(Please carefully read this user manualbefore using the apparatus.
Personal Care Appliances Functions:
Prostate treatment equipment, home massager, male physiotherapy instrument, frequent urination, chronic inflammation 1.Far infrared hyperthermia 2.Magnetic therapy 3.Vibration massage
1. General Introduction to NE-91 GOT Prostate Treatment Device
The NE-91 OCT Prostate Treatment Device is a modem prostate gland therapy instrument capable of tar infrared (FIR) them1cAhery, maçjiet thery and vtromassage. Through these therapies, physical energy is released directly to action spot in human body and causes senes of biophysical and biochenical changes, which in turn lead to an array of pathological and physiological changes. For instance, such energy can treat prostate diseases through restralnrng and elriinating etiologies, strengthening the no-speaflc inmLzllly and improving the potential of physical functions of human body. This device contains an anatomically shaped treatment probe, which is applied directly on the lesion locabon. To reach spasmolysis and analgesia, transform stasis and disperse swelling, promote blood circulation, unimpeded and no pain, eliminate mfiammation
1.1 Features and Mechanisms
This device adopts state-of-the-at digital integrated circuits as its signal control component. which owns high degree of satety, high stability and high reliability. It has a si'nple structixe and enables friendly and flextie operon, Also it igrates m14le functions. And the users may choose any a'x at ofit airnd treatment Compared with conventional treatment ttrough the urettra or invitro treatment, this device enables treatment through the rectum to the diseased gland, which alleviates the pain and debvers better results.
• FIR Thermal Therapy
Infrared rays are also called thermal rays due to the fact that they generate heat after being absorbed by thje FIR components with CHI4O ridel-chromitzn cods are used to radiate FIR waves to human tissues The FIR waves accelerate the moleci,dar movement of cells and generate heat ii the local area where the temperature nses (ideally to 40t''-SOt). The heat then cause angiedasis in the tissues around that area. and the blood 'ows rruch faster, accelerating the absorption and ebiWiation of the eftusions. The wi strengthen the metabok kaidion of cells and the ni.Aflbon process of tissues. Moreover, the regenerative abály is improved The cells become more vital Strengthened inTuity hek, to ease the imation. This trenent also reduces the excitabáty of the nerve terminals aid relaxes the musdes. which m turn ease the spasm and k the pan.
• Magnet Therapy
The probe contains a permanent magnet. which generates rotating magnetic field towards human tissues for treatment Clinical operation and studies show that magnetic fields provide energy to human bodies. They improve the blood aroistion in the lesion location and accelerate the transportation of antibodies, leukocyte niinent siki and oxygen to the iranied pert, as J as the absoipöon of plasma protele The treatment also speed ic the absorption and elimination of effusions and strengthen the metabolism. Further it .TiPS the mro circulation, reverse ischem.a, oxygen deficit, edema, accumulation of algogenic substances and decrease of activity of the hydrolase. The strengthened non-specific resistace he to eliminate the non-spec* pathogenic factors, which in turn ease spasm and kill the pain and eliminate the inflammation and swelling.
• Vibromassage Therapy
This device can massage the prostate gland with continual high-frequency mechanical vibration. which reduce the tension of the prostate gland, the patient feels no pain in the therapy process.
1.2 Purpose and Applicable Scope
This device is used tor adjuvant therapies of chronic pi-ostatitis, prostate hyperplasia and seminal vesicutitis.
1.3 Contraindication
Use of this device on patients with planted cardiac pacemaker or robotic artificial bths is prohibited; Patients with haemorthoids in pathogenic period and patients with prostate cancer are also prohibited to use tiis device.
