便携式生物反馈仪具体内容及参数

生物反馈治疗仪技术参数
生物反馈治疗仪
（双通道多功能神经康复诊疗系统）
技术参数
一、临床应用要求
主要用于运动功能障碍的治疗及康复训练，同时也可用于包括感觉障碍、痉挛、面瘫、脑血管扩张及微循环治疗（小脑顶核仿生刺激）等。

无临床体征（认知、肌力水平等）限制，可满足病人全过程（急性期、发展期、后遗症期）、多体征的康复需求。

二、主要技术参数
（一）计算机系统：
1、一体化计算机；
2、通讯方式：USB2.0数据接口，并采用光电隔离，传输速率大于10Mbit/s；超强抗干
扰性能，4000V隔离安全标准；
（二）EMG反馈放大器系统
1、强抗干扰能力，适合任何环境下使用
2、EMG放大器灵敏度：2—10000μV（10mV）
3、通道设置：2通道左右分屏显示，可同时治疗两个病人或同一病人的两个部位，两
个独立的控制时钟，互不干扰和影响。

（三）声音输出系统
在同时治疗两个部位或两个病人时，有两套独立的多媒体声音提示系统，由不同的时钟控制，病人完全不相互干扰
（四）功能电刺激系统
1、二套独立的功能电刺激系统，可独立进行输出、控制及设置
2、电流强度：0—100±1mA恒流且可调和电子锁定（3K欧姆）
3、最大输出电压：300V
4、刺激频率：10—100Hz；仿真电刺激时可调制到中频（1000HZ以上）
5、刺激脉宽：50—1000μs
6、刺激波形：单极性、双极性、交替式、多形态
7、刺激持续时间：1—60S，也可根据需要任意设定
8、系统可自动测量最合适的电流强度，并进行锁定处理。

医用生物反馈仪的使用与数据解读医用生物反馈仪是一种先进的医疗设备，通过监测和测量人体的生理指标，帮助医生进行病情诊断和治疗。

本文将介绍医用生物反馈仪的使用方法和数据解读技巧。

一、医用生物反馈仪的使用方法医用生物反馈仪可以测量和监测多种生理指标，如心率、呼吸频率、皮肤电活动等。

使用该仪器需要按照以下步骤进行：1. 准备工作：将生物反馈仪连接至电源，确保设备正常工作。

同时，确保患者处于放松且适合测量的环境中。

2. 粘贴传感器：根据要测量的生理指标，选择相应的传感器并将其粘贴在患者身体特定位置。

例如，心电图需要将传感器粘贴在胸部，皮肤电活动需要在手与脚上放置传感器。

3. 启动设备：按照设备说明书的指示，启动医用生物反馈仪，并对其进行基本设置。

根据需要设定所测量的生理指标和记录时间。

4. 测量数据：患者在放松状态下，开始测量。

医用生物反馈仪会自动记录和保存数据，并在屏幕上显示出来。

5. 停止测量并保存数据：测量结束后，停止医用生物反馈仪的运行，并将数据保存到计算机或其他存储设备中，以备后续分析和解读使用。

二、医用生物反馈仪数据的解读1. 数据分析：通过医用生物反馈仪记录的数据，可以分析患者的生理变化和反应模式。

比如，心率的变化可以反映情绪和压力水平的变化，皮肤电活动则可以用来评估患者的焦虑水平。

2. 数据比较：将不同时间段的数据进行比较，可以获得更加详细的信息。

比如，将患者处于压力情境下和放松情境下的数据进行比较，可以评估患者在应对压力方面的效果。

3. 参数计算：医用生物反馈仪可以根据测量数据计算出一些重要的参数，如平均心率、皮肤电活动幅度等。

这些参数可以帮助医生进行更加精确的病情判断和治疗方案制定。

4. 数据解读与诊断：综合分析测量数据和参数计算结果，医生可以对患者的病情进行解读和诊断。

例如，通过分析心率的变化可以判断患者是否存在心脏疾病的风险。

总结起来，医用生物反馈仪的使用方法相对简单，但对于数据的解读和分析需要医生具备一定的专业知识和经验。

肌电生物反馈治疗仪（神经功能组织重建仪）生物反馈治疗仪是利用肌电生物反馈技术并结合多种电刺激模式进行肌肉训练治疗，以达到改善肌肉功能，帮助病人重建并恢复肌肉正常运动功能，脑血管、中枢神经系统损伤的运动功能障碍及盆底肌肉功能障碍等。

