User Manual
49 Pages
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Page 1
User Manual
Servotome
This document is an English translation of the original French version. Reference J57210 version V7 and drawing number NE28FR010G
Contents 1 Documentation 1.1 Associated documentation 1.2 Electronic documentation 1.3 Archiving period 2 Required information 2.1 Indication for use 2.2 Operating principle 2.3 Main performance characteristics 2.4 Date of first CE marking 2.5 Latest document update 2.6 Repairing or modifying the medical device 2.7 Warranty 2.8 Accessory usage conditions 2.9 Manufacturer responsibility 3 Warnings 3.1 Federal Law 3.2 Warning applicable to all countries in which the device is sold 3.3 User population 3.4 Specific user training 3.5 Patient population 3.6 Patient population restriction 3.7 Parts of the body or types of tissues treated 3.8 Essential performance 3.9 Basic safety in normal use 3.10 Normal usage conditions 3.11 Bracelet’s service life 3.12 Service life of electrodes 3.13 Broken electrodes 3.14 Warnings specific to electrosurgical medical devices 4 Interactions, contraindications, prohibitions 4.1 Contraindications 4.2 Using accessories not supplied by the manufacturer 4.3 Prohibited uses 4.4 Interference with other medical devices 4.5 Moving the medical device 4.6 Assembly and disassembly 5 Removal from packaging, installation, connections 5.1 Removing the medical device from its packaging 5.2 Installing the medical device 5.3 Installing cords 5.4 Connecting the medical device to the electrical network 5.5 Installing the control pedal 5.6 Fixing the medical device to a non-removable support 6 Medical device description 6.1 Before using the medical device for the first time 6.2 Connecting and disconnecting accessories during use 6.3 Switch ON the medical device. 6.4 Using the medical device 6.5 Control unit 6.6 Bracelet 6.7 Footswitch
9 9 9 9 11 11 11 11 11 11 11 12 12 12 13 13 13 13 13 13 13 14 14 14 14 14 14 14 15 17 17 17 17 17 18 18 19 19 19 19 19 20 20 21 21 21 21 21 21 22 22
6.8 Indicator lamps and light indicators 6.8.1 Indicator lamp ON 6.8.2 Indicator ON 6.9 Control knobs 6.10 Electrode holder connector 6.11 Installing an electrode 6.11.1 Choosing an electrode 6.12 Fuse recess 6.13 Switch 6.14 Air inlets 6.15 Switching off the medical device 7 Cleaning, disinfecting and sterilising 7.1 Cleaning and disinfecting the medical device 7.2 Cleaning, disinfecting and sterilising accessories 7.2.1 Cleaning the bracelet and its cord 7.2.2 Cleaning electrodes and the electrode holder 7.2.3 Cleaning/sterilization cycle limits 7.2.4 Containment and transportation 7.2.5 Preparation for pre-disinfection/cleaning 7.3 Pre-disinfection and cleaning – Manual method 7.4 Pre-disinfection and cleaning – Automated method 7.5 Cleaning, automated method 7.6 Inspection 7.7 Packaging 7.8 Sterilisation 7.9 Storage 8 Monitoring the medical device 9 Maintenance 9.1 Thermal cutout 9.2 Identifying incorrect operation 9.2.1 Not working 9.2.2 Indicators or buzzer not working 9.3 The electrode is not working or is working incorrectly 9.4 Corrective maintenance 9.4.1 Replacing the fuses 10 Electromagnetic compatibility 10.1 Cable length 10.2 Recommended separation distances 10.3 Electromagnetic emissions 10.4 Magnetic and electromagnetic immunity 10.5 Electromagnetic immunity, handheld radiofrequency equipment 11 Technical specifications of the medical device 11.1 Characteristic curves 11.2 Electrode summary table 11.3 Identification 11.4 Applied parts 11.5 Power settings 11.6 Control unit 11.7 Generator 11.8 Length of cords 11.9 Footswitch 11.10 Environmental characteristics 11.11 Environmental restrictions
22 22 22 22 23 23 23 23 23 24 24 25 25 25 25 25 26 26 26 26 26 27 27 27 27 27 29 31 31 31 31 31 32 32 32 33 33 33 34 34 35 37 37 37 38 38 38 38 38 39 39 39 39
12 Regulations and standards 12.1 Official Texts 12.2 Medical class of the device 12.3 Symbols 12.4 Manufacturer identification 12.5 Branch addresses 12.6 Disposal and recycling 13 Index
41 41 41 41 43 44 45 47
Foreword The medical device that you are about to install and use in your surgery is a medical device designed for professional use. It is therefore a key tool with which you will provide treatment within the context of your work. To ensure optimum safety for yourself and your patients, comfort in your daily practice and to benefit fully from your medical device's technology, please read the documentation provided carefully. This document contains the following information: l l l l l l l l l l l l l l l l
documentation format documentation archiving period warnings concerning user and patient populations treatment area medical device usage interactions, contraindications and prohibitions electromagnetic compatibility disposal and recycling of the medical device manufacturer responsibility unpacking and installing the medical device using the medical device monitoring and maintaining the medical device technical specifications of the medical device. preparation of parts for sterilisation detailed manual and automated instructions packaging information for sterilisation recommendations for the inspection of parts.
