ztcube - zamar.carezamar.care/cubemanual.pdf · 2004/108/eec (compatibilidad electromagnetica),...

Installation, use and maintenance

ZTCu

be

Original Instruction - 0MAN100GB Rev.04 - 2016.06

1370

We would like to thank you for having chosen our pro-ducts.

This manual has been designed in order to give you all the explanations thus enabling you to use your unit at its best. Therefore you are kindly invited to read it care-fully before operating the unit.

installation, use and maintenance

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DEALER STAMP

Date..........................................................................................

Signature.................................................................................

Document reserved according to the law. Reproducing or di-stributing this document without the express written permis-sion of ZAMAR MEDICAL d.o.o. is strictly forbidden. The origi-nal language used by the manufacturer to write this manual is Italian. As the unit may be updated, it could look slightly different from the figures; however, this does not undermine the content of these instructions.


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CONTENTS


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1 GENERAL INFORMATION .................................................... 51.1 Declaration of conformity .................................................................... 51.2 Symbology ....................................................................................... 61.3 General safety .................................................................................. 61.4 Permitted use .................................................................................. 61.5 not permitted use ............................................................................. 71.6 Manufacturer and unit identification data ................................................. 71.7 Technical support information ............................................................... 71.8 How to place stickers and label ............................................................. 81.9 Symbol legend .................................................................................. 9

2 BEFORE YOU START ........................................................ 102.1 General description ......................................................................... 102.2 Features ....................................................................................... 102.3 Specifications ................................................................................ 112.4 Accessories .................................................................................... 11

3 TRANSPORT AND HANDLING .............................................. 123.1 General cations .............................................................................. 123.2 How to package .............................................................................. 123.3 How to store .................................................................................. 123.4 Delivery ........................................................................................ 123.5 How to handle the unpacked unit ........................................................ 123.6 Package dimensions ......................................................................... 133.7 Packaging labels .............................................................................. 13

4 INSTALLATION ............................................................... 144.1 General cautions ............................................................................. 144.2 Initial cleaning ............................................................................... 144.3 Space required to use the unit ............................................................ 144.4 How to connect hoses ....................................................................... 144.5 How to place hoses during transport ..................................................... 144.6 How to supply liquid ......................................................................... 154.7 How to connect the unit to the mains .................................................... 15

5 PREPARATION OF THE MACHINE ......................................... 165.1 General warnings ............................................................................ 17

5.1.1 Patients .................................................................................. 175.2 How to programme .......................................................................... 17

5.2.1 Patients ......................................................................................... 185.2.1.1 Information .................................................................................... 185.2.1.2 Sessions ........................................................................................ 185.2.2 Automatic Program .............................................................................. 205.2.3 Manual Program .................................................................................. 215.2.3.1 How to create a new program .............................................................. 225.2.3.1.1 Group name ................................................................................. 225.2.3.1.2 Program name ............................................................................... 225.2.3.1.3 Treatment typology ........................................................................ 235.2.3.1.4 Number of cycles ........................................................................... 23


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5.2.3.1.5 Acute - Subacute ........................................................................... 245.2.3.1.6 Massage ..................................................................................... 245.2.3.1.7 Functions .................................................................................... 245.2.4 Options ............................................................................................ 275.2.4.1 How to modify date/time ................................................................... 275.2.4.2 How to modify the temperature’s unit of measurement ............................... 285.2.4.3 How to adjust display’s Brightness and Contrast ......................................... 285.2.5 Language .......................................................................................... 29

5.3 USB socket ....................................................................................... 29

6 ACCESSORIES ON DEMAND ................................................ 30

7 MAINTENANCE ............................................................... 317.1 Routine maintenance .......................................................................... 317.2 Special maintenance ........................................................................... 31

8 TROUBLESHOOTING ........................................................... 318.1 Useful life ....................................................................................... 32

9 ELECTROMAGNETIC COMPATIBILITY ........................................ 329.1 Electromagnetic emissions.................................................................... 339.2 Electromagnetic immunity .................................................................... 349.3 Recommended separation distances between the communications equipment portable and mobile and ZTCube ................................................................ 36

1 GENERAl INFORMATION

1.1 Declaration of conformity

ZAMAR MEDICAL d.o.o. Sv. Martin 6, 52450 Vrsar Istria,Croatia

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CERTIFICATO CE DI CONFORMITA’ – EWG KONFORMITATSERKLARUNG – CERTIFIE CE DE CONFORMITE’ - EC CERTIFICATE OF CONFORMITY - CERTIFICADO CE DE CONFORMIDAD

Nome e indirizzo della ditta Nom et adresse de l’enterprise Name und addresse der firma Name and address of the firm Nombre y direccion del la empresa

ZAMAR MEDICAL d.o.o. Sv. Martin 6,

52450 Vrsar - Istria,Croatia

Dichiariamo sotto la Nostra Responsabilità che Wir erklaren in alleiniger verantwortung dass

Nous declarons sous notre proper responsabiliteque We declare under our sole responsibility that Declaramos bajo nuestra responsabilidad que

Il dispositivo medico Das medizinproduct Le dipositif medical The medical device El dispositivo medico

APPARECCHIATURA A SCAMBIO TERMICO PER CRIOTERAPIA E TERMOTERAPIA

MEDICAL DEVICE BASED ON HEAT EXCHANGE FOR CRYOTHERAPY AND THERMOTHERAPY

Nome Bezeichnung Nom Name Nombre

ZTCube ZTClinic

ZCCarepace

Anno costruzione Year of manufacture Annèe de fabrication 2016Aňo costruccion:

Tipo -Modello Typ - Modell Type - Modele MG465AA00EType - Model Tipo - Modelo

Matricola Matrikelnummer Numero de serie xxxxxxx Serial number Numero de serie

Della Classe IIa Der Klasse IIa De la Classe IIa Of Class IIa De Clase IIa

Secondo l’allegato IX della direttiva 93/42/CE-2007/47/CE Nach anhang IX der richtlinie 93/42/EWG-2007/47/EEC Selon l’annexe IX de la directive 93/42/CE-2007/47/EEC

According to annex IX of directive 93/42/EEC-2007/47/EEC Segun el anexo IX del la Directiva 93/42/CEE-2007/47/EEC

Soddisfa i requisiti essenziali dell’allegato II della direttiva 93/42/CE-2007/47/CE(dispositivi medici), 2004/108/CE (compatibilità elettromagnetica), 2006/95/CE

(bassa tensione).

