Ruck Podolog Nova 3S User Manual
GB
Operating Instructions | REV 0 | Print I REF 8011042
Operating instructions for PODOLOG NOVA 3s | REV. 0
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1. www.hellmut-ruck.de
2. 11400
3. DOWNLOADS
11400
11000_Gebrauchsanweisung_PODOLOG_NOVA_3_DE.pdf
11000_Gebrauchsanweisung_PODOLOG_NOVA_3_EN.pdf
HELLMUT RUCK GmbH | Daimlerstraße 23 | D - 75305 Neuenbürg
web www.hellmut-ruck.de | fon +49 (0)7082. 944 20 | fax +49 (0)7082. 944 22 22
Copyright
© 2018 Hellmut Ruck GmbH. All rights reserved. This document must not be copied, edited,
reproduced or translated without the prior written permission of Hellmut Ruck GmbH.
Operating instructions for PODOLOG NOVA 3s | REV. 0
Dear Customer,
With the PODOLOG NOVA 3s, you have acquired a Footcare System that sets completely new
standards in terms of functionality and performance. It has been developed throughout "based
on best practice for use in the best pra-tices". You will clearly feel the many details that are taken
into consideration in this new development, details that reflect over 90 years of experience and
expertise.
The "internal qualities" of the device will impress you including the patented and extremely
effective extraction, the maintenance-free micromotors with a high speed range, the freedom
from vibration and a long service life. It is the quietest device on the market, which is very important for facilitating commu-nication between patient and practitioner. Weight is a significant
factor when it comes to mobile deployment. This has been further reduced and is now about
1 kg less than comparable devices. The innovative ergonomics result from an optimised handpiece, which is light and has a sophisticated design that moulds to the shape of your hand.
The capacitive glass operating panel offers simple and intuitive handling. The magnetic speed
controller can be removed making the front panel very easy to disinfect. The clear display not
only provides information about the current device status. It also gives the option of having
illustrated, step-by-step instructions for the cleaning procedure for the clamping unit in the
handpiece. Professionally made and thought through to the last detail. That is the essence of
the PODOLOG NOVA 3s.
Backed by our name and our two-year guarantee, you can be assured of many years of enjoyable and problem-free operation.
The PODOLOG NOVA 3s Footcare System has been built in accordance with the 93/42 EEC
Directive Guidelines on healthcare products.
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Please take some time to read through these operating instructions carefully before setting up
the system. This constitutes part of the guarantee agreement, helps you avoid possible operational errors and should be kept in the proximity of the device.
We wish you much success and enjoyment in the very responsible and chal-lenging work that
you undertake.
KIND REGARDS HELLMUT RUCK GmbH
QUALITY
SINCE MORE THAN
YEARS
WARRANTY
YEARS
MADE IN
GERMANY
Medizinprodukt
Richtlinie 93/42 EWG Klasse 2a
Operating instructions for PODOLOG NOVA 3s | REV. 0
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1. DEVICE DESCRIPTION ................................................................................. 7
1.1 Front view ...............................................................................................................................7
1.2 Back view ...............................................................................................................................8
1.3 Explanation of the characters and icons used ...........................................................9
1.3.1 On the device and transport packaging .................................................................... 9
1.3.2 In the operating instructions .......................................................................................10
1.4 Declaration relating to these operating instructions ................................................10
1.5 Scope of delivery .............................................................................................................10
1.6 Packaging .........................................................................................................................11
1.7 Recycling ..........................................................................................................................11
2. INTENDED USAGE .....................................................................................11
3. STAFF AND PATIENT SAFETY ................................................................... 12
3.1 Operator requirements ...................................................................................................12
3.2 Staff and patient safety ...................................................................................................12
3.3 Possible patient risks ......................................................................................................13
3.3.1 Hazards caused by removed material .....................................................................13
3.3.2 Allergy risks....................................................................................................................13
3.3.3 Hazards caused by moving parts .............................................................................13
3.4 Potential risks for the user .............................................................................................14
3.4.1 Hazards caused by removed material ......................................................................14
3.4.2 Allergy risks .........................................................................................................................