生物反馈治疗仪治疗原理：生物反馈治疗仪是利用肌电生物反馈技术并结合多种电刺激模式进行肌肉训练治疗，以达到改善肌肉功能，帮助病人重建并恢复肌肉正常运动功能，脑血管、中枢神经系统损伤的运动功能障碍及盆底肌肉功能障碍等。

生物反馈治疗仪结合生物反馈和神经功能重建的最新康复理念，集肌电、直肠、盆底的评估、治疗、训练于一身的康复专家。

什么是生物反馈生物反馈(biofeedback)又称生物回授。

它在不同的场合下具有不同的涵义，既可以指有机体内发生的一种过程；又可以表示一种方法；还可以表示一种特殊的治疗手段。

生物反馈疗法运用生物反馈疗法，就是把求治者体内生理机能用现代电子仪器予以描记，并转换为声、光等反馈信号，因而使其根据反馈信号，学习调节自己体内不遂意的内脏机能及其他躯体机能、达到防治身心疾病的目的，由于此疗法训练目的明确、直观有效、指标精确，因而求治者无任何痛苦和副作用。

据国内有关报道证实：生物反馈疗法对多种与社会心理应激有关的身心疾病都有较好的疗效。

运用于生物反馈治疗的设备有：肌电反馈仪、皮肤湿度反馈仪、脑电反馈仪、脑电反馈仪及脉搏反馈仪等。

仪器的操作者需经过专业训练，以保证结果的可靠性和科学性。

生物反馈治疗仪的作用生物反馈治疗技术是根据条件反射理论发展起来的，于20世纪60年代末首先在美国用于临床。

生物反馈是用电子仪器测定神经-肌肉和自主神经的正常或异常活动情况，并把这些信息放大成视觉和听觉信号，反映给受试人。

医生帮助受试人了解原来不能感觉的机体的变化，通过学习控制这些反映信息，学会调节心理生理变化，来治疗与预防特定疾病。

治疗焦虑障碍用脑电生物反馈等治疗后，多数人能控制焦虑和惊恐发作，不再影响其工作和生活，能更好地平稳发挥脑功能。

便携式生物反馈治疗仪原理
一、便携式生物反馈治疗仪原理
便携式生物反馈治疗仪是一种利用脑波、体感和呼吸来改善心理健康的设备，常常被用于改善焦虑、失眠、精神分裂症等症状的康复。

其原理是通过测量用户的脑波，从而分析出当前的心理健康状态，通过控制用户的体感和呼吸，调整和调节用户的心理状态，以达到改善心理健康的目的。

1、脑波分析
脑波分析是便携式生物反馈治疗仪的核心部分。

它首先用传感器测量用户的脑波，然后通过计算机软件分析用户的脑波，来分析用户当前的心理健康状况。

用户的脑波将根据不同的状态显示不同的波形，计算机软件可以将这些波形进行分类，由此分析出用户当前的心理健康状况。

2、体感控制
体感控制是便携式生物反馈治疗仪的另一部分。

通过体感控制，可以通过体感刺激，改变用户的情绪，以实现心理健康的改善。

该技术可以利用体感刺激来改善用户的情绪，通过刺激人体皮肤来引起神经的兴奋，通过调节神经的兴奋度来改变用户的情绪，用人体感觉上的刺激来改变用户的心理状态。

3、呼吸训练
呼吸训练是便携式生物反馈治疗仪的最后一部分。

通过呼吸训练，可以通过呼吸来调整用户的心理状态。

例如，用户可以放慢呼吸，放
松身体，改变情绪，有助于减轻压力，改善心理健康。

总之，便携式生物反馈治疗仪是一种利用脑波、体感和呼吸来改善心理健康的设备，其原理是通过测量用户的脑波，从而分析出当前的心理健康状态，通过控制用户的体感和呼吸，调整和调节用户的心理状态，以达到改善心理健康的目的。