Entrspricht den betreffenden grundanforderungen der anlage I und VII der richtlinie 93/42/EWG-2007/47/EEC (medizinische gerate), 2004/108/

EEC(elektromagnetische verordnung), 2006/95/EEC(niederspannung).

Ce produit satisfait aux conditions principales definies dans l’annexe I et VII de la directive 93/42/CEE -2007/47/EEC (dispositives medicaux), 2004/108/EEC

(compatibilitè electromagnetique), 2006/95/EEC (basse tension), qui le concerne.

Satisfying the essential requirements of annex I and VII directive 93/42/EEC -2007/47/EEC (medical device),

2004/108/EEC (electromagnetic compatibility), 2006/95/EEC (low voltage), concerning this product.

Satisface los requisitos esenciales del anexo I y VII de la directive 93/42CEE -2007/47/EEC (dispositivos medicos),

2004/108/EEC (compatibilidad electromagnetica), 2006/95/EEC (baja tension), relacionada.

Certificato n° - Zertifikat Nr. - Certificat n° Certificate No - Certificato n° IT256270

Organismo notificato - Verantwortliche gestaltung - Organisme notofié Notified body - Organismo responsible Bureau Veritas – CE 1370

Il Fascicolo Tecnico è redatto e custodito dal Resp.di Progetto Gianmarco Zanotti / Responsabile Tecnico di Progetto

Nome e funzione - Name und function - Nom et fonction Name and Function - Nombre y function

Raffaele Zanotti / Amministratore Unico

Luogo, data - Ort, datum - Lieu, date - Place, date - Lugar, fecha Vrsar, ……………..


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1.2 SymbologyThe pictogrammes in the next chapter convey quick and precise information for the correct and safe use of the unit.

Service - It marks situations where you have to contact

the internal company SERVICE:CUSTOMER SERVICE.

General warnings - It marks the the procedure described may result

in personal injurues, when not carried out accor-ding to security regulations.

Index - This symbol means tha the paragraph contains

very important information, specifically concer-ning safety.

Failure to follow these procedures may result in: - safety risk for operators; - cancellation of the contractuao warrenty; - manufacturer’s disclaimer.

Prohibition - It marks things you must not do.

Dangerous voltage - It marks theat the described procedure, when

not carried out according to the safety regula-tions, may result in electric shock.

Intense heat danger - It marks that the described procedure, when not

carried out according to safety regulations, may result in contact burns caused by high tempera-ture components.

Wast disposalThe symbol on the item or on the package indica-tes that the item should not be treated as normal household waste, but must be taken to an appro-priate collection point for the recycling of electrical and electronic equipment.

Correct disposal of this item will help prevent pos-sible negative consequences for environment and health.For further information about recycling this pro-duct, please contact the local authority or waste disposal service, or the shop where you purchased the product.

This arrangement is valid in the EU States only.

1.3 General safety warningsYou should always use the optional accessories on demand only. The unit should always be operated by a single operator. Working and control position is opposite the control panel.

1.4 Permitted use - ZT Clinic unit has been designed for rehabilita-

tion through a dynamic management of tem-perature, designed and built for the complex needs of clinics and hospitals in order to treat more patients using the same programme si-multaneously.

- The unit is designed for medical use in normal environmental conditions.

- The unit should be operated by trained person-nel specifically instructed on the unit’s characte-ristics and informed on this manual’s content.

- The unit usually works in automatic mode, the operator is responsible for the operator panel and for the therapeutic strips.


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1.5 Not permitted useIt is forbidden to use the unit, even partially: - without protective clothing and/or with disa-

bled, damaged or missing security devices; - if it hasn’t been correctly set up; - in hazardous conditions or in case of malfun-

ctioning; - for improper use or by unqualified personnel; - for any use contrary to the relevant legislation; - if a supply defect occurs; - in case of serious maintenance deficiencies; - without the DPI gloves required for the specific

procedure; - without having adequately educated and trai-

ned the operator as required by D.Lgs. 81/2008 (and its further supplements and modifications) regarding safety in workplaces;

- after unauthorized modifications; - with materials and/or tools different from the

ones specified for the normal operation of the unit;

- with operating temperatures over 45°C; - with partial or total in-observance of instruc-

tions.

The unit should not be used if one or more of these conditions occur:

- environments with a temperature below +10 °C and over 40°C;

- relative humidity less than 10% and more than 50%;

- aaltitudes exceeding 2000 mt above sea level; - in explosive atmospheres or where there is fire

hazard.

DEVIATIONS FROM THESE STANDARDS SHOULD REQUIRE A SPECIFIC WRITTEN DE-CLARATION BY ZAMAR S.R.L.

YOU WILL BE COMPLETELY RESPONSIBLE FOR ANY CHANGE, UNAUTHORIZED BY THE MANIFACTURER, WHICH MODIFIES THE FE-ATURES, THUS ALTERING AND/OR CAUSING ADDITIONAL RISKS.

