Disposable & Reusable Hot Biopsy Forceps
Contents
1. Inserting by force may damage the endoscope or the electrode and lead to perforation bleeding or mucosal lesion of the patient as well CAUTION Please do not abruptly push or pull the electrode or it may lead to perforation bleeding or mucosal lesion of the patient and the damage of the endoscope or electrode CAUTION Keep the inserted part close to the open ended valve of the forceps channel and try to keep it straight when insert the electrode into the endoscope or the inserted part may be damaged hitch or touch tissue N Do not throw open the sliding handle or the sudden extrusion of the electrode may lead to perforation bleeding or mucosal lesion of the patient N Do not use excessive force when you hitch forceps or touch the tissue or the patient may bleed or have mucosal lesion CAUTION The ring electrodes in WILSON include that can be circumvolved and those cannot Please pay attention to the type when use it The equipment may be damaged if circumvolved by force 1 Pull the sliding handle and open the electrode 2 Adjust the inserted angle according to demand push the electrode to the disease part 3 Use the electrode product to cut or coagulation the target tissue 3 3 3 Cutting or coagulation Absorb the liquid sticking to the electrode and celom tissue If electrosurgical is conducted with the liquid sticking to the patient may perforate bleed mucosal lesion or tissue2. 4 Faan ies oe i mer Fig 3 4 _ _____ Hot Biopsy Forceps User Manual Document No WR RD 13 DG02 Rev D Heyinovo 8 Check the joints between the handle and the core and the core and the sheath Make sure the retaining ring and the lock are firmly connected See fig 3 4 2 Connect the general handle to the electric forceps and check the connection 1 Insert cable connector A into the plug until you hear the snap sound see fig 3 5 Fig3 5 S A ne eee EEN 2 Make sure cable connector A is firmly connected 3 Pull out cable connector A 3 Check the operation If anything abnormal is detected when you follow below steps please do not use the equipment and use the backup apparatus instead Pull the sliding handle Make sure the front part of the ring can be taken into the sheath tube 4 Check the forceps electrode DG see fig 3 6 1 Hold the equipment and the general handle form the inserted part into a 20cm diameter ring 2 Slide the sliding handle to and fro and make sure the forceps can fold and unfold flexibly 3 The angle of the forceps should be no less than 90 degrees when it is open and the forceps should be inosculated when they are closed 3 2 4 Inspecting the System Please check the connection of device and handle cable as instructed in the electrosurgery apparatus unit instruction manual If there were any unusual please do not use the equipment in question If there were any questio
3. Heyinovo operation of other electronic equipment 13 Regularly to inspect the accessories In particular electrode cables and endoscopical used accessories should be checked for possible damage to the insulation 14 This electrodes used with H F surgical generator can radiate radio frequency energy The equipment may cause radio frequency interference to other medical and non medical devices and radio communications Please provide reasonable protection against such interference Chapter 1 Checking Items in the package Check the items in the package according to the table below and whether any of the items damaged If any questions on the damage or missing of the items please contact WISLON in time The product repeatable packing does not undergo sterilization process before delivery Please clean disinfect and sterilize the product before initial use and then assemble the equipment according to the user manual The product disposable packing has undergone sterilization process Use it after unpacking and no refit needed Before unpacking make sure the package is not damaged or else the equipment should not be used Table 3 Repeatable Electrode Packing List External Internal User Handle Remark sheath sheath manual Hot Biopsy Forceps User Manual Document No WR RD 13 DG02 Rev D Heyinovo Chapter 2 Name Function and Specifications of the Product 2 1 Component Name and Function 1 Main unit Forcenc
