BW03 Bag Warmer Operating Manual May 2010

ENG

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Bag Warmer BW03 Operating manual

Operating manual Bag Warmer BW03 Device for the heating of peritoneal dialysis solution bags Contents Instructions for use

36

Description of the device Bag Warmer BW03

37

• Intended use • Contraindications and side effects • Setting up and initial operation of the device • Notes on safety

37 37 37 37

Description of device • Construction and function of the device • Markings Symbols and indications Data plate

ENG

39 39 40 40 40

Handling

41

Technical information

42

• Technical data • Electromagnetic compatibility according to IEC 60601-1-2:2001 • Transport and storage • Maintenance Product cleaning and disinfection Maintenance and repair • Disposal of product, environmental tolerance and recycling • Warranty • Glossary

42 43 46 46 46 47 47 47 48

Bag Warmer BW03 Operating manual

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Instructions for use This operating manual is part of the accompanying documents and thereby a component of this device. It contains all necessary information for the use of this device. The operating manual must be thoroughly studied before the device is commissioned.

Symbols used in the operating manual and on the device To ensure safe use of the Bag Warmer BW03, safety notes are identified as follows in the operating manual, depending on the degree of the potential risk:

ENG

WARNING Significance: Indicates a potentially dangerous situation or action for individuals. If a WARNING is ignored, there is a major risk of death or severe injury for the patient, the operator, or a third party. CAUTION Significance: Provides information. Compliance with this is important for the maintenance of the safety and effectiveness of the system.

NOTE Significance: NOTE on the correct use of the device and associated accessories.

CAUTION The device may only be used in accordance with the accompanying documents. Only in this case, does the manufacturer regard itself as responsible for the security, reliability, and performance of this device.

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Bag Warmer BW03 Operating manual

Description of the device Bag Warmer BW03 Intended use The Bag Warmer BW03 is intended for the heating of peritoneal dialysis solution bags at a temperature of 36°C immediately before use of the PD solution. The Bag Warmer BW03 is suitable for Baxter single and double chamber peritoneal dialysis bags with a maximum volume of 3 liters. WARNING The peritoneal dialysis solution bag must be removed from the Bag Warmer BW03 immediately before the use of the solution. The Bag Warmer BW03 is not intended to heat the peritoneal dialysis solution during the peritoneal dialysis exchange by the patient.

ENG

Contraindications and side effects At present no contraindications or side effects associated with the PD solution warmer are known.

Setting up and initial operation of the device The device Bag Warmer BW03 must always be placed horizontally with the heating surface upward and not immediately next to other heat sources. The device may only be operated if directly connected to a properly grounded AC outlet and in a dry room. The power supply voltage must be in accordance with the information on the data plate of the Bag Warmer BW03.

Notes on safety WARNING Bag Warmer BW03 shall only be used if it is free from visible defects or damages. The manufacturer only assumes responsibility for the safety, reliability, and performance of the device, if all the following conditions are met: • Assembly, upgrading, resetting, changes, or repairs have been performed by service personnel authorized by the manufacturer. • The electrical installation of the room where the BW03 is used corresponds to the standard requirements. • The device has been used in accordance with the operating instructions. In order to ensure the safe operation of the Bag Warmer BW03, the following points must be care-fully observed for the connection to the power supply: • The device may only be operated if directly connected to a properly grounded AC power outlet. • The applicable national standards must be observed when connecting the device to the mains power supply system (e.g., in Germany, VDE 0107). • When using a device of electrical safety class 1, like the Bag Warmer BW03, the quality of the protective conductor of the installation is important. It should be noted that this is officially specified by the authorities in many countries.

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WARNING Only Baxter approved components, cables and accessories may be used in the maintenance of the device. All shielding, covers, screws and seals should be reattached in exactly the same place, as described in the maintenance manual. Otherwise this could result in raised emission or reduced interference immunity of the device.

CAUTION If an alarm appears during the use of the Bag Warmer BW03, the device must be switched off and the PD solution bag must be discarded. The device must cool off during approximately 5 minutes before it is used again.

