HEINE EN50 and mPack UNPLUGGED Instructions for Use Jan 2015

HEINE® EN50 UNPLUGGED HEINE® mPack UNPLUGGED

ENGLISH

Please read and follow these instructions for use of and keep them for future reference. Intended Use The HEINE® mPack UNPLUGGED battery is intended exclusively for supplying power to HEINE instruments on headbands specially designed for the purpose. There are two chargers available for charging the Lithium-polymer battery inside the HEINE® mPack UNPLUGGED: a) the HEINE® EN50 UNPLUGGED, with two charging cradles, is intended for wall mounting. b) the HEINE® UNPLUGGED plug-in transformer is intended as a charger for mobile operation.

The primary plug is interchangeable. This allows a world wide use. The procedure of changing the plugs is as per the pictures. Take care to mount the charging station outside the patient environment. There must be adhered to the distances (1.5m) in accordance with IEC60601-1 (see figure).

For U.S. only: Federal law restricts this device to sale by or on the order of a Physician or Practitioner. Warnings and Safety Information CAUTION! Indicates potential hazardous situations. Ignoring the corresponding instructions may lead to dangerous situations of mild to moderate extent. (Background color yellow; foreground color black). NOTE! Note indicates valuable advice in terms of installation, operation, maintenance or repair. Notes are important, but not related to hazardous situations. Product overview HEINE® mPack UNPLUGGED: Connector for the instrument or an UNPLUGGED power unit for mobile charging Capacity indicator Serial-No.

reverse view Fig. 1: Minimum dimensions of the patient environment

Charging contacts for charging via the HEINE® EN50 UNPLUGGED

The device should never be operated or even stored at places listed below, because this could lead to operating failures: a. which are heavily exposed to moisture or where water condensing may occur b. which are exposed to special environmental conditions c. which are subject to constant vibrations d. which are subject to high temperature fluctuations e. Outdoors

HEINE® EN 50 UNPLUGGED: Charging cradle II Contact pins

Wall mounting the HEINE® EN50 UNPLUGGED:

Charging cradle I

Use the four provided screws to fix the mounting bracket to the wall. Place the EN50 UNPLUGGED on top of the mounting racket and fasten with the two top screws.

HEINE UNPLUGGED power unit (plug-in transformer): Mains adapters HE IN E X-95.16.316

Mains adapters:

EU

USA / Japan

UK

Australia

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Setting up the HEINE® mPack UNPLUGGED Fitting the mPack UNPLUGGED to the instrument headband: First remove the rear segment cover of the headband. To do this, hold the headband in the region of the rear segment cover with your left hand and pull the segment cover to the right with your right thumb.

The following applies to either charging method: The charging process is dependent on the residual charge of the battery and requires a maximum of approximately 2 hours. The charging process switches off automatically when the battery is full, all LEDs go out. Overcharging of the battery is not possible. Direct operation: Direct operation is possible if there is no capacity in the mPack UNPLUGGED battery but you want to continue to work with the instrument. To do this, simply connect the UNPLUGGED plug-in transformer to the connector on the left or right hand side and switch the instrument on with the brightness control. The battery will not be charged at the same time during “direct operation”.

off Then fit the mPack UNPLUGGED to the rear part of the headband by supporting the headband with your left hand and placing the mPack UNPLUGGED on the headband so that the LEDs are arranged to the left. The mPack UNPLUGGED will engage securely with a little light pressure from your left thumb. Connect the brightness control to the mPack UNPLUGGED.

