9801-30 - Fax: + 49 (5202) 9801-99 - E-mail: [email protected]
 Instructions for Use
Barkey S-line

or slide it! If the holder is not fixed securely, the device may
slide down with the infusion line and prevent or interrupt the
infusion flow. In the process, please also ensure that the screw
is not tightened so much that this damages the support or infu-
sion stand. Normal hand-tightening of the screw is sufficient.
The warming device can be used at ambient temperatures of
+10°C to +40°C and is approved for permanent use.

When installing and fastening the Barkey S-line to an infusion

WARNING stand make sure of the bearing capacity and stability against
tipping over.
Do not clamp any lines or tubes in the fastening slot.
If a fault occurs during the self test, do not use the system.
Make sure that the luminous ring first shows yellow after
switching on and that the device sounds the acoustic signal so
that it can be heard. This shows that the alarm signals are func-
tioning correctly.
In case of an overtemperature alarm the flow of fluid to the
patient must be stopped immediately or the warming device
removed from the patient.
The patient must not lie on the warming section. This can cause
a heat build-up and the infusion line can be squeezed.
If the patient suffers from irritation of the skin in spite of the
biocompatible material remove the warming device from the
patient immediately.
The Barkey S-line must not be used if there is a fault signal.
The device must be inspected by Barkey GmbH & Co. KG or
authorised personnel.
If the infusion flow is stopped and the warming section cools
down at the same time, overheating of the infusion fluid cannot
be ruled out.
The warming section may not be cooled or heated. Keep the
warming section in the open air. Do not cover it with dressing
material, cloths, bedding or warm-air blankets. Do not expose
the warming section to direct sunlight or heat radiation and do
not lead it in or through incubators.
These instructions for use are to be considered as part of the
device. They must be kept during the service life of the device
and must be handed to any subsequent owner or operator.
Make sure that any supplements that are issued are kept to-
gether with the original instructions for use.
During the overtemperature protection control the
overtemperature control symbol appears in the bottom left of
the display. The Barkey S-line must not be used for heating
fluids in this status.

Instructions for Use Barkey S-line - V3 GB - ae-100-EW-0000-05 - 2014-03-31 17

Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Telephone: + 49 (5202) 9801-0
Service department: + 49 (5202) 9801-30 - Fax: + 49 (5202) 9801-99 - E-mail: [email protected]
Instructions for Use
Barkey S-line

3.2 Safety information for handling the device

Read these instructions for use carefully before using the de-
WARNING vice.
To ensure that the device is safely disconnected from the elec-
tricity supply pull the plug out of the socket.
Cleaners for cleaning and disinfecting other
than those described in these instructions for
use may damage the device. Contact the manu-
facturer before using any cleaners that are not
expressly recommended. You are warned in
particular against using the following solutions:
- halogenated aromatic and aliphatic solvents;
- ketonic solvents.
The device does not contain any parts that the owner can re-
pair. Do not repair the device yourself. Contact Barkey GmbH
& Co. KG or your medical technical service, which can request
information on repairs from the manufacturer. Repairs to and
modifications of the device may only be carried out by Barkey
GmbH & Co. KG or authorised personnel.
The Barkey S-line must be cleaned regularly. Before cleaning,
ATTENTION disconnect the device by pulling the supply lead from the
mains supply.
The ventilation slots may not be covered or sealed.
Do not bend or fold the warming section so that it has sharp
edges!
Do not stick pointed objects into the warming section!
Do not cover the warming section or insulate it thermally!
Do not warm or cool the warming section from outside!
Do not change the shape of the warming section or damage it!
The device's rating plate is fitted to the back of the housing.
This shows among other things the requirements for the power
supply and the serial number ("SN") of the device.

18 Instructions for Use Barkey S-line - V3 GB - ae-100-EW-0000-05 - 2014-03-31

Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Telephone: + 49 (5202) 9801-0
Service department: + 49 (5202) 9801-30 - Fax: + 49 (5202) 9801-99 - E-mail: [email protected]
 Instructions for Use
Barkey S-line

