High-energy bio-ion instrument (HNTG-162 Single-channel）

Product description
According to the conductance fundamental equilibrium principle of biological electrophysiological and biological tissue ,High-energy bio-ion instrument for coronary artery disease convert biological ion wave to bio-electric ion  and re-integrate the disordered charge for diseased tissue( nerves, bloods, muscles) to restore their normal function when it effects on human body. Especially its high technology not only broke through the difficulties that traditional physical therapy factor is hard to penetrate deeply into human organs and tissues, but also according to the principle of TCM meridian, combined the therapy of acupuncture and moxibustion with the effect of biological ionizing to get excellent physiological and therapeutic effects, and achieve its effect:
 

Five therapeutic mechanism to make the treatment of encephalopathy effectively.
a. Improve vasomotor state, Restore the vasomotion in resistance vessel, relieve wall fibrosis, change the status of vascular stenosis,make the vascular softened and reduce blood pressure.
b.Strengthen circulatory function, open microvascular, increase blood supply for myocardial infarction lesions, as well as improve the ischemic injury of myocardial tissue and promote nerve function to activate.
c.Relieve myocardial degeneration and the fibrillation of myocardial cell atrophy interstitial, also improve coronary atherosclerosis and the status of cardiac hypertrophy.
d.Increase the motion of electric charges of nerve cells membrane (inside and outside);Improve nerve inflammation edema, enhance the activity of neuronal cell and resurrect nerve function.
f.It is conductive to the rehabilitation of limb function by making make muscles passive shrink by rhythm, speeding up metabolism, and reducing lactic stimulation, as well as improving muscle strength.  

Clincal characteristics
a. One course of treatment can make the symptoms caused by hypertension disappearing, such as dizziness, headache, insomnia and neurasthenia. 2-4 courses of treatment could basically control the blood pressure and strengthen memory. Long-term treatment can keep the blood pressure stable, and gradually reduce to use the dosage of antihypertensive drug, until completely without any antihypertensive drugs.
b. One course of treatment can make the patients with cerebral thrombosis and cerebral infarction keep clearheaded and enhance their memory, as well as improve or eliminate the symptoms of numbness in hands and feet.2-4 course can basically improve the symptom of cerebral insufficiency capital and keep energetic;  Long-term treatment can gradually recovery limb function caused by stroke hemiplegics.
C, Patients with stroke hemiplegics who take the treatment for 2-4 course will be keep clearheaded and enhance their memory, also will improve or eliminate the symptoms of numbness in hand and feet, as well as it will improve language barriers and alleviate the symptoms of choking water and food, some patients function of hemiplegic limb will be improved. Long-term treatment will achieve better results(especially the course within three months)
d.The symptoms of shortness of breath and chest tightness that the patients with coronary artery disease will be significantly relived with 2-4 courses; long-term treatment will improve regional myocardial ischemia or necrosis that are caused by coronary artery stenosis and obstruction, and it also will prevent the symptoms of angina pectoris, myocardial infarction, arrhythmias and sudden death happened.

Adaptation disease
a.Hypertension, cerebral arteriosclerosis, cerebral insufficiency, dizziness, headache, insomnia, neurasthenia.
b.Mental transition fatigue, brain function decline, headache, memory loss , and so on.
c.Cerebral thrombosis, cerebral embolism, lacunars infarction and ischemic encephalopathy.
d.The sequel of stroke disease caused by hypertension and vascular disease, such as aphasia, limb dysfunction.
e.Patients with coronary atherosclerosis and myocardial infarction.
f.Old men with prostatic hypertrophy and prostatitis which will cause the disease of regency, frequent urination and difficulty urinating caused by prostatitis.
g.The pain caused by lumbar and neck disease, as well as various soft tissue injuries.

Contraindications
a.Patients with malignant tumors, bone deformities, internal bleeding, glaucoma and other serious diseases.
b.Psychiatric patients, Pregnant or lactating women, Children and patients in critical condition
c.Patients with pacemakers and artificial limbs.