1 Documentation This document contains the following information: l l l l l l l l l l
relating to patient, practitioner and environmental safety required to install your medical device under optimum conditions required to contact the manufacturer or representatives if necessary. indications for use; medical device description; positioning and installation of the medical device; medical device use; preparation prior to cleaning and disinfecting the medical device; monitoring and general maintenance of the medical device; maintenance to be performed by the user.
1.1 Associated documentation This document must be used in association with the following documents: Document title
References
Consulting electronic user instructions
J00000
Quick Start Servotome
I57211
Quick Clean Servotome
J57230
Warning sticker
J57234
The Quick Start and Quick Clean documents are summaries created for your approval. The only binding instructions are the user manuals and regulatory documentation associated with the medical device.
1.2 Electronic documentation The user instructions for your device are available in electronic format on the specified website and not in printed format. If the website is unavailable, try again later. You can also request a free printed copy of the user instructions within seven days via our website, by telephone or in writing. The electronic user instructions are available in PDF format (Portable Document Format). You will need to have a PDF file reader installed to read the electronic user instructions. It is important for you to have read and understood the content of the user instructions relating to the use of your device and its accessories. The device user instructions are available at the following address: www.satelec.com/documents
When you receive your device, you are asked to print and/or to download all documents or sections of documents that you may need to refer to in the event of an emergency, if you are unable to connect to the internet or if your electronic display tool is not working (computer, tablet, etc.). We recommend that you visit the website regularly to consult and/or to download the latest version of your device's user instructions. Never use your device without first reading the user instructions.
1.3 Archiving period Users are asked to keep documentation close at hand for reference when necessary. You are asked to print and/or to download all documents or sections of documents that you may need to refer to in the event of an emergency, if you are unable to connect to the internet or if your electronic display tool is not working (computer, tablet, etc.). All printed and electronic documentation relating to your medical device must be kept for the device's entire service life. When loaning out or selling the medical device, the documentation must be provided with it. Users are asked to keep documentation close at hand so that it can be consulted when necessary.
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2 Required information 2.1 Indication for use This medical device is used for the incision and coagulation of soft gingival tissue. It is used in conjunction with a bracelet (neutral electrode) and an electrode holder which can be fitted with a wide range of monopolar incision or coagulation electrodes using high-frequency electrical energy.
2.2 Operating principle The medical device converts the low voltage electrical energy into high-frequency electrical energy which flows through the patient's body between the active electrode fixed to the electrode holder and a bracelet (neutral electrode) in contact with the patient. The high-frequency electrical energy density at the end of the active electrode produces the desired effect, incision or coagulation.
2.3 Main performance characteristics High-frequency electrical energy frequency. Electrical power. Characteristic impedance. Surface of electrodes.
2.4 Date of first CE marking 2013
2.5 Latest document update 01/2016
2.6 Repairing or modifying the medical device Contact the supplier of your device. Using the services of an unapproved repairer could render your device dangerous for you and your patients. Do not repair or modify the device without seeking the prior permission of SATELEC, an Acteon group company. If the device is modified or repaired, specific checks and tests must be carried out to ensure that the medical device is still safe to use. In the event of doubt, contact an approved dealer or the SATELEC, an Acteon group company customer service team:
www.acteongroup.com [email protected] SATELEC, an Acteon group company, at the request of technical personnel working for the network of approved dealers, will provide any information required to repair defective parts on which they may perform repairs.
