BW 585 M Instructions for Use Feb 2021

BW 585 M

IMPORTANT These directions are essential for operating the device. They must therefore be kept in a suitable place near the device and should be kept with the device if it is given to other users. This manual is valid for BW 585 M devices with serial number 550345 or higher. For proper and safe use of this device, it is essential that the following warnings and safety instructions, as well as the operating instructions, 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 is not used before the required service and repair work has been carried out.

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BW 585 M TABLE OF CONTENTS 1.

WARNINGS AND SAFETY INSTRUCTIONS ... 4

2.

DESCRIPTION ... 6

2.1

GENERAL DESCRIPTION... 6

2.2 INTENDED USE ... 6 2.3 INDICATION ... 6 2.4 CONTRAINDICATION ... 6 2.1 CONSUMABLES ... 7 2.2 SCOPE OF DELIVERY ... 7 3.

INITIAL OPERATION ... 8 3.1 INITIAL OPERATION OF THE DEVICE ... 8 3.2 ALARMS ... 10 3.3 SHUTTING DOWN THE DEVICE ... 12 3.4 TROUBLESHOOTING ... 12

4

MAINTENANCE ... 13

5

CLEANING AND DISINFECTION ... 13

6

PERIODIC INSPECTIONS ... 14

7

MANUFACTURER LIABILITY ... 16

8

WARRANTY CONDITIONS ... 16

9

RETURN OF DEVICES ... 17

10

DISPOSAL ... 17

11

ELECTROMAGNETIC COMPLIANCE ... 18 11.1 EMISSION ... 18 11.2 IMMUNITY TEST LEVELS ... 18

12

MANUFACTURER'S DECLARATION ... 19

13

SYMBOLS ... 20

14

OPERATING AND STORAGE CONDITIONS ... 21

15

TECHNICAL DATA ... 22

16

MANUFACTURER ... 23

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BW 585 M 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.  Unplugging the mains plug is the only safe way to disconnect from the mains power supply. Place the device so that it can easily be disconnected from the mains.  If the high temperature 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 device may only be fastened to infusion stands, tripods or equipment rails which have sufficient stability and load capacity to support the device.  The device must only be used in areas in which the electrical installations are in accordance with the standards and regulations in force. To prevent the risk of an electric shock the device shall only be connected to a supply network with protective earth connection.  The device must not be used in rooms with potential explosion hazard.  The device must not be immersed in liquids or sterilized with steam or by thermochemical methods.  All extraneous influences such as electromagnetic waves or high temperatures are to be kept to a minimum.  The device can be influenced by other devices or equipment nearby or it can influence them. It is subject to special precautions regarding electromagnetic compatibility (EMC). Portable and mobile RF communication equipment can affect medical electrical equipment.  Avoid exerting force on the device or its accessories.  If the device is dropped, damaged due to force, or functions in a way other than described in the operating instructions, stop using the device immediately and return it to the service centre.  Persons and services authorized by BIEGLER must carry out repairs and modifications on the device.  Periodic technical safety inspections must be carried out as described in the "Periodic inspections" section.

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BW 585 M  No mechanical or electrical modifications may be made to the components of the warming system.  The device may not be set up and operated in direct proximity to devices which generate high levels of excess heat. The BW 585 M may not be used if:  the housing is damaged or one of the front film layers becomes detached.  the device has been exposed to a hard physical shock (e.g. dropped, hit or shaken)  the device has been immersed in water  the device has triggered a high temperature alarm that was not caused by external factors.  the mains power cord or plug is damaged  the device has given someone an electric shock  the fixing clamp is damaged in such a way that safe clamping to the infusion stand is no longer guaranteed. If there is a malfunction, suitable warning signs should be attached to the device to ensure that it is not used until the required service and repair work has been carried out. Safety Instructions for consumable materials:  Only sterile consumables or material specified by BIEGLER or approved by BIEGLER for use with this device may be used in conjunction with the BW 585 M.  Only use items with intact individual packaging.  Consumables are only for one-time use (disposable). The reuse of disposable products results in possible infection risks for the patient or user. Product contamination may lead to health problems, diseases or death of the patient.  Do not re-sterilize!  Observe the safety instructions for the media to be warmed.