THOSE MODIFICATIONS, IF CARRIED OUT WITHOUT THE AUTHORIZATION OF THE MA-NUFACTURER, WILL RESULT IN THE CANCEL-LATION OF THE OF THE MANUFACTURER’S WARRANTIES AND IN THE INVALIDATION OF THE DECLARATION OF CONFORMITY REQUIRED BY THE MACHINERY DIRECTIVE 2006/42/ CE.

ZAMAR disclaims any responsibility for any damages to persons, properties or animals arising from an improper use of the machi-nery.

1.6 Manufacturer and unit identification data

ZAMAR MEDICAl d.o.o.Office and Production:Sv. Martin 652450 Vrsar - Croatia (HR)

Tel. +385 (0) 52 496 444 Fax: +385 (0) 52 496 112 [email protected]

1.7 Technical support informationPlease contact the Supplier where you bought your unit for any service and maintenance not mentio-ned in these instructions.


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On the back of the device there are some technical and informative labels.- “TECHNICAL” label, made by a material such thatin case of removal can not be used, which showsthe technical data of the device, model - serial num-ber - year of manufacture - Electrical Technical Data- “LIQUID” label warning that the tank of the devicecan be refilled liquid ONLY with liquid recommen-ded by Zamar Medical d.o.o.- “Transport” Label that provides information onthe conditions of TRANSPORT, STORAGE AND CON-DITIONS OF USE - “WARNING” Label that informs the operator incase of maintenance or service to disconnect theelectrical power before servicing.

1.8 How to place stickers and labelOn the machine are affixed identification stickers.

It is mandatory to acknowledge them befo-re any use. Any different use from that specified shall be considered not proper and may cause damage to the unit and the Operators.

On the front side of the device in addition to the label with the company logo, close to fittings, a label identifies the application parts to be con-nected to the device which are “BF” type.


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1.9 Symbol legend

Attenzione – Tensione pericolosa

Attenzione – consultare la documentazione interna

Apparecchio emette radiazioni non ionizzanti

Questo prodotto è conforme alla direttiva EU2002/96/EC. Il simbolo del cestino barrato riportato sull‘ apparecchio indica che il prodotto, alla fine della propria vita utile, dovendo essere trattato separatamente dai rifiuti domestici, deve essere conferito in un centro di raccolta differenziata per apparecchiature elettriche ed elettroniche, oppure riconsegnato al venditore al momento dell‘acquisto di una nuova apparecchiatura equivalente. L‘utente è responsabile del conferimento dell‘apparecchio a fine vita alle appropriate strutture di raccolta. L‘adeguata raccolta differenziata per l‘avvio successivo dell‘apparecchio dismesso al riciclaggio, al trattamento e allo smaltimento ambientalmente compatibile contribuisce ad evitare possibili effetti negativi sull‘ambiente e sulla salute e favorisce il riciclo dei materiali di cui è composto il prodotto. Per informazioni più dettagliate inerenti i sistemi di raccolta disponibili rivolgersi al locale servizio di smaltimento rifiuti.

Parte applicata di tipo BF

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Marcatura CE di conformità Europea e numero di organismo notificato

Fabbricante

Nome del modello di dispositivo

Numero seriale del dispositivo [vedere etichette]

Anno di fabbricazione [vedere etichette]

Mantenere il dispositivo asciutto


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2 BEFORE YOU START

2.1 OverviewPortable unit with a confortable handle for moving, also a trolley is available (optional) with several shelves for pipes and wripes. The ideal solution for Rehabilitation Centres and Leisure Centres. The touch screen uses a TFT panel which makes it easy to read even in critical light conditions and can be used by the operator even when wearing gloves. The operator is able to access the different preset programs that allow the application of therapies. It is possible for your doctor to create and store coun-tless cycles of work in absolute freedom, adapting them to the patient’s needs and the physical sha-pe. The control panel can be updated both by the touch screen and via USB with new cycles of the-rapy downloaded from Zamar website. The intui-tive touch-screen interface, with simple icons and graphics, allows the operator to use the system in all its power and practicality continuously monito-ring the patient. The Zamar wraps allow an ideal transferring of the heat on the part to be treated thanks to the ana-tomical shape which increases the contact surface. The disposable wraps are also available for hospital use. The technical material used keeps the wraps flexible and soft even with treatments at temperatures below zero in the acute stages, helping to prevent cold burns. Through the Zamar wraps it is possible to apply a compression, pulsed or continuous, suitably programmed by touch screen, which plays an im-portant role as lymphatic drainage. The wraps are available for all parts of the body: shoulder, elbow, hand-wrist, thigh, knee, ankles, face and breasts.

SYMPTOMATOlOGIES TREATEDZamar Therapy applies to:

• Muscles- Contusions

. - Contractures

. - First and second grade lesions• Tendineous apparatus

- Tendinitis- Tenosynovitis- Tendinopathy

• Osteocartilagineous apparatus- Contusions- Fractures

• Capsular Ligament structures- Strains- Ligaments contusions

• Pre and Post-surgical- Orthopedic Surgery interventions- Prosthetic surgery (first

Installations and revisions)• Cosmetic surgery

- Rhynoplasty operation, mastoplasty- Liposuction and mesotherapy operations

2.2 Features• Achievable temperature min. 0° C max. +40° C• Managing up to 2 strips simultaneously• Touch screen control panel 7’’• Selection of duration, temperature and pressure

of the treatment• Transportable with the ergonomic handle• Specific NON-TOX coolant• Treatment temperature and duration alarms.


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2.3 Specifications

• Dimension: see picture.• Power suplply: 230V 50Hz (115/230V 60Hz).• Weight fully loaded: 16,5 kg.• Coolant: R134a• Temperature range: 0°C ÷ +40°C• Screen: Touch Screen 7 TFT.