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2.7 Warranty
The screws marked A and B must never be unscrewed by the user. Unscrewing these screws will void the warranty for the medical device.
2.8 Accessory usage conditions The accessories of theServotome must be cleaned, disinfected and sterilised before being used.
2.9 Manufacturer responsibility The manufacturer shall under no circumstances be liable for: l l l l l l
non-compliance with manufacturer recommendations maintenance or repair procedures performed by people who are unauthorised by the manufacturer use on an electrical fixture that is not compliant with regulations in force; uses other than those specified in this manual use of accessories or handpiece not supplied by SATELEC, an Acteon group company non-compliance with the instructions contained in this document. Note: the manufacturer reserves the right to modify the medical device and/or any documentation without notice.
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3 Warnings 3.1 Federal Law The indication below applies to the United States of America only. The United States Federal Law restricts the use of this medical device in its territory to qualified, fit and certified dental health professionals (either directly or under their supervision).
3.2 Warning applicable to all countries in which the device is sold The information below is based on the requirements of standards to which the manufacturers of medical devices must adhere (as stated in standard IEC62366).
3.3 User population This medical device must only be used by qualified dental health professionals, fit and certified to perform their professional duties. Users must be familiar with and adhere to the rules of dental practice in compliance with the knowledge acquired in the field and the key medical hygiene principles including cleaning, disinfection and sterilisation of medical devices. The medical device can be used by any adult dental practitioner of any weight, age, height, gender and nationality. The user must wear gloves. The user is not the patient. The user must not be prone to any of the following: l l l l l
visual impairments: any vision problems must be corrected by glasses or lenses arm disability that may prevent the user from holding a handpiece leg disability that may prevent use of a footswitch hearing difficulties that could prevent the user hearing audible alarms depending on medical devices difficulty memorizing or concentrating that could affect the setting of sequences or the performance of treatment protocols.
3.4 Specific user training No specific training other than initial professional training is required to use this medical device. The practitioner is responsible for performing clinical treatments and for dangers that may arise due to a lack of skill and/or training.
3.5 Patient population This medical device is designed to be used with the following patient populations: l l l l
Children Teenagers Adults Old age pensioners.
This medical device can be used on any patient of any weight (except children), age, height, gender and nationality.
3.6 Patient population restriction This medical device must not be used on the following patient populations: l l
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Infants Pregnant or breastfeeding women due to restrictions associated with the possible use of medical solutions such as anaesthetics Patients with medical issues Patients allergic to some of the medical device components Patients with a clinical site not suitable for treatment
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Patients who wear an implantable medical device such as a pacemaker, cochlear implants, vagus nerve stimulators.
The patient must be calm, relaxed, still, ideally lying flat on a dental chair. The user is the only person who can decide whether or not to treat his/her patients. Patients who have the items listed below must take additional precautions to prevent any risk of collateral injury: l l l l l
intraoral and perioral piercing; dental implants; dental crowns; metallic prostheses jewellery.
3.7 Parts of the body or types of tissues treated Treatments must only be carried out on the patient's oral environment.
3.8 Essential performance As stated in the applicable safety standard pertaining to electrical medical devices, The manufacturer has determined that the medical device did not manage essential performances.
3.9 Basic safety in normal use The active part, the electrode holder and its electrode are in the practitioner's hand throughout the medical act.Being medically qualified, the practitioner is qualified to immediately detect any problem at the treatment site and to react accordingly. The force applied to the electrode holder equipped with its electrode must be controlled by the practitioner according to good dental practices. Basic safety is ensured by the practitioner. It is advisable to have a spare medical device or an alternative means with which to perform the medical treatment in the event of device failure.
3.10 Normal usage conditions The normal usage conditions are as follows: l l l l l
storage installation use maintenance disposal.
3.11 Bracelet’s service life Because it is impossible to determine the maximum number of uses, we recommend changing the bracelet once the silicone is used and the metallic parts become visible. Using the Servotome medical device with a defective bracelet may cause burns on the patient’s arm or loss of power in the device.
3.12 Service life of electrodes Because it is impossible to determine the maximum number of times the electrodes can be used (may depend on many parameters such as operating time, force exerted, wear, etc.), we recommend that you renew routinely used electrodes at least once a year.