3.3 Safety information for environmental influences

Medical electrical devices are subject to special safety meas-

ures with regard to EMC (electromagnetic compatibility).
WARNING
Make sure that the device is installed and operated in accor-
dance with the EMC information contained in these instruc-
tions for use.
The influence of strong electromagnetic fields (eg through HF
treatment or surgical devices) can lead to malfunctions of the
Barkey S-line. In the event of such malfunctions, increase the
distance between the device that is malfunctioning and device
causing the malfunction, or do not operate the two devices at
the same time. The Barkey S-line functions perfectly within the
limit values of the standard EN 60601-1-2. The devices may be
influenced outside the limit values of the standard EN 60601-1-
2.
The Barkey S-line may not be located directly next to or
stacked with other devices. If operations near to or stacked with
other devices are necessary, the Barkey S-line should be ob-
served in order to check its correct operation in this layout.
Portable and mobile HF communication devices, eg mobile
phones, can affect the devices.
The Barkey S-line may not be used in the vicinity of
- flammable substances (eg gases, liquids),
- flammable mixtures of anaesthetics with air,
- flammable mixtures of anaesthetics with oxygen or nitrous
oxide
whose flash point is below 50°C. In particular, the Barkey S-
line may not be used in areas in which alcoholic disinfectants
and anaesthetics are used at the same time.
Only power cables supplied by Barkey GmbH & Co. KG that
are dimensioned for the device's mains voltage may be used.
Using accessories, converters or conductors with devices or
systems other than those indicated can lead to an increased
emission or a reduced immunity to interference of the device.
The Barkey S-line may not be used in the direct vicinity of de-
vices with high waste heat production.
The lines must be laid in such a way that interference with
other devices is safely avoided.

Instructions for Use Barkey S-line - V3 GB - ae-100-EW-0000-05 - 2014-03-31 19

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Instructions for Use
Barkey S-line

The device is ventilated from the back. The air supply must not
be obstructed by covering or blocking the ventilation slots on
the back of the device.

3.4 Electromagnetic properties / safe clearances

3.4.1 Electromagnetic emission

Guidelines and manufacturer's declaration - emitted electromagnetic interference

The Barkey S-line is intended for use in the electromagnetic environment shown below. The cus-
tomer or the operator of the Barkey S-line should ensure that it is used in this type of environ-
ment.
Electromagnetic environment -
Measuring emitted interference Conformity
guideline
The Barkey S-line uses HF energy
exclusively for its inner function.
HF emissions in accordance with This is why its HF emission is very
Group 1
CISPR 11 low, and it is unlikely that
neighbouring electronic devices will
be disturbed.
HF emissions in accordance with Class A The Barkey S-line is suitable for use
CISPR 11 in facilities other than residential
Emissions of harmonics in accor- Class A installations and those that are con-
dance with IEC 61000-3-2 nected to a public supply network
Emissions of voltage fluctua- Conforms that also supplies buildings that are
tions/flickering in accordance with used for residential purposes.
IEC 61000-3-3

20 Instructions for Use Barkey S-line - V3 GB - ae-100-EW-0000-05 - 2014-03-31

Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Telephone: + 49 (5202) 9801-0
Service department: + 49 (5202) 9801-30 - Fax: + 49 (5202) 9801-99 - E-mail: [email protected]
 Instructions for Use
Barkey S-line

3.4.2 Immunity against electromagnetic interference

Guidelines and manufacturer's declaration - immunity to electromagnetic interference

The Barkey S-line is intended for use in the electromagnetic environment shown below. The cus-
tomer or the operator of the Barkey S-line should ensure that it is used in this type of environ-
ment.
Interference IEC 60601 test Electromagnetic environment -
Conformity level
immunity tests level guidelines
± 6 kV Floors should be made of wood or
Electrostatic dis- ± 6 kV
contact discharge concrete or be fitted with ceramic
charge (ESD) in contact discharge
tiles. If the floor is covered with
accordance with
± 8 kV air dis- synthetic material the relative hu-
IEC 61000-4-2 ± 8 kV air discharge
charge midity must be at least 30%.
± 2 kV for mains
± 2 kV for mains
Bursts in accor- cables The quality of the supply voltage
cables
dance with should conform to that of a typical
IEC 61000-4-4 ± 1 kV for input business or hospital environment.
Not applicable
and output lines
± 1 kV voltage ± 1 kV voltage
outerconductor- outerconductor-
Surges in accor- outerconductor outerconductor The quality of the supply voltage
dance with IEC should conform to that of a typical
61000-4-5 ± 2 kV voltage ± 2 kV voltage business or hospital environment.
outerconductor - outerconductor -
earth earth
< 5% UT < 5% UT
(> 95% dip in the (> 95% dip in the
U T) U T) The quality of the supply voltage
for 1/2 period for 1/2 period should conform to that of a typical
Voltage dips,
40% UT 40% UT business or hospital environment.
short-term inter-
(60% dip in the (60% dip in the UT) If the operator of the Barkey S-line
ruptions and fluc-
UT) for 5 periods for 5 periods requires the function to continue
tuations in the
70% UT even on the occurrence of interrup-
supply voltage in 70% UT
(30% dip in the tions to the energy supply, we rec-
accordance with (30% dip in the UT)
UT) for 25 peri- ommend that the Barkey S-line is
IEC 61000-4-11 for 25 periods
ods supplied from an uninterruptible
< 5% UT < 5% UT power system or a battery.
(> 95% dip in the (> 95% dip in the
UT) for 5s UT) for 5s
Magnetic field in 3 A/m 3 A/m Magnetic fields in the network
the network fre- frequency should conform to the
quency typical values found in the busi-
(50/60 Hz) in ac- ness and hospital environment.
Instructions for Use Barkey S-line - V3 GB - ae-100-EW-0000-05 - 2014-03-31 21
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Instructions for Use
Barkey S-line