4. and disinfecting it for a second use is not permitted 4 1 General The person in charge of cleaning disinfection and sterilization should fully understand and abide by all the regulations and policies of the state and the local hospital Endoscope room should have specially assigned person to clean disinfect and sterilize the endoscope equipment And training of backup staff will be preferred All the staff in charge of cleaning disinfection and sterilization should understand the items as below fully a The procedures of cleaning disinfection and sterilization of the hospital should including Occupational health and safety regulations b Provisions and policies of the state and local hospital c The regulations of this user manual d The mechanical knowledge of the endoscope equipment e Signs and explanations related to sterile agents 2 0 3 2 glutaraldehyde solution may be used to sterilize the accessories of WILSON endoscope but normal biological monitoring can not be conducted when glutaraldehyde solution is used Therefore it is better not to use glutaraldehyde solution on the repeatable equipment when Hot Biopsy Forceps User Manual 19 Document No WR RD 13 DG02 Rev D Heyinovo other sterilization methods such as gas sterilization which can have biological monitoring are applicable N Improper cleaning and sterilization of the equipment after use may endanger the safety of the patient The equipment may tou
5. burnt When use the high frequency apparatus of the endoscope try your best to take the minimum output value and the shortest time required by the operation Excessive output will lead to perforation bleeding or mucosal lesion of the patient Do not knot cable A or tie it together with other cables for medical equipment or the high frequency signals and the interference of the spark discharge during the electrosurgery may cause the function of other medical equipment abnormal and incur bad consequences to the patient It may also make the output of the electrosurgery equipment abnormal and lead to perforation bleeding and mucosal lesion of the patient Hot Biopsy Forceps User Manual 16 Document No WR RD 13 DG02 Rev D Heyinovo While operating make sure the electrode is electrified Operating without electricity may cause bleeding or mucosal lesion of the patient When endoscopic equipment is used with other medical electrical equipment advice on the avoidance of potential safety hazards caused by their use together shall also be given AN Failure of the HF SURGICAL EQUIPMENT could result in an unintended increase of out put power A statement of compatibility with specific MONITORING NE A warning that unless a compatible MONITORING NE is used with a CONTACT QUALITY MONTIOR loss of safe contact between the NE and the patient will not result in an auditory alarm CAUTION Do not use the equipment when the power supply exceeds t
6. head with HFE current External tube Inner tuke Protective sleevy tie Fig 4 Component diagram DG 2 General use handle Hanale Electric socket Fig 7 General use handle diagram 2 2 Model and specification The table below lists all of our company s electrode products In addition we will continuously extend our product range Please contact our company for detailed information CAUTION The internal sheath external sheath and handle of the electrode can only be used together with the apparatus suggested by WILSON or else the patient or operator may be injured and the function of the equipment may be abnormal or damaged CAUTION Please do not use the equipment when the voltage exceeds the rated voltage listed below or else the patient operator or assistant may be injured such as burned and the endoscope and equipment may be damaged Hot Biopsy Forceps User Manual 9 Document No WR RD 13 DG02 Rev D Heyinovo The product type and specification description WF S OU UU DG ddo Code of the head shape Effective length Numerical x100mm The maximum outside diameter of the inserted part Numerical x0 1mm S Sign for disposable products F Sign for reusable products Table 4 Model list Electrode Wii Max Effective Rated voltage head Figure Model diameter of length mm shape the inserted part mm 1807DG 40 Cutting mode 1810DG 48 1600Vp 1815DG 3200Vp p F
7. waste Page 23 Chapter 7 Service Information Page 23 Hot Biopsy Forceps User Manual Document No WR RD 13 DG02 Rev D Heyinovo Chapter 0 Notice upon Use of Product 0 1 Product Description The hot biopsy forceps are used for cutting and coagulation in the alimentary canal They are used together with various types of endoscopes connected to high frequency surgical generator transfer heat to conduct cutting or coagulation operation on polyp tissue The obtained tissue can be used for biopsy Please do not use them for other purposes 0 2 User Qualification The qualified operator of the equipment should be a physician or medical professional staff under the supervision of the physician The operator must have received sufficient training on clinical endoscope technology Therefore the manual will not explain or discuss any clinic endoscope technology 0 3 Accessories Make sure the equipment is compatible with the apparatus in use The use of apparatus that is incompatible with the equipment may lead to the injury of the patient or damage of the equipment The equipment is compatible with OLYMPUS high frequency electrosurgery apparatus PSD 10 UES 10 PSD 20 UES 20 and WILSON HF surgical equipment UES 30 Recommended electrosurgery apparatus devices output frequency 400KHZ 0 4 Repair and Modification All the components of the equipment should not b
