Protherm II Instructions for Use Edition 6- 2007

IMPORTANT: These instructions are an essential part of the device. They must therefore be kept in a suitable place near the device and should accompany the device if it is transferred to other users. For proper and safe use of this device it is essential that the warnings and safety instructions, as well as the instructions for use are read and carefully observed by all users before first using the device. It is the responsibility of those using the device to fully acquaint themselves with its proper use and operation. If a malfunction is suspected, the device is to be taken out of service immediately and suitable warning signs should be attached to the device to ensure that it cannot be used before necessary service and repair work has been carried out.

BIEGLER

Instructions for use - protherm II

Table of contents 1 Warnings and safety instructions...2 2 Description...4 2.1 General Description...4 2.2 Scope of delivery...4 2.3 Consumable material...4 3 Initial operation...5 3.1 Setting up procedure...5 3.2 Alarms...7 3.3 Shutting down the device...7 4 Maintainance...8 5 Cleaning and disinfection...8 6 Periodic inspections...8 7 Manufacturer liability...10 8 Warranty conditions...10 9 Return of devices...11 10 Manufacturer's declaration...11 11 Electromagnetic emission...12 12 Symbols...16 13 Operating and storage conditions...16 14 Technical Data...17 15 Manufacturer...17

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Instructions for use - protherm II

BIEGLER

1 WARNINGS AND SAFETY INSTRUCTIONS •

In the event of any suspected malfunction while in operation, the device should be immediately removed from service and not used for infusions or transfusions until appropriate investigations have demonstrated that there has been no impairment.

•

If the high temperatur alarm is triggered the supply of liquid to the patient must be immediately stopped by disconnecting the connection tube to the patient. The medium being used in the device must no longer be administered to the patient.

•

The system must be depressurized before opening the device by switching off the pressure cuffs or infusion pump and releasing the pressure remaining within the system. Closing the system forcibly when the warming bags are full and under pressure may cause the warming bag to burst. The maximum pressure of the system must not exceed 300mmHg.

•

The device may only be fastened to infusion stands or tripods which are suitable due to their stability and load capacity.

•

Only sterile BIEGLER consumable materials may be used in conjunction with the protherm II.

•

The device must only be used in areas in which the electrical installations are in accordance with the rules and regulations in force.

•

Safe disconnection from the mains power supply can only be achieved by unplugging the mains plug.

•

The device must not be used in rooms subject to explosion hazard.

•

Repairs and modifications to the device may only be carried out by persons or service centres authorized by BIEGLER.

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The device must not be immersed in liquids or sterilized with steam or by thermochemical methods.

•

All extraneous influences such as radiation or high temperatures are to be kept to a minimum.

•

Avoid exerting force to the device or its accessories.

•

If the device is dropped, damaged by force or if it shows a function deviating from the instructions for use, do not use the device and return it to the service centre.

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BIEGLER •

Instructions for use - protherm II

The periodic technical safety inspections must be carried out according to the section „periodic inspections“.

The protherm II must not be used in the following circumstances: •

If the case is damaged or one of the front film layers becomes detached

•

If the device has been exposed to a hard physical shock (e.g. dropped, hit or shaken)

•

If the device has been immersed in water

•

If the device has triggered a high temperatur alarm that was not caused by external factors

•

If the mains power cord or plug is damaged

•

If the device has given somebody an electric shock

•

If the fixing clamps are damaged and no longer assure safe clamping to the infusion stand

Should a malfunction be evident, suitable warning signs should be attached to the device to ensure that it cannot be used before necessary service and repair work has been carried out.

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Instructions for use - protherm II

BIEGLER

2 DESCRIPTION 2.1GENERAL DESCRIPTION The BIEGLER protherm II is a warmer for infusions and transfusions at high flow rates. The device operates on the basis of the dry heat principle and uses warming plates heated on both sides. The medium is heated rapidly, efficiently and gently by using three independently controlled heat zones. The design of the casing allows rapid and simple fitting to any suitable infusion stand. The plate temperature can be set between 37°C and 41°C in steps of 0.5°C and is displayed as an illuminated band. The preset temperature after switching on the protherm II is 38.5°C. The alarm and self-test functions for high and low temperature that are incorporated into the device assure safe operation.

2.2SCOPE OF DELIVERY Blood and infusion warmer protherm II and instructions for use

2.3CONSUMABLE MATERIAL Two sizes of bags are available according to requirements. The bags are supplied as a complete unit with drip chambers containing built-in blood filters and an air trap at the outlet. Order numbers: Large bag Small bag

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FP100301 FP103102

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BIEGLER

Instructions for use - protherm II

3 INITIAL OPERATION 3.1 SETTING UP PROCEDURE

Diag. 1 1 Entry of liquid 2 Mounting for the air trap 3 Air trap 4 Attachment hooks for warming bag

5 Tube holder 6 Clips for closure of device 7 Tube holder 8 Tube holder

Diag. 2 1 Temperature scale 2 Temperature scale 3 Control to increase temperature 4 Control to decrease temperature 5 ON / STANDBY switch 6 LED ON 7 LED STANDBY

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Instructions for use - protherm II

BIEGLER

Users must familiarise themselves in detail with the contents of these instructions for use before putting the system into operation.

