Spengler Smartled 5500 Otoscope Fiber Optic Instruction Manual

Spengler Smartled 5500 Otoscope Fiber Optic

Product Information

Specifications

• Manufacturer: [Manufacturer]
• Model: [Model]
• Product Code: [Product Code]
• Compliance: CEE/93/42
• Material: Latex-free

Product Overview & DETAIL

The otoscope is a medical device used for spot check and examination of the external ear canal and tympanic membrane. It features a magnification viewing window, insufflation port, and an on/off switch on the handle.

1. Otoscope Head
2. Magnification Window
3. Insufflation Port
4. On/off Switch
5. Handle
6. Battery lid
7. Disposable Ear Tip

Product Usage Instructions

Setting up the Product

1. Grip the handle attached to the otoscope head.
2. To turn on the light, slide the switch with your thumb towards the bottom of the handle.
3. To turn off the light, slide the switch with your thumb towards the top of the handle.
4. Open the battery lid by rotating the end cap counterclockwise.
5. Insert two AA/LR6 size alkaline batteries into the handle with the positive (+) terminal towards the head.
6. Close the battery lid by rotating it clockwise.

Head & Handle Assembly:
To setup the Smartled® 5500 Otoscope, align the otoscope thread with handle and rotate the head clockwise until head and handle firmly joined (Fig-2, A).

Smartled® 5500 Battery Handle:
The Smartled® 5500 battery handle should only be used as a power source for Smartled® 5500 instruments. Grip the handle attached to Otoscope head. To turn ON the light, slide the switch with thumb towards the bottom of the handle .To turn OFF the light, slide the switch with thumb towards the top of the handle (Fig-2, B).

Insert Batteries (model Smartled® 5500):
Arrange two AA/ LR 6 size good quality alkaline batteries for power. Rotate end cap counterclockwise to open the handle end cap. Insert two batteries into handle with positive (+) terminal towards the head and close the cap by rotating clockwise.

Insert Batteries (model Smartled® 5500-R (rechargeable)):
The rechargeable batteries of the otoscope 5500-R are placed in the handle. Place the otoscope on the charging station and we recommend you to read the operating instruction.

• The Otoscope is intended for spot check and the handle may gets warm by longer use. So let it cool down before next use.
• The temperature should never exceed 60°C.

Smartled® 5500 LED otoscope model:

• The LED is fixed and sealed into the otoscope head and cannot be changed because of its long lasting life.
• LED has 50,000 hours of extended lifetime.
• Excellent light output of 50K LUX.
• Extended battery life of 50 HOURS due to low energy consumption of LED.
• With a colour temperature of 4000K and CRI> 95 colours are visible as they are.

Operating **

**

To use the otoscope:

1. Choose the appropriate disposable ear tip for examination.
2. Gently insert the ear tip into the external ear canal.
3. Turn on the light by sliding the switch towards the bottom of the handle.
4. Inspect the external ear canal and tympanic membrane through the magnification viewing window.
5. Rotate the viewing window as needed for better visibility.
6. After examination, turn off the light by sliding the switch towards the top of the handle.
7. Dispose of the used ear tip properly.

Smartled® 5500 Otoscope should only be inserted into the auditory canal when a ear tip is fitted. Place the ear tip on the otoscope in such a way the projection inside the ear tip fits into the slit (Fig-4,1) and tighten the ear tip by turning it slightly to the right.

• Do not use otoscope without ear tip that may cause ear injury and / or cross contamination.
• Do not reuse disposable ear tip that may result in contamination from one patient to another patient.
• Do not point light in patient eyes that may cause eye injury.
• Do not use excessive force while locking the ear tip on head.

MAGNIFYING LENS:
Smartled® 5500 Otoscope has 3x magnification that produces distortion-free images of the examined object. The magnification viewing window is permanently attached and can be swivelled aside for instrumentation. To facilitate the instrumentation, rotate the viewing window clockwise as much as required .

• Peel off the lens protective sheet before use (Fig-5)

FAQ
Q: Can the otoscope be used with rechargeable batteries?
A: Yes, the otoscope can be used with rechargeable batteries. Please refer to the operating instructions for more information on charging.

Q: Can the otoscope be used on children?
A: Yes, the otoscope can be used on children. However, please ensure that the appropriate size disposable ear tip is used for their comfort and safety.