LED display Charging: During charging the LEDs operate sequentially, in use they remain switched on. If all LEDs are out, the charging process is complete and the battery is fully charged. Operating the mPack UNPLUGGED: The number of LEDs illuminated indicates the level of charge in the battery. The full operating period is achieved when at least 4 LEDs are lit. If LED is flashing, you should charge the mPack UNPLUGGED. If all the LEDs are out, the battery is fully discharged. Cleaning and disinfection Always disconnect from the mains before cleaning. Spray disinfection, soaking or disinfection in a machine is not permitted. A soft cloth can be used to wipe all surfaces clean. It is possible to wipe with a damp cloth. If a cleanser is used, it must be approved for use on plastics. For disinfecting cleaning, quaternary ammonia compounds-based surface disinfectants can be used.

on

off

The batteries must be charged before using the mPack UNPLUGGED for the first time. You can charge the mPack UNPLUGGED either from the UNPLUGGED plug-in transformer or from the EN50 UNPLUGGED charging station. When supplied, new batteries are only partially-charged. The mPack UNPLUGGED must be charged before the instrument is used for the first time. The LED indicator corresponds to the actual battery capacity only after a full charge and discharge cycle. (Also applies when changing the battery.) To enable the LED display of the mPack UNPLUGGED to show the true battery capacity, the unit must first be completely discharged and then recharged. Switch on the instrument connected to the mPack UNPLUGGED until the battery is completely discharged, then recharge the mPack UNPLUGGED until charging is completed. (Also applies when changing the battery).

Check the correct function of the device in regular intervals. Do not use the device if you identify any kind of damage. Do not damage the contact surfaces on the mPack UNPLUGGED or the contact pins in the EN50 UNPLUGGED charger with pointed or sharp-edged objects. Clean the contacts of EN 50 UNPLUGGED and mPack UNPLUGGED with a cloth moistened with alcohol. Maintenance EN50 UNPLUGGED and power supply does not require regular maintenance. The power supply must not be opened. (Risk of electrical shock). Li-Polymer batteries can be replaced in mPack UNPLUGGED, please read the chapter “changing the battery”. Service EN50 UNPLUGGED and mPack UNPLUGGED do not require regular service

Operation Charging via the HEINE® EN50 UNPLUGGED (wall-mounted charger): Connect the plug-in transformer to a suitable mains outlet (pay attention to the mains supply voltage). The green LED on the plug-in transformer will light. The mPack UNPLUGGED can be charged in charging cradle I or charging cradle II. Using gentle pressure, insert the mPack UNPLUGGED into the charging cradle until it engages securely. Charging cradle I is intended for parking the complete instrument and for charging the mPack UNPLUGGED. The instrument is automatically switched off as soon as the complete instrument is parked in charging cradle I. The mPack UNPLUGGED will engage in the charging cradle with light pressure, thus ensuring safe charging. After approx. 1 second, the LEDs start to light in sequence. During charging, the LEDs blink. (See the “LED display” chapter for further information.) When you remove the instrument from the charging station and switch it on with the brightness control, all five LEDs will light if the battery is fully charged. As the level of charge falls, the LEDs go out in turn. If the orange LED starts to flash, you should recharge the battery. You can park the instrument in the charging station at any time, even after short periods of operation. To increase the working life of the battery, recharging only occurs if the residual charge is less than 75%.

Changing the battery In the course of time, batteries gradually wear out and require longer charging times; this is normal. If you charge the batteries regularly and notice a shortening of the operating time or an extension of the charging time, it is probably time to replace them. The new Li-Pol battery can be inserted simply by opening the lid of the mPack UNPLUGGED.

Charging by means of the UNPLUGGED power unit: Please note that charging with the UNPLUGGED mains transformer is only possible when the brightness control is switched off.

Do not short-circuit the Li-Pol battery. This can occur when a metal object such as a coin or paper clip connects the two battery contacts together. This can damage the battery.

Use only original HEINE Li-Pol rechargeable batteries. Isolate the mPack by removing it from the charger cradle or by unplugging the UNPLUGGED mains transformer. Unscrew the eight screws in the lid of the mPack UNPLUGGED with the screwdriver supplied and remove the lid, which contains the Li-Pol battery. Make sure that no metal objects such as screws fall into the unit. Protect the electronics from electrostatic discharge (ESD), by avoiding contact with electronic components. Before replacing the lid, remove the protective cap from the three-pole battery contacts. Reattach the lid with the eight screws, making sure that no wires are damaged when doing so. The battery should be disposed of correctly and should be completely discharged before disposal.

