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11

Please carefully read this user manual!

Read completely this user manual and get familiar with the use and functions of the unit and all accessories, before you start using the 

device clinically.

Unless you do not follow the directives as instructed, the following problems may occur:

•  Serious injuries to the patient

•  Serious injuries to the operator or to the service personal

•  Damage of malfunction of the unit or of the accessories

Intended Purpose

The high frequency device hf-Surg is used for surgical applications in soft tissue in dentistry and is suitable for the following applications: 

oral surgery such as cutting, removal of soft tissue. No essential performance features according to EN 6061-1 are assigned to the device.

Field of application

The area of application is professional dentistry facilities.

Modifications

The manufacturer has the right to modify the appearance and technical data because of new product developments.

The marks: 

“WARNING“

,  

“ATTENTION“

 and  

“REMARK“

 contain important hints.

Responsibility of manufacturer

Warranty and liability by Hager & Werken GmbH & Co KG is given, if:

•  installation and start of operation is done by own personal or by personal authorized by the manufacturer

•  installation and safety measures comply with national norms and regulations

•  the unit is used in accordance with the user manual

•  no manipulations to the unit or to the accessories, if manufacturer does not agree.

Warranty

The hf Surg unit has a legal warranty of 12 months.  

Page 11 

Advices and warranty / Scope of delivery  

Page 12 

Comments to content / Radio frequency (HF) – mode of action

Page 13 / 14 

Technical data / Protection and safety checks  / Operator‘ regulation

Page 15 

Preparation to start the device / Lockout after use

Page 16 

Labelling / Device description

Page 17 

Performance graph  

Page 18 

Select the right HF-Mode / Practiacl exercise on a beef mode 

Page 19  

Example of clinical applications / Environment-directive

 

 / Processing guidance for hand pieces

 

Index

User Manual

GB

Scope of Delivery

hf Surg - REF 452 400

HF set of instruments:

Cutting electrode No. 40 Multi-Tip  REF 452 402

Cutting electrode No.  2 

REF 452 404

Cutting electrode No.  15 

REF 452 407

Cutting electrode No.  13 

REF 452 411

HF hand piece Yellow 1,50 m 

REF 452 423

Neutral electrode 

REF 452 421

Foot pedal

User manual

Medical product journal

Содержание hf SURG

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Страница 2: ...wesentlichen Leistungsmerkmale nach EN 60601 1 zugeordnet Anwendungsbereiche Das Einsatzgebiet sind professionelle Einrichtungen in der Zahnheilkunde nderungen Der Hersteller beh lt sich das Recht vo...

Страница 3: ...einen Stromschlag erleidet wird ein hochfrequenter Strom verwendet THERMISCHE WIRKUNG MONO POLAR SCHNEIDEN CUT KOAGULIEREN COAG Bei dem Vorgang des monopolaren Schneidens wird der hochfrequente Strom...

Страница 4: ...tromagnetische Vertr glichkeit Gem DIN EN ISO 60601 1 2 Sicherheit HF Chirurgie Gerate Gem DIN EN ISO 60601 2 2 Schutz und Sicherheitsbestimmungen in der zahn rztlichen Praxis bei der Benutzung des hf...

Страница 5: ...ttmachern oder anderen aktiven Implantaten besteht eine m gliche GEF HRDUNG dadurch dass eine St rung der Schrittmacherfunktion auftreten kann oder der Schrittmacher besch digt werden k nnte Im Zweife...

Страница 6: ...oder schnei den koagulieren wollen Au erbetriebnahme nach Anwendung 1 Handst ck in die Ablage stecken 2 Elektrode entfernen und entsprechend aufbereiten 3 Ger t mit dem Hauptschalter 1 R ckseite auss...

Страница 7: ...lung Defibrillationsgesch tztes Anwendungsteil Herstelldatum 6450300004 1252 D001 452400 Ger tevorderseite 1 Regler 2 Ausgang Handst ck 3 Ausgang Neutralelektrode 4 Wahltaste 5 Schneidmodus 6 Schneid...

Страница 8: ...g in Betriebsart Cut vs Last 25 50 0 10 20 30 40 0 500 1000 1500 2000 P W R W HF Leistung vs Last in Betriebsart Cut Coag bzw Coag bei verschiedenen Leistungseinstellungen Koagulationsgrad C4 15 30 HF...

Страница 9: ...nis Sie werden bemerken dass die Intensit tseinstellung zu hoch gewesen ist wodurch Funkenschlag und bemerkenswerte Verf rbung entlang der Schneidspur verursacht wurden 7 ReduzierenSiedieIntensit tauf...

Страница 10: ...it Reinigungst chern und geeigneten Reinigungsmitteln s ubern F r die maschinelle Rei nigung ist der schraubbare Kopf vom Handst ck zu entfernen und dieser in das entsprechende Ger t zu legen Handst c...

Страница 11: ...bility by Hager Werken GmbH Co KG is given if installation and start of operation is done by own personal or by personal authorized by the manufacturer installation and safety measures comply with nat...

Страница 12: ...ION MONOPOLAR CUTTING CUT COAGULATION COAG At monopolar cutting the radio frequency current is led from the device via a work electrode and a large neutral electrode back to the device The current den...

Страница 13: ...tions might occur that could cause un wanted output power increase Technical Data HF frequency power 2 2 MHz max 50 W load resistance 1000 Ohm method of operation monopolar wave form permanently pulse...

Страница 14: ...the patient e g on the instrument table 5 The output power should be set as low as possible for the corresponding purpose 6 An obviously low output value or functional failure of the hf Surg device i...

Страница 15: ...ant to cut or cut coagulate Lockout after use 1 Place the hand piece into the instrument holder 2 Remove the electrode and reprocess it accordingly 3 Switch off the device to position 0 using main swi...

Страница 16: ...OAG 2 1 4 3 5 6 3 1 2 4 Unit Back 1 ON OFF switch 2 2230 V Power supply with fuses 3 Footswitch 4 Label Label Attheback side of the unit Explanations Manufacturer On Off Mains fuse Foot cotrol CE mark...

Страница 17: ...rt Cut Max output voltage in operating mode Cut Performance indication 0 10 20 30 40 50 60 0 500 1000 1500 2000 P W R W HF Leistung in Betriebsart Cut vs Last 25 50 RF power in operating mode Cut vs l...

Страница 18: ...also not suited Wait until the beef has obtainedroom temperature Make sure that the meat is placed on the plugged in neutralelectrode If this is not the case the waves cannot derivate and consequentl...

Страница 19: ...Sight check on damages wear deformation Storage No special requirements The a m instructions have been validated as SUITABLE for preparation of a medical device and its re use by the medical device ma...

Страница 20: ...12803 Rev1 2021 01 WEEE Reg Nr DE 21760541 HAGER WERKEN GmbH Co KG Ackerstra e 1 47269 Duisburg Germany T 49 203 99269 0 F 49 203 299283 info hagerwerken de www hagerwerken de Medizinprodukt Medical d...

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