生物反馈仪治疗仪技术参数一、项目名称：生物反馈仪二、适用范围：可用于焦虑、儿童多动症等神经精神疾病的生物反馈治疗，无任何禁忌症。

三、技术性能：（一）硬件1、全进口核心部件，包括信号处理器、传感器、专用电极、光纤；2、多参数信号处理器，可监测和记录脑电、肌电、皮温、皮电、心电、心率/血容量搏动、呼吸等多种生理信号；3、信号处理器的物理通道均为独立通道（非集成通道），任意通道可采集任意参数；4、信号处理器采用直流供电，可脱离计算机作为动态Holter使用；5、外置独立传感器（非集成），内置IC芯片；6、脑电电极必须是专业盘状电极，可用于头部任何位点；肌电电极可用于全身任何部位肌肉；7、数据采用光纤传输，光纤的长度可调节。

（二）软件8、全进口操作平台软件BioNeuro Infiniti 6.0中文版，支持AVI、Flash、MIDI、Wave、MP3、DVD等通用媒体格式；9、全进口开发工具软件Developer Tools 6.0，内含通道编辑软件（Channel Editor）、界面编辑软件（Screen Editor）、方案编辑软件（Script Editor）；10、提供40种以上运算方式，11、评估功能：心理量表、视听整合连续测试、基线阈值评估、脑电认知评估、应激评估。

12、孤独症神经生物反馈训练，采集双极脑电进行生物反馈训练。

13、多动症、抽动症及其共病的生物反馈训练；14、儿童生物反馈训练软件，阶梯式训练；15、双耳差拍的脑电波诱发训练；16、多种放松治疗方式：呼吸放松、冥想、渐进式放松、音乐治疗等多种形式的放松治疗；17、一键式治疗模式，包含孤独症、ADHD、抽动等多种治疗方案的快捷模式；18、智能语音提示，在患者训练前，给予语音指导，帮助患者了解治疗流程及方法；19、支持视频实时采集、反馈功能；20、数据管理功能，可回放训练、进行分析并生成报告，支持多次训练趋势报告分析。

（三）技术指标：21、采样率：256-2048 Hz22、共模抑制比：≥110 dB23、噪声电平：≦5 μV24、输入阻抗：≥50 MΩ。

生物反馈仪设备技术参数及配置要求1、根据生物反馈原理，适用于焦虑症等神经精神疾病的生物反馈治疗。

用于临床治疗时，无禁忌症。

2、zigbee传输无线型披戴式传感器：披戴式传感器内置锂电池，每次治疗同时集合化采集sEMG信号与BVP两个信号,采用无线传输模块，使用者可不受任何干扰的移动，方便团体训练中成员互动，在100米范围内可随意活动。

3、物理通道信号处理器，同时采集HRV及EMG信号，实时反应心理与身体的压力与放松情况，亦可进行生物反馈训练。

支持升级到20通道，可满足20人同时治疗。

4、可同步监测2人指标；可进行2人的生物反馈治疗。

5、状态指示灯：无线型披戴式传感器具备心理状态指示灯功能，位置位于前额的状态指示灯，便于治疗师通过心理指示灯的不同显示实时的直接观测到每一个使用者即时的心理状态；心理状态指示灯可实时随放松指数的不同变换红、蓝、绿等不同颜色，以直观显示不同的心理状态。

6、AD采样位数：≥14 Bit7、AD采样率：128~256Hz8、sEMG测量范围：1~200μv9、sEMG最高分辨率：≤0.2μv10、sEMG输入噪声：＜1μv11、sEMG通频带：25~450Hz12、表面肌电反馈通道差模输入阻抗：＞5 MΩ13、sEMG共模抑制比：＞100 dB14、阻抗测试：有15、Heart Rate测量范围：40~140bmp，BVP测量范围：0~100%16、无线模块参数：工作电压＋3.3V,工作电流≤20mA17、基线测试，多人同时测试，时间五分钟，自动生成测试数据报告，内置通用参考常模，并可选用标准压力评估等评估形式。