Treatment operation of hypertension
a.Head treatment: basic portion of hypertension treatment
Operation: Place two treatment physical probes(small or medium) in the therapy cap as according the Figure 1, put the therapy cap on the head with the probes correct pressing on the bilateral vasomotor of the head. Set the treatment time for 10-20 minutes, then slowly adjusting the fine-tuning to make the treatment current increase to the patient tolerance. The best treatment current is 5-6.5 mA, plus the stalls when current is not enough, and the current should not exceed 7.5 mA


b.Treatment of upper limb buck points( mainly suitable for the treatment of higher low-voltgage)
According to the Figure 3 to make the treatment
Operation: Fasten two electrodes(medium) in the bilateral Quchi with limb bandage , setting the treatment time for 15-20 minutes, then slowly adjusting the fine-tuning to make the treatment current increase to the patient who can tolerant. The best treatment current is 10-12 mA, plus the stalls when current is not enough, and the current should not exceed 15mA.





c.The treatment of waist buck point(mainly suitable for the treatmen lower low-voltgage)
According to the Figure 4 to make the treatment
0peration: Fasten two electrodes(medium) in the waist hypertension point with waistband , setting the treatment time for 12-15 minutes, then slowly adjusting the fine-tuning to make the treatment current increase to the patient who can tolerant. The best treatment current is 12-15 mA, plus the stalls when current is not enough, and the current should not exceed 15mA.( This site is the effect acupoint for hypertension, it is very effect to make the blood pressure come down as long as make the treatment on this site when blood pressure elevated; The hypertension acupoint is a very important acupuncture point, especially for the treatment of chronic fatigue and lower limb weakness.)

The treatment operation for Stroke (Ischemic cerebrovascular disease)
a.Vasodilator therapy
Operation: Make the terrier race site that the patients diagnosis by CT as electrode placement sites, which will make the lesions establish collateral circulation as soon as possible. setting the treatment time for 10-12 minutes, then slowly adjusting the fine-tuning to make the treatment current increase to the patient who can tolerant. The best treatment current is 5-6.5 mA, plus the stalls when current is not enough, and the current should not exceed 15mA.(First treatment must be carried out under the guidance of professions)
b. The treatment for the expansion of blood volume
According to the Figure 5 to make the treatment
Operation: Place the electrodes next to mastoid that according to the figure 5, setting the treatment time for 15-20 minutes, then slowly adjusting the fine-tuning to make the treatment current increase to the patient who can tolerant. The best treatment current is 6-7.5 mA, plus the stalls when current is not enough, and the current should not exceed 8.5mA




The treatment operation for stroke hemiplegia
a.Head treatment: basic portion of hypertension treatment
Operation: Place two treatment physical probes(small or medium) in the therapy cap as according the Figure 6, put the therapy cap on the head( as Figure 7) with the probes correct pressing on the bilateral motor areas of the head to make alternative treatment，upper 1/5 is the torso movement area of the lower extremity; Middle 2/5 is motor area of the upper extremity, under 2/5 is motor area of head and face. Set the treatment time for 20 minutes, then slowly adjusting the fine-tuning to make the treatment current increase to the patient tolerance. The best treatment current is 5-6.5 mA, plus the stalls when current is not enough, and the current should not exceed 7.5 mA.





b. limb treatment
Operation: Fasten two treatment electrodes(medium) in the hemiplegic limb treated acupuncture points with limb bandages, making alternate treatment with two points for each time. Each side setting the treatment for 10 minutes, then slowly adjusting the fine-tuning to make the treatment current increase to the patient tolerance. The best treatment current is 10-15 mA, plus the stalls when current is not enough, and the current should not exceed 18mA.
c.Treatment operation for Prostate disease（This treatment is the attached treatment）
Supine to press the electrode placed in the patient’s sacrum, compress the other electrode placed at the bottom of small abdominal with bags. Setting the treatment for 30 minutes, then slowly adjusting the fine-tuning to make the treatment current increase to the patient tolerance. The best treatment current is 8-10 mA, plus the stalls when current is not enough, and the current should not exceed 15mA.
d.The treatment for lumbar muscle strain（This treatment is the attached treatment）
Fasten two electrode pads placed at the waist ache with belt, Setting the treatment for 30 minutes, then slowly adjusting the fine-tuning to make the treatment current increase to the patient tolerance. The best treatment current is 10-15 mA, plus the stalls when current is not enough, and the current should not exceed 20mA.
 
