ESH 04 Operating Instructions Nov 2019

ESH 04 IMPORTANT These operating instructions 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 instruction for use is valid for devices with serial number 6574 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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ESH 04

Table of contents 1

Warnings and safety instructions ... 4

2

Description ... 6

3

2.1

General description ... 6

2.2

Intended Use ... 6

2.3

Indication ... 7

2.4

Contraindication / Exclusions from Intended Use... 7

2.5

Scope of delivery ... 7

Starting the device ... 8 3.1

Setting up procedure ... 8

3.2

Alarms ... 11

4

Maintenance ... 12

5

Cleaning and disinfection ... 12

6

Periodic inspections ... 13

7

Manufacturer's liability ... 13

8

Warranty conditions ... 14

9

Return of devices ... 14

10 Electromagnetic Compliance Levels ... 15 10.1

Emission ... 15

10.2

Immunitiy Test Levels ... 15

11 Manufacturer’s Declaration ... 16 12 Symbols ... 17 13 Operating and storage conditions ... 18 14 Technical Data ... 18 15 Manufacturer ... 19

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ESH 04 1

WARNINGS AND SAFETY INSTRUCTIONS



The emergency warmer can only be used or connected in vehicles where the on-board installations comply with the standards and regulations in force.



The emergency warmer must always be used in a hanging position. The device shall not be used for infusion in a horizontal or an incorrect position. This could lead to a hazardous situation due air bubbles leaking into the infusion set.



Make sure there are no air bubbles in the tubing set in case the device falls down or temporarily gets into an inclined position.



Always ensure that the infusion bottles are vertical aligned with infusion outlet directed downwards and positioned 20cm higher than the patient infusion access.



To minimize the risk of air bubbles entering the tubing set, always use an infusion set with drip chamber or air trap



The treating physician must check the condition of the patient at regular intervals. Failure to do so could seriously harm the patient.



If the device is attached to infusion stands or tripods, then these must be sufficiently stable and able to carry the load.



The device must only be used with electrical installations that comply with the standards and regulations in force.



Only use original BIEGLER parts in conjunction with the ESH 04: mains adaptor 30 W E2EFMW3, PowerPort 12 V.



Unplugging the mains plug is the only safe way to disconnect from the mains power supply. Only plug the mains adaptor into easily accessible sockets, to ensure that it can be unplugged from the mains quickly if required.



The device must not be used if the power connector is damaged.



The device must not be used in rooms with potential explosion hazard.



Persons and services authorized by BIEGLER must carry out repairs and modifications on the device.



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

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ESH 04 

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



The device may interfere with other devices set up in the vicinity or vice versa. It is subject to specific preventive measures in terms of electromagnetic compatibility (EMC). Portable and mobile RF communications equipment may interfere with electrical medical devices.



Charge the battery of the device only under the specified permissible environmental conditions for operation. (See Chapter 13)



Infusion solutions shall not be prewarmed above 55°C before inserted in device.



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.



Periodic technical safety inspections must be carried out as described in the "Periodic inspections" section.

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ESH 04 2

DESCRIPTION

2.1

GENERAL DESCRIPTION

Description

Article number

Emergency warmer ESH 04

LB1000004

The ESH 04 emergency warmer can keep two pre-warmed 500 ml infusion bottles at a control temperature of 37 °C for up to 90 minutes. The device is suitable for continuous operation when mains-connected, and it can also pre-warm infusion bottles in this mode. The ESH 04 emergency warmer has been specifically designed for mobile use. An insulated compartment with carrying strap offers space for 2 infusion bottles. An integrated pressure cuff ensures good heat transfer to the heating foil. The electronics and the battery are located in an aluminum housing in the upper part of the device. The device is operated via two buttons (ON + OFF / Standby) on the housing. Unintended operation of the device is prevented by a safety button, which must be pressed simultaneously with the function keys. Handling this device requires knowledge and the observance of the instructions for use. The device and its accessories may only be used by emergency doctors, paramedics or other qualified personnel. Its dimensions are 160 x 105 x 300 mm, and it weighs 1.4 kg. The designated mains adapter is regarded as part of the unit. The emergency warmer ESH 04 can be used for all patient groups regardless of age and sex. The average number of applications per patient is one application.

2.2

INTENDED USE

The Emergency Warmer ESH 04 is intended to keep prewarmed infusion solutions at a control temperature of 37°C in field applications to minimize the risk of subsequent hypothermia.