Connect the plug-in transformer to a suitable mains outlet (pay attention to the mains supply voltage). The green LED on the plug-in transformer will light. Next connect the cable to the right or left connector on the mPack UNPLUGGED. The charging process begins. All LEDs will go out as soon as the charging process is complete. Disconnect the charger. You can now switch the instrument on by means of the brightness control.

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Disposal The product must be recycled as separated electrical and electronic devices. Please observe the relevant state-specific disposal regulations. General Notes and Warnings Check the correct operation of the device before use! Do not use the device if there are visible signs of damage. Do not use the device in fire- or explosive risk area (e.g. oxygen saturated or anesthetic environments). Do not modify the device. Use only original HEINE parts, spare parts, accessories and power sources. Repairs shall only be carried out by qualified persons. The device is not allowed to be entered into strong magnetic fields like MRI scanners. It is not allowed to charge batteries from other manufacturer with HEINE EN50 UNPLUGGED or HEINE power supply. Take care that the housing does not get damaged. Damaged batteries must not be used. Safety Notes The warranty for the entire product is invalidated if non-genuine HEINE products or non-original parts are used and if repairs or modifications are made to the device by persons not authorized by HEINE. For more information, please visit www.heine.com. Use only an original HEINE plug-in transformer to connect the unit to the local mains supply. Make sure that the local mains voltage is the same as the nominal voltage shown on the identification plate of the HEINE plug-in transformer. Unplug the mains connector if you will not be using the unit for a long period if you are cleaning it or if a fault occurs. It should not be assumed there is no voltage present just because the Power LED is not lit. Pay attention to the mounting instructions when wall-mounting the EN50 UNPLUGGED charging station. The capacity of the mPack UNPLUGGED Battery can reduce with increasing use. This is a normal procedure with time and inevitable. Careful use of the battery can reduce this effect. We recommend that the instrument is use should be switched off after use and the battery recharged regardless of its state of charge.

↔

The LED indicates the operation status of the power supply.

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What if...? In the event of a fault, it is generally recommended that the mPack UNPLUGGED be connected briefly to the charger. Fault description

LED display on mPack UNPLUGGED

Cause of problem

Remedy

Green Power LED on – power unit does not light

– no mains supply voltage present – mains supply voltage outside permissible range

–

Instrument does not No LEDs on function

Battery is discharged

Charge the mPack UNPLUGGED

Electronics defect in the mPack UNPLUGGED or brightness controller

Refer to your service center. Check whether direct operation is still possible.

Ambient temperature too high LEDs on

Bulb in instrument is defective

Fault on brightness controller mPack UNPLUGGED fourth green LED does not charge does not light

Do not expose the mPack UNPLUGGED to ambient temperatures greater than 40°C. Change the bulb – Turn the rotary knob on/off briefly. – Plug in the connecting cable again

remaining capacity in the battery is greater – than 75%; frequent, brief recharging is to be avoided, to preserve the battery.

even after a long Due to a disturbance in the instrument, charging time, e.g. when changing the bulb, the LED only the orange LED display on the mPack UNPLUGGED no is flashing longer corresponds to the actual state of charge.

If the instrument is functioning, fully discharge and recharge the battery once; the LED display will then be resynchronized.

– no mains voltage present – mains voltage does not correspond to the nominal mains voltage

–

Instrument does not LEDs blink function

Change the bulb or instal corretly. Switch HC 50 off and then on again.

Defective bulb or bulb not correctly installed.

Electromagnetic Compatibility Medical electric devices are subject to special precautionary measures with regard to electromagnetic compatibility (EMC). Portable and mobile high frequency communication equipment can affect medical electric devices. This device is intended for use by medical professionals in the electromagnetic environment specified below. The user of this device should assure that it is used in such an environment. The use of accessories, converters or cables other than the ones specified by HEINE might lead to increased emission reduced electrical immunity of the medical equipment. The device may not be stacked directly near or used directly beside other devices. If the device is to be operated in a stack or with other devices, the device should be watched to ensure it operates properly in this location. The appendix contains the tables „Guidance and Manufacturer’s declaration – Electromagnetic immunity“, technical specification and an explanation of the used symbols.