8. 044 20 79006187 Hot Biopsy Forceps User Manual 23 Document No WR RD 13 DG02 Rev D
9. Heyinovo Hot Biopsy Forceps User Manual Technical Publications Document No WR RD 13 DG02 Rev D C 0197 Copyright By Wilson Instruments SHA Co Ltd Hot Biopsy Forceps User Manual Document No WR RD 13 DG02 Rev D Heyinovo Regulatory Requirement This product complies with regulatory requirements of the following European Directive 93 42 EEC concerning medical devices C q 0197 Revision History REV Gomplied by Approved by Apr 02 2007 Mr Yao dong Wang Mr Xin Huang Jun 18 2009 Mr Yao dong Wang Mr Xin Huang Oct 08 2013 Ms Xiaoping Qian Mr Xin Huang Nov 28 2013 Ms Xiaoping Qian Mr Xin Huang Wilson Instruments SHA Co Ltd 25D He Yi Business Plaza No 420 Jiang Ning Rd Shanghai 200041 P R China Hot Biopsy Forceps User Manual 2 Document No WR RD 13 DG02 Rev D Heyinovo Certifications e General Electric Medical Systems is ISO 9001 and ISO 13485 certified Original Documentation e The original document was written in English Attention This manual contains necessary and sufficient information to operate the system safely Advanced equipment training may be provided by a factory trained Applications Specialist for the agreed upon time period Read and understand all instructions in this manual before attempting to use the Hot Biopsy Forceps Keep this manual with the equipment at all times for ready use Periodically review the procedures for operation and safety
10. When the clothes of the patient are wet please do not turn on the output or the patient may get burnt When the patient touches the operating desk or the metal parts of other equipment please do not turn on the output or the patient operator or assistant may get burnt While putting out please do not touch cable connector A or let others touch it or the patient operator or assistant may get burnt When pull out cable connector A please do not pluck the cable or cable connector A may be damaged 1 Connect the equipment and connect the cable of the device 2 Turn on the electrosurgery apparatus 3 Depress the foot switch to start the output 4 Pull the sliding handle and remove the target tissue or freeze petechiae 5 Turn off the electrosurgery apparatus 6 Remove the cable from the electrosurgery apparatus and device handle 3 3 4 Draw out the electrode from the endoscope AN Please do not draw out the electrode with a fast speed or the blood grume or other chipping may spatter and infection may occur CAUTION When the electrode is not closed or has not totally draw back into the sheath please do not withdraw it from the endoscope or the endoscope or the electrode may be damaged CAUTION Please do not draw out the electrode when the elevator stretches up or the electrode will be damaged 1 Ifthe elevator is in the endoscope lower the elevator 2 Draw out the electrode from the endoscope 3 3 5 Withdr
11. al storage conditions suggested by the sterile packaging manufacturer 5 3 Storage conditions Ambient Temperature 40 C to 70 C Relative Humidity 10 to 95 Atmospheric Pressure 700hPa 1060hPa 0 7 to 1 1kgf cm 10 2 to15 4 psia Hot Biopsy Forceps User Manual 22 Document No WR RD 13 DG02 Rev D Heyinovo Chapter 6 Disposal of waste N The used disposable electrode products and the discarded repeatable ones should be controlled and disposed together or they may cause pollution to the environment and the public and cause bad consequences 6 1 Waste control The used disposable electrode products and the discarded repeatable ones should be collected together and closed off They should never be stored at will 6 2 The Disposal of the waste The waste of the electrode products should be destroyed and disposed according to related local law and regulatory requirements of the state or area Randomly cast off is strictly forbidden Chapter 7 Service information If you have any questions about any information in these instructions please contact our by the following information ual WILSON INSTRUMENTS SHA CO LTD 25D He Yi Business Plaza No 420 Jiang Ning Rd Shanghai China 200041 Tel 0086 21 66311471 Fax 0086 21 66311472 EC Ec REP EC Representative Company Lotus Global Co Ltd Address 15 Alexandra Road London NW80DP United Kingdom Contact Person Peter Tel 0044 20 75868010 Fax 0