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BW 585 M 2. DESCRIPTION 2.1

GENERAL DESCRIPTION

Description

Article number

Blood and Infusion Warmer BW 585 M (230 V)

LB22B4585

The BW 585 M is a warmer for infusions or transfusions and operates on the basis of a continuous flow warmer, where the heat from the heat exchanger is transferred via the extension tubing to the liquid flowing within it. The design of the housing allows rapid and simple fitting to all suitable infusion stands and equipment rails. The temperature of the heating element can be set between 37 °C and 41 °C in steps of 0.5 °C, and is clearly displayed. The default temperature after switching on the BW 585 M is 38.5 °C. The alarm and self-test functions for high and low temperature ensure safe operation. 2.2

INTENDED USE

The device is used for warming infusions and transfusions to minimize the risk of hypothermia. 2.3

INDICATION

The blood and infusion warmer BW 585 M is applied in cases where warming of fluids to be infused is necessitated. 2.4

CONTRAINDICATION

The blood and infusion warmer BW 585 M is not able to deliver significant data to use the device as flow rate monitoring or control system. Therefore, the device shall not be used as a substitute for infusion pumps for medication administration control.

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BW 585 M 2.5

CONSUMABLES

Various consumables are available according to requirements. Description

Length

Order No.

Extension set 35000

350 cm

FP1002001

Extension set 46000

460 cm

FP4600003

Extension set 25000 with bubble trap

460 cm

FP4600001

The optimal and safe heat transfer is only achieved with BIEGLER consumables (or those approved by BIEGLER for this device). 2.6

SCOPE OF DELIVERY

Quantity Description 1

Blood and Infusion Warmer BW 585 M (230 V)

1

Instructions for use

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BW 585 M 3. INITIAL OPERATION Observe the directions for use! Handling of this device requires knowledge and adherence to these instructions. The BW 585 M and accessories may only be used by qualified specialized staff. 3.1

INITIAL OPERATION OF THE DEVICE Fig. 1 1 Heat exchanger 2 Temperature scale 3 ON / STANDBY button 4 LED STANDBY 5 Button to reduce the temperature 6 Button to increase the temperature 7 Extension tube 8 Fastening clamp 9 Fluid entry point 10 Fluid exit point Flow direction

Fix the BW 585 M firmly to the infusion stand using the clamps at the back (Fig. 1/8). Only use infusion stands, tripods or equipment rails that are sufficiently stable. Connect the power cable to the power supply. Before connecting to the mains power supply, check that the voltage specified on the device label matches the mains voltage. The device emits a short beep (control of alarm) and the standby LED (Fig. 1/4) lights up. If a temperature other than 38.5 °C is desired, this can be preset in Standby mode with the buttons and (Fig. 1/5 and Fig. 1/6). If one of the control buttons is pressed, the current default temperature is shown on the display. You can use the and buttons to adjust the temperature. The temperature can only be adjusted in Standby mode.

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BW 585 M Press the button (Fig. 1/3) to start the heating of the BW 585 M. The device performs a self-test of safety-relevant functions, the completion of which is indicated by a short acoustic signal. The BW 585 M reaches the set target temperature within 1 minute. The actual temperature (± 0.5 °C) is indicated on the display. Select suitable consumables. See the "Consumables" section. Prepare infusion or transfusion. Important: The length of the tube between the BW 585 M and the patient must be at least 40 cm, and the tube must not be stretched.

Fig. 2 Position of the tube in the groove of the heat exchanger

Starting from the rear of the heat exchanger, gently pull the extension tube and coil it forwards in a counter-clockwise direction. It is advisable not to increase the distance between the BW 585 M and the patient much beyond 80 cm. Important: The tube must be completely inserted into the groove. (Fig. 2) The flow direction specified in Figure 1 must be complied with. Check the flow rate constantly during operation.