Symbol Description

• Attention
• Type B applied part
• Instructions For Use MUST be Consulted
• Batch number
• Product reference
• Dispose of used product at a collection point for recycling in accordance with local regulations./
• This product complies with directive 93/42/CEE regarding medical devices.
• Manufacturer
• European Legal Representative
• Medical device
• Transportation and storage temperature range
• Model number
• Manufacturing date and country
• Importer
• Distributor
• Non contiene lattice

INSTRUCTIONS FOR USE:
The operating and maintenance instructions found in this manual should be followed to ensure years of reliable service.

• Please read these instructions carefully before using the Smartled® 5500 and keep them in a safe place for future references.

INTENDED USE:
Smartled® 5500 Otoscopes and associated accessories are intended for the examination of ear, the external auditory canal and the eardrum. This instrument has an optical magnifying lens and battery-powered illumination handle, and recommended for use by medically qualified personnel to assess the health of ear through transmitting light into the ear canal. This device is intended for spot check and examination.

EAR TIP:
Ear tip is used in otoscope as viewing passage for direct examination of the external ear canal and tympanic membrane. Choose the size of Ear tip suitable for the examination of the ear canal.

Disposable Ear Tip:
Disposable ear tip is made up of (Acrylonitrile-butadiene-styrene) plastic through injection moulding process and is compatible with biological human tissues, cells and body fluids.

Available Sizes:
Disposable Ear tip Dia 2.5mm (L20847)
Disposable Ear tip Dia 4.0mm (L20848)

CLEANING / STERILIZATION AND MAINTENANCE

The Smartled® 5500 F.O. Pocket otoscope is not suitable for treatment in ultrasonic bath, for steriliza-tion, spray disinfection or treatment by immersion in liquids.

MANUAL CLEANING PROCESS:
Use a damp cloth for cleaning the Smartled® 5500 pocket otoscope.
For cleaning and disinfection, a disinfectant agent suitable for plastic medical products must be used.

Handle Cleaning:

• The handle can be cleaned with a cloth soaked with disinfectant, however it cannot be dipped into liquids.
• Do not use the equipment if it is damaged. Contact your distributor.
• Periodically check the battery conditions, making sure that no sign of corrosion of oxidation is present. If needed, replace them with new alkaline ones.
• Carefully handle the batteries as the liquids they contain can irritate the skin and eyes. Before being used, thoroughly check the product. The same operation shall be carried out after cleaning.
• Check that the connection between the head and the handle is perfect and that the On/Off button works correctly.
• If the light is intermittent or in case it does not turn on, check the bulb, the batteries and the electrical contacts.

Precautions:

• Read the label before disposing of the packaging.
• Do not use if packaging has been opened or damaged.
• Only qualified person should use the device.
• Handle the device with care and keep the instrument away from insects and rodents.
• Autoclaving is not possible for this type of handle.
• Ultrasonic cleaning is not recommended.
• Store the device in clean environment at normal temperature.
• Please ensure that the batteries, Handles and Ear Tips and other Sub-assemblies are discarded as clinical waste in accordance with local policies.
• In accordance with local regulations this product should be disposed of as an electronic device separately.

TRANSPORT AND STORAGE:
Before transporting the appliance, make sure that it is correctly packaged ensuring also that there are no risks of shocks bumps or falls during the transport itself. Damage to the appliance caused during transport and handling is not covered by the guarantee. The device must be stored in a dry, Cool area away from direct sunlight. It must not be placed in contact with any substances or chemical agents which could cause damage and reduce safety characteristics.

(without condensation)
Air pressure| 500 hPa – 1 060 hPa

WARRANTY

We guarantee this device for 3 years from the date of purchasing (this excludes consumables such as lamps, tips and batteries). We guarantee the proper functioning of the unit provided it is used as intended by the manufacturer and according to the instructions for use. Any faults or defects which occur during the guarantee period will be repaired free of charge provided they are caused by faults in material, design or workmanship. In the case of complaint of a defect in the product during the guarantee period. The usual legal guarantee and warranty do not apply to incorrect use, the use of non-original parts or accessories, such as lamps. Are also excluded, any repairs or modifications made by un-authorized person or cases where the customer does not follow the instructions supplied with the product.

SPENGLER SAS
30 rue Jean de Guiramand, 13290 Aix-en-Provence, FRANCE

Medical Devices (Pvt) Ltd.
Wazirad Road, Ugoki, Sialkot – Pakistan
Tel: 0092-52-3571214, 3571215
Fax: 0092-52-3571210, 3571211.
Web: www.mdevices.com
Email: info@mdevices.com

OBELIS s.a
Bd.Général Wahis 5310, 0 Brussels, BELGIUM

References

• MD-Health Care

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