2.4 Accessories

A. Power cable (UE, UK, USA, AUS).B. Liquid for circuits, tank of 1 l (cod. 3LIQ010).C. Use and maintenance instruction manual.


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330

mm

325 mm 375 mm

3 TRANSPORT AND HANDlING

3.1 General cautionsAll the personnel involved in the unit transport and installation should be informed about these instructions.

3.2 How to packageThe unit should be packaged for transport in a car-ton box where you can find the instructions “TOP” and “FRAGILE”. The unit, packaged as said, can be carried by hand by an operator with a handtruck.

3.3 How to storePlease store the packaged unit in an indoor en-closed environment, soil isolated through wood sleepers or similar. Temperature between -5°C and +60°C; humidity between 30% and 90%.

Don’t turn the packaging upside down. Check the arrow “TOP” printed on the box.

Don’t stack up the units.

The unit without packaging must stand stable and covered with a cloth.

3.4 DeliveryThe packaging is made of proper material and car-ried out by trained personnel, therefore the units leave our company complete and in perfect condi-tions. The goods are at buyer’s risk and peril when travelling, even if delivered home for free. However, in order to check transport service’s quality and in case of insurance, please proceed as follows: - as the unit is delivered, before proceeding with

unpacking, immediately verify whether the packaging is damaged: if it is, make the goods conditional accepted, taking pictures as eviden-ce of possible apparent damages;

- unpack, checking the correspondence between lists and contents;

- verify that the unit’s components haven’t been damaged during transport and notify, within

3 days from delivery, possible damages to the cou-

rier with a registered mail, return receipt requested, contextually showing documented photographic evidence. Send the same information to ZAMAR s.r.l. via fax.

Information regarding damages during transport will not be considered after 3 days from delivery. After 10 days from delivery complaints will not be accepted. With respect to any dispute which may arise you consent to the jurisdiction of the court of Mantova

3.5 How to handle the unpacked unit

The machine, once unpacked, is always carried by handle (rif. A).

Pay attention: uncoordinated move-ments may result in imbalance and pos-sible fall of the unit with damage to per-sons and properties.

A


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3.6 Package dimensionsThe packaging is made of double corrugated cardboard with double flaps on the bottom. Dimensions of the box: 60CM x 40CM x 60CM height.

3.7 Packaging labelsOn two sides of the package there are some very important identification labels to guarantee the in-tegrity of the product and some indications useful for maintaining the best conditions of the device over time.

- in the upper part of the package a label is pro-vided; a control device shows whether the packa-ging during the various phases of transport hasbeen overturned; the indicator in the case of over-turning becomes RED; of course the customer orthe goods consignee must checked on receipt thatthe indicator is still WHITE.

- in the lower part of the package a label definessome indication of the conditions of TRANSPORT,STORAGE and USE


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4 INSTAllATION

4.1 General cautionsPlace the unit in a stable and levelled ground. Always make sure that the unit’s wheels are blo-cked before any use.

4.2 Initial cleaningYou should clean the unit before starting.

Clean the unit when the power cable is disconnected from mains only.

Clean the outer surfaces with a soft cloth moiste-ned with lukewarm water containing neutral deter-gent only.

The screen panel should be cleaned with a soft and dry microfiber cloth.

4.3 Space required to use the unitPlace the unit as to facilitate movements of the personnel of the unit itself; pay attention to the hoses connecting to the thermal strips, you should not push them to let the coolant flow properly. The control and programming panel should be easily reachable and correctly visible.

4.4 Connection hosesInsert the hoses in the quick release connection in the unit’s front pressing the metal button.

4.5 How to place hoses during transport You can envelop the carrying handle with the ho-ses, after having removed them from the quick re-lease connections.

Before moving the unit, unplug the ho-ses from the front quick release connec-tions and the power plug from the wall socket.


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4.6 How to supply coolantThe unit is endowed with a tank containing the co-olant. You must open the cap (A) and add the extra coolant supplied with the unit (on demand when finished) every time you see the alarm lack of co-olant.

4.7 How to connect the unit to the mainsThe unit is endowed with a plug that can be con-nected to the earthed power outlet (A).

Make sure the earthing system in the mains where the unit is installed is adequate.

Before connecting the device to the mains power supply it is necessary to verify that the main supply has the voltage and frequency which correspond to what is indicated on the rating plate of the devi-ce; then you can connect the harness to the switch on the rear of the device, then to the plug to the main power supply.


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5 PREPARATION OF THE MACHINE

CONTRAINDICATIONS

The cold-hot treatment by ZTCube device should not be applied on patients who:

• who are in the acute stages of inflammatory phle-bitis in the concerned area• who have previously suffered or are actually suf-fering for clinical signs which suggest deep vein thrombosis or pulmonary embolism in the concer-ned area.• with significant arteriosclerosis or other ischemic vascular disease in the concerned area• presenting a patolagia (eg carcinoma) for which it is not appropriate an increase of venous return or lymph in the affected part• who have hypertonia in decompensated phase in the affected area• with a significant vascular compromisein the con-cerned area• with blood dyscrasias which influence on the on-set of thrombosis.