Fix the BIEGLER protherm II firmly to the infusion stand using the clamps at the back. Only use infusion stands or poles that are sufficiently stable. Connect power cable to power supply. Before connecting to mains power supply, check the voltage specified on the device label. The device gives a short beep and the standby light (Diag.2/7) lights up. If a different temperature to 38.5°C is desired, it can be preset in Standby and (Diag.2/3 and Diag.2/4). If an adjustment mode using the controls control is pressed, the visual display indicates the existing preset temperature. By repeated operation of the control or the temperature can be reset. The indicator automatically goes out after approximately 7 seconds. Resetting of temperature can only be performed in Standby mode. (Diag.2/5). Heating of the protherm II can be started by pressing the control The protherm II attains the set target temperature within 1 minute. The indicator display shows the actual temperature (+/- 0.5°C) as an illuminated band. Open the device: release the two clips on the right (Diag.1/6) by pressing the button on the clip and open the device. The heating zones are visible, the attachment hooks for the warming bag are on the reverse at the top (Diag.1/4). Hang the warming bag on the attachment hooks (Diag.1/4) and push the tube outlets into the tube holders (Diag.1/5,7,8). The tube with the two drip chambers must be placed at the top, the tube to the air trap below (Diag.1/3). The warming bag hangs without creases in the open device. Close the protherm II and lock with the clips on the right side (Diag.1/6). Place the air trap in the mounting provided (Diag.1/2). Fill the system. Take care that filling proceeds without air bubbles occuring. When the device is opened, the system must not be under pressure. Closing the system when it is under pressure can cause the warming bag to burst. The clips are designed so that they resist opening above a certain operating pressure. The device must not be forcibly opened.

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Instructions for use - protherm II

3.2 ALARMS The protherm II can trigger two types of temperature alarm: The low temperature alarm is activated when the average temperature from the three zones falls below 36.5°C. The audio low temperature alarm is deactivated during the first 60 seconds after switching on. The high temperature alarm is activated when the temperature of one of the six heating plates exceeds 42.0°C. In this event visual and audio alarm signals are given and the heating plates in all the zones are switched off. To reset the device or switch off the alarm, the device must first be disconnected from the power supply. Attention: The temperature alarm can also be set off externally e.g. by exposure to sunlight.

3.3 SHUTTING DOWN THE DEVICE After being used for treatment, the device is shut down as follows: Switch the device into Standby mode using control

(Diag.2/5).

Remove pressure from the system by switching off any pressure cuffs or infusion pumps used and release remaining pressure from the system. Empty and disconnect the system as far as possible. Release the two clips on the right (Diag.1/6) and open the device. Remove the bag from the attachment hooks (Diag.1/4) and dispose of it according to the relevant regulations. Disconnect the device from the power supply and clean and sterilize as in section „cleaning and disinfection“ of these instructions.

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Instructions for use - protherm II

BIEGLER

4 MAINTAINANCE The protherm II is designed as a low-maintenance device. To preserve the quality and functional safety, please comply with the following points: •

Always keep the device and its accessories clean (see section: cleaning and disinfection).

•

The periodic technical safety inspections must be carried out (see section: periodic inspections)

5 CLEANING AND DISINFECTION The device may only be cleaned using a soft cloth with water-soluble, nonaggressive cleaning agent or a special cleaning agent for plastics. For the purposes of disinfection, ready-made alcohol-based spray disinfectants can be used. Important: Before cleaning or disinfection, the device must always be disconnected from the mains power supply.

6 PERIODIC INSPECTIONS Periodic technical safety inspections must be performed on the protherm II at least every 12 months by persons who on the basis of their training, knowledge and practical experience are qualified to carry out such technical safety testing. The results of the periodic inspection are to be entered, together with the date and the inspecting agency, on the reverse side of the instructions for use. Important: If a malfunction is identified in the periodic inspection, affix a suitable warning notice on the device to ensure that it can no longer be used until the necessary repairs have been carried out.

CHECKING THE WARM-UP PERIOD This is the time taken by the protherm II to heat up to 38.5°C from room temperature. The device is malfunctioning if it takes much longer than one minute.