3.4.3 Hazards caused by moving parts ...............................................................................14
4. SET-UP .......................................................................................................15
4.1 Technical safety ................................................................................................................15
Operating instructions for PODOLOG NOVA 3s | REV. 0
5. OPERATION.............................................................................................. 18
5.1 Preparations for operation ...........................................................................................20
5.1.1 Inserting a rotary tool ..................................................................................................21
5.1.2 Switching on the PODOLOG NOVA 3s ...................................................................22
5.1.3 Switching the handpiece on ......................................................................................24
5.1.4 Switching the handpiece off ......................................................................................24
5.1.5 Switching off the PODOLOG NOVA 3s ...................................................................25
5.2 Settings ............................................................................................................................. 25
5.2.1 Handpiece motor speed ............................................................................................25
5.2.2 Removing the magnetic speed control knob ........................................................26
5.2.3 Righthand / lefthand direction of rotation .............................................................. 26
5.2.4 Modifying the rotation direction ................................................................................ 27
5.2.5 Selecting the extraction level .....................................................................................27
5.2.6 Storing settings ............................................................................................................. 28
5.3 Tool changing ................................................................................................................. 29
5.4 Ergonomic handpiece grip .......................................................................................... 29
5.4.1 Fountain pen grip .......................................................................................................... 29
5.4.2 Overhand grip ................................................................................................................ 30
5.5 Info menu ......................................................................................................................... 30
5.5.1 Filter change .................................................................................................................. 31
5.5.2 Display next service date ............................................................................................ 31
5.5.3 Activating the service reminder ................................................................................ 32
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5.6 Filter change .................................................................................................................... 33
5.6.1 Changing the dust filter bag ...................................................................................... 33
5.6.2 Where can you get replacement dust filter bags? ...............................................35
5.7 Cleaning the motor unit ................................................................................................36
5.7.1 Loosening the sleeve .................................................................................................. 36
5.7.2 Easy cleaning of the motor unit ................................................................................ 36
5.8 Exchange of the alternate chuck .......................................................................... 37
Operating instructions for PODOLOG NOVA 3s | REV. 0
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6. MAINTENANCE, CLEANING AND DISINFECTION .................................... 37
6.1 Maintenance by RUCK service ...................................................................................... 37
6.2 Cleaning and disinfection ............................................................................................. 37
7. ACCESSORIES AND SPARE PARTS. LANGUAGE AND AREA OF ACTIVITY 38
7.1 Tools...................................................................................................................................38
7.2 Dust filter bags .................................................................................................................38
8. TECHNICAL DATA (INCL. EMC TEST RESULTS) ...................................... 40
8.1 Environmental conditions ............................................................................................. 41
8.2 Information regarding electromagnetic compatibility ............................................42
9. WARRANTY .............................................................................................. 49
10. DISPOSAL ................................................................................................. 49
11. FAQs ......................................................................................................... 50
11.1 I can‘t switch the device on ..........................................................................................50
11.2 The device is not responding ......................................................................................51
11.3 Resetting language and area of activity .................................................................. ..51
12. POTENTIAL ERROR MESSAGES ON THE DISPLAY ................................. 52
Operating instructions for PODOLOG NOVA 3s | REV. 0
1. DEVICE DESCRIPTION
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1.1 FRONT VIEW
01
02
i
M1
M1 M2
M3
7
05
03
04
01 Controller
02 Display
03 Dust filter bag drawer
04 Handpiece
05 Magnetic speed control knob
06 Hose connection
06
Operating instructions for PODOLOG NOVA 3s | REV. 0
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1.2 BACK VIEW
01
02
01 Power cable
02 Power switch (On/Off)
= OFF (power switch off)
= ON (power switch on)
If the power cable is damaged, the device must be disconnected from
the mains and may not be used any more.
A damaged power cable may only be replaced by an authorised specialist.
Operating instructions for PODOLOG NOVA 3s | REV. 0
1.3 EXPLANATION OF THE CHARACTERS AND ICONS USED
1.3.1 ON THE DEVICE AND TRANSPORT PACKAGING
Device with protection class II
Application part, Type BF
Refer to the Operating instructions
9
First digit Protection against
0
1
2
contact
No special protection 0 No special
Against large
areas of the body
Against fingers or
objects of a
similar size
Protect against wet and damp
Protection against
foreign bodies
Large foreign bod-
ies with a diameter
of more than 50
mm
Medium-sized foreign bodies with a
diameter
of more than
12 mm
Second digit Protection
1 Against
2
against water
protection
dripping water
striking verti-
cally
Against drip-
ping water
striking at an
angle
(up to 15° from
the vertical
Operating instructions for PODOLOG NOVA 3s | REV. 0
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1.3.2 IN THE OPERATING INSTRUCTIONS
Warning! This icon identifies a potential point of danger for people or for
the device itself. It must be taken note of.
This symbol identifies useful advice that offers you additional information
related to the operation of your PODOLOG NOVA 3s.
1.4 DECLARATION RELATING TO THESE OPERATING INSTRUCTIONS
Hellmut Ruck GmbH reserves all rights to modify and supplement these operating instructions. Hellmut Ruck GmbH has taken great care to keep these instructions free of inaccuracies and omissions. Please contact us if you find mistakes or inaccuracies. However, Hellmut
Ruck GmbH assumes no liability for mistakes in these operating instructions or consequential damage resulting from the provision of these operating instructions or their application
when using the product.