WARNINGS

• incorrect positioning or prolonged use of theZamar Medical system can cause tissue injury

• in the course of therapy, patients should be mo-nitoring the skin around the treated area of thetreated limb or fingers to detect possibly bur-ning, itching, increased swelling or pain. If thesesymptoms are present or if any alterations of su-perficial skin (such as blistering, redness, disco-loration or other signs of change) patients areadvised to discontinue use and consult a doctor

• the thermal wraps are available in various con-figurations but are not intended for all possibleorthopedic uses

For example, the Ankle Wrap is not intended to be used on the fingers and the Lumbar Wrap is not intended to be used in abdominal region

• Thermic therapy should be used only under thecontrol of an authorized physician operator:1) has a wound in the concerned area (the wound

should be medicated before treatment withthe device)

2) presenting an acute fracture, unstable in theconcerned area

3) that are less than 18 years or who suffer fromcognitive disabilities or barriers to commu-nication, both temporary (due to drugs) andpermanent

4) who suffer from heart failure or congestiveheart failure

5) which have a localized skin condition (eg der-matitis, vein ligation, gangrene) in the con-cerned area

6) suffering from erysipelas or other active infec-tion in the affected region

7) suffering from Raynaud’s phenomenon orhypersensitivity to cold

8) who suffer from hypertension or extremehypotension

9) who suffer from diabetes10) who suffer from impaired local circulation, or

neurological impairmentin the concerned area11) who suffer from rheumatoid arthritis in the

concerned area.

PRECAUTIONS

• to avoid the risk of electric shock do not removeany panel from the control unit. For any mainte-nance or repair, contact the Technical AssistanceZamar Medical d.o.o..

• to prevent electric shock, malfunction or pro-duct damage, never operate the device withcables and pipes and accessories mechanicallydamaged whose condition can jeopardize thecorrect operation of the machine

• fill the tank always and exclusively with ZamarMedical d.o.o. recommended product


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• to avoid potential damages to the product, donot use thermal wraps of other brands with Za-mar Medical System

• to avoid injury, be careful not to trip over powerharness

• the Zamar Medical Device is Medical Technicaldevice; to avoid damaging the product, treat itwith care, do not drop, hit it or treat it with ne-glect.

5.1 General warningsPlace the unit on a stable and levelled ground. Always make sure you have blocked the unit’s whe-els before any use. Connect the hoses to the unit in the quick release connections on the unit’s front; connect the power outlet (see par. 4.7) and supply power to the unit switching on position “I” (A).

5.2 How to programme

As the unit is switched on you will see the frame Home Page where you can choose 5 functions:

1. : You can create new patient’s profiles orload existing ones with their story board.

2. : You can view the list of the unit’s defaultprogrammes.

3. : ou can manually create therapeutic pro-grammes.

4. : You can set the device (date, time, tem-perature’s unit of measure, display brightness andcontrast).

5. : You can set the language.


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5.1.1 Application thermal wrapsFor application and connection of various thermal wraps it is necessary to check the use and mainten-nace of accessories reference code “0IST100”.

5.2.1 Patients

From the Home Page if you click on the icon you reach the frame where you can create the pa-tient’s profile.

In the main frame you can find the patient’s list that you can browse using the arrows.

In the window below you can see, according to your selection:

• Information• Sessions

5.2.1.1 Information

If you press this button you will see the previously registered credentials of the patient selected above.

5.2.1.2 Sessions

If you press this button you will see the programmes registered on the patient selected above. You can see the previously registe-red credentials of the patient selected above.

The buttons allow you to: • State of programme (Programme completed –

GREEN light – Programme partially performed- RED light)

• Date/time• Programme name.

The buttons allow you to:

1. Reach the frame where you can ma-nage manual programmes2. Reach the frame where you can ma-nage automatic programmes3. Load a programme from the list andactivate it


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You can find the following functions at the bottom:

1. : Pressing the button you can create anew user’s folder. With the button you can selectthe gender , mandatory fields are red (Name, Surname and tax identification number). By selecting each line you open a window where you can edit data.

Once you have written the correct data you need to

confirm with button .

If you want to cancel the changes and restore your

previous data, just push button .To come back to the previous frame press button

.

Note If you click on the patient’s icon you can load JPG ima-ges through the USB Port.

From this window you can save the patient’s profile

with the button or go back to the previous fra-

me pressing .

2. : If you press the button you can modify thedata of the patient selected above.

3. : If you press the button you can cancel apatient.

You will need to confirm the cancellation.

4. : If you press the button you go back.

5. : f you press the button you go back to theHome Page.


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5.2.2 Automatic programme

From the Home Page if you click on the icon you can access the frame where you can load the preloaded programmes.

In the main frame you can find:

The list of groups you can browse with the arrow buttons.

The programmes which form the group, highligh-ting through pictogrammes treatment typology and injury typology.

You can preview the data of the programme se-lected using the stripe at the bottom:

• Temperature

• Duration

• Pause

At the bottom of the screen the following functions are available:

1. : Pressing the button you can modify a pro-gramme.

2. : Pressing the button you can load the pro-gramme selected.

3. : Pressing the button you can go back.

4. : Pressing the button you go back to theHome Page.


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5.2.3 Manual programme

From the Home Page if you click on the icon you can access the frame where you can create ma-nual programmes.

In the main frame you can find:

The list of groups which you can browse with the arrow buttons.

The programmes which form the group, highligh-ting treatment typology and injury typology throu-gh pictogrammes.

ou can preview the data of the programme se-lected using the strip at the bottom:

• Temperature

• Duration

• Pause


1. : If you press this button you can create anew programme.

2. : If you press this button you can edit a pro-gramme.

3. : If you press this button you can load a pro-gramme.

4. : If you press this button you can cancel aprogramme.

5. : PIf you press this button you go back.

6. : If you press this button you go back to theHome Page.


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5.2.3.1 How to create new programmesIf you press the button you access the frame to create a new programme

From this frame you can define:

5.2.3.1.1 Group name

To enter the name of the group you need to select the line with group name

You can type the name of the programme with the keyboard

When you have correctly typed the name, you need

to confirm through button .

If you want to cancel your editing and restore the

previous one just click the button .

To go back to the previous frame press button .

If a programme needs to be associated to an alre-ady existing group of therapies you can select an

existing group with the button .

