ADC Diagnostix 5500N User manual

Questions?
Call ADC toll free:
1-800-232-2670
Desk Charging Base
5500N
Instructions for Use
IB p/n 93-5500N-00 rev 0 (3/23/2021) Printed in U.S.A.
Made in Germany
Inspected and Packaged in the U.S.A.
tel: [phone]
toll free: 1-800-232-2670
fax: [phone]
www.adctoday.com
email: [email protected]
Consult instructions
for use
ADC
55 Commerce Drive
Hauppauge, NY 11788
mdi Europa GmbH
Langenhagener Str. 71
30855 Langenhagen
GERMANY

215
DiagnostixTM Desk Instrument
Table of Contents
1. A Special Thank You 3
2. Introduction and Intended Use 3
3. Contraindications 3
4. Symbols 4
5. Warnings and Precautions 4-5
6. Start-Up and Operation 5-7
7. Specula Compartment 8
8. Wall Mounting 8
9. LED Indicators 9
10. Cleaning and Disinfection 9
11. Technical Specifications 10
12. Maintenance 10
13. Electromagnetic Compatibility 10-14
14. Warranty 15
15. Quality Standards 15
16. How to Contact Us 15
14. WARRANTY
This ADC Diagnostix Desk Charging Base is warranted for 2 years from date of
purchase. This warranty includes the instrument. The warranty does not apply
to damage caused by improper handling, accidents, improper use, or
alterations made to the instrument by third parties. The warranty is only valid
after the product is registered online at www.adctoday.com.
15. QUALITY STANDARDS
Device fulfills the stipulations of the International standard IEC60601-1-2
16. HOW TO CONTACT US
To register your product and obtain further detailed user
information about our products and services visit us at:
www.adctoday.com
and follow the links.
For questions, comments, or suggestions call us toll free at:
1-800-232-2670

1. A SPECIAL THANK YOU
Congratulations on your purchase of an ADC®DiagnostixTM Desk Charging Base.
ADC professional diagnostic products are the instruments of choice where
accuracy and dependability are critical.
This feature-rich instrument was designed to simplify physical exams and
non-invasive diagnostics. With proper use and care it will provide many years
of dependable service.
Read this booklet thoroughly before attempting to use your new ADC Diagnostix
Desk Charging Base.
2. INTRODUCTION AND INTENDED USE
This manual is for the ADC Diagnostix Desk Charging Base. The charger base is
manufactured for use with ADC or compatible 2.5V or 3.5V power handles and
instrument heads. The base is designed to recharge compatible power handles.
If you have any questions, call our toll-free number or visit our website.
For contact information, see the last page of this instruction booklet.
Please note that the ADC Diagnostix Desk Charging Base is only suitable for
charging ADC instruments operated with ADC rechargeable batteries.
Do not use with any other equipment. To learn more, visit our website at:
www.adctoday.com.
3. CONTRAINDICTIONS
There are no known contraindictions. The device is only intended for the use
specified in the instructions for use.
Recommended distances between portable and mobile RF communications equipment
and the charging stations.
The charging station is intended for use in an electromagnetic environment in which radiated RF distur- bances are controlled. The customer or
user of the charging station can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communication equip- ment (transmitters) and the charging station as recommended below, according to the maximum output
power of the
communications equipment.
For transmitters rated at a maximum output power not listed above, the recommended distance d in metres
(m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maxi- mum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. The electromagnetic propagation is affected by absorption and reflection by
structures, objects and people.
Rated output power of the
transmitter (w)
d =12√P
0.01
d =1, 2√P
0.12 0.12 0.23
0.1 0.38 0.38 0.273
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
150 kHz to 80 MHz 80 MHz to 800 MHz
d =2, 3√P
800 MHz to 2,7 GHz
Separation distance according to the frequency of the transmitter (m)
314