cordance with
IEC 61000-4-8
NOTE UT is the a.c. supply voltage before use of the test level

22 Instructions for Use Barkey S-line - V3 GB - ae-100-EW-0000-05 - 2014-03-31

Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Telephone: + 49 (5202) 9801-0
Service department: + 49 (5202) 9801-30 - Fax: + 49 (5202) 9801-99 - E-mail: [email protected]
 Instructions for Use
Barkey S-line

Guidelines and manufacturer's declaration - immunity against electromagnetic interference

The Barkey S-line is intended for use in the electromagnetic environment shown below. The cus-
tomer or the operator of the Barkey S-line should ensure that it is used in this type of environ-
ment.
Interference IEC 60601 Electromagnetic environment -
Conformity level
immunity tests test level guidelines
Portable and mobile radios should not
be used at a distance from the Barkey
S-line, including the conductors, that
is less than the recommended safe
clearance that is calculated in accor-
dance with the corresponding equation
for the transmission frequency.
Recommended safe clearance
d  1.17 P

d  1.17 P
for 80 MHz to 800 MHz
Conducted HF d  2,33 P
disturbances in 3 Veff
accordance with 150 kHz to 3 Veff for 800 MHz to 2,5 GHz
IEC 61000-4-6 80 MHz 150 kHz to 80 MHz

Radiated HF dis- 3 V/m 3 V/m with P as the nominal output of the

turbances in ac- 80 MHz to 80 MHz to 2.5 GHz transmitter in watts (W) in accordance
cordance with 2.5 GHz with information from the transmitter
IEC 61000-4-3 manufacturer and d as the recom-
mended safe clearance in metres (m).
With all frequencies the field strength
of stationary radio transmitters should
be less than the conformity levela in
accordance with an on-site inspec-
tionb.
Disturbances are possible in the envi-
ronment of devices that show the fol-
lowing symbol.

NOTE 1 With 80 MHz and 800 MHz the higher frequency range applies.
NOTE 2 These guidelines may not be applicable in all cases. The propagation of electromag-
netic variables is influenced through absorptions and reflections from the buildings, objects and
people.
a
Over the frequency range of 150 kHz to 80 MHz the field strength should be less than 3
V/m.
b
In theory, the field strength of stationary transmitters, eg base stations of radio telephones
and mobile terrestrial radio equipment, amateur radio stations, AM and FM radio and television
transmitters cannot be determined accurately beforehand. In order to determine the electromag-
netic environment with regard to the stationary transmitters, a study of the electromagnetic phe-
nomena of the location should be considered. If the measured field strength at the location at
which the Barkey S-line is used exceeds the above conformity level, the Barkey S-line should be
observed to verify the intended function. If unusual performance factors are observed, additional
measures may be necessary, eg a change of alignment or another location for the Barkey S-line.

Instructions for Use Barkey S-line - V3 GB - ae-100-EW-0000-05 - 2014-03-31 23

Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Telephone: + 49 (5202) 9801-0
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Instructions for Use
Barkey S-line

3.4.3 Recommended safe clearances

Recommended safe clearances between portable and mobile

HF telecommunication appliances and the Barkey S-line
The Barkey S-line is intended for use in an electromagnetic environment in which the HF distur-
bances are controlled. The customer or the operator of the Barkey S-line can help to avoid elec-
tromagnetic disturbances by complying with the minimum clearance between portable and mo-
bile HF telecommunication appliances (transmitters) and the Barkey S-line as shown below - in
dependence on the output power of the communications appliance.
Transmitter's Safe clearance in dependence on the transmission frequency m
nominal output 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
W d  1,17 P d  1,17 P d  2,33 P
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.17 1.17 2.33
10 3.69 3.69 7.38
100 11.67 11.67 23.33
The recommended safe clearance d in meters (m) can be determined for transmitters whose
maximum nominal output is not shown in the above table by using the equation that belongs to
the respective column, whereby P is the transmitter's maximum output in watts (W) in accor-
dance with the transmitter manufacturer's information.