1.4 Name and Model NE9100T
1.5 Model Number composition and meaning
NE - 9100 T Design a sequence number (B - portable. T - desktop, S single channel. etc.) Product code The code name of the enterprise (two words Chinese pinyr capitalize the first letter)
1.6 Operating Environment
a. Temperature:1OV''-40t b. Relative Humidity: 30%-75% C. AtmospheriC PressUre: 700hpa - lO6Ohpa
1.7 Classification and Safety Requirements
1.7.1 Electric Shock Hazard Protection Classification: Type BF applied part of Class I 1.7.2 Type of Power Supply: single-phase power grid supply 1.7.3 Output Power: 5OVA 1.7.4 Uquid Protection Classification: IPXO 1.7.5 This device MUST NOT be used in enviromient contáning mixture at air and flammable anesthetic gases or mixture of flanmable anesthetic gases and oxygen or nitrous oxide 1.7.6 Classification by Operation Method' Touch device 1.7.7 Classification by Running Mode: continuous running. 1.7.8 This prostate treatment device contains no application for protection from Defibrillation discharging effect 1.7.9 This device contains signal output. 1.7.10 This device is permanently installed equipment
2. structural feature and Operating Pnncipl. Picture 1
2.1 Structure & Composition of the DevicE
2.1.1 NE-9100T (Portable single channel) Is consisted of main device, treatment probe, static magnetic disk.
3. Technical Specifications
3.1 FIR wave length 8'-l5pm. normal total emessivity: 0.83 3.2 This prostate treatment device is capable of FIR thermotherapy, magnet therapy and balanced vibromassage therapy. 3.3 Central Magnetic Field of Eccentric Magnet: 200mT-300mT 3.4 Magnetic Induction Intensity of Treatment Probe: l5OmT-220mT 3.5 Magnetic Induction Intensity of Static Magnetic Disk: 120mTh-l6OmT 3.6 Vibration Frequency Level I : 100O2O00 RPM(adjustable) Level II: 1500'-2500 RPM (adjustable) iii: 2000-3000RPM (adjustable) 3.7 Range of Temperature Control: 38t-'50t ; accuracy : *1 ,5t 3.8 Timing Range 2O90min; erro: ±10% 3.9 Overheat Protection: Sound and light alarm is initiated when the temperature is higher than set value SOt, and the output is cut off iiimediately.
4. Dimensions and Weight
[ Model Dimensions (mm) Vight (KG) LNE-9100T I 342x260*114 2.2
5. Installation and Commissioning
5.1 Preparation Work look round the operating environment and check the grid power supply to determine whether it meets operation requirements. 5.1.1 Installation Environment Install this device in a sunny, well ventilated and air-conditioned room. Keep the device away from X-ray room, elevator, substation, high-voltage cables and electric cables,to minimize electromagnetic interference. 5.1.2 Grounding Requirements This prostate treatment device belongs to Type BF applied part of Class tin terms of electric shock protection classification. This device, while m use, should be well grounded by connecting its metal housing to the earth. So the external grId power supply must be equipped with effective grounding protection system. 5.2 Unpacking Check: Unpack the packaging and check against the packing list. 5.3 Installation 5.3.1 Connect the external power plug to the socket, make them firm. And make the device lie flat in the suitable place. 5.3.2 Connect the selected treatment probe to the output socket in the back of the device. Ensure the connection is tight and steady. 5.3.3 Turn on the Main Switch. The Switch Indicator and The LCD panel is on.press the OK button for three seconds. 5.3.4 The LCD panel displays text as following : time 30 minutes Temperature 38 °C;The vibration level: level one Checking the shows are nomal and can enter the next step treatment process.
