Instructions
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HEINE F.O. 4 NT/F.O. Laryngoscope Handles
Please read and follow these instructions for use and keep them for future reference. Intended Use The internally powered HEINE laryngoscope handles are intended for the transient use with laryngoscope blades according to the ”green standard“ ISO 7376 for tracheal intubation. It should only be operated by qualified medical personnel within a professional healthcare facility. 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! This symbol 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! This symbol indicates valuable advice in terms of set up, operation, maintenance or repair, as applicable. Notes are important, but not related to hazardous situations. Setting up
2 Standard F.O. 4 3 4 Standard F.O. battery handle Connect the rechargeable battery (c) with the bottom insert (b), so that you hear a distinct clicking sound. Insert the battery (c) into the casing (a) leading with the positive terminal. Screw the bottom insert (b) into casing (a). Finally, screw the casing (a) into the handle shell (d). If your handle is delivered preassembled, remove the insulation film between the base unit and the rechargeable battery and remove the information band from the handle.
5 6 F.O. 4 SLIM 7 8 Small F.O. battery handle Insert the rechargeable battery (c) in direction of the arrow into the casing (a) and screw on the bottom insert (b). Finally, screw the casing (a) into the handle shell (d).
9 F.O. 4 SHORT Insert the bulb unit (a) into the handle shell (d). Screw the rechargeable battery (c) into the handle shell. Short F.O. battery handle Insert the batteries (c), regarding the markings on the plastic, into the casing (a). Insert the casing with the bulb first into the handle shell (d) and screw on the bottom insert (b). F.O Angled handle F.O. SP Insert the batteries (c) with the positive terminal first into the handle (d) and screw the bottom insert (b) on.
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Operation 1. Press!
„Click“
3. Lock
2. Pull and move
The F.O. SP laryngoscope handle should not be used in combination with a metal blade, as this may affect the stability of the hook-in connector, especially in case of incompatibility with ISO 7376. Use plastic blades exclusively. Only use a laryngoscope handle – blade combinations with green markings to ensure proper function. The HEINE laryngoscope handles correspond to the ”green standard“ according to the ISO 7376. If non HEINE laryngoscope blades are used, component compatibility and functionality are to be checked before each use! Only trained personnel are allowed to use a laryngoscope for intubation purposes. HEINE laryngoscopes are designed for use < 5 minutes. Before commencing a clinical application, the state of the internal electrical power source must be tested by turning on the lamp. We strongly recommend a functional backup of laryngoscopes in an emergency situation. Charging of the battery If rechargeable batteries are not sufficiently charged before use, the light intensity may be reduced or cut out during operation. We recommend to charge HEINE rechargeable batteries for at least 15 minutes before use in a HEINE charger. Rechargeable handles should not be switched on during the charging process. Hygienic reprocessing The instruction is available: - at www.heine.com - in a paper version which you can request from the address listed Maintenance The LED lights cannot be changed. Check the correct function of the device after each battery or bulb change. Routinely inspect the condition of the battery and XHL bulb and replace them if necessary. The XHL lamp is subject to wear and tear. To ensure safe illumination, we recommend to proactively change the lamp annually. Before each use, check the condition of the connector for damage and wear and tear. If defects are present, do not use the laryngoscope and replace it with one that is in working order.
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Changing the batteries
– 8 Standard F.O. and F.O. 4 SLIM / Small F.O. Unscrew the bottom insert from the handle shell and then out of the casing and replace the (charging) battery.
9 F.O. 4 SHORT Unscrew the charging unit from the handle shell and replace it. Short F.O. Unscrew the handle head from the handle shell and replace the battery. F.O. Angled Handle / F.O. S.P. Unscrew the bottom insert and replace the battery. Changing the bulb
2468 To replace the XHL lamp, unscrew it and screw in a new lamp to the end stop.
F.O. Angled Handle Unscrew the handle head (f) from the handle shell (e). Unscrew the nut (g) using the spanner (k) or a coin. When using a coin, it must be inserted simultaneously into the slot of the nut (g) and socket (h) and pushed down. Completely unscrew the nut (g) and remove the socket (h) and lamp (i) from the fixture. Insert a new bulb into the opening (j) and screw the fixture and nut on again. Place the handle head onto the handle shell so that the markings face each other, and then screw it on tight.