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ESH 04 2.3

INDICATION

The Emergency Warmer ESH 04 is applied when it is necessary to administer infusions for volume substitution (liquid) in a warmed state. 2.4

CONTRAINDICATION / EXCLUSIONS FROM INTENDED USE

Glasbottles must not be used with ESH 04. The Emergency Warmer ESH 04 must not be used with blood, plasma and enteral nutrition solutions. 2.5

SCOPE OF DELIVERY

Quantity Description

Article number

1

Emergency warmer ESH 04

LB1000004

1

Mains adaptor 30W E2EFMW3

FL1000001

1

PowerPort 12V

FL1000002

1

Instructions for use

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ESH 04 3

STARTING THE DEVICE Observe the operating instructions! Users must thoroughly familiarize themselves with the contents of these instructions before putting the system in operation. The ESH 04 and accessories may only be used by qualified specialized staff.

3.1

SETTING UP PROCEDURE

Setting up the system 

Open the zip along the bottom of the emergency warmer.



Undo the cord.



If necessary, adjust to the sizes of the bottles.



Add infusion solutions to the warmer as shown in the diagram. (Care must be taken that the infusion bottles are inserted "upright" on both sides of the pressure cuff).

Underside of emergency warmer open

Emergency warmer closed



Tie the cord.



Use the pressure cuff to inflate to approx. 100 mm Hg, so that the infusion solutions are optimally placed next to the warming area.

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ESH 04 Charge-LED ON-LED

Standby

Error-LED

ON

Safetybutton

Setting up with mains adaptor 

Connect the emergency warmer using the mains adaptor supplied (110 - 240 V). When connecting the mains adaptor and the emergency warmer, the alarm LED may be briefly activated. This is a self-test function. The device starts to charge, this is indicated by the yellow LED.



Press the buttons and simultaneously to switch on the device (Charge LED and green ON LED light up). When switched on at the mains, the infusion solutions are first heated to 37°C, then the battery is charged to full capacity and at the same time the infusion solutions are kept warm at 37 °C.



If the device is switched off by pressing both the and buttons, then the heating is also switched off. The charging process continues until the battery is fully charged (indicated by the yellow charge LED).

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ESH 04 Note: The safety button must always be pressed simultaneously along with the desired function to prevent only one of the buttons being pressed inadvertently. Starting up for use 

Press the buttons and simultaneously to switch on the device (green ON LED lights up). When switched on and running on battery power, the infusion solutions are heated to 37 °C or kept warm for approx. 90 minutes at 37 ± 3 °C.



The yellow LED on the left indicates the status of the battery pack. A flashing LED indicates that the battery is empty.

Setting up for use 

Release pressure from the pressure cuff completely.



Hang the emergency warmer at an appropriate place.



Connect the infusion fittings.



If ordered by the physician, the pressure cuff can be used for pressure infusion. Attention: The emergency warmer must not be used in a lying or upside-down position. If used improperly, especially in case of pressure infusion, there is the risk of air bubbles entering the infusion line. This can lead to serious damage to the patient (danger of air embolism).

Decommissioning Switch off the device via the Standby button and if no charging is required, unplug the mains adaptor.

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ESH 04 3.2

ALARMS

In principle, the emergency warmer differs between "self-test" and "overtemperature" errors. Alarm – Self-test The "Self-test" is carried out by the software at periodic intervals. If malfunctions are found during the “self-test”, then the device automatically shuts down the heating. If this error occurs, switch off the device and then switch it back on. If the error occurs again, the device must be sent for servicing. Alarm – High temperature If the control unit detects an error, then the hardware safety shutdown is activated. The high temperature is signaled to the user via an illuminated yellow error LED. The safety shutdown is triggered by the hardware when the temperature exceeds 55 °C. The safety shutdown can also be triggered by external factors, e.g. excessive exposure to sunlight. Error overview The ESH 04 triggers Technical Alarms. Self-test

High temperature

Condition

Self-test detects a critical error

Sensor detects high temperature

Consequence

Device shuts down automatically

Device shuts down automatically

Resetting

Not possible – return device for servicing

Automatically after cooling down

Visual signal

Yellow error LED lights up

Yellow error LED lights up

Audio signal

No audio signal

No audio signal

Priority

Low

Low

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ESH 04 The alarm system does not need to be verified. The alarm limits cannot be adjusted. Risk management has shown that it is not advisable to deactivate the alarm signals, because detection of the error (e.g. high temperature) is required. The operator position is in front of the device.