18、技能训练模式：脑呼吸训练、雅克布逊式肌肉放松、意象式音乐治疗、萨提亚式冥想等构成。

19、团体训练模式：2人团体协作式训练方案，使参加团体训练的所有成员，可以保证同一时间互动。

团体训练时，2人同时控制同一训练界面，并可以进行成员互动式训练，即在同一训练界面中拥有竞争式互动或协作式互动。

MYOTRAC INFINITIDual SEMGThe Manufacturer: Thought Technology Ltd.2180 Belgrave AvenueMontreal, Quebec, CanadaH4A 2L8Product Name: MyoTrac Infiniti System Product #: T9800Device Name: MyoTrac Infiniti Encoder Device #: SA9800•Type BF Equipment •Internally powered equipment•Continuous operation•Read Instruction Manual•The pins of the connectors identified with the ESD warning symbol should not be touched unless ESB precautionary procedures are used.CAUTION•US Federal Law restricts this device to sale by, or on order of, a physician or any otherpractitioner licensed by the law of the state in which he or she practices to use or order theuse of this device.WARNING•Do not operate Active Sensors within 10 feet of an operating cellular phone, similar radio transmitting device, other powerful radio interference producing sources such as arcwelders, radio thermal treatment equipment, x-ray machines, or any other equipment thatproduces electrical sparks. Portable and mobile RF communication equipment can affectthis equipment.•With the MyoTrac Infiniti Encoder SA9800 use only with supplied power supply. GlobTek Part Number WR92B2500LF9P-Y-MED (WR95/WR93/WR97) or GS889•The PC used with MyoTrac Infiniti must be placed outside the patient/client environment(more than 3 meters or 10 feet) or the PC must comply with EN60601-1 (system safety).•After use, the Batteries or the Battery pack must be disposed of in accordance with local, state and federal regulations and laws.•After use, the Disposable Electrodes may be a biohazard. Handle, and when applicable, dispose of these materials in accordance with accepted medical practice and any applicablelocal, state and federal laws and regulations.•Reusable electrodes present a potential risk of cross-infection especially when used onabraded skin, unless they are restricted to a single patient or sterilized between patients. Ifsterilizing electrodes, employ only gas sterilization.•Radiated radio frequency electromagnetic fields can cause performance degradation in the MyoScan-Pro EMG sensor. In the worst case, an RF field strength of 22mV/M can causean increase of 1μV in the signal reading from a MyoScan-Pro sensor. Be sure to keep inmind that a very relaxed muscle should provide an EMG reading of approximately 1-3μV.•This device is capable of generating current densities exceeding 2mA r.m.s./cm² this may require special attention of the operator.•Avoid accidental contact between connected but unused applied parts and other conductive parts including those connected to protective earth.•Explosion Hazard; Do not use in the presence of a flammable anesthetic mixture with air, or with Oxygen or Nitrous Oxide.•Not to be immersed in water.•Take care in arranging patient and sensor cables to avoid risk of patient entanglement or strangulation.•The operator is responsible for ensuring the safety of any devices controlled or triggered by Infiniti equipment or software, or by any software or hardware receiving data from Infinitiequipment. Infiniti equipment must not be configured or connected in such a way thatfailure in its data acquisition, processing or control functions can trigger patient feedbackstimulus that poses an unacceptable level of risk.•Use of any equipment in a biofeedback or stimulation context should be immediatelyterminated upon any sign of treatment-related distress or discomfort.•Not to be connected to a patient undergoing MRI, Electro surgery or defibrillation.•Not for use with patients with undiagnosed pain conditions.•Only use the unit for which it was prescribed.•Do not immerse the unit in water or any other liquid substance.•Do not use if you have symptoms of bladder infection.•Do not use with diminished mental capacity or physical competence limiting the use of the device.•Caution should be used for patients with suspected or diagnosed heart problems.•Caution should be used for patients with suspected or diagnosed epilepsy.•Electrode placement and stimulation settings should be based on the guidance of theprescribing practitioner.•If damage is evident of the unit or accessories, discontinue use and contact your supplierfor further information on repair.