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Instructions for use - protherm II

CHECKING THE CONTROL TEMPERATURE The control temperature is checked on the lower third of the rear heating plates, about 7 cm from the right-hand edge of the device. The sensor of a suitable contact thermometer (tolerance +/- 0.15°C) is fixed to this place e.g. using adhesive tape. The check is performed with the device closed and at a temperature setting of 38.5°C. The measured value is read after it has stabilized. The difference must not exceed +/- 0.5°C. This check is carried out on each of the three heating areas. There is a malfunction if a difference from control temperature of greater than +/- 0.5°C is obtained.

CHECKING THE LOW TEMPERATURE ALARM Preheat the device to 38.5°C, then disconnect the mains plug. Hold down the and and reconnect the mains plug. Push the switch. The controls device is now in an operational state where all the alarms are active, but the heating is switched off. The protherm II now slowly cools down. When the temperature drops below the 36.5°C threshold, the low temperature alarm should be active. For reasons of safety, short beeping sounds are given at intervals of a second in this operational mode. There is a malfunction if the low temperature alarm is not triggered.

CHECKING THE HIGH TEMPERATURE ALARM Preheat the device to 41°C and wait for the temperature to stabilize, then and and reconnect the disconnect the mains plug. Hold down the controls mains plug. Push the switch. The device now heats up to a target temperature of 43.5°C. Observe the temperature indicator carefully. The high temperature alarm should be triggered at a temperature of 43,0°C. For reasons of safety, short beeping sounds are given at intervals of a second in this operational mode. There is a malfunction if the high temperature alarm is not triggered.

VISUAL CHECK OF GENERAL CONDITION AND STICKERS The device should be checked for mechanical damage (general condition) and for the completeness of sticker information, particularly the plate on the reverse. There is a malfunction if mechanical damage to the device is evident which could be harmful or impair the functional operation of the device.

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Instructions for use - protherm II

BIEGLER

ELECTRICAL SAFETY All relevant electrical safety data should be checked, particularly the earth conductor resistance (< 0.3 Ohm) and leakage current (< 0.75 mA). There is a malfunction if there is a value outside the tolerances.

7 MANUFACTURER LIABILITY The manufacturer and the supplier of the device reject all liability if: •

the device is not used in accordance with the instructions for use

•

the operating personnel are inadequately qualified or are not sufficiently informed about the functioning of the device on the basis of the instructions for use and the safety instructions

•

repairs are not performed exclusively by the manufacturer or by persons and service centres expressly authorised by manufacturer

•

the device is used in places in which the electrical installations do not comply with the applicable national standards, or if power supply during the period of use of the device is not guaranteed

•

original spare parts material are not used or the maintenance interval is not complied with.

Disposal of the device and its accessories is carried out in accordance with the applicable local regulations.

8 WARRANTY CONDITIONS The manufacturer guarantees that all flaws of material and workmanship which arise within 24 months from date of purchase will be repaired free of charge. Claims are only accepted under the following terms: •

The manufacturer and/or supplier is informed immediately of the fault for which the warranty claim is being made.

•

The instructions of the manufacturer and/or supplier on storage or return of the device are complied with.

•

Presentation of a legible copy of the invoice for the device concerned, showing the date of purchase.

•

An exact description of the defects or malfunctions identified by the

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Instructions for use - protherm II

customer. The manufacturer's warranty will be void if it is found that the maintenance, disinfection and inspection instructions have not been followed according to the instructions for use, the device was damaged by force or operating error, or was used in any way contrary to the instructions for use and safety instructions. The warranty will also be void if not original Biegler materials were used as replacement parts, or measures for repair were undertaken by persons not authorised by the manufacturer or supplier. If the manufacturer is required to meet a warranty claim in accordance with these terms, the customer shall bear the costs and risks of transport of the device from and to the place of use. The manufacturer and/or supplier under no circumstances assume liability for slight negligence. The compensation for lost earnings and profits is likewise excluded.

9 RETURN OF DEVICES Devices must be carefully cleaned and disinfected before being placed in the original packaging for returning. If the original packaging is no longer available, the product has to be suitably packaged for the method of dispatch.

10 MANUFACTURER'S DECLARATION The blood and infusion warmer protherm II is a medical product as defined by Directive 93/42/EEC. This is documented with the CE mark. Notified Body: TÜV Product-Service, Approval Number CE0123

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Instructions for use - protherm II

BIEGLER

11 ELECTROMAGNETIC EMISSION Table 201 – Guidance and manufacturer´s declaration – electromagnetic emission – for all EQUIPMENT AND SYSTEMS (see 6.8.3.201 a) 3)) Guidance and manufacturer´s declaration – electromagnetic emission The Protherm II is intended for use in the electromagnetic environment specified below. The customer or the user of the Protherm II should assure that it is used in such an environment. Emissions test