(k) (f )
(g) (h) l
(i)
(j)
(e)
F.O. SP Unscrew the handle-head and pull out the bulb. Push in a new bulb and replace the handle-head. Please note that when replacing the lamp, the spring does not need to be not be removed. If the spring was removed unintentionally, attention must be payed to the mounting orientation during reassembly. Failure to do so, could cause a malfunction. Service The device has no components serviceable by the end-user.
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General 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. The expected service life, when the device is used as intended and the warning and safety information as well as the maintenance instructions are observed, is up to 7 years, SP handle 6 years. Beyond this period, the product may continue to be used if it is in a safe and good condition. If you don’t use the device for a longer period of time, please remove the batteries in advance. Ensure that moisture does not penetrate the area around the rechargeable battery and the bottom insert. Check the rechargeable batteries regularly. In case of any abnormalities in the operating or recharging times, replace the rechargeable batteries. General Warnings Do not use the device in fire- or explosive risk area (e.g. oxygen saturated or anaesthetic environments). This product is not allowed to be entered or used in strong magnetic fields like MRI scanners. Do not shine light directly into the eyes to avoid dazzle, especially if the pupils are dilated. Do not use the laryngoscope for eye reflex testing. Warning notice for (rechargeable) batteries Do not put into fire, do not short-circuit, do not modify, do not sterilise, do not drop, do not expose to severe shocks or to direct sunlight. Dispose of batteries in the event of visible or presumed damage (e. g. leaking liquid, mechanical damage). The batteries can be damaged by liquid. They must not be rinsed in running water or submerged under water. For more information on handle types and components please visit www.heine.com. Disposal The product must be recycled as separated electrical and electronic devices. Please observe the relevant state-specific disposal regulations. Dispose at your local collection point. The appendix contains following tables - Electromagnetic disturbances – Requirements and tests - Technical specification - Option - Explanation of the used symbols
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Electromagnetic disturbances – Requirements and tests 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 environments. Statement for the operational environments
Inside hospitals except for: near active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances are high.
Performance features of the ME system that have been determined to be essential to the performance
None
Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
Warning
Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the laryngoscope handle, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
A list of all cables, transducers and other accessories that are relevant for the EMC compliance
As applicable, see attachment
Test
Compliance
RF emissions CISPR11
Group 1 Class B
Harmonic Emissions
Not applicable
Voltage Fluctuations/Flicker
Not applicable
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Technical specification handles
2
6
1
5
9
Standard F.O. 4
F.O. 4 SLIM
F.O. 4 SHORT
Standard F.O. 4 LED NT
F.O. 4 SLIM LED NT
F.O. 4 SHORT LED NT
Nominal load voltage [V] Input load current [mA]
5 max. 700
max. 400
Nominal voltage light source [V]
max. 700
max. 400
3.5
Current draw light source [mA]
2.5
typ. 770
max. 300
Class
Internally powered
Classification according to IEC 62471
LED, exempt group
Protection class
IP40
34
78
Standard F.O.
Small F.O.
Short F.O.