12. aw the electrode from the handle 1 Circumvolve the retaining ring on the handle to 180 degree until you see the blue mark clearly 2 Press the button on the handle and pull out the connector of the electrode from the handle Hot Biopsy Forceps User Manual 18 Document No WR RD 13 DG02 Rev D Heyinovo Chapter 4 Cleaning Disinfection and Sterilization The equipment repeatable packing does not undergo sterilization process before delivery Please clean disinfect and sterilize the product before use The equipment disposable packing has undergone sterilization process Use it after unpacking and there is no need to refit Before unpacking make sure the package is not damaged or else the equipment should not be used Please clean disinfect sterilize and store the equipment after use Any improper or incomplete operation during the processes of cleaning disinfecting and sterilizing may lead to infection and the damage of the equipment or its performance N This chapter does not apply to the equipment disposable packing The equipment repeatable packaging has not undergone sterilization process before delivery Please follow the instructions of this chapter to clean disinfect and sterilize the product before initial use N The equipment disposable packaging has undergone sterilization process before delivery so it can be used directly except when the seal is broken Dispose it in time after use and cleaning
13. ch the mucosa To lower the cross infection among the patients the equipment should undergo thorough cleaning and sterilization after use N If the equipment is not completely cleaned it can not be sterilized effectively Therefore before sterilization it must be cleaned thoroughly to eliminate animalcule or organism which can lower the sterilization effect N The chipping of the patient and the chemical preparations used in cleaning disinfection and sterilization are dangerous things Wearing personal protective tools can prevent the operator from being endangered by dangerous chemical preparations Appropriate personal protective tools must be put on during the cleaning and sterilization processes Before leaving the sterilization area the protective clothing should be taken off N Follow the cleaning disinfection and sterilization processes according to the manual on the day the equipment is used If the processes are delayed the remaining tissue chippings will coagulation so it will be hard to conduct effective cleaning disinfection and sterilization for the equipment Sterilization Procedure Water cleaning soaked in diluted enzyme solution and scrubbing ultrasonic cleaning 15min immersed in 2 0 glutaraldehyde solution 10 hours sterile water cleaning keep for future use Pressure vapor sterilization can also be adopted 4 2 Apparatus for Cleaning Disinfection and Sterilization Put on appropriat
14. contact with metal parts which are earthed or which have an appreciable capacitance to earth for example operating table supports etc The use of antistatic sheeting is recommended for this purpose 4 Skin to skin contact for example between the arms and body of the patient should be avoided for example by insertion of dry gauze 5 When HF surgical equipment and physiological monitoring equipment are used simultaneously on the same patient any monitoring electrodes should be placed as far as possible from the surgical electrodes Needle monitoring electrodes are not recommended In all cases monitoring systems incorporating high frequency current limiting devices are recommended 6 The cables to the surgical electrodes should be positioned in such a way that contact with the patient or other leads is avoided Temporarily unused active electrodes should be stored so that they are isolated from the patient 7 For surgical procedures where the h f current could flow through parts of the body having a relatively small cross sectional area the use of bipolar techniques may be desirable in order to avoid unwanted coagulation 8 The output power selected should be as low as possible for the intended purpose 9 Apparent low output or failure of the HF surgical equipment to function correctly at the normal operating settings may indicate faulty application of the neutral electrode or poor contact in its connections In this case the app