3.13 Broken electrodes An electrode is a medical device to which a mechanical force is applied to carry out dental treatments.
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The electrodes have been developed to ensure safe use in association with the electrode holder SATELEC, an Acteon group company in accordance with the power levels defined. However, the electrodes may break depending on frequency of use, force exerted or by being dropped. To reduce all risk, however minimal, we recommend the use of a suction device such as a non-metal saliva suction cannula. You should also encourage your patient to breathe through their nose.
3.14 Warnings specific to electrosurgical medical devices The following information is from the normalization requirements which the manufacturers of medical devices for high-frequency surgery are subject to (in the sense of the IEC60601-2-2 standard). l
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The whole surface of the bracelet (neutral electrode) must be securely fastened to the patient's right wrist. The bracelet must be adjusted to remain in direct contact with the patient's skin. The patient must not have skin lesions. The patient should never come into contact with earthed or grounded metal parts or parts with a high capacitance (e.g. operating table, supports, suction cannula, etc.). Skin-to-skin contact (e.g. between the patient's arms and body) must be avoided, for example by placing a dry gauze between them. Contact between the patient's skin and that of the practitioner must be avoided. If the device is used simultaneously with physiological monitoring devices and the medical device on the same patient, the monitoring electrodes should be placed as far away as possible from the surgical electrodes. Needle-type monitoring electrodes are not recommended. In all cases, monitoring systems with high-frequency current limiting are recommended. Surgical electrode cables must be positioned so that all contact with the patient or with other conductors is avoided. Active electrodes that are temporarily not being used must be kept well away from the patient. During surgical procedures in which the high-frequency current could flow through relatively thin parts of the body, the use of bipolar techniques may be desirable to avoid accidental damage to tissue.
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The selected output power must be the lowest possible for the required purpose.
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A low output power or malfunction of a high-frequency electrosurgical medical device at the normal operating settings may be due to an incorrectly fitted conductive bracelet (neutral electrode) or a bad contact in its connections. In this case, check that the neutral electrode and its connections are correctly fitted before selecting a higher power output.
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All use of flammable anaesthetics or oxidizing gases such as nitrous oxide (N O) and oxygen during the surgical 2 operation must be avoided, unless these agents are evacuated by suction. Non-flammable agents must be used for cleaning and disinfection, where possible. The flammable products used for cleaning and disinfection or as adhesive solvents must be allowed to evaporate before beginning high-frequency surgery. There is a risk of buildup of flammable solutions under the patient or in the depressions or cavities of his/her body. Some materials like cotton wool or gauze may, when saturated with oxygen, be ignited by the sparks produced during the normal use of high-frequency electrosurgical medical devices. The interference produced by a high-frequency electrosurgical medical device may disrupt the operation of other electronic equipment.
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The operator must regularly check the accessories.
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In particular, the electrode cords and accessories must be checked.
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The failure of a high-frequency electrosurgical medical device may result in an accidental increase in the output power. The medical device must be used in combination with a surgical suction system to reduce the propagation of smoke. In some cases, electric arcs between the electrode and the clinical site may induce neuromuscular stimulation. This may result in injuries caused by involuntary and uncontrolled movements.
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4 Interactions, contraindications, prohibitions This includes information relating to the interactions, contraindications and prohibited operations known by the manufacturer on the date on which this document was written.
4.1 Contraindications The medical device must not be used in the presence of unruly, emotional or excessively nervous patients. The medical device must not be used in the following cases: l
incomplete anesthesia;
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delicate surgery (mucoperiosteal surgery, grafts);
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very fragile tissue;
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ignorance of the theory of electrosurgery;
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lack of practice on anatomical parts;
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insufficient knowledge of the patient or his general condition;
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presence of metallic surgical equipment implanted on the patient, especially on the high-frequency current conduction path.
4.2 Using accessories not supplied by the manufacturer The medical device was designed and developed with its accessories to guarantee maximum safety and performance. The use of accessories from another source could put you and your patients at risk and could damage your medical device. Even if the manufacturer or dealer of your accessory claims full compatibility with SATELEC (a company of the Acteon group) equipment, it is advisable to exercise caution with regards to the origin and safety of the product offered. Look out in particular for lack of information, information in a foreign language, very attractive prices, unusual appearance, poor quality or premature wear. If necessary, contact an approved dealer or the SATELEC, an Acteon group company customer services department.