Compliance

RF emissions Group 1 CISPR 11

Electromagnetic environment - guidance The Protherm II uses RF energy only for its internal function. Therefor, 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 Class A IEC 61000-3-2 Voltage fluctuations / flicker emissions

The Protherm II is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Complies

IEC 61000-3-3

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Instructions for use - protherm II

Table 202 – Guidance and manufacturer's declaration – electromagnetic immunity – for all EQUIPMENT and SYSTEMS (see 6.8.3.201 a) 6)) Guidance and manufacturer´s declaration – electromagnetic immunity The Protherm II is intended for use in the electromagnetic environment specified below. The customer or the user of the Protherm II should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electrostatic discharge (ESD)

± 6 kV contact

± 6 kV contact

IEC 61000-4-2

± 8 kV air

± 8 kV air

Electrical fast transient / burst

± 2 kV for power

± 2 kV for power

supply lines

supply lines

± 1 kV for input/output lines

not applicable

± 1 kV differential mode

± 1 kV differential mode

± 2 kV common mode

± 2 kV common mode

< 5 % UT (>95 % dip in UT ) for 0,5 cycle

< 5 % UT (>95 % dip in UT ) for 0,5 cycle

40 % UT (60 % dip in UT ) for 5 cycles

40 % UT (60 % dip in UT ) for 5 cycles

70 % UT (30 % dip in UT ) for 25 cycles

70 % UT (30 % dip in UT ) for 25 cycles

< 5 % UT (>95 % dip in UT ) for 5 sec

< 5 % UT (>95 % dip in UT ) for 5 sec

IEC 61000-4-4

Surge IEC 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

Power frequency (50/60 Hz) magnetic field

3 A/m

IEC 61000-4-8

NOTE

3 A/m

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

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

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

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

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

UT is the a. c. mains voltage prior to application of the test level.

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Instructions for use - protherm II

BIEGLER

Table 204 – Guidance and manufacturer´s declaration – electromagnetic immunity – for EQUIPMENT and SYSTEM that are not LIFE-SUPPORTING (see 6.8.3.201 b)) Guidance and manufacturer´s declaration – electromagnetic immunity The Protherm II is intended for use in the electromagnetic environment specified below. The customer or the user of the Protherm II should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the Protherm II, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

Conducted RF

3V

IEC 61000-4-6

150 kHz to 80 Mhz

Radiated RF

3 V/m

IEC 61000-4-3

80 MHz to 2,5 GHz

3V

d = 1,17 P

10 V/m

d = 0,35 P 80Mhz to 800MHz d = 0,7 P 800MHz to 2,5GHz where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).b Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic is affected by absorption and reflection from structures, objects and people a

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

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

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Instructions for use - protherm II

Table 206 – Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING (see 6.8.3.201 b)) Recommended separation distances between portable and mobile RF communications equipment and the Protherm II The Protherm II is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Protherm II can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Protherm II as recommended below, according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter m Rated maximum output of transmitter

150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2,5 GHz

d = 1,17 P

d = 0,35 P

d = 0,7 P

0,01

0,12

0,04

0,07

0,1

0,37

0,11

0,22

1

1,17

0,35

0,70

10

3,69

1,11

2,21

100

11,67

3,50

7,0

W

For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres (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 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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Instructions for use - protherm II

BIEGLER

12 SYMBOLS 0123

Certifies compliance with Directive 93/42/EEC Observe the instructions for use Do not dispose of this product as unsorted municipal waste Control for increasing the temperature setting Control for decreasing the temperature setting Control for switching On / Standby

13 OPERATING AND STORAGE CONDITIONS Permissible environmental conditions for transport and storage: Temperature: Relative humidity: Air pressure:

10 – 40°C 30 – 75 % 700 – 1060 hPa

The operating temperature must be in the range of: 10 – 30 °C Values higher or lower than the ranges specified above may cause damage to the device or its accessories.

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Instructions for use - protherm II

14 TECHNICAL DATA Device: Type designation: Voltage: Power consumption: Type of protection against electric shock: Degree of protection against electric shock: Degree of protection against ingress of liquids: Safety protection: Temperature setting: High temperature cut-out: Max. system pressure: Dimensions: Weight: Classification: Type of operation:

Blood and infusion warmer protherm II 230 V / 50-60 Hz 1200 W I B IPX4 primary 2 x 6.3 AT secondary 500 mAT 37°C - 41°C adjustable in steps of 0.5°C 43,0°C / 43.5°C / 45°C±3°C 300 mmHg WxHxD 300 x 400 x 120 mm 5 kg IIb according to rule 9 continuous operation

MANUFACTURER

E. Biegler GmbH Allhangstrasse 18a A-3001 Mauerbach Austria Tel. +43 1 979 21 05 Fax +43 1 979 21 05 16 email: [email protected] www.biegler.com

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