15. d or have mucosal lesion CAUTION i Do not poke the patient s celom tissue with the front of the inserted part or it may lead to perforation bleeding or mucosal lesion of the patient CAUTION i Do not use other accessories when the equipment is used together with a big double channel endoscope Or else the patient the operator or his assistant may be burnt 3 3 1 Connect the electrode plate Connect the electrode plate to the patient 3 3 2 Insert the endoscope CAUTION Please do not insert the electrode into the endoscope when it has not been taken back to the sheath completely closed or the front of the inserted part may protrude suddenly from the front of the endoscope This may lead to perforation bleeding or mucosal lesion of the patient and probably the damage of the endoscope or electrode Hold the sliding handle firmly when insert the electrode into the endoscope or the electrode may throw open and extrude from the endoscope all of a sudden which may lead to perforation bleeding or mucosal lesion of the patient and probably the damage of the endoscope or electrode mi gee H Tus oOA I Fig 3 7 O emon Hot Biopsy Forceps User Manual 15 Document No WR RD 13 DG02 Rev D Heyinovo CAUTION Do not insert the electrode by force when it meets great resistance Instead the angle of the endoscope should be monished or the elevator should be lowered until the electrode can smoothly pass through
16. e equipment for cleaning disinfection and sterilization g Utensil for lubricant h Cloth without fine hair i 70 ethanol or cymene i High temperature and pressure sterilizer 4 3 Cleaning N Not to touch the liquid or the cleansing solution flowing from the inserted part while cleaning or it may cause infection or skin irritation CAUTION While cleaning disinfecting and sterilizing do not coil the Insertion Portion with a diameter of less than 15 cm or the electrode may be damaged Brushing in the Diluted Enzyme Solution N Immerse the electrode product in enzyme solution right after use or it may be impossible to conduct effective cleaning disinfection and sterilization and the performance of the electrode will be lowered as well 1 Disassemble the handle from the electrode 2 Immerse the handle and the electrode in the enzyme solution for a time period suggested by the manufacturer If the period is not provided then immerse them for 5 minutes to 3 hours Ultrasonic cleaning 1 Immerse the handle and the electrode in the ultrasonic cleaner with cleansing solution 2 Ultrasonic cleaning for 15 minutes For detailed information on ultrasonic cleaning please refer to the user manual Hot Biopsy Forceps User Manual 21 Document No WR RD 13 DG02 Rev D Heyinovo 3 Take out the electrode and the handle 4 Clean the electrode and the handle with clean water wiping out the remains of the cleansing
17. e personal protective tools according to the instructions below 1 Prepare below utensils The amount of detergent lubricant and other utensils depends on the number of electrode products that need cleaning disinfecting and sterilizing 2 Inpour detergent and lubricant into the cleaning utensils according to the temperature and concentration suggested by the manufacturer Inpour cleansing solution that is suitable for ultrasonic cleaners into the later a Protective tools Appropriate personal protective tools include safety goggles mask water proof clothing and chemical protective gloves Hot Biopsy Forceps User Manual 20 Document No WR RD 13 DG02 Rev D Heyinovo b Utensil for cleansing solution The utensil should be deep and big enough so that the electrode can be thoroughly immersed in and the diameter should not be less than 15cm c Cleaning solution for immersing Use neutral and low foam medical cleansing solution d Ultrasonic cleaner Use medical ultrasonic cleaner with a frequency range between 38 47 kHz and it should have sufficient depth and diameter so that the electrode can be totally immersed and its diameter should not be less than 15cm e Cleaning solution for ultrasonic cleaning Use neutral low foam non abrasive medical cleansing solution f Lubricant Use emulsive lubricant of medical water solubility or low viscidity Lubricant of high viscidity is hard to be injected into the entrance of th