You can select through the arrow the group, then press button to confirm.

To go back to the previous frame, press button .

5.2.3.1.2 Programme name

To enter the programme name you need to select the line with the name of the programme


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You can type the programme name with the keybo-ard

Once you have correctly typed the name you need

to confirm with button .

If you want to cancel your changes and restore the

previous data, just press button .

To go back to the previous frame press button .

5.2.3.1.3 Treatment typology

• Cold• Hot• Cold/Hot• Hot/Cold

ou can find the windows for settings at the bottom, where you can set:• Temperature• Running time• Pause time

ou can modify these values through their respecti-

ve buttons or .

NotePlease note the unit of measurement: time is expres-sed in minutes, temperatures in Celsius or Fahrenheit according to the setting in the frame OPTIONS (you can see in brackets which unit of measurement is set on the display).

5.2.3.1.4 Number of cycles

You can set the number of cycles for each program-me at the bottom.

You can modify these values through their respec-tive buttons or . If you repeatedly press

the button you set the function to repeat the programme endlessly and you see the respective

symbol


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5.2.3.1.5 Acute – Sub-acute

Basing on injury typologies you can select through the buttons acute or sub-acute functions.

5.2.3.1.6 Massages

Through the appropriate button you can activate or deactivate the massage function.

Set the massage clicking on the appropriate button and regulate the strip’s compression and decom-pression times (expressed in seconds) with buttons

or .

5.2.3.1.7 Functions

You can find the following functions at the bottom of the screen:

1. : Pressing this button you can save a newprogramme

2. : Pressing this button you can load the pro-gramme selected

3. : PPressing this button you go back

4. : Pressing this button you go back to theHome Page.

1) How to save a programmeIf you press the button save a frame which confirms the correct saving will appear.

OK to confirm

2) How to load a programme

Pressing the button you access the program-me running frame


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The frame shows:The group name (if created beforehand)

The programme name

Treatment typology

Injury typology

Start or Stop the program See the phase data and the state of the running cycle.

NoteSYou can modify the phase parameters when the pro-gramme is in stand-by mode only. In this case a confirm is requested.

The cycle counter

The current temperature

The duration of the whole phase (countdown)

Total time of the whole programme.


A. : Pressing this button you can access thegraphs frame

B. : Pressing this button you can go back

C. : Pressing this button you go back to the HomePage

Note.If you stop the unit when a programme is running and decide to exit, the software will ask you whe-ther you consider the therapy completed (Com-pleted) or not completed (Not Completed). If you select not completed when you will load the programme again for that particular patient, it will start right where you stopped it.

With the button Cancel you cancel the exit and go back to the therapy.


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A) Graphs frameIn the graphs frame you can check.

The temperature set in the hot water tank (RED AR-ROW)

The temperature set in the cold water tank (BLUE ARROW)

The yellow line indicates the temperature on the strip, Y axis indicates temperature and X axis indi-cates time.

The background colour depends on whether we are in a hot phase programme (red) or cold (blue), when the temperature is achieved the background is (grey).


• Browse graph (on time axis X)• Zoom on the graph• Stop or start the programme

Example:Let’s analyse a programme typology, to better un-derstand:

The current frame says that our programme is run-ning with function Cold/Hot

With 0°C set point for cold temperature running for 6 minutes and a 1 minute pause,


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Then 36°C set point running for 4 minutes and a fi-nal pause of 2 minutes, and here one cycle is com-pleted.

This cycle will be repeated for other 2 times to reach the total number of cycles requested by the pro-gramme (3).

All in Acute mode

5.2.4 Options

From the Home Page you can access to the page

setup manager clicking on the icon

5.2.4.1 How to modify date and time

You can modify date or time formatting with but-

ton at the value field’s right; a preview will be shown.

Date settings:DD-MM-YYYY oppure YYYY-MM-DD

Time settingsHH:MM:SS oppure HH.MM.SS


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If you want to modify date or time, follow the same procedure, press on date or time field and a win-dow for changes opens.

You can modify the relevant values with respecti-

ve buttons or . Once the correct value has

been set you need to confirm with button .

If you want to cancel the changes and restore the

previous values, just press button .

To go back to the initial frame Options press but-

ton .

5.2.4.2 How to modify the temperature’s unit of measurement

You can select the unit of measurement pressing the respective buttons: Celsius or Fahrenheit. When activated, the button colour changes and the light in the button turns on.

5.2.4.3 How to adjust display’s Brightness and Contrast

If you want to adjust Brightness or Contrast you need to increase or decrease values through but-

tons or


: Interface with password: only authorized Zamar technicians are allowed.

: If you press this button you can import data from the USB stick.

: If you press this button you can export set-tings on the USB stick

: If you press this button you can save the chan-ges in settings

: If you press this button you can go back to the Home Page.

Before exit the software will ask you to save the set-tings previously changed.


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5.2.5 language

From the home page you can select the language

and confirm your choice clicking on the icon .

You go back to the Home Page pressing button

Home

5.3 USB socket

On the top right you can find a USB socket to: im-port/export data, update software and firmware.


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6 ACCESSORIES ON DEMAND

1. Linear pipe 1ACS4222. “V” shape pipe 1ACS4243. Ankle thermal wrap 1ACS272 RIGHT / 1ACS273 LEFT4. Shoulder thermal wrap 1ACS2695. Elbow/wrist thermal wrap (size 260x360) code 1ACS270 - Knee/calf (size 260x470) code 1ACS267 - Thi-

gh (size 260x700) code 1ACS266 - Lumbar (size 260x700) code 1ACS268

For mounting, ordinary maintenance and cleaning of Applied Parts an instruction dedicated reference code 0IST100 Rev.00 is supplied with all of Accessories on request .