ENG

If alarm appears repeatedly during the use of the Bag Warmer BW03, the device must be taken out of operation and the Baxter Technical Service must be notified. The Bag Warmer BW03 as well as all electro medical devices require special precautions in relation to the electromagnetic compatibility and must be installed and commissioned according to the following instructions. The intensity of electromagnetic energy is the strongest near transmission aerial, portable and mobile RF communications equipments. These can disturb electrically operated medical devices. The Bag Warmer BW03 device is designed so that it resists to the influence of electromagnetic disturbances and corresponds to the newest valid EMC standards. Nevertheless, very high levels of electromagnetic energy (above the limits set in IEC 60601 -1-2) can cause disturbances. In order to reduce the risk of an electromagnetic interference, the following recommendations are to be considered: • Do not switch on or use mobile radio equipments, for example mobile radiotelephones or mobile phones near the BW03. If the use of such equipment is necessary, refer to the data in the “recommended distance” tables in the section “Electromagnetic compatibility”. • In case of an unexplainable disturbance check whether transmission equipments like radio or TV stations are nearby. The location of the device may require changing or attaching a shielding between the transmitter and the device. • A change to the device or the adding of accessories or components without authorisation of Baxter can make the device more sensitive to high-frequency waves. • The Bag Warmer BW03 should not be operated near or on top of other medical electrical devices. If it is necessary to operate the device next to another device, the function of the BW03 must be carefully observed to guarantee a normal operation in the intended configuration.

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Bag Warmer BW03 Operating manual

Description of device Construction and function of the device The device consists of an aluminium heating plate installed on a plastic housing. The power supply is made by firmly connecting the power plug to a grounded AC mains outlet (CEE7/7, Type E / F). NOTE If an adapter is needed to connect the plug of type E/F to the available power supply outlet, this adapter must comply with the requirements of the IEC 60601-1.

The power switch (green) and the indications ALARM and Ready are located on the control panel.

ENG

The regulation and monitoring of the solution temperature is performed electronically. The heating plate temperature is automatically and constantly set to a temperature of 39°C ± 1°C. A special PD solution temperature monitoring function ensures that the green indicator starts to flashes when the solution temperature has reached 35°C ± 1,5°C. The indicator remains steady as soon as the solution temperature reaches 36°C ± 1,5°C, indicating that the solution is ready to use. Another temperature monitoring of the heating plate guarantees that the heating is immediately switched off if the heating plate temperature exceeds 41±0.5°C. Would this happen, optical and audible alarms are activated. The plate temperature will never exceed 45°C. The Bag Warmer BW03 can be operated in continuous operation with and without PD solution bags on the plate.

Bag Warmer BW03 Operating manual

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Markings Symbols and indications Indications and meanings of the symbols placed on the Bag Warmer BW03: Symbol

Meaning ON Power switch ON position

off Power switch OFF position

ENG

Alarm Signal indication “Alarm”

READY Signal indication “Ready”

READY Signal indication “Ready”

Visual signals

Comment

Green illuminating

BW03 is switched on

Does not illuminate

BW03 is switched off

Red steady ON

Temperature of heating plate ≥ 41°C

Green flashing

PD solution has reached a temperature of 35°C ± 1,5°C

Green steady ON

PD solution has reached a temperature of 36°C ± 1,5°C

Read instruction for use!

Data plate The data plate of the Bag Warmer BW03 has the following information. RIC 8344 PD BAG WARMER

Baxter Healthcare, SA 8010 Zurich Switzerland

SI-F125-01

230 V~ 1.25A - 250W IPX1

NOTE The Glossary, page 48 of this operating manual provides meaning of these symbols.

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Bag Warmer BW03 Operating manual

Handling The Bag Warmer BW03 device must be used horizontally with the heating surface upward and not immediately next to other heat sources.

1: Set the power switch to “ON” and check that the power switch is illuminated green. 2: Place the PD solution bag with overpouch on the heating plate, so that the bag covers the whole heating surface and the side of the bag with the transfer tubes is facing upwards.

ENG

3: When the PD solution is ready for use, if the indication READY remains steadily on.

4: Take the PD solution bag from the Bag Warmer BW03 just before use and prepare for the PD exchange as instructed.

NOTE The heating of a 2 litres PD solution bag from 20°C to 36°C takes about 60 minutes1 and approximately 120 minutes1 from 5°C to 36°C. The indication (READY) flashes when the PD solution has reached the temperature of 35°C ± 1,5°C and it remains steadily on when 36°C ± 1,5°C is reached. 1. Note: The values are valid for a 2 Liter PD solution bag and 21°C room temperature.

CAUTION If an alarm occurs during the use of the Bag Warmer BW03 (red visual and audible signal), the device must be switched off and the PD solution bag located on the heating plate must be discarded. The device must cool off approx. 5 min, before it is powered on and used again per the instructions above. If the alarm occurs repeatedly the device must be immediately removed from operation and your Baxter Service must be notified.