•The system should not be used adjacent to or stacked with other equipment, if usedadjacent or stacked the unit should be observed to verify normal operation in theconfiguration in which it will be used.•Use of accessories, transducers or cables other than those specified by ThoughtTechnology ltd may result in increased emissions or decreased immunity of the equipmentto electromagnetic energy.ATTENTION•Sensors and equipment damaged by static electricity are not covered under warranty. Toprevent static discharge from damaging the sensor and/or encoders, use anti-static mats orsprays in your working area. A humidifier may also be used to prevent static environmentsby conditioning hot, dry air. It is recommended that all staff involved with the unit receive anexplanation of the ESD symbol and the precautions described above as a minimum.•Do not apply any electrode gel or equivalent directly on the sensor snaps. Always useelectrodes as a medium between the sensor and the client.•Not for diagnostic purposes, not defibrillator proof, not for critical patient monitoring.•To prevent voiding warranty by breaking connector pins, carefully align white guiding dot onsensor plug with slot on sensor input.•Make sure to remove electrodes from sensor snaps immediately after use.•Do not plug third party sensors directly into instrument inputs. Plug only ThoughtTechnology Active Sensor cable connectors into instrument inputs. All electrodes and thirdparty sensors must be connected to active sensors, either directly or through an adapter.•Remove batteries when the device is not being used for an extended period of time. Pleasedispose of battery following local regulations.INTENDED PURPOSE•Biofeedback, Relaxation & Muscle Re-Education purposes•Relaxation of muscle spasms•Prevention or retardation of disuse atrophy•Increasing local blood circulation•Muscle re-education•Maintaining or increasing range of motionNOTE•No preventative inspections required; maintenance must be performed by qualified personnel.Factory re-calibration can be requested.•The supplier will make available, upon request, circuit diagrams, component parts lists anddescription or other information required for the repair of product by qualified personnel.•The operator must be familiar with typical characteristics of signals acquired by thisequipment, and be able to detect anomalies in the acquired signal that could interfere withtreatment effectiveness. Depending on the importance of signal integrity, it may be advisableto continuously monitor the raw signals, in time and/or frequency domain, while the device isbeing used for biofeedback or other purposes. If anomalies are observed on acquired signals,and if you suspect a problem with electromagnetic interference, contact Thought Technologyfor a technical note on identification and remediation.•This product conforms to standards EN60601-1, EN60601-2-10 and EN60601-2-40; someencoder labeling may indicate superceded standards.MAINTENANCE AND CALIBRATION•Wipe encoder with a clean cloth•Factory testing and calibration ensure equipment accuracy and frequency response. Contact Thought Technology for factory re-calibration if necessary.STORAGE•Store in its original case at up to 90% humidity / 30C°TRANSPORTATION•Transport in its original caseManual # SA9814 Rev 4Guidance and manufacturer’s declaration – electromagnetic immunity The MyoTrac Infiniti is intended for use in the electromagnetic environment specified below. The customer or the user of the MyoTrac Infiniti should assure that it is used in such an environment, and that precautions regarding that environment are heeded.Immunity test IEC 60601test level Compliance level Electromagnetic environment –guidanceElectrostatic discharge (ESD) IEC 61000-4-2 ±6 kV contact±8 kV air±6 kV contact±8 kV airFloors should be wood, concrete orceramic tile. If floors are covered withsynthetic material, the relative humidityshould be at least 30 %.Electrical fast transient/burst IEC 61000-4-4 ±2 kV for powersupply lines±1 kV for input/outputlines±2 kV for powersupply lines±1 kV for input/outputlinesMains power quality should be that of atypical commercial or hospitalenvironment.SurgeIEC 61000-4-5 ±1 kV differentialmode±2 kV common mode±1 kV differentialmode±2 kV common modeMains power quality should be that of atypical commercial or