4. SYMBOLS
5. WARNINGS AND PRECAUTIONS
This ADC Diagnostix Desk Charging Base has been manufactured to the
highest quality standards and is subject to rigorous quality control. Read
these instructions for use carefully before putting the unit into operation and
keep them in a safe place.
If you should have any questions, call our toll-free number or visit our
website. Our address can be found on the last page of this booklet.
Please note that instruments described in these instructions for use are to be
used by suitably trained personnel only. The safe functioning of this
instrument is guaranteed only when original parts and accessories from ADC
are used.
Read operating instructions
Medical device
Type BF Equipment
Protection Class II Unit
Warning! The general warning
sign indicates a possibly dangerous
situation that can lead to serious
injuries.
Caution! Important note in these
instructions. The caution symbol
indicates a potentially dangerous
situation that can lead to minor or
moderate injuries. It can also be
used to warn of unsafe practices
Direct current
Alternating current
Date of Manufacture
YYYY-MM-DD / (year-month-day)
Manufacturer
Manufacturer serial number
Lot number
Reference number
Temperature for transport and
storage conditions
Relative humidity for transport and
storage conditions
Air pressure for transport and storage
Air pressure for ambient operation
CE marking
Discard according to national
regulations or EU directives
Non-ionizing radiation
Caution: Federal law restricts this
device to sale by or on the order of a
physician (licensed physician).
Not made with natural rubber latex
Phthalate free
SN
Symbol Definition Symbol Definition
Guidance and manufacturer‘s declaration - electromagnetic immunity
The charging station is intended for use in the electromagnetic environment specified below.
The custo mer or user of the charging station should ensure that it is used in such an environment.
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. The electromagnetic propagation is affected by absorption and reflection by
structures, objects and people.
a.)
Field strengths from fixed transmitters, such as base stations for radio (mobile/cordless phones) and land mobile radios, amateur radio, AM and
FM radio broadcasts and television broadcasts, 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 where the charging
station is used exceeds the RF compliance level specified above, the charging station should be monitored to verify normal operation. If abnormal
performance is observed, additional measures may be required, such as re-orienting or relocating the charging station.
b.)
With a frequency range over 150 kHz to 80 MHz, the field strengths should be less than 3 V/m.
Immunity testing
Conducted RF
IEC 61000-4-6
Fast transient electrical disturbances /
bursts IEC 61000-4-4
Proximity fields from RF wireless
communications equipment
Pass
Pass Pass
3 V/m
80 Mhz to
2,7 GHz
3 V/m
Pass Portable and mobile RF communications equipment
should be used no closer to any part of the
charging station, including the cables, than the
recommended distance calculated using the
equation applicable to the frequency of the
trans mitter.
Recommended separation distance
d= 1.2√P 150 KHz to 80 MHz
d= 1.2√P 80 MHz to 800 MHz
d= 2.3√P 800 MHz to 2,7 GHz
Where P is the maximum output power of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended distance
in meters (m). Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey, should be below the
compliance level in each frequency range. In the
vicinity of devices marked with the following symbol,
interference may occur:
Where P is the maximum output power of the
transmitter in watts (W) according to the transmitter
manufacturer and the recommended distance is
indicated in meters (m).
Field strengths from fixed RF transmit ters,
as determined by an electromagnetic site
survey, should be below the compliance level in
each frequency range.
IEC 60601 test level Compliance level Electromagnetic environment guidance
134

Warning: The device must not be operated in rooms in which flammable
mixtures or mixtures of pharmaceuticals and air or oxygen or nitrous oxide are
present, e.g. operating theatres.
Warning: Do not use in a magnetic resonance environment.
Warning: There is a danger of life-threatening electrical shock. Unplug the
instrument before cleaning or when disinfecting.
Warning: The device contains sensitive electronic components. Avoid strong
electrical or electromagnetic fields in the direct vicinity of the device (e.g.,
mobile telephones, microwave ovens). These can lead to temporary impairment
of the ADC Diagnostix Desk Charging Base.
Warning: This device must be used in a controlled environment. The device must
not be exposed to harsh environmental conditions.
Warning: Do not use batteries or electrical cords other than those included with
this product or replacement parts supplied by the manufacturer.
Caution: Old electronic devices must be disposed of in accordance with the
institutional guidelines for the disposal of expired devices.
6. START-UP AND OPERATION:
The ADC Diagnostix Desk Charging Base is suitable for charging of 2.5V or
3.5V handles.
a) Preparation prior to charging
• Ensure that the charging base is
positioned on a level surface. Do not
position unit in the direct vicinity of a
radiator. Protect against direct sunlight.
• Fluids must not penetrate into the interior
of the enclosure. Do not use fluids in close
proximity of the charging base.
Guidance and manufacturer‘s declaration - electromagnetic immunity
The charging station is intended for use in the electromagnetic environment specified below.
The custo mer or user of the charging station should ensure that it is used in such an environment.
Hinweis UT is the AC mains voltage prior to application of the test level.
Immunity testing
Electrostatic discharge (ESD)
IEC 61000-4-2
Fast transient electrical disturbances /
bursts IEC 61000-4-4
Con: ± 8 kV
Air: ± 15 kV
5/50 ns, 100 kHz;
±2 kV
5/50 ns, 100 kHz;
±2 kV
Con: ± 8 kV
Air: ± 15 kV
Floors should be made of wood, concrete or
ceramic tiles. If the floor is covered with synthetic
ma terial, the relative humidity must be at least
30%.
The quality of the supply voltage should be that of a
typical business or hospital environment
Surge
IEC 61000-4-5
1,2/50 (8/20) μs
LtL: ±1,0 kV
LtG: ±2,0 kV
1,2/50 (8/20) μs
LtL: ±1,0 kV
LtG: ±2,0 kV
The quality of the supply voltage should be that of a
typical business
or hospital environment.
Voltage dips, short interruptions and
voltage fluctuations on power supply
input lines
IEC 61000-4-11
Power frequency (50Hz/60Hz)
magnetic field IEC 61000-4-8
0% UT for 0.5 cycle
(1 phase)
0% UT for 1 cycle
70% UT for 25/30
cycles (50/60 Hz)
0% UT for 250/300
cycles (50/60 Hz)
30 A/m
50 Hz
30 A/m
50 Hz
0% UT for 250/300
cycles (50/60 Hz)
0% UT for 0.5 cycle
(1 phase)
0% UT for 1 cycle
70% UT for 25/30
cycles (50/60 Hz)
The quality of the supply voltage should be that of a
typical business or hospital environment.
Mains frequency magnetic fields should be at a
level characteristic of a typical location in a
typical commercial hospital environment.
IEC 60601 test level Compliance level Electromagnetic environment guidance
512

