S-line Instructions for Use Ver 2GB July 2013

Instructions for Use

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Instructions for Use Barkey Version 2 GB Issue

2013-07-12

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

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 ... 10

2.5

Earthing stud... 11

2.6

Use for the intended purpose ... 12

2.7

Contraindication ... 12

2.8

Safety features ... 12

2.9

Cooling the control unit... 13

2.10

Overtemperature protector ... 13

2.11

Fault signal ... 13

Safety information ... 15 3.1

Safety information for using the device ... 15

3.2

Safety information for handling the device ... 17

3.3

Safety information for environmental influences ... 18

3.4 Electromagnetic properties / safe clearances ... 19 3.4.1 Electromagnetic emission ... 19 3.4.2 Immunity against electromagnetic interference ... 20 3.4.3 Recommended safe clearances ... 22

Installation / start-up ... 23 4.1

Location... 23

4.2 Starting installation / start-up ... 23 4.2.1 Fitting the device ... 24 4.2.2 Connecting the mains cable ... 27 4.2.3 Switching on ... 28 4.2.4 Switching off ... 28

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 ... 29

Cleaning and care ...31

Maintenance ...32

Guarantee and disclaimer of liability...33

Service department ...34

Technical data ...36

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

Introduction We would like to congratulate you on your decision to use the Barkey S-line to warm infusion 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 following symbols: WARNING

On non-compliance: danger for persons.

ATTENTION

On non-compliance: danger for property, the device or elementary device functions.

INFORMATION

Additional useful pointers and 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 qualification in a human medicine occupation. WARNING Only persons who satisfy these requirements may operate this device.

Instructions for Use Barkey S-line - V2 GB - ae-100-EW-0000-05 - 2013-07-12 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 handling 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 noncompliance 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 together 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 installed 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 expressly 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 - V2 GB - ae-100-EW-0000-05 - 2013-07-12 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

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 permanently factory-set to +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.

Instructions for Use Barkey S-line

2.1

Components of the Barkey S-line 1.

Control unit

Controls the temperature in the warming section.

Warming section

The flexible warming section holds the infusion tube and transmits the heat to the flowing fluid.

Warming section holder

The warming section can be placed at its head and end in the holder provided. This prevents unintentional contact with the floor.

Fastening clamp

The fastening clamp fixed to the back of the housing is used to fasten the Barkey S-line to an infusion stand.

Power cable

Transmits electricity from the socket to the warming device.

3 1

Fig. 2: Barkey S-line

Instructions for Use Barkey S-line - V2 GB - ae-100-EW-0000-05 - 2013-07-12 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

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.

Fig. 3: Display and control panel

The display and control elements are marked by symbols, which are explained in the following 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.

Instructions for Use Barkey S-line

2.3

Technology description When the Barkey S-line is switched on and ready for use the warming section is heated to a temperature of 39 ± 2°C by an internal heat conductor. The warming section is constructed in such a way that standard infusion lines (Ø 5 mm, length 1.5 m) can be placed easily into the groove. An independent overtemperature protector monitors the temperature in the warming section. In case of a fault the operator is informed by the yellow luminous ring showing 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 warming 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 temperature, the flow rate, the ambient temperature, etc. The following graph shows a typical initial temperature curve (Initial temperature Fluid and ambient temperature: 20°C) Outlet temperature fluid /°C

Flow rate ml / min Fig. 4: Typical starting temperature of the fluid that has passed through at different flow rates

Instructions for Use Barkey S-line - V2 GB - ae-100-EW-0000-05 - 2013-07-12 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

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.

IP X2

This symbol states that the device is protected in the planned operating conditions against water drops falling up to 15° from the vertical in accordance 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 returned to the manufacturer for disposal. (EU Directive 2002/96/EC on waste electrical and electronic equipment, WEEE)

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.

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 conductors must not be connected to this earthing stud.

Instructions for Use Barkey S-line - V2 GB - ae-100-EW-0000-05 - 2013-07-12 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

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 2.9).

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

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 controlled in dependence on the temperature, i.e. it can be switched off fully at low temperatures 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 section. 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 eliminated, 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. 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 2.9), 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.

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.

Instructions for Use Barkey S-line - V2 GB - ae-100-EW-0000-05 - 2013-07-12 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

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

Safety information

3.1

Safety information for using the device

WARNING

Check the device for damage before each use. Damaged devices 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 installation. Read these instructions for use carefully before using the device. 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 instructions 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 instructions for use. Use the device solely for the intended purpose and in conformity 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 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. The warming device can be used at ambient temperatures of +10°C to +40°C and is approved for permanent use.

Instructions for Use Barkey S-line - V2 GB - ae-100-EW-0000-05 - 2013-07-12 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

WARNING

When installing and fastening the Barkey S-line to an infusion 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 functioning 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 together with the original instructions for use.

Instructions for Use Barkey S-line

3.2

Safety information for handling the device

WARNING

ATTENTION

Read these instructions for use carefully before using the device. To ensure that the device is safely disconnected from the electricity 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 manufacturer 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 repair. 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, 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.

Instructions for Use Barkey S-line - V2 GB - ae-100-EW-0000-05 - 2013-07-12 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

3.3

Safety information for environmental influences

WARNING

Medical electrical devices are subject to special safety measures with regard to EMC (electromagnetic compatibility). Make sure that the device is installed and operated in accordance with the EMC information contained in these instructions 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 60601-12. 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 observed 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 Sline 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 devices with high waste heat production. The lines must be laid in such a way that interference with other devices is safely avoided. 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.

Instructions for Use Barkey S-line

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 customer or the operator of the Barkey S-line should ensure that it is used in this type of environment. 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 installations and those that are conEmissions of harmonics in accorClass A nected to a public supply network dance with IEC 61000-3-2 that also supplies buildings that are Emissions of voltage fluctuaConforms used for residential purposes. tions/flickering in accordance with IEC 61000-3-3

Instructions for Use Barkey S-line - V2 GB - ae-100-EW-0000-05 - 2013-07-12 19 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 customer or the operator of the Barkey S-line should ensure that it is used in this type of environment. Interference IEC 60601 test Electromagnetic environment Conformity level immunity tests level guidelines Floors should be made of wood or ± 6 kV ± 6 kV Electrostatic disconcrete or be fitted with ceramic contact discharge contact discharge charge (ESD) in tiles. If the floor is covered with accordance with ± 8 kV air dissynthetic material the relative hu± 8 kV air discharge IEC 61000-4-2 charge midity must be at least 30%. ± 2 kV for mains ± 2 kV for mains Bursts in accorcables 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- outerconductorSurges in accorouterconductor 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 flucUT) for 5 periods for 5 periods requires the function to continue tuations in the even on the occurrence of interrup70% UT supply voltage in 70% UT tions to the energy supply, we rec(30% dip in the accordance with (30% dip in the UT) ommend that the Barkey S-line is UT) for 25 periIEC 61000-4-11 for 25 periods supplied from an uninterruptible ods power system or a battery. < 5% UT < 5% UT (> 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 frefrequency should conform to the quency typical values found in the busi(50/60 Hz) in acness and hospital environment. cordance with IEC 61000-4-8 NOTE UT is the a.c. supply voltage before use of the test level

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S-line Instructions for Use Ver 2GB July 2013