18. e repaired by the user Please do not disassemble refit or repair the equipment or it may lead to the injury of the patient or the operator and the damage of the equipment For the loss incurred by the above practice our company will not take any responsibility 0 5 Marking and labels Table 2 Marking and labels CE Mark Indicates that the device conforms to Council dii Directive 93 42 EEC Aeaee medical devices Keep away from sunlight w Consult instructions for use Hot Biopsy Forceps User Manual 5 Document No WR RD 13 DG02 Rev D Heyinovo Symbol for Environment Protection Waste electrical products should be disposed of with household waste Please recycle where facilities exist Check with your local Authority or retailer for recycling advice Product marking il iit Hot Biopsy Forceps User Manual Document No WR RD 13 DG02 Rev D Heyinovo 0 6 Important Notes Before using the product please read carefully this instruction to fully understand all warnings cautions and attentions incorporated herein 1 In order to avoid incompatibility and unsafe operation please use suitable cables accessories active and neutral electrodes and HF surgical equipment set with suitable maximum allowed h f peak voltage 2 The entire area of the neutral electrode should be reliably attached to the patient s body and as Close to the operating field as possible 3 The patient should not come into
19. en the HF surgical equipment is turned on or the operator or his assistant may be burnt CAUTION Do not pluck the cable when you pull out the joint cable or the cable or the joint of the apparatus may be damaged N Advice concerning selection of a monitoring NE with respect to compatibility with the operator s available contact quality monitor If anything abnormal is detected when you follow below steps please do not use the equipment Use the backup apparatus instead Hot Biopsy Forceps User Manual 12 Document No WR RD 13 DG02 Rev D Heyinovo 1 Connect the handle to the electric forceps and check the connection 1 Circumvolve the retaining ring of the general handle until the blue mark appears see fig 3 1 2 Move the sliding handle to the retaining ring see fig 3 1 Fig 3 1 3 Press the button on the sliding handle insert the core joint of the electrode into the retaining ring see fig 3 2 Bet ee Fig 3 2 4 Loosen the button until the internal sheath joint can no be longer inserted in 5 Push and pull the sliding handle make sure the core joint is firmly connected 6 Adjust the four protuberances at the end of the sheath to the four grooves within the retaining ring and then insert the lock into the ret a f eet Kz i RL _ m Fig 3 3 en 7 When the lock can not insert any longer circumvolve the retaining ring for 180 degrees See fig 3
20. he rated voltage or the patient operator or his assistant may get hurt and the electrode may be damaged Do not connect any equipment when the electrosurgery apparatus is turned on or the operator or his assistant may get burnt When high frequency electric current is required do not turn on the electrode when it touches with the normal coelom tissue or it may burn the non target tissue If the bowel is dilated with air nonflammable gases can replace it or air dilatation will cause burning or explosion and the patient s tissue may get burnt Avoidance of a safety hazard in the event of explosive gas concentrations being present in the area of use of HF endoscopically used accessories To prevent healthy tissue from getting burnt please do not turn on the electrode when it touches non target tissue When any part of the target tissue such as polypus head touches non target tissue please do not turn on output or the non target tissue may get burnt When the front part of the endoscope is close to or touches the celom tissue please do not turn on output or the tissue may get burnt and the endoscope may be damaged When the front metal part of the endoscope touches or is close to the electrode please do not turn on the output When the skin of the patients touches one another please do not turn on the output or the patient may get burnt Hot Biopsy Forceps User Manual 17 Document No WR RD 13 DG02 Rev D Heyinovo
21. lication of the neutral electrode and its connections should be checked before selecting a higher output power 10 The use of flammable anaesthetics or oxidizing gases such as nitrous oxide N2O and oxygen should be avoided if a surgical procedure is carried out in the region of the thorax or the head unless these agents are sucked away Non flammable agents should be used for cleaning and disinfection wherever possible Flammable agents used for cleaning or disinfecting or as solvents of adhesives should be allowed to evaporate before the application of h f surgery There is a risk of pooling of flammable solutions under the patient or in body depressions such as the umbilicus and in body cavities such as the vagina Any fluid pooled in these areas should be mopped up before HF surgical equipment is used Attention should be called to the danger of ignition of endogenous gases Some materials for example cotton wool and gauze when saturated with oxygen may be ignited by sparks produced in normal use of the HF surgical equipment 11 For patients with cardiac pacemakers or other active implants a possible hazard exists because interference with the action of the pacemaker may occur or the pacemaker may be damaged In case of doubt approved qualified advice should be obtained 12 Interference produced by the operation of h f surgical equipment may adversely influence the Hot Biopsy Forceps User Manual 7 Document No WR RD 13 DG02 Rev D