NOTE 1 With 80 MHz and 800 MHz the higher frequency range applies.

NOTE 2 These guidelines may not be applicable in all cases. The propagation of electromag-
netic variables is influenced through absorptions and reflections from the buildings, objects and
people.

24 Instructions for Use Barkey S-line - V3 GB - ae-100-EW-0000-05 - 2014-03-31

Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Telephone: + 49 (5202) 9801-0
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 Instructions for Use
Barkey S-line

4 Installation / start-up

4.1 Location
The Barkey S-line is conceived for use in buildings as a fixed installation. Mobile use is
not planned.
Before operating the device, check the location for suitability.

WARNING
When selecting the installation location, it is essential to take account of the prox-
imity to other devices with electromagnetic emissions indicated in these instruc-
tions for use. The Barkey S-line is not approved for use in potentially explosive ar-
eas.
It is also essential that you take account of the information in these instructions for
use that indicates the environmental conditions in which the device may not be
used or in which its function can be disturbed.
The device is ventilated from the back. The ventilation slots on the back of the de-
vice must not be covered.
Fasten the Barkey S-line to an infusion stand as shown in chapter 4. The control panel
must be easily accessible, the device operator must be able to read the display and the
lamps.
To achieve the maximum benefit, position the Barkey S-line so that the end of the warm-
ing section is close to the injection point on the patient's body.
4.2 Starting installation / start-up
The Barkey S-line is designed for the mains voltage range shown on the rating plate and
must be fastened to an infusion stand.

WARNING
Before the installation and start-up of the device, read the instructions for use care-
fully in full.
All electrical installations must conform to the currently valid regulations and stan-
dards and the specifications stipulated by the manufacturer. The owner is responsi-
ble for the correct installation..
Always check the device for damage before each use. Do not use a damaged de-
vice. In order to safeguard the safety of the patient and/or the operator, do not use
the device if one of the following conditions is found:
 damaged or worn mains cable, mains plug, control lead
 damaged housing, damaged control panel
 device was dropped, or the internal electronic components have become
wet

Instructions for Use Barkey S-line - V3 GB - ae-100-EW-0000-05 - 2014-03-31 25

Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Telephone: + 49 (5202) 9801-0
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Instructions for Use
Barkey S-line

 device does not warm correctly (shown by optical and acoustic alarms)
 yellow alarm lamps or acoustic alarm are activated
4.2.1 Fitting the device
Fasten the Barkey S-line to an infusion stand.
The fastening clamp for fitting the device is on the back of the device.

The vertical fastening slot for the fastening device enables the device to be fitted to an in-
fusion stand or other vertical fastening elements.

Fig. 5: Fastening clamp on the back of the device

WARNING
When installing/fastening the Barkey S-line insure that the infusion stand has ade-
quate bearing capacity and stability .

26 Instructions for Use Barkey S-line - V3 GB - ae-100-EW-0000-05 - 2014-03-31

Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Telephone: + 49 (5202) 9801-0
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 Instructions for Use
Barkey S-line

Fasten the Barkey S-line close to the infusion line on the infusion stand so that the re-
ceiver for the head of the warming section (left next to the control unit) points to
the infusion line.
Place the device with the clamp on the infusion stand. The infusion stand must be in con-
tact with the bottom of the fastening slot. If the fastening screw is in the way, un-
screw it from the slot by turning in an anti-clockwise direction (Fig. 6).
Fix the device in place by tightening the fastening screw in a clockwise direction (Fig. 6).

WARNING
Do not clamp lines or tubes in the fastening slot.
Screw the fastening screw so that the device is firmly fixed to the infusion stand. If
the device is not firmly fixed in place, it may be difficult to use it and it may dis-
lodge. In the process, please also ensure that the screw is not tightened so much
that this damages the support or infusion stand. Normal hand-tightening of the
screw is sufficient.