hospitalenvironment.Voltage dips, short interruptions and voltage variations on power supply input linesIEC 61000-4-11 <5 % U T(>95 % dip in U T)for 0,5 cycle40 % U T(60 % dip in U T)for 5 cycles70 % U T(30 % dip in U T)for 25 cycles<5 % U T(>95 % dip in U T)for 5 sec<5 % U T(>95 % dip in U T)for 0,5 cycle40 % U T(60 % dip in U T)for 5 cycles70 % U T(30 % dip in U T)for 25 cycles<5 % U T(>95 % dip in U T)for 5 secMains power quality should be that of atypical commercial or hospitalenvironment. If the user of theMyoTrac Infiniti requirescontinued operation during powermains interruptions, it is recommendedthat the MyoTrac Infiniti bepowered from an uninterruptible powersupply or a battery.Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 3 A/m 3 A/m Power frequency magnetic fieldsshould be at levels characteristic of atypical location in a typical commercialor hospital environment.NOTE U T is the a.c. mains voltage prior to application of the test level.NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the MyoTrac Infiniti is used exceeds the applicable RF compliance level above, the MyoTrac Infiniti should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the MyoTrac Infiniti.Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.Guidance and manufacturer’s declaration – electromagnetic emissionsThe MyoTrac Infiniti is intended for use in the electromagnetic environment specified below. The customer or the user of the MyoTrac Infiniti should assure that it is used in such an environment.Emissions test Compliance Electromagnetic environment – guidanceRF emissions CISPR 11 Group 1 The MyoTrac Infiniti uses RF energy only for its internal function.Therefore, its RF emissions are very low and are not likely tocause any interference in nearby electronic equipment.RF emissionsCISPR 11Class BHarmonic emissionsIEC 61000-3-2Not applicableVoltage fluctuations/ flicker emissions IEC 61000-3-3 Not applicableThe MyoTrac Infiniti is suitable for use in all establishments,including domestic establishments and those directly connected tothe public low-voltage power supply network that suppliesbuildings used for domestic purposes.Table of ContentsAbout This Guide (9)Chapter 1 (10)Introduction to your MYOTRAC INFINITI™ Dual SEMG Encoder (10)System Requirements (11)MyoTrac Infiniti Components (12)Connection to the Client (15)Connection to the PC (19)Screen Elements (20)Thought Support (20)Settings Menu (21)Chapter 2 (25)SEMG sessions on your MYOTRAC INFINITI™ Dual SEMG Encoder (25)Open SEMG Sessions (25)Script SEMG Sessions (27)Chapter 3 (28)Data Management on your MYOTRAC INFINITI™ Dual SEMG Encoder (28)MyoTrac Infiniti Review (29)Chapter 4 (30)Display Options on your MYOTRAC INFINITI™ Dual SEMG Encoder (30)Displays (30)Chapter 5 (34)Flow on your MYOTRAC INFINITI™ Dual SEMG Encoder (34)Chapter 6 (35)Reference (35)Technical Support and Order Placing (36)Technical Support (36)Product Numbers & Accessories (37)Placing Orders (38)Specifications (39)MyoTrac Infiniti Hardware Copyright Notice (44)About This Guide Welcome to the MYOTRAC INFINITI™ encoder. This guide is designed to help you get up and running quickly with your new encoder. It will describe the operation of the encoder, and how it interfaces to the host personal computer (PC).It walks you through:•Physical Operation of the encoder.• EMG sessions.• Data management.• Display options.After you have become familiar with the key concepts of your new encoder, you can use the rest of this guide as a reference for less common tasks, and also as a source of information if you have problems operating it.Chapter 1 Introduction to your MYOTRAC INFINITI™ Dual SEMG EncoderThis chapter explains the physical interface with the MyoTrac Infiniti Encoder, how to use it for the first time, and how to transfer data to the host PC.Getting to know your MyoTrac Infiniti Dual SEMG EncoderWhat is a MyoTrac Infiniti Dual SEMG Encoder?The MyoTrac Infiniti is the cutting edge in handheld, dual channel Surface Electromyography(SEMG). With it you will be able to deliver targeted and customized treatment directly to the client’s clinically relevant areas.A simple first approach has been adopted in the design of the MyoTrac Infiniti to make it as easyand fast as possible to get the clinical results desired from this powerful device.Customizing the MyoTrac Infiniti to your clinical needs couldn’t be easier; all users input is directed through a series of intuitive and guided screens using touch screen technology.The partnership of the MyoTrac Infiniti with the BioGraph Infiniti PC software enhances yet further the power and flexibility of the MyoTrac Infiniti. This link enables you to transfer session data to the PC for further viewing, analysis and reporting, in real time or post session.System RequirementsTo install the BioGraph Infiniti software, your computer system must meet or exceed the following requirements.