22. n on electrosurgery apparatus please refer to the instructions on checking the contents of the steps 3 3 Operation The qualified operator of the equipment should be a physician or medical workers under the supervision of the physician The operator must have received sufficient training on clinical endoscopic technology Therefore the manual does not explain or discuss any clinic endoscopic technology but only introduces the basic operation and notices of the equipment Hot Biopsy Forceps User Manual 14 Document No WR RD 13 DG02 Rev D Heyinovo CAUTION i We should be equipped with proper personal protection tools while using the equipment or the patient s blood grume and other potential infective substances may lead to infection Appropriate personal protection tools include safety goggles mask water proof clothing and chemical protective gloves CAUTION i Only when the eyeshot of the endoscope is crystal clear can the electrode product be inserted into the endoscope If the front of the inserted part cannot be seen in the endoscope s eyeshot please do not use the equipment or it may lead to perforation bleeding mucosal lesion of the patient and the severe damage of the apparatus or equipment CAUTION i When the front of the inserted part protrudes from the front of the endoscope please do not swerve in the endoscope s curvy part or operate the elevator Or else the patient may perforate blee
23. orceps me l 2415DG Coagulation electrode S d amp 7 sates See gt 41 7 D G a 2421DG 900Vp 2423DG 6 5800Vp p Note 1 18 Series is fit for the endoscopes whose forceps aperture diameter 22 0 mm 2 24 Series is fit for the endoscopes whose forceps aperture diameter 22 8 mm 2 3 Classification MDD 93 42 EEC classification Class Il b Model of operation Continuous Operation Degree of protection against electric shock Type BF Applied part Electric shock protection grade The electric shock protection grade of the product depends on the connected high frequency electrosurgery generator apparatus Please refer to the user manual of the high frequency apparatus 2 4 Operating environment Ambient temperature 10 40 C 50 104 F Relative humidity 30 85 Atmospheric pressure 700 to 1060hPa 0 7 to 1 1kgf cm 10 2 to15 4 psia Rating voltage 1600Vp 3200Vp p for cutting mode 2900Vp 5800Vp p for electrode coagulation mode Hot Biopsy Forceps User Manual 10 Document No WR RD 13 DG02 Rev D Heyinovo Chapter 3 Preparation Inspection and Operation gt Please do not use the equipment on the patients who have implanted pacemaker Or the interference of the high frequency signals and spark discharge may lead to ventricular fibrillation or the damage of the pacemaker s electronic components and finally incur lethal injury CAUTION i Follow below instructions to prepare and check the equipmen
24. precautions If any queries about the content of this manual feel free to contact us Conformance Standards International Electrotechnical Commission IEC e IEC EN 60601 1 Medical Electrical Equipment Part 1 General Requirements for Safety e Medical electrical equipment Part 2 2 Particular requirements for the safety of high frequency surgical equipment Hot Biopsy Forceps User Manual 3 Document No WR RD 13 DG02 Rev D Heyinovo Table of Contents Regulatory Requirement Page 2 Revision History Page 2 Certification Page 3 Original Documentation Page 3 Attention Page 3 Conformance Standards Page 3 Chapter 0 Notice upon Use of Product Product Description Page 5 User Qualification Page 6 Accessories Page 6 Repair and Modification Page 6 Marking and labels Page 6 Important Notes Page Chapter 1 Checking Items in the package Page8 Chapter 2 Name Function and Specifications of