4.3 Prohibited uses l l l l l
Never cover the medical device and/or obstruct the air inlets. Do not immerse or use outdoors. Do not place the medical device next to a source of heat or in direct sunlight. Do not expose the medical device to water spray or mist. Do not use the medical device in an AP or APG gas-filled atmosphere.
The medical device is not designed to operate near a source of ionising radiation. A hot/cold temperature contrast can cause condensation to form in the medical device, which may be dangerous. If the medical device needs to be moved from a cold place to a warm place, do not use the device immediately. Wait until it reaches room temperature. The medical device may not be stored or used outside the temperature, atmospheric pressure and humidity ranges recommended in the User Manual supplied with your medical device. Only use the medical device for the purpose for which it has been designed.
4.4 Interference with other medical devices The medical device presents potential risks due to the emission of electromagnetic fields. Interferences may occur when the system is used on patients fitted with a pacemaker. It may in particular cause malfunction of all types of active implanted device: l
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before using this medical device, check whether patients and practitioners are fitted with a device of this type (active or inactive); explain the situation; weigh up the risk/benefit ratio and contact your patient's cardiologist or another qualified health professional prior to starting treatment; keep this system away from implantable devices; apply suitable emergency measures and act fast if the patient shows signs of being unwell.
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Symptoms such as an increased heart beat, irregular pulse or dizziness may indicate a malfunction of a pacemaker or an implantable defibrillator. The medical device is not designed to withstand electrical defibrillation shocks.
4.5 Moving the medical device After its initial installation, the medical device is not designed to be moved. The medical device must be fixed to ensure that it cannot be removed or moved without the use of a tool. Do not move the medical device during use.
4.6 Assembly and disassembly Unless otherwise indicated in the instructions specific to your medical device: l l
Control devices are not designed to be removed or disassembled. Access doors and/or flaps are not designed to be removed or disassembled.
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5 Removal from packaging, installation, connections 5.1 Removing the medical device from its packaging When you receive your medical device, check for any damage that may have occurred during transportation. If you have received this medical device by mistake, please contact the supplier to arrange for it to be collected. If you have any questions or requirements, contact your supplier. The medical device includes the following items: l l l l l l l l l
a control unit; a control pedal; an electrode holder and its cord; a mains cord with ground conductor; a cord with bracelet (neutral electrode); a box of electrodes; a Quick Start guide for the medical device [I57211] a Quick Clean guide for the medical device [J57230] a warning about the bracelet [J57234].
5.2 Installing the medical device Place the control unit in the position that is suitable for your activity. Check that the cords do not hinder the movement or free circulation of anyone. The medical device must be placed on a secure and flat surface or a surface with a maximum slope of 5 degrees. Fix your medical device using the attachments provided to ensure that the device cannot be removed without the use of a tool. Adjust the position of your medical device to correspond to your angle of vision and the characteristics of your workstation, e.g. lighting or distance between the user and the medical device. Ensure that your medical device is readily accessible. Do not install your medical device near or on another device.
5.3 Installing cords Check that the cords do not hinder the movement or free circulation of anyone. Never rotate the handpiece connector on its cord as this can damage your medical device. Never wind the electrode holder cord around the medical device. Make sure that it is not possible to wheel over or walk on the different cords. The cord attached to its handpiece must be easily accessible. Make sure that the cord is slack during use. Do not put the medical device cords in a cable cover or a cable tray.
5.4 Connecting the medical device to the electrical network Have your medical device connected to the mains power by an approved dental installation technician. Switch the medical device OFF (position O) and check that the mains voltage is compatible with that indicated on the medical device or its mains adapter. Next, connect the cord to the wall socket in compliance with the standards in force in the country of use. A different voltage would cause damage to the medical device and could injure the patient and/or user. Any variation in the electrical network voltage or electromagnetic field that is non-compliant with the limits in force, could interfere with the medical device's operation. Medical devices equipped with a protective earth must be connected to a supply network equipped with a protective earth. Do not plug the medical device into an extension lead and do not put the mains cord in a cable cover or cable tray.
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If when using the medical device, a power outage can create an unacceptable risk, the user and the installer must ensure that the medical device is connected to an appropriate power source such as an uninterruptable power supply.