•IBM PC compatible(Intel/Pentium/Celeron family or AMDK6/Athlon/Duron family, CPU P4 speed 3GHz or higher), Desktop or Laptop withtwo monitor capability•Windows 2000/XP Professional or Home edition.•50 - 60 gigabytes hard disk space for video recording and processing. (Thesoftware needs 2.5 gigabytes to installand run on available hard drive space) •Memory, 512 MB of RAM or more•CD ROM or DVD drive•SVGA graphic card (1024 x 768) or higher resolution adapter & monitor•32 bit Sound Blaster compatible sound card & speakers• 1 to 4 USB ports, depending on thedesired number of MyoTrac Infinitiencoders•Mouse or compatible pointing device •MS Word 97 or higher (for printingpurposes)•Compact Flash Reader (For use with compact flash card only)•Webcam 30 frames per second (for video purposes only)NOTE: When using certain more complex screens, you must adhere to the Recommended Computer Requirements.••IBM PC compatible(Intel/Pentium/Celeron family or AMDK6/Athlon/Duron family, CPU P3speed 1.8 GHz), Desktop or Laptop •Windows 2000/XP Professional or Home edition.•10 - 20 gigabytes hard disk space •(The software needs 2.5 gigabytes to install and run on available hard drivespace)•Memory, 256 MB of RAM or more •CD ROM or DVD drive•SVGA graphic card (1024 x 768) or higher resolution adapter & monitor •16 Bit Sound Blaster compatible sound card & speakers• 1 to 4 USB ports, depending on the desired number of MyoTrac Infinitiencoders•Mouse or compatible pointing device •Word 97 or higher (for printingpurposes)NOTE: For most recent computer requirements contact Thought Technology Ltd for MAR473Update informationPeriodically updates may become available for the BioGraph Infiniti software and for the MyoTrac Infiniti Hardware. Please contact your local distributor or visit our website for further information on how to obtain updates.MyoTrac Infiniti Components•Compact Flash for increased memory capacity and one method for transfer of data to the PC.•USB for real time transfer of data to the PC.•Touch screen enables graphically guided navigation through the software.•Rugged Ergonomic Case, easy to hold or attach to the subject and will withstand the rigors of daily use.•Battery Charging jack for wall connection enables fast built-in battery charging.•Headphone Jack for stereo sound feedback (or use the built-in speaker).•Push button On/Off switch to prevent accidental switching.• 2 Channels of Surface EMG.PowerThere are three basic methods to power the MyoTrac Infiniti unit: Inserting batteries into the battery compartment of the unit, plugging it into the wall using the supplied AC adapter, or plugging it into a powered up computer using a USB cable.The MyoTrac Infiniti is available with battery charging capabilities. It will work with four standard Alkaline AAA batteries available in all consumer electrical stores. It is also possible to run the unit on removable, externally rechargeable batteries. A rechargeable battery pack is supplied with the MyoTrac Infiniti and can be charged while still inside the unit.Note: When changing batteries it is recommended to plug the unit into external power, either USB or wall transformer so that data is not lost. Failure to supply external power will result in data and script loss.The battery compartment cover slides open by pushing up using the notch provided. Place four AAA batteries in the slots, observing the polarity as illustrated. Please note that a diagram of the correct battery polarity is embossed on the inside surface of the compartment.Alternatively it is possible to use a rechargeable battery pack (Thought Technology Part Number MI1028). This battery pack is plugged into the connector in the battery compartment marked BATT. The pack then fits into the normal battery