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Emission test RF emissions CISPR11 RF emissions CISPR 11

Harmonic Emissions IEC 61000-3-2 Voltage Fluctuations/ Flicker Emissions IEC 61000-3-3

Guidance and manufacturer’s declaration – electromagnetic emissions The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such environment. Compliance Electromagnetic environment – Guidelines Group 1 The device uses RF energy only for its internal function. Therefore, RF-emission is very low and it is unlikely that any interference in nearby electronic equipment. Class B The device 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. Warning: This device is intended only for use by medical professionals. This is a device of class A CISPR 11 in the domestic environment, this device may cause radio interference, so that it may be necessary in this case, to take appropriate remedial measures, as e.g. orientation, new arrangement or shielding of the device or restrict the connection to the site. Class A Symmetrical three-phase devices and other devices. Passed

Immunity test Electrostatic discharge (ESD) acc. to IEC 61000-4-2

Electrical fast transient/burst 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 IEC 61000-4-8

Guidance and manufacturer declaration - Electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such environment. IEC 60601 test level Compliance level Electromagnetic environment – Guideline ± 6 kV contact discharge ± 6 kV contact discharge Floors should be wood, concrete or covered with ± 8 kV air discharge ± 8 kV air discharge ceramic tiles. If floors are covered with synthetic material, the relative humidity should be at least 30 %. ± 2 kV for mains cables ± 2 kV for mains cables The supply voltage quality should be that of a ± 1 kV for input and output lines ± 1 kV for input and output lines typical commercial or hospital environment. ± 1 kV voltage phase – phase, ± 1 kV voltage phase – phase Mains power quality should be that of a typical ± 2 kV voltage phase – earth ± 2 kV voltage phase – earth commercial or hospital environment. < 5% UT, (>95% dip in UT) Mains power quality should be that of a typical < 5% UT, (>95% dip in UT) commercial or hospital environment. If the user for 1/2 period for 1/2 period of the device requires continued operation 40% UT, (60% dip in UT) 40% UT, (60% dip in UT) for 5 periods for 5 periods during power mains interruptions, it is recom70% UT, (30% dip in UT) 70% UT, (30% dip in UT) mended that the device be powered by a UPS for 25 periods for 25 periods (uninterruptible power supply) or a battery. <5% UT, (>95% dip in UT) <5% UT, (>95% dip in UT) for 5 seconds for 5 seconds 3 A/m

3 A/m

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

Comment: UT is the a.c. supply voltage prior to application of the test level. Guidance and manufacturer’s declaration – electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment Guidelines

Conducted RF IEC 61000-4-6

3 Veff 150 kHz to 80 MHz

3 V eff

Radiated HF IEC 61000-4-3

3 V/m 80MHz to 2,5GHz

3 V/m

Portable and mobile RF communication equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: d = 3,5/3 * SQRT (P/W) d = 3,5/3 * SQRT (P/W) 80 MHz to 800 MHz d = 7/3 * SQRT (P/W) 800 MHz to 2,5 GHz 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). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveyaa, 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 80Hz and 800MHz, 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. Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless) telephones and land mobile radios, amateur radio, AM and FM a  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 device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V / m.