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MAINTENANCE

The ESH 04 has been designed to be maintenance free. For long-term maintenance of quality and functional safety, observe following points: 

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.

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CLEANING AND DISINFECTION

The device may only be cleaned using a soft cloth with water-soluble, non-abrasive cleaning agents or special cleaning agents for plastics. Only ready-to-use alcohol-based spray disinfectants (e.g. Meliseptol Foam pure Fa. BRAUN) may be used for disinfection, whereby the instructions of the manufacturer must be followed. Fluff or dust can have an influence on heat transfer and must be kept away from the device.Important:

Before cleaning or disinfecting, the device must always be disconnected from the mains power supply or external power supply.

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ESH 04 6

PERIODIC INSPECTIONS

The periodic technical safety inspections (according to the local standards in force - e.g. EN 62353) on the ESH 04 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 safety labels on the device and its accessories must be easily legible.



The mechanical condition of all components must permit an additional and safe use (housing, zip, cord, viewing window, seams, cables, tubes, pressure gauge and hand pump).



The device must not have any dirt on it that might impair safety.



If necessary, carry out electrical verification of the mains adaptor.

Results of the periodic inspection along with the date and the testing station are to be entered on the reverse side of the instructions for use. 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.

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MANUFACTURER'S 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 at locations where the electrical installations do not correspond with the relevant national standards,



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

Disposal of the device and its accessories must be carried out in accordance with the applicable local regulations. 13

ESH 04 8

WARRANTY CONDITIONS

The manufacturer guarantees that all material and manufacturing defects that 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 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.

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 instructions 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.

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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.

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ESH 04 10

ELECTROMAGNETIC COMPLIANCE LEVELS

10.1 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, Class A

Voltage fluctuations and flicker

IEC 61000-3-3, Complies

10.2 IMMUNITIY 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 385 MHz; Pulse Modulation: 18 Hz; 27 V/m 450 MHz, Pulse Modulation: 18 Hz: 1 kHz sine; 28 V/m

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

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 15

ESH 04 Electrical fast transients / bursts (IEC 61000-4-4)

Power lines: 2 kV; 100 kHz repetition frequency 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 at 0°

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MANUFACTURER’S DECLARATION

The ESH 04 is a medical products as defined by Directive 93/42/EEC. This is documented through the CE mark. Notified Body: TÜV SÜD Product Service, Approval Number

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ESH 04 12

SYMBOLS Certifies compliance with the Directive 93/42/EEC Observe the directions for use Do not dispose of this product as unsorted municipal waste Serial number Safety button (This button must always be pressed simultaneously along with the desired function to prevent only one of the buttons being pressed inadvertently) OFF / STBY button ON button (thermal control)

IP34

IP-classification (IEC 60529)  Protection against splash water penetration  Protection against penetration of foreign bodies with diameter greater than 2.5 mm Degree of protection Type BF AC voltage

DC voltage

Date of manufacture

Manufacturer

Permissible temperature for transport and storage

Humidity limitation

Protection class II device (mains adaptor)

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ESH 04 13

OPERATING AND STORAGE CONDITIONS

The ESH 04 may be used outside buildings and in rescue vehicles if the permissible ambient conditions for the device and accessories are given: Transport storage Temperature

and Transient operating conditions

-20 to +60 °C

-20 to +50 °C

Relative humidity

15 to 75 %

Ambient pressure

620 to 1060 hPa

Operating

0 to +40 °C

The device may be used for less than 20 minutes at transient operating conditions. Important: Values higher or lower than the ranges specified above may cause damage to the device or its accessories. 14

TECHNICAL DATA

Device: Type designation: Operating voltage: Power consumption : Supply type: Degree of protection against electric shock: IP-classification (IEC 60529): Classification (93/42/EEC): Operating mode: Dimensions: Weight: Application part: Battery specification Type: Typical service life: 18

Emergency warmer ESH 04 12V DC max. 20 W power and battery operation BF IP34 IIa according to Rule 9 continuous 160 x 105 x 300 mm 1.4 kg IV set (not included) Li-ion battery (Type designation: FB3S1P18650-26) 5 years

ESH 04 Mains adaptor Type designation: Input: Output: 15

30 W E2EFMW3 100 – 240 V AC | 50-60 Hz | 590 mA 12 V DC | 2.5 A max.

MANUFACTURER

Biegler GmbH Allhangstrasse 18a 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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