Fig. 6: Fitting the control unit to the infusion stand

Hang the free ends of the warming section (head and end) in the recess, on the left next to
the control unit (Fig. 7).
Place the head of the warming section from above into the holder so that the warming
section runs downwards (Fig. 7; sketches 1 to 3).
Place the end of the warming section from above into the holder for the end so that the
warming section runs downwards (Fig. 7; sketches 4 to 6).

Instructions for Use Barkey S-line - V3 GB - ae-100-EW-0000-05 - 2014-03-31 27

Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Telephone: + 49 (5202) 9801-0
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Instructions for Use
Barkey S-line

1.
2.

3. 4.

5. 6.
Fig. 7: Fitting the warming section in the holder

WARNING
The warming section may not be covered, insulated, warmed or cooled.
If the infusion flow stops and the warming section is cooled at the same time, an
overheating of the infusion fluid cannot be ruled out.

28 Instructions for Use Barkey S-line - V3 GB - ae-100-EW-0000-05 - 2014-03-31

Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Telephone: + 49 (5202) 9801-0
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 Instructions for Use
Barkey S-line

4.2.2 Connecting the mains cable

WARNING
The mains supply must conform to the data on the device rating plate, the technical
data in these instructions for use and the regulations for electrical installations, as
amended. When laying the mains cable for the Barkey S-line make sure there is no
interference with other devices.
The device's rating plate is attached to the back of the housing. This shows among
other things the specifications for the power supply and the serial number ("SN")
of the device.
Insert the plug for the mains cable into the socket for your power supply.

CAUTION
Install the device so that the mains plug is accessible at all times and the mains
plug can easily be withdrawn from the socket, for instance in an emergency.

CAUTION
To avoid the risk of an electric shock this device must be plugged only into a mains
power supply which is provided with an earth conductor.

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Instructions for Use
Barkey S-line

4.2.3 Switching on
Touch the ON / OFF button to switch the device on.
A function test of the alarm signals is carried out when the device is switched on: the yel-
low fault lamp (luminous ring) shows and an acoustic signal for is heard for approx. 1
second. After this the green status display (luminous ring) shows. The Barkey S-line is
now ready for use and the warming section is warmed.

Fig. 8: Switching on

WARNING
Make sure that the luminous ring first shows yellow after the device is switched on
and the device emits the acoustic signal and this can be heard. Only this shows that
the alarm signals are functioning correctly.
The device must not be used if a fault occurs during the self-test.
4.2.4 Switching off
Touch the ON / OFF button on the control panel if you want to switch the device off.

INFORMATION
The device can be switched off at any time. This stops the device's operation.

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 Instructions for Use
Barkey S-line

4.2.5 Inserting the infusion line

We recommend that the primed infusion line is inserted in the warming section.
Start inserting the infusion line at the end of the warming section with the connection of
the infusion line on the patient side (Fig. 9, sketches 1 and 2).
Insert the infusion line in the end of the warming section approx. 3 cm downstream from
the luer lock connection.
Move your thumb over the infusion line and press the line gently into the slot of the
warming section (Fig. 9 sketch 3).
Lead the infusion line to the head of the warming section (Fig. 9 sketch 4).

1. 2.

3. 4.
Fig. 9: Inserting the infusion line

For dosing clamps (roll clamps) the infusion line can be led out of the warming section at
any point or at the head or end of the device.
Place the head of the warming section from above into the holder for the head so that the
warming section runs downwards.
Connect the infusion line to the patient and secure it against tension from the warming
section.

WARNING
Make sure that the infusion line is not twisted or kinked. This can obstruct or block
the infusion flow.
The warming section may not be bent, damaged or shortened.
The warming section may not be covered, insulated, warmed or cooled.
The patient must not lie on the warming section. This can cause a
heat build-up and the infusion line can be compressed.

Instructions for Use Barkey S-line - V3 GB - ae-100-EW-0000-05 - 2014-03-31 31

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Instructions for Use
Barkey S-line

WARNING
If the infusion flow stops and the warming section is cooled at the same time, an
overheating of the infusion fluid cannot be ruled out.
If infusion solutions or medicines are kept warm, the operator must ensure that
they are suitable for the preset temperature in the device and retain their efficacy; if
this is not the case the operator must not use the device.
If the patient suffers from irritation of the skin in spite of the biocompatible mate-
rial remove the warming device from the patient immediately.
Always check the Barkey S-line for damage before each use. Do not use a dam-
aged device.
In order to safeguard the safety of the patient and/or the operator, do not use the
device if one of the following conditions is found:
- damaged mains cable, mains plug, control lead or socket
- damaged housing, damaged control panel
- device was dropped, or the internal electronic components have become wet
- the alarm lamp and/or the acoustic alarm of the control unit are activated
- damaged warming section.