N.B. all of our connections are equipped with a safety valve to prevent leakage of liquid.


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2

3

4

7 MAINTENANCE

7.1 Routine maintenance

- Once a week check the integrity of the power harnessand the connecting pipes to accessories, if you noti-ce exposed parts or particularly damaged parts, replace the damaged harness / pipe with another providedand recommended by the manufacturer.- Check every 15 days the liquid level of the circuit; Always top up with the original liquid ZAMAR NOT FRE-EZE TOX (1 liter).- Monthly clean with compressed air the left side grille air inlet; absolutely not wash with water or othercleaning liquids.- Annually check the leakage current at a qualified laboratory or contact the manufacturer.

7.1 Special maintenance

- On an annual basis from the first operation you should contact your local dealer or distributor to arrange a complete maintenance service, necessary to maintain the efficiency of the device.

8 TROUBlESHOOTING

AlARMS FAUlTS SOlUTIONSThe unit does not power on Lack of electric power - Check the power supply

connection- Check the fuse’s conditionsin the mains- Check the fuse’s conditionsin the switch at the unit’s edge

Level alarm Low glycol level in the tank - Check the glycol level in thetank- If necessary, add liquid up to¾ of the tank

High temperature alarm Temperature in hot tank too high - Check that the hoses andthermal strip are correctlyconnected

Low temperature alarm Temperature in cold tank too low - Check that the hoses andthermal strip are correctlyconnected

Pump alarm Pump circulation failure - Exclude massage functionif active and verify whetherthe glycol is circulating in thethermal strips


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8.1 Useful life

When properly used and maintained, the construction materials and components confer heat exchange equipment ZTCube model MG465A a significantly elevated useful life; by convention it is assigned a theo-retical deterioration of materials due to wear and established an average useful life of 5 years.

To applied parts (thermal wraps) it is given an average useful life of 1 year or 200 uses.

9 ElECTROMAGNETIC COMPATIBIlITY

The medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the technical data sheet.

The portable and mobile communications equipment can affect the operation of the EUT.

The use of accessories, transducers and cables different than those specified, with the exception of those sold by the manufacturer as replacement parts for internal components, may result in an increase in emis-sions and a decrease in immunity.

The equipment or system should not be used near or placed on top of other equipments and, if you must use it near or on other devices, the equipment or system should be checked to control the normal opera-tion in the configuration in which it is used it.

This tool has been tested and found in compliance with the emission limits and immunity of the devices according to the standard electro-IEC60601-1-2: 2001. These limits are designed to ensure an adequate protection against harmful interference in a typical medical installation. However, there is no guarantee that interference will not occur in a particular installation. If this equipment, interacting with another devi-ce, cause or receive interference detected, the user is encouraged to limit the interference by one or more of the following measures:

- Reorient or relocate the receiving device (concerned);- Increase the separation between the equipment;- Connect the equipment into an outlet on a circuit different from device or devices that cause interference;- Contact the manufacturer or local technical assistance for assistance.


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9.1 Electromagnetic emission

Guida e dichiarazione del fabbricante – emissioni elettromagnetiche

ZTCube è previsto per funzionare nell'ambiente elettromagnetico sotto specificato. Il cliente o l'utilizzatore dell'apparecchio dovrebbe garantire che esso venga impiegato in tale ambiente Prova di emissione Conformità Ambiente elettromagnetico

Emissioni a RF CISPR 11 Gruppo 1

ZTCube utilizza energia a RF solo per il suo funzionamento interno. Di conseguenza le emissioni a RF sono molto basse e verosimilmente non provoca alcuna interferenza negli apparecchi elettronici posti nelle vicinanze.

Emissioni CISPR 11 Classe B ZTCube è adatto per l'uso in tutti gli ambienti e quelli collegati direttamente ad un'alimentazione di rete pubblica a bassa tensione che alimenta edifici utilizzati per scopi domestici

Emissioni armoniche IEC 61000-3-2 Classe A

Emissioni di fluttuazioni di tensione/flicker IEC 61000-3-3

Conforme


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9.2 Electromagnetic immunity

Guida e dichiarazione del fabbricante – immunità elettromagnetica

ZTCube è previsto per funzionare nell'ambiente elettromagnetico sotto specificato. Il cliente o l'utilizzatore di ZTCube dovrebbero garantire che esso venga utilizzato in tale ambiente

Prova di Immunità Livello di prova della IEC 60601 Livello di conformità Ambiente elettromagnetico

Scarica Elettrostatica (ESD) IEC 61000-‐4-‐2

a contatto +-‐ 6kV a contatto +-‐ 6kV I pavimenti devono essere in legno, calcestruzzo o in piastrelle di ceramica. Se i pavimenti sono rivestiti di materiale sintetico, l’umidità relativa dovrebbe essere almeno pari al 30 %.

in aria +-‐ 8kV in aria +-‐ 8kV

Transitori/sequenza di impulsi elettrici rapidi IEC 61000-‐4-‐4

+-‐2kV per le linee di alimentazione

+-‐2kV per le linee di alimentazione La qualità della tensione di rete

dovrebbe essere quella di un tipico ambiente commerciale o ospedaliero. +-‐ 1 kV per le linee di

ingresso/uscita +-‐ 1 kV per le linee di

ingresso/uscita

Sovratensioni IEC 61000-‐4-‐5

+-‐1kV tra le fasi +-‐1kV tra le fasi La qualità della tensione di rete dovrebbe essere quella di un tipico ambiente commerciale o ospedaliero.