6. Operation of Prostate Treatment Device
6.1 Function Description A. This device contains functions like FIR thecmotherapy, magnet therapy and vibromassage therapy. B. Display mode: LCD display 6.2 Control Panel Introduction 6.2.1 Control Panel, see picture 3 6.2.2 back panel 6.2.3 Magnetic therapy bag Picture 5 6.3 Operational Instructions 6.3.1 Half an hour before bed every day, after cleaning, side position. 6.32 Put the magnet in the magnetic bag be the magnetic therapy bag to 6 cm below the belly button. 6.3.3 Time set to 30 minutes, the temperature is set to 47°- 42°. temperature according to the personal ability to ascend. temperature is not more than 47 . 6.3.4 Put the condom on the treatment head, this is more sanitary, the treatment probe is forbidden to wash with water, you can use the disinfectant to wipe. 6.3.5 Put the treatment head into the anus, you will feel nervous for the first time, and you can apply the lubricant, 6.3.6The treatment head is placed in about 6 centimeters, need to lean forward, dose to the straight intestine wail and sway to the left and right, you can feel the chestnut gland body 6.3.7 Turn on the main switch. The switch indicator and the LCD panel is on,press the OK button for three seconds for treatment 6.3.8 Note: A. Initial use may increase the sense of defecation, which is an instrument that stimulates the glands function and drives the movement of the gland So before treatment, you need to drink a small amount of water to prevent holding urine in the middle of treatment. After treatment, you need to drink water. On the one hand, you need to supplement water, so that the glands can absorb and clean themselves. On the other hand, urine is used to detoxify. B.The anus needs to adapt to 2-5 days. do not worry about the initial tension. C.You need to increase the temperature treatment properly, such as 42 °today. you feel the temperature is low, or you can accept, you can choose to increase the temperature the next day 6.3.9 others: A.Underwear needs to be changed frequently, the underwear should be exposed after washing. B.You need to bathe regularly C.You need to drir* more wr and defec during the day D.Dunng the initial 3 Period of treatment, you need to limit your sex life properly. After 3 Period of treatment, you can release it property. 6.3.10 Cooperate with treatment Patients with inflammation need to woiic with anti-inflammatory drugs,After 3 days of Inflammation disappeared, stop taking anti-inflammatory drugs. If there is a patient who wants infusion, it is best to treatment after an hour and a half after infusion. It can be combined with some herbal medicines.
7. Maintenance
7.1 Place the device in a clean and well ventilated room. Keep the device away from heat, moisture.dust, chemicals, toxic gases. corrosive substances and metal objects. 7.2 The device should work under the stable voltage, best equipped with AC regulated power supply,so as to avoid the voltage too high or too low to damage the device. 7.3 the operator shouk operate the device according to the operating rules, before operation please careful to read the manual. 7.4 Turn off the power when the device is not is use. Reboot may require at least 5mm interval Frequent turning onloff is prohibited. Cover the device after use to avoid dust Keep the device dean Do not stack on the device to avoid damages 7.5 Check lithe treatment probe Is broken or damaged Clean and stenlize the treatment probe with 75% medical alcohol wipes after each use 7.6 If the device is not going to be used in a king time, regtiaity turn on the power of the device for inspection. 7.7 This device is a precise instrument and should be kept from water and moisture. If the device is not going to used in a long time, place it in a plastic bag and seal the bag tight,
8. Cautions and Warnings
8.1 Please carefuHy read Operational Instructions (6.3) of this user manual before using this device. 8.2 Use separate and independent grid power socket (three-hole socket with grounding protection),and external power must be equipped with effective grounding protection system. 8.3 Do comply with this user manual in terms of the Contraindication part hereof Install and operate ,this device in accordance with the operational instructions. 8.4 Maintain tight and steady connections and. Do not drag. bend, rotate or twist the cables 8.5 Do not move or shake any part of the device when it is in use Do not plug or unplug when the power is on. Do disconnect the power when move or instalt!uninstall the device. 8.6 Ahgn the plug of the treatment probe to the notch in the output socket on be back panel Insert the plug and screw on the nut to ensure tight connection. To replace the treatment probe, screw off the nut and pull out the probe. 