Notice
a.The product specification must be red before operation.
b.It must be skilled learning to master the operation method of high-energy bio-ion instrument.
c.It must strictly put attention to the change of the current, especially the head current must be within 7MA.
d.Therapy electrodes must be soaked in warm water before starting to make the treatment, and make sure they have soaked enough to stimulate the patients in course of the treatment
 

Everyday  for 1-2 times, each time for 30-45minutes, 10 days for a treatment. course.

受海南天光高科技開發有限公司（法人代表：任道常）委托，由山東省千佛山醫院中醫科具體實施，于2005年1月至２005年7月對該公司生產的“高能生物離子治療儀”治療缺血性中風進行了系統嚴謹的臨床觀察，現將結果報告如下。
　　摘要 目的：觀察高能生物離子治療儀對恢復期缺血性腦血管病的療效。方

法：生物電組為杏丁注射液25ml靜滴，加高能生物離子治療儀治療；對照組為單純杏丁注射液25ml靜滴。10d為一個1個療程，共2個療程。觀察指標：神經功能缺損評分，病殘程度評定，肌力測定。結果：經過2個療程的治療，治療組上肢和下肢肌力均顯著高于對照組。結論：高能生物離子治療儀治療缺血性中風療效是肯定的，是缺血性中風康復治療的重要手段之一。
　　關鍵詞 高能生物離子；缺血性中風
　　腦血管病是一種嚴重危害人們生命和健康的疾病，其發病率高，是中老年人致死、致殘的主要病因之一，腦卒中患者由于未進行及時和適當的功能鍛煉，經常會導致永久性殘疾，給家庭和社會帶來沉重的負擔。本文對腦卒中患者急性期和恢復期實施藥物結合高能生物離子治療，并與對照組比較，探討高能生物離子在腦卒中患者功能恢復及減輕殘疾方面的效果。

　　1 資料與方法
　　1.1病例選擇標準：2002年中藥新藥臨床研究指導原則《中藥新藥治療中風病的臨床研究指導原則》選擇恢復期患者43例，隨機分為兩組。治療組29例，男21例，女8例，平均年齡64（52-73）歲；對照組14例，男9例，女5例，平均年齡62（54-70) 歲。合并冠心病10例，高血壓病11例，糖尿病8例。中醫辨證氣虛血瘀證23例，陰虛風動證11例，風痰瘀阻證9例。
　　1.2治療方法：兩組均采用5% 葡萄糖溶液或生理鹽水250ml、杏丁注射液25ml靜滴qd，為常規治療。10d為1個療程，共2個療程,療程間隔3d。治療組在常規治療的同時加用海南天光高科技開發有限公司生產的高能生物離子治療儀治療。治療方法：患者取仰臥位，機器一處電極置于頸項部4-7椎體處，另一處手持電極由治療師左手掌握，治療師右手則放在患者前額部，微調調幅在最小值，然后開機治療，10分鐘后再將右手先后放在左、右兩側額顳部各治療5分鐘，然后再在患側肢體治療10 分鐘。電流強度：6-10mA。治療過程中，患者頭部應有舒適的麻震感，或視覺閃爍感。治療時間共30分鐘，每日一次，共2 個療程。治療過程中，結合中醫八綱辯證，按揉點穴等手法以提高療效。2個療程結束后進行療效評定。

　　1.3觀察指標:（1）臨床神經功能缺損改善程度。（2）患者總的生活能力狀態（病殘程度0-7級）。（3）肌力改善程度。（4 ）中醫證侯改善情況。
　　1.4療效判斷標準：參照2002年中藥新藥臨床研究指導原則《中藥新藥治療中風病的臨床研究指導原則》。
　　1.4.1 神經功能缺損評分改善情況。
　　1.4.2 臨床療效評定分級標準：