These operating instructions must not be disseminated or supplemented without the express approval of Hellmut Ruck GmbH.
1.5 SCOPE OF DELIVERY
Please take some time to read through these Operating Instructions carefully before setting
up the PODOLOG NOVA 3s. This constitutes part of the medical product and should be kept
in close proximity to the device itself. Please check that the delivery is complete.
The following items make up the scope of the delivery:
1 PODOLOG NOVA 3s controller
1 Handpiece with hose and drawer
1 Dust filter bag
1 Set of operating instructions
1 Device logbook
1 Interchangeable chuck for PODOLOG NOVA 3s (Item No. 11067)
1 Operating instructions for replacement of interchangeable chuck
Operating instructions for PODOLOG NOVA 3s | REV. 0
1.6 PACKAGING
The packaging has been designed to protect the device while in transit. The packaging
materials used have been selected with due regard for environmen-tal issues and can be
recycled.
Please keep the packaging (box, plastic bag, PU foam parts) to use for returning the device
in case of any maintenance work.
1.7 RECYCLING
Old equipment must be disposed of as electronic waste and should not be treated as domestic waste. Full dust bags can be disposed of with general rubbish.Please make sure you
follow any local guidelines in this respect.
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Special country-specific requirements should also be taken into account.
2. INTENDED USAGE
The PODOLOG NOVA 3s Footcare System activates rotating tools which can be used to remove hard skin, calluses or nails, for example. The device is intend-ed for use in the following
fields of activity:
Podiatry (medical footcare), cosmetic footcare, nail design, beauty, wellness and by doctors.
Use in any other field is at the user’s own risk and may be dangerous. Improp-er usage of the
device can lead to personal and material damage.
The manufacturer cannot be held responsible for any damage caused by im-proper or incorrect usage of the equipment.
All rights under the terms of the guarantee are rendered null and void by any improper usage
or if the device is opened!
No changes or modifications may be made to the device or its acces-sories.
Should a repair be required, the necessary safety checks must be repeated.
Operating instructions for PODOLOG NOVA 3s | REV. 0
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Rotating tools without a CE label must not be used for
podiatry/medical purposes in combination with this device.
3. STAFF AND PATIENT SAFETY
The likelihood of any person-related risk can be restricted to a very few points by the proper
usage of the PODOLOG NOVA 3s.
3.1 OPERATOR REQUIREMENTS
The PODOLOG NOVA 3s Footcare System should only be used by podiatrists, pedicurists,
cosmeticians, nail designers or doctors, who are aware of how the system operates and have
received the necessary training.
3.2 STAFF AND PATIENT SAFETY
To protect users, patients and third parties, the following must be observed:
– Only high-quality rotary tools in accordance with DIN EN ISO 1797-1, which
have a standardised shaft diameter of 2.35 mm, cylindrical, Type 2, may be
used. For the rotary tools, the manufacturer’s instruc-tions relating to maximum speed and preparation (cleaning, disinfection and sterilisation) must
be followed. You will find addition-al information in the current catalogue
from HELLMUT RUCK GMBH, in the section “Rotary instruments”.
– Operating staff must wear protective goggles and mouth and nose protec-
tion while using the equipment. Long hair must be tied back or protected
by a hairnet.
– During the treatment, ensure that no objects that could become caught in
the rotating parts can enter the treatment area.
Operating instructions for PODOLOG NOVA 3s | REV. 0
3.3 POSSIBLE PATIENT RISKS
The extraction of potentially pathogenic dust significantly reduces the risks caused by transferable germs (micro-organisms).
Regular and careful anamnesis can help to identify potential risks of infection.
The risk to patients through inhalation is reduced to a minimum and the treatment of patients with low levels of immunity can be responsibly undertaken. Nevertheless, the practitioner
should still always wear mouth and nose protectors as well as safety gloves while carrying out
the treatment.
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If any germ-intensive work has been carried out, disinfected and steri-lised tools must
be used during the next work process, to treat any unaffected areas of skin or nail.
3.3.1 HAZARDS CAUSED BY REMOVED MATERIAL
The hazard level caused by removed particles (nail splinters or parts of the coarse surface) is
low because there is a sufficient distance from the treatment area.
The efficient suction technology of the PODOLOG NOVA 3s minimises the risk of inhaling
dust which may potentially contain pathogens. The risk of infection can be further reduced by
practising thorough antiseptic skin hygiene prior to the treatment.
3.3.2 ALLERGY RISKS
Since the patient does not generally come into contact with the surfaces of the PODOLOG
NOVA 3s, the only potential cause of an allergic reaction is parts of the rotary tools. However,
due to the very short contact times (less than 30 minutes), this risk is minimal.