• Connect unit to an electrical outlet. Ensure that the voltage stated on the
rating plate on the bottom of the unit agrees with the mains voltage.
After connection of the charging base, a self-test is performed. During the
test, the LEDs on the front of the unit will be repeatedly switched on.
• When charging 19mm handles
(AA size), insert plastic reducers in
handle recesses. When charging
28mm handles (C size), remove
reducers from handle recesses by
lifting in an upward direction before
inserting handle.
• The ADC Diagnostix Desk Charging Base
may be used for charging 2.5V and 3.5V rechargeable batteries.
The charging chambers are interchangeable and may be used
with 2.5V or 3.5V battery handles. A 2.5V and 3.5V unit may be charged
simultaneously.
b) Charging
• The rechargeable battery is tested when inserted into the charging
chamber. At voltages of less than 1.5V, the rechargeable battery is either
fully discharged or faulty. The charging base will try to recharge the battery
by applying a pulsating charging current. The yellow charging LED will flash.
• For rechargeable battery voltages of more than 1.5V, charging will
commence. The yellow charging LED will turn on.
c) Charging Time
• The end of the charging time is detected
by evaluation of the negative voltage differential
caused by heating of the rechargeable battery
cells when fully charged. The yellow charging
LED will switch off and the green “rechargeable
battery full” LED will switch on.
611
Guidance and manufacturer‘s declaration - electromagnetic emissions
The charging station is intended for use in the electromagnetic environment specified below.
The custo mer of the user of the charging station should ensure that it is used in such an environment.
Emissions testing
RF emissions CISPR 11
RF emissions CISPR 11
Group 1
Class B
Harmonic emissions IEC 61000-3-2 Pass
Voltage fluctuations/flicker emissions
IEC 61000-3-3
Pass
The charging station uses RF energy for its internal function only. Therefore, the RF
emissions are very low and are unlikely to cause interference in nearby electronic
devices.
The charging station is intended for use in all facilities, including residential areas and
those directly connected to a public supply net- work that also supplies buildings
used for residential purposes.
Compliance Electromagnetic environment guidance