32 Instructions for Use Barkey S-line - V3 GB - ae-100-EW-0000-05 - 2014-03-31

Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Telephone: + 49 (5202) 9801-0
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 Instructions for Use
Barkey S-line

5 Cleaning and care

Thanks to its smooth surfaces and rounded corners the Barkey S-line is simple and easy
to clean.
Clean the surfaces of the control unit and the fastening clamp, as well as the inside and
outside of the warming section, and wipe them with disinfectant regularly, where possible
after each use.

WARNING
Before cleaning or wiping with disinfectant:
 Switch the Barkey S-line off by pressing the on/off button and pull the de-
vice's mains plug out of the mains socket.
 Do not apply cleaners and disinfectants directly to the device. Moisten a
cloth with them and use this cloth on the device.
 Never put cleaning liquids into the device's ventilation openings.
 Do not disinfect the device with steam (eg in an autoclave), hot air or with
thermochemical agents.
Commercially available preparations on an alcohol base without oxygen-releasing com-
ponents (with sodium hypochlorite with a 1.4% bleach solution or aldehyde content
<0.2%) should be used as disinfectants.
Clean the device where possible with a water/soap solution.
Dry the surfaces and use a surface disinfectant.
Observe the reaction time indicated by the disinfectant manufacturer!
After expiry of the reaction time dry the device with disposable cloths.

WARNING
The operator may not use any cleaning or decontamination methods other than
those recommended by the manufacturer.
If other cleaning or decontamination methods are to be used, a check must be made
beforehand with the manufacturer to see whether these suggested methods damage
the device.
We refer otherwise to your clinic's hygiene measures and regulations.

Instructions for Use Barkey S-line - V3 GB - ae-100-EW-0000-05 - 2014-03-31 33

Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Telephone: + 49 (5202) 9801-0
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Instructions for Use
Barkey S-line

6 Maintenance

Apart from the cleaning of the device and the prescribed checks of electrical safety there
are no regular maintenance measures or safety checks that have to be carried out.
All servicing work is described in separate servicing instructions that can be requested
from Barkey GmbH & Co. KG.
Servicing work may only be carried out by qualified service personnel or employees of
Barkey GmbH & Co. KG.
On the last page of these instructions for use you will find a draft device master sheet.
You can use this as a cover sheet for your files with the maintenance records.

WARNING
The device does not contain any parts that the owner can repair. Do not repair the
device yourself. Contact Barkey GmbH & Co. KG or your medical technical ser-
vice, which can request information on repairs from the manufacturer. Repairs to
and modifications of the device may only be carried out by Barkey GmbH & Co.
KG or authorised personnel.

6.2 Overtemperature protection control

Although there is no regular safety control required on your Barkey S-line, it is advisable
to check the overtemperature protection function from time to time, e.g. on a monthly ba-
sis.
► Install the Barkey S-line onto an infusion stand as described in chapters Fehler!
Verweisquelle konnte nicht gefunden werden. to Fehler! Verweisquelle konnte
nicht gefunden werden. of this instruction manual.

You have to put the Barkey S-line into a special operating mode to check the
overtemperature protection function.

WARNING
To carry out the overtemperature protection control, take any infusion tube that
may have been inserted out of the Barkey S-line's heating profile. The Barkey S-
line must not be used for heating fluids during the control of the overtemperature
protection function.
During the measurements, do not expose the device to any direct sunlight, draughts
or any other influences, which might affect the measurement.

► Press the Barkey S-line's ON / OFF button continuously until the symbol for the
overtemperature test appears in the bottom left of the display (approx. 5 seconds).

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 Instructions for Use
Barkey S-line

Figure 10: Display with symbol for overtemperature test circled

NOTE
The Barkey S-line is switched on and the function test started by pressing the ON /
OFF button. The light ring in the display and operating panel lights up yellow and
an acoustic signal sounds for approx. 1 second. The light ring then goes green. You
only go into the special operating mode if you continue to press the ON / OFF but-
ton.