3.3.3 HAZARDS CAUSED BY MOVING PARTS
High speeds and pressure may cause an undesired level of heat to develop in the treatment
area. In the worst case scenario, the affected tissue may be damaged by the heat produced.
Sudden movements by the patient or a lack of attention on the part of the user may result in
unintentional penetration of the skin. However, if the equipment is used properly and the process is constantly visually monitored, this risk is low.
Warning! Penetration of the skin must be avoided!
Operating instructions for PODOLOG NOVA 3s | REV. 0
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3.4 POTENTIAL RISKS FOR THE USER
The extraction of potentially pathogenic dust significantly reduces the risks caused by transferable germs (micro-organisms).
Risks to the operator through inhalation are kept to a minimum.
For reasons of hygiene we recommend wearing face/mouth protection.
3.4.1 HAZARDS CAUSED BY REMOVED MATERIAL
Removed particles (nail splinters, parts of the treated surface) and dusts pre-sent a hazard
due to their proximity to the treatment area.
To minimise the risk the user must wear goggles and mouth and nose protec-tion during the
treatment.
3.4.2 ALLERGY RISKS
It is possible, but extremely unlikely, that allergic reactions to the material of the handpiece
may occur. For hygiene reasons we would also recommend that disposable gloves be worn.
3.4.3 HAZARDS CAUSED BY MOVING PARTS
Hair, jewellery and clothing may get caught in rotating parts. To avoid injury, long hair should
be tied back or protected by a hairnet. In the interests of hy-giene, jewellery should not be
worn. The user should wear clothes that cannot get caught in the tool.
Operating instructions for PODOLOG NOVA 3s | REV. 0
4. SET-UP
4.1 TECHNICAL SAFETY
– Before using the device for the first time, you should ensure that mains
power characteristics match the values quoted on the rating plate.
– Make sure the controller is located on a flat, stable surface.
– The ventilation slots in the device must be kept uncovered at all times.
– Avoid damaging the mains cable through squashing, bending or rub
bing against sharp edges.
– Don’t introduce any fluids into the unit.
– Protect the device from all types of moisture that could find its way in
side the housing. There is a danger of electrical shock if there is damp
ness in the device!
– Switch the device off before maintenance and cleaning and unplug it
from the mains power
– Never immerse the device in water or other fluids.
– You must remove the plug from the mains immediately, if the device or
hose is damaged or if it starts to function incorrectly.
– Repairs should only be carried out by qualified repair technicians.
– If the device is opened, all rights under the terms of the guarantee are
void!
– See Chapter 7.1 for tools which may be used.
– The PODOLOG NOVA 3s is a STAND-ALONE device. To avoid elec-
tro-magnetic interference, we do not envisage it being used in conjunc
tion with other devices. Do not position the device directly next to or
with other devices. Should this be necessary, please make sure that all
intended func-tions of the device work properly in this position.
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Operating instructions for PODOLOG NOVA 3s | REV. 0
16
The use of accessories or spare parts other than that prescribed may
result in increased emissions or reduced immunity to interference.
Because of EN 60601-1-2 relating to the electromagnetic compatibility of electrical medical devices, we must draw your attention to
the following:
• Medical electrical devices are subject to special measures in terms
of electromagnetic compatibility and must be operated in accordance with the requirements laid out in these Operating instructions.
• Portable and mobile high-frequency communication devices (including accessories, such as antenna cable and external cables) can
influence medical electrical equipment. Such equipment should be
operated at a minimum distance of 30cm from the PODOLOG NOVA
3s and its parts.
Otherwise the possibility of device performance impairments cannot
be excluded.
Please also refer to: 8.2 Specifications referring to electromagnetic
compatibility in accordance with EN 60601-1-2
The compliance criteria relating to immunity to interference apply to
all functional impairments.
Risk of strangulation from handpiece hose and power cable. Keep
children away from the device.
Risk of swallowing in the case of required accessories (small parts),
e.g. nail file drills. Keep children away from the device.
Use the supplied packaging to protect the device against mechanical damage and damp when transporting it between deployments.
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.
Operating instructions for PODOLOG NOVA 3s | REV. 0
When using the device in domestic premises, there can be a risk
resulting from power cables that have been damaged by animals,
for example.
Please check the mains power connection regularly for signs of
damage and if any are found, disconnect the device from the mains.
When using the device in domestic premises, there can be a risk that
the device may be tampered with by children.
Keep children away from the device.
Protect the device against pest infestation through regular checks
and cleaning.
The instructions regarding operation and transport of the device
must be adhered to.
Please ensure that you have easy access to the mains plug at all
times so that the device can be unplugged from the mains without
difficulty. The mains plug represents the separator to the mains power supply.
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Operating instructions for PODOLOG NOVA 3s | REV. 0
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