+-‐2kV tra la fase(i) e la terra

+-‐2kV tra la fase(i) e la terra

Buchi di tensione, brevi interruzioni e variazioni di tensione sulle linee di ingresso dell'alimentazione IEC 61000-‐4-‐11

<5% 230V (<95% buco in 230V) per 0,5 cicli

<5% 230V (<95% buco in 230V) per 0,5 cicli

La qualità della tensione di rete dovrebbe essere quella di un tipico ambiente commerciale o ospedaliero. Se l'utilizzatore di ZTCube richiede un funzionamento continuato durante le interruzioni della tensione di rete si raccomanda di utilizzare ZTCube con un gruppo di continuità o batterie

40% 230V (60%buco in 230V) per 5 cicli

40% 230V (60%buco in 230V per 5 cicli

70% 230V (30% buco in 230V)per 25 cicli

70% 230V (30% buco in 230V)per 25 cicli

<5% 230V (>95% buco in 230V) per 5 s

<5% 230V (>95% buco in 230V) per 5 s

Campo magnetico ad alta frequenza (50/60Hz) IEC 61000-‐4-‐8

3A/m 3A/m

I campi magnetici a frequenza di rete dovrebbero avere livelli caratteristici di una località tipica in un ambiente commerciale o ospedaliero.

NOTA: 230V è la tensione di rete in c.a. prima dell’applicazione del livello di prova


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Guida e dichiarazione del fabbricante – immunità elettromagnetica

ZTCube è previsto per funzionare nell'ambiente elettromagnetico sotto specificato. Il cliente o l'utilizzatore di ZTCube dovrebbero garantire che esso venga utilizzato in tale ambiente

Prova di Immunità

Livello di prova della IEC 60601

Livello di conformità Ambiente elettromagnetico -‐ Guida

Gli apparecchi di comunicazione a RF portatili e mobili non dovrebbero essere usati più vicino a nessuna parte di ZTCube, compresi i cavi, della distanza di separazione raccomandata calcolata con l’equazione applicabile alla frequenza del trasmettitore Distanza di separazione raccomandata:

RF Condotta IEC 61000-‐4-‐6

3 Veff da 150kHz a 80 MHz 3 Veff d= 1.2 √P

RF Irradiate IEC 61000-‐4-‐3

3 V/m da 80 MHz a 2,5

GHz 3 V/m

d= 1.2 √P da 80 MHz a 800 MHz

d = 2.3 √P da 800 MHz a 2.5 GHz Dove P è la potenza massima nominale d’uscita del trasmettitore, in watt (W), secondo il fabbricante del trasmettitore e d è la distanza di separazione raccomandata, in metri (m). Le intensità di campo dei trasmettitori a RF fissi determinate da un ‘indagine elettromagnetica in locoa dovrebbero essere inferiori al livello di conformità per ciascun intervallo di frequenzab. Si può verificare intrerferenza in prossimità di apparecchi contrassegnati dal seguente simbolo:

NOTA 1 A 80 MHz e 800 MHz si applica la distanza di separazione per intervalli di frequenza più alto.

NOTA 2 Queste linee guida potrebbero non applicarsi in tutte le situazioni. La propagazione elettromagnetica è influenzata dall’assorbimento e della riflessione di strutture, oggetti e persone. a Le intensità di campo per i trasmettitori fissi, come le stazioni base per radiotelefoni (cellulari(cordless) e

radiomobili terrestri, apparecchi per radioamatori, trasmettitori radio in AM FM e trasmettitori TV non possono essere previste teoricamente con precisione. Per valutare un ambiente elettromagnetico causato da trasmettitori RF fissi si dovrebbe considerare un’indagine elettromagnetica del sito. Se l’intensità di campo misurata nel luogo in cui si utilizza ZTCube supera il livello di conformità applicabile di cui sopra, si dovrebbe porre sotto osservazione il funzionamento di ZTCube. Se si notano prestazioni anormali, possono essere necessarie misura aggiuntive come un diverso orientamento o posizione di ZTCube.

b L’intensità di campo nell’intervallo di frequenze da 150 kHz a 80 MHz dovrebbe essere minore di 3 V/m


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9.3 Recommended separation distances between the communications equipment portable and mobile and ZTCube

Distanze di separazione raccomandate tra apparecchi di radiocomunicazione portatili e mobili e ZTCube

ZTCube è previsto per funzionare nell'ambiente elettromagnetico in cui sono sotto controllo i disturbi irradiati a RF. Il cliente o l'utilizzatore di ZTCube possono contribuire a prevenire le interferenze elettromagnetiche assicurando una distanza minima tra gli apparecchi di comunicazioni mobili e portatili a RF (trasmettitori) e ZTCube, come sotto raccomandato, in relazione alla potenza di uscita massima degli apparecchi di radiocomunicazione Potenza nominale massima in uscita del trasmettitore (W)

Distanza di separazione alla frequenza del trasmettitore (m)

da 150 kHz a 80 MHz d=1,2√P

da 80 MHz a 800 MHz d=1,2√P

da 800 MHz a 2,5 GHz d=2,3√P

0,01 0,12 0,12 0,23 0,1 0,38 0,38 0,73 1 1,2 1,2 2,3 10 3,8 3,8 7,3 100 12 12 23

Per i trasmettitori specificati per una potenza massima di uscita non riportata sopra, la distanza di separazione raccomandata d in metri (m), può essere calcolata usando l’equazione applicabile alla frequenza del trasmettitore, ove P è la potenza massima nominale di uscita del trasmettitore in watt (W) secondo il fabbricante del trasmettitore.

NOTA 1 A 80 MHz e 800 MHz si applica la distanza di separazione per l’ intervallo di frequenza più alto.

NOTA 2 Queste linee guida potrebbero non applicarsi in tutte le situazioni. La propagazione elettromagnetica è influenzata dall’assorbimento e della riflessione di strutture, oggetti e persone.


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