Bag Warmer BW03 Operating manual

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Technical information Technical data Bag Warmer BW03

ENG

42

Article number

RIC 8344

Dimensions

36x20x6cm

Weight

2,25 kg

Electrical connection

230 V ±10%, ~ , 50 Hz

Fuses

2 x T 1.25 A, 250 V (5x20 mm)

Applied part classification (IEC 60601)

No applied part The values of the discharge current correspond to devices of the application type B

Protection against electric shock

Safety class 1

Protection against moisture

IPX 1

Power consumption, nominal

250 W

Classification acc. to Annex IX of the Directive 93/42/EEC

Class II a, (rule 9)

Stability

max. 10° tilting angle

Operating Conditions Ambient air temperature Air humidity

15°C to 37°C 30 to 95 % rel. air humidity

Transport and storage conditions Storage temperature Air humidity

-5°C to 50°C; 10 to 95 % rel. air humidity

Audible signals alarm

Rapid succession of beeping signals

Considered technical standards

IEC-60601-1-1:2006 (3rd Edition) IEC-60601-1-2:2001; IEC-61000-x IEC 60417; ISO 7000; DIN 49441

Bag Warmer BW03 Operating manual

Electromagnetic compatibility according to IEC 60601-1-2:2001 Table 1: Guidance and manufacturer’s declaration – electromagnetic emissions The Bag Warmer BW03 device is intended for use in the electromagnetic environment specified below. The operator of the Bag Warmer BW03 must ensure that it is operated in an environment of this sort.

Emission test

Compliance

Electromagnetic environment – guidance

RF emissions CISPR 11

Group 1

Bag Warmer BW03 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Class B

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations / flicker emissions IEC 61000-3-3

Complies

ENG Bag Warmer BW03 is suitable for use in all environments including domestic environments, and in establishments directly connected to the public power supply network that supplies buildings used for domestic purposes.

WARNING The safety references in accordance with “Notes on safety” on page 37º of this operating instruction must be considered.

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Table 2: Guidance and manufacturer’s declaration – electromagnetic immunity The Bag Warmer BW03 device is intended for use in the electromagnetic environment specified below. The operator of the Bag Warmer BW03 must ensure that it is operated in an environment of this sort.

ENG

Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment – guidance

Electrostatic discharge (ESD)

±6 kV contact

±6 kV contact

IEC 61000-4-2

±8 kV air

±8 kV air

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

Electrical fast transient /Burst

±2 kV for power supply lines

±2 kV for power supply lines

IEC 61000-4-4

±1 kV for input /output lines

±1 kV for input /output lines

Surge

±1 kV differential mode

±1 kV differential mode

IEC 61000-4-5

±2 kV common mode

±2 kV common mode

Voltage dips, short interruptions, and voltage variations on power supply input lines IEC 61000-4-11

<5 % µT (>95 % dip in µT) for 0,5 cycles

<5 % µT (>95 % dip in µT) for 0,5 cycles

<40 % µT (>60 % dip in µT) for 5 cycles.

<40 % µT (>60 % dip in µT) for 5 cycles.

<70 % µT (>30 % dip in µT) for 25 cycles.

<70 % µT (>30 % dip in µT) for 25 cycles.

<5 % µT (>95 % dip in µT) for 5 sec

<5 % µT (>95 % dip in µT) for 5 sec

3 A/m

3 A/m

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

Comment: µT is the AC mains voltage prior to application of the test level.

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Bag Warmer BW03 Operating manual

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

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

The mains power quality should be that of a typical commercial or hospital environment. If the user of the Bag Warmer BW03 needs a continuous operation also during an interruption of main power supply, is recommended to operate the Bag Warmer BW03 about a power supply without interruption or a battery.

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

Table 3: Guidance and manufacturer’s declaration – electromagnetic immunity The Bag Warmer BW03 device is intended for use in the electromagnetic environment specified below. The operator of the Bag Warmer BW03 must ensure that it is operated in an environment of this sort.

Immunity test

Conducted RF disturbance variable IEC 61000-4-6

IEC 60601 test level

3 Vrms 150 kHz to 80 MHz

Compliance level

Electromagnetic environment – guidance

Portable and mobile RF communications equipment should be used no closer to any part of the Bag Warmer BW03, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. 3V

Recommended separation distance: d = [3,5 / 3] √P

ENG

d = [3,5 / 3] √P 80 MHz to 800 MHz d = [7 / 3] √P 800 MHz to 2,5 GHz P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Radiated HF disturbance variable IEC 61000-4-3

3 V/m 80 MHz to 2,5 GHz

3 V /m

Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol:

Note 1: With 80 MHz and 800 MHz applies the higher frequency. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio transmitters, AM and FM radio broadcast and television broadcast, cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Bag Warmer BW03 is used exceeds the applicable RF compliance level above, the Bag Warmer BW03 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Bag Warmer BW03. b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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Table 4: Recommended safety distances between portable and mobile RF telephones and mobile RF telecommunication instruments and the Bag Warmer BW03 – valid for equipment and systems that are not life-supporting The Bag Warmer BW03 device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the operator of the Bag Warmer BW03 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Bag Warmer BW03 as recommended below, according to the maximum output power of the communications equipment.