25. regulations Follow below steps to check the equipment before use If there is anything abnormal please change to backup apparatus Meanwhile have a thorough check on the backup apparatus before use 3 2 1 Sterile packaging inspection Disposable product Check if the sterile packaging is broken loose or wet If there is anything abnormal the sterile packaging has been damaged so it should be changed by backup apparatus 3 2 2 Appearance inspection If anything abnormal is detected when you follow below steps please do not use the equipment Use the backup apparatus instead Sheath inspection Please make sure the front sheath of the inserted part does not have sharp protuberance pointed edge or other damages 1 Touch the surface of the inserted part with your fingers make sure it is not smashed over bending or has other damages 2 Make sure the joint of the core has not dropped or become loose 3 Check the general handle 4 Make sure the handle has not any cracks Handle inspection Please check there is no crack on the handle CAUTION That before each use the outer surface of the portions of th endoscope and any ehdoscopically used accessories which are intended to be inserted into a patient should be checked to ensure there are no unintended rough surfaces sharp edges or protrusion which may cause a safety hazard 3 2 3 Connection and check the joint CAUTION Do not connect any equipment or check any joint wh
26. solution 5 Disinfection and Sterilization N If electrolytic ionized water is used to disinfect the equipment please make sure the PH value of the ionized water is between 2 5 2 7 and the immersing time should be strictly controlled as well The equipment will be damaged if the PH value is too low or the immersing time is too long Applicable sterilization methods for our product 1 Immersed in 2 glutaraldehyde solution disinfection 20 30 min sterilization 10 hours 2 Sterilize in high pressure steam cleaner with a 126 C temperature for 20 30 minutes After high temperature sterilization let the equipment cool down to the room temperature An abrupt change of the temperature will damage the equipment Chapter 5 Storage N Do not store the electrode product in a damp environment with a high temperature or the equipment will be infected by bacteria so the patient may be infected and the tissue will rankle 5 1 Check before storage Follow below steps to check the sterile packaging before storage 1 Make sure the sterile packaging of the electrode product disposable packaging is not broken or tightly sealed 2 Make sure the electrode product disposable packaging is water proof 5 2 Storage requirement Put the sterile packaging of the equipment in a dry and clean place And it should avoid direct sunshine Make sure the packed equipment not be pressed by surrounding objects Meanwhile please abide by the addition
27. t before use i CAUTION The damage of apparatus or equipment or the deviation of their function may endanger the safety of the patient or the operator leading to perforation bleeding mucosal lesion and tissue causalgia or burning and the severe damage of the apparatus or equipment CAUTION The equipment repeatability does not undergo sterilization process before delivery Please clean i disinfect and sterilize it before use CAUTION i Please do not use the equipment that has not been cleaned and sterilized or it may lead to infection and tissue rankling CAUTION i Do not coil the Insertion Portion with a diameter of less than 15 cm or the inserted part may be damaged CAUTION Do not use the equipment with excessive force or it may be damaged i 3 1 Preparation Apparatus and personal protection tools Prepare all the tools used together with the equipment according to respective manual Proper personal protection tools include safety goggles mask water proof clothing chemical protective gloves and etc Apparatus backup Backup apparatus should be prepared Devices for cleaning disinfecting and sterilizing Prepare utensils for cleaning disinfecting and sterilizing so that the equipment can be cleaned in time after use Hot Biopsy Forceps User Manual 11 Document No WR RD 13 DG02 Rev D Heyinovo 3 2 Inspection Wear personal protection tools according to the
28. the Product Page9 Component Name and Function Page 9 Model and specification Page 9 Classification Page 10 Operating environment Page 10 Chapter 3 Preparation Inspection and Operation Page 11 Preparation Page 11 Inspection Page 12 Operation Page 15 Chapter 4 Cleaning Disinfection and Sterilization Page 19 General Page 19 Apparatus for cleaning disinfection and sterilization Page 20 Cleaning Page 21 Lubrication Page 21 Assembly Page 21 Sterilization Page 21 Chapter 5 Sl0lag ss seers asencesssseecoscoreasdeeteesseseseeess Page 22 Inspection before Storage Page 22 Storage Page 22 Chapter 6 Disposal of
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