F.O. Angled handle
F.O. SP
Nominal load voltage [V]
N/A
Input load current [mA]
N/A
Nominal voltage light source [V]
2.5
Current draw light source [mA]
LED: max. 300 XHL: typ. 760
Class
Internally powered
Classification according to IEC 62471
XHL, exempt group
Protection class
IP40
Environmental conditions Operation
+10 °C to +35 °C 30 % to 75 % rel. humidity 700 hPa bis 1060 hPa
Storage and transport (without (charging-) battery)
-40 °C to +70 °C 45 % to 80 % rel. humidity 500 hPa to 1060 hPa
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Technical specifications rechargeable batteries Li-ion L M2Z 4 NT Li-ion Cell type
M3Z 4 NT Li-ion
S2Z 4 NT Li-ion
K3Z 4 NT Li-ion
Lithium-ion technology
Rated voltage [V]
3.7
2.5
3.5
2.5
3.5
Capacity [mAh]
2300
800
800
800
800
2
2.75
2.75
2.75
2.75
Typ. Charging time NT4 [h] Environmental conditions
30 % to 75 % rel. humidity 700 hPa to 1060 hPa
Operation
+10 °C to +35 °C
Storage
+5 °C to +45 °C
Transport
-20 °C to +45 °C
Option NT 4 table charger
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X-002.99.494
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Hersteller Manufacturer Fabricant Fabricante Produttore Tillverkare Fabrikant Producent Produsent Valmistaja Fabricante Herstelldatum Date of manufacture Date de fabrication Fecha de fabricación Data di produzione Tillverkningsdatum Productiedatum Produktionsdato Produksjonsdato Valmistuspäivä Data de fabricação Getrennte Sammlung von Elektro- und Elektronikgeräten (Europäische WEEE Richtlinie) Product bearing this symbol may not be disposed of together with general household waste, but instead requires separate disposal according to local provisions. (European Waste Electrical and Electronic Equipment Directive, WEEE) Tri sélectif des appareils électriques et électroniques (Directive européenne DEEE) Desechado separado de aparatos eléctricos y electrónicos (Directiva Europea RAEE) Raccolta differenziata di apparecchi elettrici ed elettronici (direttiva europea RAEE) Separat insamling av elektriska och elektroniska apparater (det europeiska WEEE-direktivet) Gescheiden inzameling van elektrische en elektronische apparaten (Europese AEEA richtlijn). Separat indsamling af elektrisk og elektronisk udstyr (det europæiske WEEE-direktiv) Produkter med dette symbolet skal ikke avhendes sammen med vanlig husholdningsavfall, men krever separat kassering i henhold til lokale bestemmelser. (European Waste Electrical and Electronic Equipment Directive, WEEE) Sähkö- ja elektroniikkalaitteille tarkoitettu erillinen keräyspiste (eurooppalainen WEEE-standardi) Coleção separada de aparelhos elétricos e eletrônicos (Diretrizes Europeias WEEE) Entsorgung an einer kommunalen Sammelstelle Dispose at your local collection point Mise au rebut au point de collecte local Desechar en un punto limpio de la comunidad Smaltimento in un centro di raccolta comunale Avfallshantera på ett kommunalt insamlingsställe Afvoer naar een gemeentelijke inzamellocatie Bortskaffelse på et kommunalt indsamlingssted Avhend hos ditt lokale avfallshåndteringsanlegg Laite on hävitettävä paikalliseen keräyspisteeseen Proceda à eliminação do aparelho em um ponto de coleta municipal
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Trocken lagern! Keep dry! Conserver au sec ! Conservar en un lugar seco! Evitare ambienti umidi! Förvaras torrt! Droog bewaren! Opbevares tørt! Hold tørt! Säilytetään kuivassa paikassa! Armazenar em ambiente seco! Gebrauchsanweisung verbindlich befolgen. (Hintergrundfarbe: blau, Vordergrundfarbe: weiß) Follow instructions for use! (Background color: blue, foreground color: white.) Suivre le mode d’emploi. (Couleur de fond : bleu ; couleur du premier plan : blanc) Seguir obligatoriamente las instrucciones de uso. (Color de fondo: azul, color de primer plano: blanco) Attenersi obbligatoriamente alle istruzioni per l’uso. (Colore dello sfondo: blu, colore in primo piano: bianco) Bruksanvisningen ska alltid följas. (Bakgrundsfärg: blå, förgrundsfärg: vit) De gebruiksaanwijzing is bindend en dient gevolgd te worden. (achtergrondkleur: blauw, voorgrondkleur: wit) Følg altid brugsanvisningen. (Baggrundsfarve: Blå; forgrundsfarve: Hvid) Følg bruksanvisningen! (Bakgrunnsfarge: blå, forgrunnsfarge: hvit.) Käyttöohjetta on noudatettava tarkasti. (Taustaväri: sininen, etualan väri: valkoinen) Siga as instruções de uso! Cor de fundo: azul, cor de primeiro plano: branco) Anwendungsteil Typ BF Type BF applied part Partie appliquée de type BF Pieza de aplicación del tipo BF Applicazione di tipo BF Användningsdel för typ BF Gebruiksonderdeel van het type BF Anvendelsesdel type BF Anvendt del type BF Tyypin BF liityntäosa Parte de aplicação do tipo BF Gleichstrom Direct current DC Tension continue Tensión continua (CC) Tensione continua Likspänning Gelijkspanning Jævnspænding DC Likestrøm DC Tasajännite Tensão contínua (CC)
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