Keeler Jazz Ultra User manual

Jazz Ultra Instruments
INSTRUCTIONS FOR USE
A world without vision loss

1 EN
Jazz Ultra Instruments by KEELER
CONTENTS
1. INDICATIONS FOR USE ........................................................................................ 3
2. SAFETY................................................................................................................. 3
2.1 PHOTOTOXICITY ............................................................................................................................3
2.2 WARNINGS AND CAUTIONS..........................................................................................................4
2.3 CONTRAINDICATION.....................................................................................................................5
3. CLEANING AND DISINFECTION INSTRUCTIONS.................................................... 6
3.1 STERILISATION ..............................................................................................................................6
4. BATTERY HANDLES AND START-UP....................................................................... 6
4.1 PURPOSE ......................................................................................................................................6
4.2 START UP AND INSERTION AND REMOVAL OF BATTERIES..............................................................7
4.3 TURNING ON AND OFF..................................................................................................................7
4.4 CHANGING THE COLOUR CODED RINGS .......................................................................................7
5. OTOSCOPE AND ACCESSORIES ............................................................................. 7
5.1 INSERTION AND REMOVAL OF EAR SPECULUM .............................................................................7
5.2 INTRODUCTION OF EXTERNAL INSTRUMENTS INTO THE EAR.........................................................7
5.3 REPLACEMENT OF LED – OTOSCOPE .............................................................................................8
6. OPHTHALMOSCOPE AND ACCESSORIES............................................................... 8
6.1 LENS WHEEL AND CORRECTING LENSES........................................................................................8
6.2 APERTURES AND FILTERS...............................................................................................................8
6.3 REPLACEMENT OF LED – OPHTHALMOSCOPE ...............................................................................9
7. MAINTENANCE..................................................................................................... 9
8. WARRANTY .......................................................................................................... 9
9. SPECIFICATIONS AND ELECTRICAL RATINGS...................................................... 10
9.1 ELECTROMAGNETIC EMISSIONS..................................................................................................10
9.2 ELECTROMAGNETIC IMMUNITY ..................................................................................................10
9.3 RECOMMENDED SAFE DISTANCES ..............................................................................................12
10. TECHNICAL SPECIFICATIONS.............................................................................. 13
11. ACCESSORIES AND SPARES................................................................................ 14
12. PACKAGING AND DISPOSAL INFORMATION....................................................... 14

2
EN
Jazz Ultra Instruments by KEELER
Consult instructions for use General warning sign
Date of manufacture Warning: Electricity
Manufacturer’s name and
address Warning: Floor level obstacle
Country of manufacture Warning: Non-ionizing
radiation
Waste Electrical and Electronic
Equipment (WEEE) recycling Warning: Optical radiation
This way up Warning: Hot surface
Keep dry Conformité Européene
Fragile Type B applied part
Do not use if package is
damaged Class II equipment
Temperature limit Atmospheric pressure
limitation
Authorised representative in
the European Community Humidity limitation
Catalogue number Serial number
Translation Medical device
The Keeler Jazz Ultra Instruments are designed and built in conformity with Directive 93/42/EEC, Regulation (EU)
2017/745 and ISO 13485 Medical Devices Quality Management Systems.
Classification: CE: Class I
FDA: Class II
The information contained within this manual must not be reproduced in whole or part without the manufacturer’s
prior written approval. As part of our policy for continued product development we the manufacturer reserve the right
to make changes to specifications and other information contained in this document without prior notice.
This IFU is also available on the Keeler UK and Keeler USA websites.
Copyright © Keeler Limited 2021. Published in the UK 2021.

3 EN
Jazz Ultra Instruments by KEELER
1. INDICATIONS FOR USE
These devices are intended to be used only by suitably trained and authorised healthcare
professionals.
CAUTION: Federal Law restricts this device to sale by or on the order of a
physician or practitioner.
Intended use / purpose of instrument
Keeler Jazz Ultra Otoscopes are indicated for the examination of the health of the external
auditory canal, the tympanic membrane, and the middle ear. Otoscopy can aid in the detection
of ear conditions, including but not limited to earache, ear infection, hearing loss, ringing in the
ears, inflammation, and foreign bodies.
Keeler Jazz Ultra Ophthalmoscopes are indicated for examining the posterior segment of
the eye referred to as the fundus, to aid in the screening and diagnosis of retinal pathology
including, but not limited to, diseases such as cataracts, papilloedema, glaucomatous disc
cupping, diabetic retinopathy, hypertensive retinopathy and retinal detachments. When set to
a high power and magnification, it can also be used to examine the anterior segment of the
eye, which includes the eyelids, cornea, sclera, conjunctiva, iris, aqueous, crystalline lens and
anterior vitreous.
2. SAFETY
2.1 PHOTOTOXICITY
CAUTION: The light emitted from this instrument is potentially hazardous.
The longer the duration of exposure, the greater the risk of ocular
damage. Exposure to light from this instrument when operated at
maximum intensity will exceed the safety guideline after 21 minutes.
While no acute optical radiation hazards have been identified for
Diagnostic Instruments, we recommend keeping the intensity of the light
reaching the patient’s retina to the minimum possible for the respective
diagnosis. Children, people with aphakia and people suffering from
eye conditions are most at risk. An increased risk may also occur if the
retina is exposed to the same or a similar device with a visible light
source within 24 hours. This applies, in particular, if the retina has been
photographed with a flashbulb in advance.
Keeler Ltd shall on request, provide the user with a graph showing the
relative spectral output of the instrument.