5.5 Installing the control pedal The control pedal must be positioned near the feet of the operator and must be readily accessible.
5.6 Fixing the medical device to a non-removable support Your medical device is not designed to be moved. To avoid accidentally dropping the device, we recommend that you fix it in a precise place in your treatment room, using the mounting kit supplied in the packaging box, to ensure that it cannot be dismantled or moved without needing a tool.
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6 Medical device description 6.1 Before using the medical device for the first time Before using the medical device for the first time, it is essential to carry out tests on anatomical parts (pieces of meat ideally, a piece of beef heart, chicken breast, etc.) to determine how they react to incision and to help adopt the right clinical procedure (electrode movement speed). Do not hesitate to repeat these exercises as many times as necessary. The accessories used on animal parts must not be reused on human patients. Before using the for the first time, it is essential that all the equipment is maintained and/or sterilized using the procedures defined in the chapter Cleaning, disinfecting and sterilising page 25.
6.2 Connecting and disconnecting accessories during use Do not connect or disconnect cords or the electrode holder when the medical device is on and the pedal is pressed down. Do not tighten or loosen the electrodes when the electrode holder is activated.
6.3 Switch ON the medical device. Keep the pedal well away to prevent accidentally activating it during the following phases. l
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Switch the ON/OFF switch to ON position (I); on the front face lights up; the green light The medical device is now ON and ready for use.
6.4 Using the medical device Do not check the presence of the high-frequency current by creating electric arcs on metal parts, this will damage the medical device. l
Adjust the incision and coagulation power using the
and
control knobs.
This adjustment must be made before the surgical procedure otherwise there is a risk of burns or undesirable effects. l
Move the pedal close to your foot.
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Position the electrode on the clinical site.
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Press the pedal.
The incision or coagulation effect is then obtained. The yellow indicator lamp lights up and the buzzer sounds. The indicator goes off as soon as the pressure on the pedal is released.
6.5 Control unit The top of the control unit comprises the following control items: l l
indicator lamps; incision and power control knobs.
The front of the control unit comprises the connector for the electrode holder cord. The right side of the unit comprises the electrode holder rest. The rear of the unit comprises the following items: l
a connector for the bracelet (neutral electrode);
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a pedal connector;
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a mains switch;
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fuse housing;
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a mains connector.
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6.6 Bracelet The medical device’s bracelet connector is used to connect the medical device to the bracelet cord. This neutral electrode must be installed in accordance with the following criteria: l
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Remove all metal objects that are in direct contact with the patient's skin in the current’s path: piercings, jewellery or other. Put the bracelet on the patient’s right arm, opposite the heart, so that the current is diverted toward the electrode by the patient’s right side. Please do not put the bracelet too close to the wrist, because the bones prevent the proper conductivity of the bracelet.
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Adjust the bracelet so that its entire surface is in contact with the patient’s arm. Check that the bracelet is well attached and does not move. You can use the electrically conductive gel to promote the contact between the bracelet and the patient’s arm.
6.7 Footswitch The ON/OFF type pedal is used by the practitioner to operate the medical device. The pedal connector connects the medical device to the control pedal. Pressing the pedal automatically activates high frequencies. The control pedal equipped with its cord can be disconnected. Its weight and antislip pad ensure good stability. Pressing the control pedal activates the medical device’s high-frequency output. For greater safety, the pedal can be fixed to the medical device by two attachment screws present on the pedal cord connector.
6.8 Indicator lamps and light indicators 6.8.1 Indicator lamp ON This yellow indicator remains lit as long as the pedal is pressed and indicates the presence of the highfrequency current. Note that a buzzer sounds (audible signal meeting current standards) when the pedal is being pressed. The volume is not adjustable.
6.8.2 Indicator ON This indicator is green; it lights up when the medical device’s ON/OFF switch is in "I" position (ON).
6.9 Control knobs The medical device is controlled by adjusting the power and coagulation control knobs. Incision power settings
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Adjusts the incision power from the minimum value to the maximum value. At maximum power (setting 10), the power delivered is 30 W approx.; however, it depends on the operating conditions and the patient's histological variables. Coagulation settings
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Value 1: Minimum coagulation.
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Value10: Maximum coagulation.
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