The heating profile's heating is permanently switched on in this special operating mode.
The heating profile is heated until the overtemperature protection is triggered. After the
overtemperature protection is triggered, the heating of the heating profile is switched off,
the light ring in the display and operating panel lights up yellow and a continuous acous-
tic signal sounds.
► Wait until the overtemperature protection is triggered.
The temperature value at which the overtemperature protection was triggered is continu-
ously shown in the Barkey S-line display until the device is switched off.
► Read the trigger value for the overtemperature protection in the Barkey S-line dis-
play.
► The overtemperature cut-out on the various device versions is dependent on the facto-
ry-set temperature. Check whether the value read in the display is within the tolerance
given below:
Temperature setting Overtemperature cut-out
37°C 41°C +/-1°C
39°C 43°C +/-1°C

WARNING
If the trigger value for the overtemperature protection determined is outside the tol-
erance given, the Barkey S-line must be recalibrated.
► Switch the Barkey S-line off.
Instructions for Use Barkey S-line - V3 GB - ae-100-EW-0000-05 - 2014-03-31 35
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Instructions for Use
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► Wait until the heating profile has cooled down to below the setpoint (37°C or 39°C).
After the heating profile has cooled down to below the setpoint, the Barkey S-line can be
used normally again.

6.2 Accidental activation of the overtemperature protection control

If you have activated the overtemperature protection control accidentally, switch the
Barkey S-line off and allow the heating profile to cool down below a temperature of 37°C
or 39°C.
After the heating profile has cooled down to below the setpoint, the Barkey S-line can be
used normally again.

36 Instructions for Use Barkey S-line - V3 GB - ae-100-EW-0000-05 - 2014-03-31

Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Telephone: + 49 (5202) 9801-0
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 Instructions for Use
Barkey S-line

7 Guarantee and disclaimer of liability

The guarantee period for the Barkey S-line is 24 months from delivery.
Barkey GmbH & Co. KG assumes this guarantee in place of other contractual or statutory
guarantees for this product including other statutory guarantees of marketability or suit-
ability for a specific purpose and does not assume any other liabilities.
Owing to the fact that Barkey GmbH & Co. KG does not have any control over the qual-
ity of maintenance work that is not carried out by Barkey personnel and because Barkey
GmbH & Co. KG is unable to assess the effects that such maintenance and repair may
have on the device and its reliability, Barkey GmbH & Co. KG does not accept any re-
sponsibility for damage to property, injuries or consequential damage that result from the
use of a device that was not repaired or maintained by Barkey service personnel.
As a basic principle Barkey GmbH & Co. KG does not accept any responsibility at all for
indirect or consequential damage of any kind and limits its obligations exclusively to the
repair or replacement of the device.
Barkey GmbH & Co. KG does not accept any responsibility or liability for the use of ac-
cessories other than those listed in these instructions for use, for the use of components
other than original components and for use/installation that does not conform to the in-
structions for use included with these components. The use of components and accesso-
ries other than those mentioned in the instructions for use shall lead to a reduction in the
manufacturer's guarantee for the device.
Barkey GmbH & Co. KG regards itself as responsible for the effects on the safety, reli-
ability and output of the device only if
 extensions, resetting, alterations or repairs are carried out by personnel it authorises
and
 the safety checks and maintenance work are proved to have been carried out by suit-
able skilled personnel at the prescribed intervals and in accordance with the manufac-
turer's instructions, and
 the electrical installation at the location of use conforms to local regulations and the
device data and, where applicable, to the IEC requirements
 the device is used in conformity with these instructions for use and
 the inspection of electrical safety in accordance with the valid regulations is proved to
have been carried out at the prescribed intervals.

WARNING
Barkey GmbH & Co. KG does not assume any liability for unauthorised alterations
and repairs of the devices by the purchaser or unauthorised third parties.
We recommend that you have necessary repairs and regular maintenance carried
out by Barkey GmbH & Co. KG.

Instructions for Use Barkey S-line - V3 GB - ae-100-EW-0000-05 - 2014-03-31 37

Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Telephone: + 49 (5202) 9801-0
Service department: + 49 (5202) 9801-30 - Fax: + 49 (5202) 9801-99 - E-mail: [email protected]
Instructions for Use
Barkey S-line