8.7 Be sure the power if oft when replacing the fuse. Open the fuse box with a phillips screwdriver to replace the fuse (Replace the damaged fuse with a new one of the same specifications) 8.8 The static magnetic disk (fragile) is designed for repeat use. ( provide one pieces of static magnetic disks for this device.) the static magnetic disk has been placed ii the static magnetic band. For treatment,wear the static magnetic band around the waist and keep the static magnetic disk to the position 4 fingers from the navel The static magnetic disk should be used together with the treatment probe for better results. 8.9 The part touching human body (biomedical polymer material) conlies with GB/T168861 requiements There is no tooc or hazardous or atleigic effect on htira'i body. To avoid cross i'fedion. each treatment viould requre a new condom to improve the satisfaction to biocompabbIty. (Be sure to use a condom before the expiration date and with Product Standard, Production Permit and Medical Device Registration Certificate). 8.10 Temperature and vibration level can be adjusted for different patients for effective treatment. 8.11 Do not wear a watch when operating the treatment probe. 8.12 Do not point the treatment probe to the eyes. Do not look directly at the treatment probe either,to avoid damage to the eyes Improper position of treatment probe may cause ñsks of burning Use of this device for a long time may cause nsks of low temperature burning. 8.13 Do not use the treatment probe when the handle of the probe gets hot. In the treatment process,if the patient feels overheat on the probe, immediately pull out the probe to avoid burning. Check if the sound and light alarm for overheat protection is failed. Contact the manufacturer. 8.14 Do not open the housing of the device, or adjust or replace its components without proper permission.Failure to comply may cause unexpected malfunction. 8,15 The treatment probe cannot be disassembled (and contains electrical heating components), Please do not disassemble it without proper permission from the manufacturer. If the treatment probe is damaged.please contact us to order a new one. 8.16 In the treatment process, if the power if off, (this would cause no harm to the patient), firstly turn off the power of the device, then disconnect the cable from the power socket Pull out the treatment probe to suspend the treatment. After the power is restored, conned the power cle and turn on the power switch Repeat the treatment procedures. 817 With regard to used or damaged device components, accessories, and consumables (including treatment probe, static magnetic Disk, fuse, and condom) or when the service life of the device expires, please follow national Laws and regulations on environment protection for proper disposal. Suggestions on the disposal of the device:plastic housing, metal parts may be recycled. Printed circuits or condom cannot be recycled or burned 8.18 Keep away from high-frequency eqLiprnent. transmitting and receiving device, to avoid electromagnetic interference or system faifure. For instance microwave oven, high-frequency electrotome. X-ray machine and mobile phone, etc. This device may cause electromagnetic interference to other products. Please do not use multiple sets of devices connecting to the same one power socket. 8.19 Adverse Reactions Frequency and physical properties of the bowels may differ during the course of treatment and would become normal after the treatment. For replacement of components, please contact us to order the same models. We are not liable for any failure or malfunction due to the replacement with uncertified components. This device is not water-proof. Please do not clean the device with water! Do not wash the treatment probe with water!
9. Icons, Symbols and Abbreviations
9.1 - or AC: alternating current 9.2 ''K: current ''V': voltage 9.3: grounding protection (to earth) 9.4: Caution! Please read the accompanied documents. - Do not disassemble the device without proper authorization. - Risk of overheat burning.
10. Transportation and Storage
10.1 We provide a one-year warranty as of the date when the device is sold(the warranty doest cover the treatment probe); we also provide life-time paid repairing services after the warranty period. Unauthorized maintenance or repairing is prohibited. 10.2 The warranty will be void in case of: Failure caused by unauthorized disassembly or modifications; Failure caused by throwing or hit or fall during the course of use and transportation: Failure caused by improper use with insufficient maintenance or in unsatisfactory environment Failure caused by operation not in compliance with the operational instructions;Failure caused by unauthorized repairing. 10.3 Please contact us for repairing services via phone, fax or letters.
11. Others
11.1 Check the items in the packaging against the packing list. Contact us in case of inconsistence. 11.2 Our Medical Device Manufacturer Permit is JSFDA Permit No. 20120039 11.3 Drawings and accessory list are only provided to users and enbties trained and ahonzed by us