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Recommended separation distances for portable and mobile RF communication equipment and the device The device is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter (W)

Separation distance according to frequency of transmitter (m) 150 kHz to 80 MHz d = 3,5/3 * SQRT (P)

80 MHz to 800 MHz d = 3,5/3 * SQRT (P)

800 MHz to 2,5 GHz d = 7/3 * SQRT (P)

0.01

0.1

0.1

0.2

0.1

0.4

0.4

0.7 2.3

1

1.2

1.2

10

3.7

3.7

7.4

100

11.7

11.7

23.3

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be determined 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 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. Erläuterung der verwendeten Symbole Auf dem Gerät bzw. der Verpackung finden sich folgende Symbole: Explanation of utilized symbols The following symbols are used on the device or on the packaging: Explication des symboles utilisés Les symboles suivants figurent sur l’appareil ou sur l’emballage : Explicación de los símbolos utilizados Sobre el aparato o sobre el embalaje se encuentran los siguientes símbolos: Spiegazione dei simboli utilizzati Sull’apparecchio e/o sulla confezione sono presenti i seguenti simboli: Förklaring av symboler som används På enheten eller på förpackningen hittar du följande symboler: Verklaring van de gebruikte symbolen Op het apparaat resp. op de verpakking staan de volgende symbolen: Forklaring af de anvendte symboler Følgende symboler findes på apparatet hhv. emballagen: Käytettyjen symbolien selitys Laitteesta ja pakkauksesta löytyvät seuraavat symbolit: Explicação dos símbolos utilizados Os símbolos seguintes são usados nos equipamentos ou nas suas embalagens:

Technical specification HEINE® EN50 UNPLUGGED: Mains voltage: 100-240 V AC / 50-60 Hz Current: 700 mA Output: 9 VDC; 3.0 A Fuse: Integral overload protection Duration of use: Continuous Protection Class: II HEINE® mPack UNPLUGGED: Input: Output: Fuse: Weight: Dimensions: Cell type: Nominal voltage: Capacity: Charging time:

9 VDC; 1.5 A Variable, max. 6.5 V / 10 W Integral overload protection approx. 190 g 162 mm x 52 mm x 24 mm Lithium-polymer 7.4 V approx.1850 mAh approx. 2 hours

Environmental conditions for operation:

10°C to +35°C 30% to 75% rel. humidity 700hPa to 1060hPa

Environmental conditions for storage:

+5°C to +45°C 45% to 80% rel. humidity 500hPa to 1060hPa

Environmental conditions for transport:

-20°C to +50°C 45% to 80% rel. humidity 500hPa to 1060hPa

REF

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CE-Kennzeichnung kennzeichnet die Übereinstimmung mit der Europäischen Medizinprodukterichtlinie 93/42 EWG. The CE mark indicates that the product complies with the European medical device directive 93/42/EEC. Le marquage CE indique la conformité à la directive européenne 93/42/CEE relative aux dispositifs médicaux. El marcado CE indique la conformidad con la directiva europea 93/42 /CEE relativa a los productos sanitarios. Il marchio CE indica la conformità con la direttiva europea sui dispositivi medici 93/42 CEE. CE-märkning markerar en överensstämmelse med det europeiska direktivet för medicinska produkter 93/42 EEG. CE-markering duidt de overeenstemming aan met de Europese Richtlijn betreffende medische hulpmiddelen 93/42 EEG. CE-mærkningen angiver overensstemmelse med det europæiske direktiv 93/42/EØF om medicinsk udstyr. CE-merkintä tarkoittaa, että laite vastaa eurooppalaisen lääkinnällisiä laitteita koskevan standardin 93/42 ETY vaatimuksia. O símbolo CE identifica a concordância com a Diretriz Européia para Dispositivos Médicos 93/42/CEE. MEDICAL - GENERAL MEDICAL EQUIPMENT AS TO ELECTRIC SHOCK FIRE, AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL60601-1/CAN/CSA C22.2 No. 601.1 ANSI/AAMI ES60601-1/CAN/CSA-C22.2 No. 60601-1 Control No. 28KY Katalog- oder Bestellnummer Catalogue- or order number Numéro de catalogue ou de commande Número de catálogo o de pedido Codice catalogo e di dell’ordine numero Katalog- eller Beställningsnummer Catalogus- of Bestelnummer Katalog- eller Ordrenummer Luettelo- tai viitenumero Número de catálogo ou pedido

Manufacturer: HEINE Optotechnik GmbH & Co. KG Kientalstr. 7 · 82211 Herrsching · Germany www.heine.com