　　基本痊愈：功能缺損評分減少90%以上，病殘程度為0級。
　　顯著進步：功能缺損評分減少46%-89%，病殘程度1-3級。
　　進步：功能缺損評分減少18%-45% 。
　　無變化：功能缺損評分減少或增加在18%以內。
　　惡化：功能缺損評分增加在18%以上。
　　1.4.3 肌力改善情況。
　　1.5 統計學處理：全部數據均采用SPSS10.0統計軟件進行統計學處理，計量資料采用t檢驗、方差分析；計數資料采用x2檢驗；等級資料采用Ridit分析。當p>0.05時表明差異無統計學意義;當p<0.05時表明差異有統計學意義;當p<0.01時表明差異有高度統計學意義。

 2 結果
 2.1 治療組29例和對照組14例患者治療2個療程后，按療效判斷標準判斷結果。（見表1）
                            表1療 效判斷結果

  注：經Ridit分析，與對照組比較，u=2.86 ，p<0.01
  2.2 兩組患者肢體肌力恢復情況。（見表2）
                            表2 肢體肌力恢復情況

注：治療組上肢、下肢肌力分級治療后比治療前均顯著提高（X²=17.78，p<0.01;X²=15.44,p<0.01）；對照組治療2個療程后，上肢、下肢肌力分級比較無顯著統計學意義（X²=4.6 0,p>0.05;X²=2.34,p>0.05）。

  2.3 兩組患者神經功能缺損情況。（見表3）
                       表3 神經功能缺損情況

 注：**表示治療組治療前與治療組后相比P<0.01；☆表示治療組治療前后差值與對照組治療前后差值相比P<0.05。
 2.4 兩組患者中醫證侯分級量化改善情況。（見表4）
                       表4 癥狀分級量化表

注：**表示治療組治療前與治療后相比P<0.01；△表示對照組治療前與治療后相比P<0.05；☆☆表示治療組治療前后差值與對照組治療前后差值相比P<0.01。

3 討論：
　　近年來用物理手段輔助治療缺血性中風病已越來越引起關注，并在臨床治療腦血管病方面逐漸普及。高能生物離子治療儀所產生的生物離子流通過治療師傳到患者的治療部位，并形成一個回路。臨床觀察證明高能生物離子治療儀,在治療腦血管病時,對患者的神經功能缺損及患肢肌力改善等療效肯定，無明顯副作用。目前高能生物離子治療儀的確切治療機理尚未研究清楚，初步認為本療法可能有如下作用：（1）治療儀輸出的正弦波信號與人類自身產生的自然電信號相類似，并通過治療師傳導，使患者產生相應的生物反應以控制和替代患者的生物機能，從而使患者的神經、肌肉通過被動刺激，而保持其活躍程度。對于急性期患者能維持神經元正常興奮性，降低致殘率；對于恢復期患者能促進神經功能的恢復與軸突再生，從而形成新的傳導通路，有良好促進神經功能強化重組作用。（2）在人體生物離子作用下，起到穩定細胞膜電位環境，抑制自由基的產生，防止腦細胞進一步損傷和發生水腫的作用。（3）電場作用下，改變血液流變學性質，降低血粘度及血小板聚集能力，增加紅細胞變形能力；通過電刺激小腦頂核使局部血流量增加。共同改善損傷區腦組織的供血，促進缺血區腦組織功能的恢復。（4）電刺激對于神經肌肉的刺激作用，使瘓肌群被動的有規律舒縮，并產生小范圍的伸指、伸肘、屈膝等關節運動 , 有利于防止肌萎縮，促

進肌力的恢復。
　　4 結語：
　　高能生物離子治療儀對缺血性腦血管病的療效確切，能使患者神經功能缺損明顯好轉，促進患者癱瘓肢體肌力的恢復，明顯改善患者的臨床癥狀，有助于減少腦血管病的致殘率和致殘程度，值得在臨床進一步觀察研究和推廣。