Ruck Podolog Nova 3S User Manual

GB	Operating Instructions | REV 0 | PrintOperating instructionsI REFfor PODOLOG8011042 NOVA 3s | REV0483.

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This manual is also available in other languages. Please use the following link to download the manual or request it on the phone.

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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 [phone]

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.

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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.

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	WARRANTY
SINCE MORE THAN
		MADE IN
		GERMANY
			Medizinprodukt
YEARS	YEARS		Richtlinie 93/42 EWG Klasse 2a

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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

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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
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

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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

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1.DEVICE DESCRIPTION

1.1FRONT VIEW

01

	10	M1	M1	M2
02
i				M3

03

04

01 Controller

02 Display

03 Dust filter bag drawer

04 Handpiece

05 Magnetic speed control knob

06 Hose connection

7

05

06

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1.2BACK 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.

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1.3EXPLANATION OF THE CHARACTERS AND ICONS USED

1.3.1ON THE DEVICE AND TRANSPORT PACKAGING

Device with protection class II

Application part, Type BF

Refer to the Operating instructions

First digit	Protection against	Protection against	Second digit	Protection
	contact	foreign bodies		against water
0	No special protection		0	No special
				protection
	Against large	Large foreign bod-	1	Against
1	areas of the body	ies with a diameter		dripping water
		of more than 50		striking verti-
		mm		cally
				Against drip-
	Against fingers or	Medium-sized for-	2	ping water
2	objects of a	eign bodies with a		striking at an
	similar size	diameter		angle
		of more than		(up to 15° from
		12 mm		the vertical

Protect against wet and damp

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1.3.2IN 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.

1.4DECLARATION 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.

1.5SCOPE 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

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1.6PACKAGING

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.

1.7RECYCLING

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.

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.

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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.

3.1OPERATOR 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.

3.2STAFF 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 protection 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.

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3.3POSSIBLE 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.

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.

3.3.1HAZARDS 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.

3.3.2ALLERGY 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.

3.3.3HAZARDS 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!

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3.4POTENTIAL 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.

3.4.1HAZARDS 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.

3.4.2ALLERGY 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.

3.4.3HAZARDS 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.

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4.SET-UP

4.1TECHNICAL 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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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.

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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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