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BW 585 M 3.2 ALARMS The BW 585 M triggers temperature alarms and information signals: The low temperature information signal is activated when the temperature of the heat exchanger drops below 36.5 °C. The audible low temperature information signal is not active during the first 60 seconds after switch-on. In the event of a low temperature information signal, i.e. temperatures < 36.5°C, the 36.5 °C LEDs flash and the device emits an information signal every 15 seconds. The low temperature information signal is automatically cancelled after reaching 36.5 °C. The high temperature alarm is activated when the temperature of the heat exchanger rises above 42.0 °C. In this case, visual (flashing) and audible (continuous sound) alarm signals are emitted and the heating is switched off. The device can only be restarted and the alarm disengaged once the device has been disconnected from the power supply. Attention: The temperature alarm can also be triggered by external factors, e.g. exposure to sunlight. To reset the alarm, the mains plug must be pulled out. All alarms are alarms of “Low priority” according to EN 60601-1-8. The alarm system does not have to be verified. The alarm limits cannot be adjusted. The risk management process has found that a shutdown of the alarms is not meaningful, because it is desirable that the error (e. g. high temperature) is detected. Resetting of the alarm is only possible through disconnection of the device from mains. The operator station is in front of the device.

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BW 585 M Alarm overview Software high Hardware-high temperature alarm temperature alarm I

Hardware-high temperature alarm II

Internal fault

Condition

High temperature alarm is triggered when the temperature rises above 42.0 °C

If the temperature rises above 42.5 °C due to a software error, a hardware high temperature alarm is triggered.

If the temperature rises above 45 °C due to a software error, another hardware high temperature alarm is triggered.

Selftest detects an internal fault.

Consequence

The heater is switched off.

The heater is switched off.

The heater is switched off.

The heater is switched off.

Resetting

The alarm can only be reset by pulling out the mains plug.

The alarm can only be reset by pulling out the mains plug.

The alarm can only be reset by pulling out the mains plug. Wait for the temperature switch to cool down.

The alarm can only be reset by pulling out the mains plug.

Visual signal

Alarm LED is on

Alarm LED is on

Alarm LED is on

Alarm LED is on + LEDs for error code

Audio signal

Continous tone 3,4 kHz min. 62 dBA

Continous tone 3,4 kHz min. 62 dBA

Continous tone 3,4 kHz min. 62 dBA

Continous tone 3,4 kHz min. 62 dBA

Low priority

Low priority

Low priority

Priority as per Low priority EN 60601-1-8

Information signals Low temperature information signal Condition

If the heater temperature is lower than 36.5 °C. The audio low temperature signal is deactivated during the first 60 seconds after switching on.

Consequence

No consequences in relation to the function of the device. (information only)

Resetting

Automatically when the temperature rises above 36.5 °C.

Visual signal

36,5 °C LED flashes at 1 Hz 50 % duty cycle

Audio signal

1 pulse with 250 ms duration every 15 s frequency: 3,4 kHz | sound pressure level: min. 62 dBA

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BW 585 M 3.3

SHUTTING DOWN THE DEVICE

After being used for treatment, the device is shut down as follows: Switch the device to Standby mode with the button

(Fig. 1/3).

Depressurize the system by switching off any pressure cuffs or infusion pumps used. Empty and disconnect the system as far as possible. Remove the consumables from the heat exchanger (Fig. 1/1) and dispose of them according to the applicable local regulations Disconnect the device from the power supply, and clean and disinfect it as described in the section "Cleaning and disinfection". 3.4

TROUBLESHOOTING

Error

(possible) Cause

Solution

LEDs do not light up

No power supply

Insert the mains plug

No LEDs light up, even though mains plug is inserted and mains voltage available

Device defective

Return device for servicing

Blue LED lights up, device does not heat

Device is in Standby mode

Press the "ON" button to start the device

Device sounds alarm and does not heat

Internal error

Return device for servicing

<36.5 °C LED flashes and device issues short signals in 15 second intervals.

Low temperature information signal has been triggered

The low temperature information signal is automatically cancelled after reaching >36.5 °C.