• The maximum charging time for NiMH rechargeable batteries is
limited to <650 minutes (10.8 hours). The maximum charging time for
Li-ion rechargeable batteries is limited to <480 minutes (8 hours).
• When the rechargeable battery is fully charged (green LED on), the
unit will switch to maintenance charge.
• The temperature inside the charger base is monitored. Do not keep
in sunlight, or close proximity of a radiator, as over heating may
cause premature actuation of the automatic switch-off mechanism
shutting the charger off before completing a full charge.
Caution:
• When the handle is removed from the charging chamber for a few
seconds while the rechargeable battery is fully charged (green LED on)
without switching on, initially the yellow charging LED will be switched
on when reinserting the unused rechargeable
battery. However, this is not due to
malfunction of the charging base but the
described “rechargeable battery full” sensor.
• When the rechargeable battery is full, no
negative voltage differential can be recorded.
The rechargeable battery must first heat up in
order to signal “rechargeable battery fully charged.”
• The time prior to the green “rechargeable
battery fully charged” LED switching on
again may vary considerably (15 minutes
or longer). Additional temperature sensing
and a timer, however, ensure that the
charging process is carefully monitored at
any time.
We recommend keeping the instrument in the
charging chambers after use to ensure that instruments are always ready.
11. TECHNICAL SPECIFICATIONS
Model: ADC Rechargeable Battery Charger Base
Display System: LEDs Connection
Main Connection (See Note on Bottom Label)
Power Adapter Input: 100 V-240 V AC / 50-60 Hz/0.6 A
Power Adapter Output: 9 V DC/2 A/18 W
Classification: Applied part type B
Operating Conditions: 32°F to 104°F (0°C to 40°C)
10% to 85% relative humidity
Storage Temperature: 23°F to 122°F (-5°C to 50°C)
10% to 85% relative humidity
Air Pressure: 700 to 1050 hPa
Dimensions: 7.3” x 3.4” x 2.9” (186 mm x 87 mm x 74 mm)
Weight: Approx. 1.1 lbs (500 g) without packing
12. MAINTENANCE
These instruments and their accessories do not require any specific
maintenance. Should an instrument have to be examined for any specific
reason whatsoever, please return it to ADC.
13. ELECTROMAGNETIC COMPATIBILITY (EMC)
Follow the instructions during the installation and operation of the device.
To avoid electromagnetic interference with the operation of the device, do not
use the device at the same time as other electronic devices.
To avoid electromagnetic interference with the operation of the device, do not
use or stack the device near, on or under other electronic devices.
Do not use the device in the same room as other electronic devices, (e.g. life-
supporting devices that have a significant impact on the life of the patient and
treatment outcomes) or other measuring instruments or treatment devices that
use little electrical power.
Do not use cables or accessories that are not specified for this device, as this
can increase the emission of electromagnetic waves from the device and reduce
the device’s electromagnetic immunity.
710

7. SPECULA COMPARTMENT
The specula compartment may be used for spare specula and lamps.
8. WALL MOUNTING
The ADC Diagnostix Desk Charging Base may
be mounted on the wall.
To Mount: Hold wall rail in place on the wall
where intended for mounting. Level and mark
hole positions with a pen. Drill 5 mm (3/16”)
wide holes. Insert the supplied mollys in the
holes. Position spacer holes over the mollys
and affix rail over the spacer and secure to
the wall with the screws supplied (fig. 1).
Slide unit bracket guide slots of the ADC®DiagnostixTM
Desk Charging Base plate onto the wall rail. When fully
inserted, the bottom cover tab will engage and lock in
the recess of the wall rail (fig. 2). Position the power
cord either to the right or left behind the base to
accommodate electrical outlet (fig. 3).
To remove: Press the bottom tab lock,
which allows the unit to
slide from the rail (fig. 4).
Spacer
Rail
(fig. 1)
(fig. 2)
(fig. 3)(fig. 4)
98
9. LED INDICATORS
10. CLEANING AND DISINFECTION
Prior to cleaning or disinfection of the unit disconnect mains cable
from socket.
Cleaning and/or Disinfection
The ADC Diagnostix Desk Charging Base may be cleaned externally with
a damp cloth.
In addition, the following disinfectants may be used for external disinfection:
Aldehyde (formaldehyde, glutaraldehyde, aldehyde derivatives), surfactants
or alcohols. After disinfection, wipe the instruments with a damp cloth to
remove any remaining disinfectant.
Never place the charging station in liquids. Use a soft lint free cloth or cotton
swabs to prevent damage to charging base.
Sterilization
According to the Test Centre for Medical Devices in Tubingen, Germany,
sterilization is only prescribed in the case of operative procedures. There is
no necessity for sterilization of this charging base.
Yellow LED on Charging in progress
LEDs switching on repeatedly,
brief permanent switch-on,
followed by off
Mains connection, self-test
Green LED on
Yellow LED flashing
Rechargeable battery fully charged, unit
changing to maintenance charge
Rechargeable battery fully discharged or
faulty. Unit trying to regenerate rechargeable
battery by a pulsating charging current.
Should no charging cycle be indicated
after approx. 16 h, the rechargeable
battery is faulty or must be replaced