cross Canada-Physician Fiber Optic LED Pocket Otoscope Diagnostic Set Instruction Manual

: June 9, 2024
: CROSS

Canada-Physician Fiber Optic LED Pocket Otoscope Diagnostic Set

cross-Canada-Physician-Fiber-Optic-LED-Pocket-Otoscope-Diagnostic-Set-
PRODUCT

Product Information

The Cross Canada Fiber Optic LED Pocket Otoscope and
Ophthalmoscope Diagnostic Set is a medical device used for
diagnosing ear, nose, and throat (ENT) conditions. The set includes
an otoscope and ophthalmoscope, both equipped with LED bulbs for
enhanced visibility. The device is manufactured by Cross
Instruments Inc., located in Edmonton, Canada.

Model: 11-118 (LED Bulb)
Manufacturer: Cross Instruments Inc.
Address: 4004 Aspen Drive East N.W. Edmonton, AB T6J 2A8, Canada
Contact Details: Tel. 780-669-1506, Fax. 780-628-4156,
Email: crossinstruments.com@gmail.com, URL: www.crossinstruments.com

Product Usage Instructions

Before use, ensure that the device is clean and free from any debris or dust.
To use the otoscope, insert the speculum into the ear canal and turn on the LED light by pressing the power button.
Adjust the focus wheel to obtain a clear view of the ear canal.
To use the ophthalmoscope, select the appropriate lens for the desired magnification level.
Hold the device about arm’s length away from the patient’s eye and shine the LED light into the eye.
Adjust the focus wheel to obtain a clear view of the retina or other structures in the eye.
After use, clean the device with a soft cloth and disinfectant solution to prevent contamination.
Replace the LED bulb if it becomes damaged or no longer functions properly. To do so, unscrew the old bulb and screw in a new 11-118 LED Bulb (some models only).

Otoscope

An instruction of otoscope for practitioner It is an internally powered device. Please read through this brochure before use, and keep it handy for future reference.

Symbols

| Manufacturer
---|---

| The symbol for the marking of electrical and
electronics devices according to Directive
2002/96/C.the device, accessories and the
packaging has to be disposed of as waste
correctly at the end of the usage. please follow
Local Ordinances or Regulations for disposal.
| Type B Applied Part
| Attention, consult accompanying documents

SAFETY INFORMATION

To assure the correct use of the product, basic safety measures should always be followed including the warnings and cautions listed in this instruction manual.

Warnings & Cautions:

Do not use the device where it may be exposed to flammable gas.
Protect this device from water, moisture, Impact, dropping, direct sunlight, heat and fire.
Do not touch the lens directly by hand or something hard.
Please use the bulb type specified in this instruction brochure.
Keep the device out of the reach of unsupervised infants and children.
Do not disassemble or attempt to repair the device or components.

GENERAL

Description

As classic medical devices in ENT (Ear, Nose and Throat), the series of otoscopes adopt a total reflection of optical fiber, and make light path and observation of light tend to a coaxial through the optimization design, which increase the visual field of view. It is used for viewing the tympanic membrane and external ear canal, helping doctors to diagnose outer and middle ear pathologies in clinic.

Technical Specifications

XHL Xenon Halogen Bulb and LED Bulb for option.
3X Magnification for the viewing window.
Fiber optic illumination.
An insufflation bulb for pneumatic testing.

HOW TO USE THIS DEVICE

Turn on (or off) the device by pushing it downwards (or upwards) as Fig. 1;
Select a reasonable tip for the patient’s ear canal and push it onto the head and screw the tip clockwise, refer to fig.2. Generally, the tip size of 4mm is for adults and 2.4mm is for children:
Put the otoscope with a tip into the ear canal of the patient (fig.3), and examine through the viewing window which is with 3x magnification;

Attention:

The otoscope should only be used to examine the ear when a tip is fitted.
It is an intermittently operated device, 1 minute ON, 5 minutes OFF.

MAINTENANCE

Changing Spare Parts:

Changing the bulb ( fig.4 )
- A. Turn off the power and unscrew the head from the handle of the device;
- B. Pull the old bulb downwards, and replace it with a new one;
- C. Screw the head back onto the handle.
  Attention:
- Please use the specialized bulb (Model: 11-118 LED Bulb)
- After the bulb burns out, the temperature will remain high for approximately 5 minutes. Please wait for a moment to avoid injury.
Changing the batteries ( fig.5 )

A. Unscrew the bottom cover from the handle;
B. Remove the old A batteries, and replace them with new ones. Ensure the anode of the batteries points to the head of the device;
C. Screw on the bottom cover of the handle.