Alarm LED lights up, audio alarm (continuous tone)

Device was overheated

Allow device to cool down. If the error occurs again → return device for servicing

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BW 585 M 4 MAINTENANCE The BW 585 M was largely designed as a maintenance-free device. For long-term maintenance of quality and functional safety, the following points have to be observed:  Always keep the device clean (see the "Cleaning and disinfection" section).  Periodic technical safety inspections must be carried out as described in the "Periodic inspections" section. 5 CLEANING AND DISINFECTION Important: Before cleaning or disinfecting, the device must always be disconnected from the mains power supply by pulling the plug. The BW 585 M may only be cleaned using a soft cloth with a watersoluble, non-aggressive cleaning agent or a special cleaning agent for plastics. For the purposes of disinfection, only ready-made alcohol-based disinfectants (e.g. Meliseptol Foam pure, BRAUN) must be used and the manufacturer’s instructions must be followed. Do not disinfect the device with steam (i.e. in autoclaves), hot air or thermochemical cleaning solutions.

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BW 585 M 6 PERIODIC INSPECTIONS The periodic technical safety inspections (according to the local standards in force - e.g. EN 62353) on the BW 585 M must be carried out at least every 12 months, by persons authorized to carry out such inspections based on their training, knowledge and practical experience. The results of the periodic inspection must be documented, along with the date, the inspecting agency and the device number. During the measurements, the heating devices may not be exposed to sunlight, draughts or other conditions which could affect the measurement. Important: If a malfunction is discovered during the periodic inspection, suitable warning signs should be attached to the device to ensure that it is not used before the required service and repair work has been carried out. CHECKING THE WARM-UP PERIOD This is the time taken by the BW 585 M to heat up to 38.5 °C from room temperature. If this time is much more than one minute, there is a malfunction. CHECKING THE CONTROL TEMPERATURE The control temperature is checked on the groove bed of the heat exchanger. The sensor of a suitable contact thermometer (tolerance ±0.15 °C) is attached here, e.g. with a piece of infusion tube. The examination is carried out at a setting of 38.5 °C. The measured value is read once it has stabilized. The difference must not exceed ± 0.5 °C. If there is a difference of greater than ± 0.5 °C from the control temperature, there is a malfunction.

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BW 585 M CHECKING THE LOW TEMPERATURE INFORMATION SIGNAL Preheat the device to 38.5 °C, then disconnect the mains plug. Hold down the button and reconnect the mains power plug. After the beep, release the button. Press the button. The device is now in an operating mode in which all alarms and signals are active but the heating is switched off. The BW 585 M now slowly cools down. When the temperature drops below the 36.5 °C threshold, the low temperature information signal should trigger. For reasons of safety, there is a short beep every second in this operating mode, and the STANDBY indicator (Fig. 1/4) flashes. If the low temperature information signal is not triggered, there is a malfunction. CHECKING THE HIGH TEMPERATURE ALARM Preheat the device to 41 °C and wait for the temperature to stabilize, then disconnect the mains plug. Hold down the button and reconnect the mains power plug. After the beep, release the button. Press the button. The device now slowly heats up to a target temperature of 42.5 °C. Observe the temperature display carefully. The high temperature alarm should be triggered at a temperature of 42 °C. For reasons of safety, there is a short beep every second in this operating mode, and the STANDBY indicator (Fig. 1/4) flashes. If the high temperature alarm is not triggered, there is a malfunction. VISUAL CHECK OF GENERAL CONDITION The device should be checked for mechanical damage (general condition) and for the completeness of the stickers, particularly the device label on the reverse. If there is mechanical damage to the device which could cause risk of injury or impair its functionality, this constitutes a malfunction. ELECTRICAL SAFETY All relevant electrical safety data should be checked, particularly the earth conductor resistance and leakage current. If a measured value is outside of the specified tolerance, there is a malfunction.