ENG

Separation distance according to frequency of transmitter (m)

Rated maximum output power of transmitter (W)

150 kHz to 80 MHz d = [3,5 / 3] √P

80 MHz to 800 MHz d = [3,5 / 3] √P

800 MHz to 2,5 GHz d = [7 / 3] √P

0,01

0,12

0,12

0,23

0,1

0,37

0,37

0,74

1

1,2

1,2

2,3

10

3,7

3,7

7,4

100

12

12

23

For transmitters rated at a maximum output power not listed above, the recommended separation distance in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note 1: With 80 MHz and 800 MHz applies the higher frequency. Note 2:These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

Transport and storage Transport and storage have to occur in the original cardboard packaging and in accordance with the conditions indicated in the technical data.

Maintenance Product cleaning and disinfection Use warm water and a mild cleaning agent for cleaning. Wipe the exterior of the device with a soft cloth and thoroughly rub dry it thereafter. WARNING For cleaning and disinfection, the device must be switched off and the power plug disconnected from the mains power outlet. Never immerse the device into water or any other liquid. Do not use chemical or alcohol-containing cleaning agent.

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Bag Warmer BW03 Operating manual

Maintenance and repair The PD solution warmer is maintenance-free. The electrical safety of the device should be checked all 24 months according to the standard EN 62353. WARNING If the device does not function perfectly, the device may not be used.

CAUTION Only qualified service engineers authorized by Baxter may carry out repairs. Do not ship the device back to Baxter without prior agreement and arrangement.

ENG

NOTE Should the device not function perfectly and a repair is necessary, please contact Baxter customer service (see addresses and telephone numbers at the back of this document)

Disposal of product, environmental tolerance and recycling The PD solution warmer is an electro medical device. The directive 2002/96/EU “Waste electrical and electronic equipment (WEEE)” applies to the BW03. Dispose of the product in the following manner: • Do not dispose this product as unsorted municipal waste. • Collect this product separately. • Use collection and return systems available to you. Further information on disposal or recycling of this product is available from your regional Baxter representative.

Warranty Baxter guarantees that the device shall be free from defect in material, workmanship and non-conformities at the time of the delivery to the first customer. Baxter’s sole obligation shall be limited to the repair or the replacement of defective parts or devices at Baxter’s choice and expenses within the term of warranty. The warranty extends only to the first customer and is not assignable or transferable and contains no warranty for equipment parts and disposable accessories. Baxter guarantees that the device is fit for the purposes and indications described in these operating instructions when used in accordance to these instructions. If the device is not used according to these operating instructions, the warranty is void. Modifications, alterations, changes, post calibrations or abuse as well as maintenance by persons not authorized by Baxter immediately result in the termination of all warranty claims for the product.

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Glossary Symbol

ENG

Meaning

Reference

“On” power supply

IEC 60417-5007

“Off” power supply

IEC 60417-5007

Alarm, general

IEC 60417-5507

Ready

ISO 7000-1140

Read the instruction for use!

ISO 7000-1641

Crossed out waste bin: • Do not dispose of this product as unsorted municipal waste. • Collect this product separately. • Use collection and return systems available to you.

(WEEE 2002/96/EC)

Bar below the waste bin: Product brought to market after August 13, 2005

AC voltage

IEC 60417-032

Date of production

ISO 7000-2497

Name of manufacturer:

EN 980 - 5.12

Baxter Healthcare, SA 8010 Zurich, Switzerland

Serial number

ISO 7000-2498

Catalogue number

ISO 7000-2498

Identification number of Notified Body

MDD 93/42/EEC

TÜV SÜD Product Service GmbH

This device meets the requirements of Council Directive 93/42 EEC

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Bag Warmer BW03 Operating manual

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Bag Warmer BW03 Operating manual

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ITA

98

Manuale operativo Bag Warmer BW03

ITA

Manuale operativo Bag Warmer BW03

113

POR

162

Manual do Bag Warmer BW03