8 Service department

The Barkey S-line is maintenance-free and is not susceptible to faults. If a repair becomes
necessary in spite of the careful selection of components and a high production quality,
the following should be noted:
Please send defective devices for recycling-repair to Barkey GmbH & Co. KG. Barkey
GmbH & Co. KG will ensure the correct separation of materials and the disposal of the
materials.
We recommend that you have necessary repairs carried out by Barkey GmbH & Co. KG
or that your technical personnel attends special product training with regard to inspection
and maintenance.
On request and against a nominal charge the manufacturer will supply servicing instruc-
tions that contain all the required circuit diagrams, parts lists, inspection instructions and
service information by means of which suitably trained and qualified technical personnel
can repair all the parts of the device that the manufacturer considers to be repairable.
If the device cannot be repaired or maintained on site it must be sent in.
Before shipping the device, please note the following rules:
 Send the defective device for recycling-repair only to Barkey GmbH & Co. KG or an
authorised sales partner.
 The device must be cleaned and, where applicable, disinfected before shipping.
 The shipped device must not cause any risk to health, eg through toxic, carcinogenic,
biologically hazardous or radioactive substances. The shipper shall be liable for
damage or injury caused by inadequate cleaning or disinfecting.
 Include a form evidencing cleaning with each shipped device. You can obtain appro-
priate forms on request from Barkey GmbH & Co. KG.
 Devices that have not been cleaned and devices without a cleaning certificate will be
returned to the sender for safety reasons without being inspected or repaired.
 Comply with the instructions for cleaning and disinfecting in these instructions
for use.
 Please enclose a brief description of the fault with the device. This will save you the
costs of an expensive search for faults.
 Pack the device for shipping to Barkey GmbH & Co. KG in such a way that trans-
port damage is reliably prevented. Barkey GmbH & Co. KG does not assume any li-
ability for transport damage caused by inadequate packaging.
The service department of Barkey GmbH & Co. KG can be reached
Monday to Friday 07.00 - 20.00
Saturday and Sunday 10.00 - 18.00
at the telephone number + 49 (5202) 9801-30
E-mail: [email protected]

38 Instructions for Use Barkey S-line - V3 GB - ae-100-EW-0000-05 - 2014-03-31

Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Telephone: + 49 (5202) 9801-0
Service department: + 49 (5202) 9801-30 - Fax: + 49 (5202) 9801-99 - E-mail: [email protected]
 Instructions for Use
Barkey S-line

WARNING
Barkey GmbH & Co. KG does not assume any liability for unauthorised alterations
and repairs of the devices by the owner or unauthorised third parties..
Our repair and installation conditions and our guarantee terms apply. We supply in accor-
dance with the "Standard terms and conditions of delivery for products and services of the
electrical industry".

Instructions for Use Barkey S-line - V3 GB - ae-100-EW-0000-05 - 2014-03-31 39

Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Telephone: + 49 (5202) 9801-0
Service department: + 49 (5202) 9801-30 - Fax: + 49 (5202) 9801-99 - E-mail: [email protected]
Instructions for Use
Barkey S-line

9 Technical data
Manufacturer Barkey GmbH & Co. KG
Gewerbestrasse 8
33818 Leopoldshoehe
Germany
Tel.: + 49 (5202) 9801-0
Fax: + 49 (5202) 9801-99
Type Barkey S-line
Connection 100–240 VAC, 50–60 Hz
Wattage max. 75 watts
Power consumption typ. 1.0 A at 230 VAC
typ. 1.8 A at 115 VAC
Fuse 2.5 A time-delay
Temperature setting + 39 °C
Control precision ± 2.0 °C
Overtemperature protection
warming section 43.0°C ± 1.0°C
Warming up time from 20°C to 39°C approx. 2 min.

Operations Storage/transport
Ambient temperature +10°C to +40°C -20°C to +70°C
Relative humidity 30% to 75%
(non-condensating)
Air pressure 700 to 1060 hPa 700 to 1060 hPa
Mode Permanent operations
Dimensions Control unit W x D x H: 90 x 60 x 160 mm
Warming section for infusion lines Ø 5 mm, length 1.5 m
Weight approx. 1.3 kg
Safety class I protective earthing
Degree of protection BF; defibrillation-protected
External and internal use on patients
with insulated application part
MDD classification II a
Moisture protection IP X2
Marking CE 0123

40 Instructions for Use Barkey S-line - V3 GB - ae-100-EW-0000-05 - 2014-03-31

Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Telephone: + 49 (5202) 9801-0
Service department: + 49 (5202) 9801-30 - Fax: + 49 (5202) 9801-99 - E-mail: [email protected]
Device master sheet for the Barkey S-line

Device name: __________________________________________

Serial number: __________________________________________

Inventory number: __________________________________________

Location: __________________________________________

Date commissioned: __________________________________________

Marking: 0123

Manufacturer: Barkey GmbH & Co. KG

Gewerbestrasse 8
33818 Leopoldshoehe
Germany

Telephone: + 49 (5202) 9801-0

Fax: + 49 (5202) 9801-99

E-mail: [email protected]