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BW 585 M 7 MANUFACTURER LIABILITY The manufacturer and the supplier of the device reject any liability if:  the device is not used in accordance with the directions for use.  the user is not sufficiently informed about the functioning of the device corresponding with the directions for use and the safety instructions  repairs are not performed exclusively by the manufacturer or by persons and service centers expressly authorized by the manufacturer  the device is used in places in which the electrical installations do not comply with the applicable national standards, or if the power supply during the period of use of the device is not guaranteed  original spare parts are not used or the maintenance interval is not adhered to. 8 WARRANTY CONDITIONS The manufacturer guarantees that all flaws of material and workmanship which arise within 24 months from the 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 regarding 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 customer.

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BW 585 M 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 operating instructions, the device has been damaged by force or operating error, or has been used in any way contrary to the operating and safety instructions. The warranty will also be void if original BIEGLER materials were not used as replacement parts, or measures for repair were undertaken by persons not authorized 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 shall 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 DISPOSAL Dispose of the device and its accessories in accordance with the applicable local regulations.

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BW 585 M 11 ELECTROMAGNETIC COMPLIANCE 11.1 EMISSION Test

Limit

Conducted emission

CISPR 11, Group 1, Class B

Radiated emission

CISPR 11, Group 1, Class B

Harmonic current emissions (IEC 61000-3-2)

IEC 61000-3-2, Class A

Voltage fluctuations and flicker (IEC 61000-3-3)

IEC 61000-3-3, Complies

11.2 IMMUNITY TEST LEVELS Test

Test level

Electrostatic Discharge (IEC 61000-4-2)

Contact Discharge: ±8 kV Air Discharge: ±2 kV, ±4 kV, ±8 kV, ±15 kV

Radiated RF EM filed (IEC 61000-4-3)

80-2700 MHz; 1kHz AM 80 %; 3 V/m

Proximity fields form RF wireless communications equipment (IEC 61000-4-3)

385 MHz; Pulse Modulation: 18 Hz; 27 V/m 450 MHz, Pulse Modulation: 18 Hz: 1 kHz sine; 28 V/m 710, 745, 780 MHz; Pulse Modulation: 217 Hz; 9 V/m 810, 870, 930 MHz; Pulse Modulation: 18 Hz; 28 V/m 1720, 1845, 1970 MHz; Pulse Modulation: 217 Hz; 28 V/m 2450 MHz; Pulse Modulation: 217 Hz; 28 V/m; 5240, 5500, 5785 MHz; Pulse Modulation: 217 Hz; 9 V/m

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BW 585 M Electrical fast transients Power lines: 2 kV; 100 kHz repetition / bursts frequency (IEC 61000-4-4) Signal lines: 1 kV; 100 kHz repetition frequency Surges (IEC 61000-4-5)

L-PE and N-PE: 2kV L-N: 1kV

Conducted disturbances inducted by RF fields (IEC 61000-4-6)

0.15-80 MHz; 1kHz AM 80 %; 3 Vrms , 6 Vrms in ISM band

Rated power frequency magnetic fields (IEC 61000-4-8)

30 A/m, 50 Hz and 60 Hz

Voltage dips / Voltage interruptions (IEC 61000-4-11)

0 % UT for 0.5 cycle at 8 phase angles 0 % UT for 1 cycle at 0° 70 % UT for 25/30 cycles at 0° 0 % UT for 250/300 cycles 0°

12 MANUFACTURER'S DECLARATION The blood and infusion warmer BW 585 M, BIEGLER consumables and associated materials (extension tubes) are medical products as defined by Directive 93/42/EEC. This is documented through the CE mark. Notified Body: TÜV SÜD Product Service

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BW 585 M 13 SYMBOLS Certifies compliance with the Directive 93/42/EEC Observe the directions for use Do not dispose of this product as unsorted municipal waste Button to increase the temperature setting Button to decrease the temperature setting High temperature or device error alarm IPX4

IP-classification (IEC 60529) Degree of prot. against electric shock: Type BF, defibrillation-proof AC voltage On / Standby button Protective earthing

SN

Serial number Manufacturer Date of manufacture High Temperature

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Low Temperature