Attention:

AA alkaline batteries are recommended.
Replace all batteries simultaneously and do not use alkali manganese batteries with lithium as bulb life will be reduced.
Do not leave worn batteries in the handle.
Please take out batteries from the device if not in use for a prolonged period.
Batteries should be disposed of in accordance with local regulations

Cleaning and Disinfection:

A. Clean the surface of the device with 75% alcohol solution at least once a week, avoiding the magnifying glass (viewing window) in the head. And corrosive or polishing detergent is prohibited.
B. Disinfect the tips of the otoscope with saturated steam for 20 minutes at 134 C.

Attention:

Do not soak, autoclave or let water dip into the device!

PERIODIC SAFETY CHECKS

Preventive inspection and maintenance to be performed including the frequency of such maintenance. The following safety check should be performed at least every 12 months by a qualified person who has adequate training, knowledge, and practical experience to perform these tests.
Inspect the equipment and accessories for mechanical and functional damage.
Inspect the safety-relevant labels for legibility.
Verify that the device functions properly as described in the instructions for use.

SPECIFICATIONS

cross-Canada-Physician-Fiber-Optic-LED-Pocket-Otoscope-
Diagnostic-Set-FIG-12

ELECTRICAL CLASSIFICATION

Equipment Classification with respect to protection from electric shock:
Internally powered equipment.
Degree of protection from electric shock: TYPE B.
Equipment was not suitable for use in the presence of a flammable mixture: Yes.
Mode of operation: intermittent operation.

The manufacturer reserves the right to make technical changes without notice in the interest of progress. Prior notices will not be given in case of any amendments within this manual.

Direct Ophthalmoscope

An instruction of ophthalmoscope for an ophthalmologist. It is an internally powered device. Please read through this brochure before using, it and keep it handy for future reference.

Symbols:

| Manufacturer
---|---
| The symbol for the marking of electrical and
electronics devices according to Directive
2002/96/C.the device, accessories and the
packaging has to be disposed of as waste
correctly at the end of the usage. please follow
Local Ordinances or Regulations for disposal.
| Type B Applied Part
| Attention, consult accompanying documents

SAFETY INFORMATION

To assure the correct use of the product, basic safety measures should always be followed including the warnings and cautions listed in this instruction manual.

Warnings & Cautions:

Do not use the device where it may be exposed to flammable gas.
Protect this device from water, moisture, Impact, dropping, direct sunlight, heat and fire.
Do not touch the lens directly by hand or something hard.
Please use the bulb type specified in this instruction brochure.
Keep the device out of the reach of unsupervised infants and children.
Do not disassemble or attempt to repair the device or components.

GENERAL

Description:

Direct ophthalmoscope, a classic medical device for ophthalmology, adopts a professional lens system. It makes doctors conveniently get a clear visual field and examine the interior structures of eyes, such as dioptricmedia etc..

Technical Specifications:

XHL Xenon Halogen Bulb and LED Bulb for option.
11-118 LED Bulb
4 different apertures (Some Models Only)
Range of lenses: -20 D to +20 D

HOW TO USE THIS DEVICE

Turn on (or off) the device by pushing downwards (or upwards) as fig.1;
Scroll the diopter wheel in two directions as fig.2 to select a suitable diopter, which helps to get a clearer observation vision for user;
Scroll the diaphragm wheel as fig. 3 for getting a needed aperture;
Diagnose by aiming the light to the patient’s eye as fig.4.

Attention:

It is an intermittent operated device, 1 minute ON, 5 minutes OFF.

MAINTENANCE

Changing Spare Parts:

Changing the bulb
- A. Turn off the power and unscrew the head from the handle of the device;
- B. Pull the old bulb downwards after opening the screw and replace with a new one;
- C Screw the head back onto the handle.
- Attention:
- Please use the specialized bulb (Model: 11-118 LED Bulb)
- After the bulb burns out, the temperature will remain high for approximately 5 minutes. Please wait for a moment to avoid injury.
Changing the batteries ( fig.6 )

A. Unscrew the bottom cover from the handle;
B. Remove the old A batteries, and replace them with new ones. Ensure the anode of the batteries points to the head of the device;
C Screw on the bottom cover of the handle.

Attention:

AA alkaline batteries are recommended.
Replace all batteries simultaneously and do not use alkali manganese batteries with lithium as bulb life will be reduced.
Do not leave worn batteries in the handle.
Please take out batteries from the device if not in use for a prolonged period.
It ioneres should be disposed ofin accordance wilh local regulations

Cleaning and Disinfection:

Clean the surface of device with 75% alcohol solution at least once a week, avoiding the lenses in the head. And corrosive or polishing detergent is prohibited.

Attention:

Do not soak, autoclave or let water dip into the device!

PERIODIC SAFETY CHECKS

Preventive inspection and maintenance to be performed including the frequency of such maintenance. The following safety check should be performed at least every 12 months by a qualified person who has adequate training, knowledge, and practical experience to perform the tests.
Inspect the equipment and accessories for mechanical and function: damage.
Inspect the safety-relevant labels for legibility.
Verify that the device functions properly as described in the instructions for use.