area. Note: only use battery packs from Thought Technology or authorized representative, as use of other battery packs will damage the device.A wall mounted AC power adapter, supplied with the MyoTrac Infiniti, is used to connect the unit toan electrical outlet. This can be used in conjunction with the batteries or without.The unit can also be powered from the computer via the USB cable. The cable is connected to the unit on one side and on the other side to the USB port of the computer. This can be used inconjunction with the batteries or without.Charging the BatteriesNote: exact power supply subject to change without notice.Internal ChargerIf your MyoTrac Infiniti was supplied with a wall mounted AC adapter it is possible to charge the battery pack while it is inserted in the device.Note: Only use Thought Technology Ltd supplied wall mounted chargers with this device. Failure to do so could result in potential injury. Use only GlobTek Part Number WR9אB2500LCP-Y-MED where א= 2 for North America, א=3 for Europe, א=5 for United Kingdom and א=7 for Australia with the exception of Japan where the part number is GS 889.To start the charging plug in either the wall mounted AC adaptor or the USB cable. A full charging cycle from fully empty to fully charged will take approximately 2hrs for AC adaptor and 5.5hrs for the USB cable. The unit can be used while plugged in to either power source. The charging cycle does not need to be completed in full; it can be stopped at anytime by removing the connector.When the unit is turned off while plugged into an external power source, the screen displays a battery symbol. Charging action is shown with an animation of the battery filling up. When the battery is fully charged, the symbol shows a full battery.If the unit is plugged into an external power source while it is turned off, it will start charging within one minute.The state of the battery charging is available by going to the power menu in the settings menu of the device. It indicates the current mode of power and whether the unit is currently charging the batteries.Note: The rechargeable batteries must be fully charged prior to initial use. In order for the batteries to reach full capacity it may be necessary to charge them several times (~2-8) after initial use.MemoryRecorded data can be saved using three methods - choose the one which most closely matches your usage needs. To select saving method, select the Settings menu from the main menu, and tap on the Save icon.•Internal Memory – Limited size, only the statistical summaries are recorded. Specifically, the statistics for 13 open sessions or 9 training sessions (work/rest) or 6 assessment sessions(work/rest + fast-flick + endurance) can be recorded. Data can be lost if the batteries areremoved from the unit for longer than a few minutes.•Compact Flash Card – Most flexible method of data saving: save all the raw data for review on the encoder or for download to the PC. Available in most electronics stores in a range ofmemory sizes. Since all EMG data is recorded, the amount of data that is saved to thecompact flash card depends on the size of the card:hours64MB 1.75128MB 3.5 hours256MB 7 hours512MB 14 hourshours1GB 27.5hours2GB 55.5The encoder is delivered with a protective insert in the compact flash slot. To remove it, push the button next to the slot once to eject the card. The CF card can then be inserted; you willnotice that the CF card can only be inserted one way into the encoder to protect from incorrect insertion. When inserted properly it will be flush with the encoder rear. Follow the procedure above to remove this card when no longer required, and re-insert the protective insert. CFcards require a CF card reader to transfer data to the PC. The CF cards and reader can bepurchased from most computer stores. Before its first use in the encoder, a CF card requires PC formatting using the file manager, then format the card using the BioGraph Infiniti MainApplication. Formatting and transferring CF data to the PC is covered in depth in theBioGraph Infiniti software manual.•Real Time PC Transfer – Connect to the PC via the USB and save and display the data on the PC in real time. See the following section “Connection to the PC”.Attention: Do not remove the CF card without first stopping recording. If the CF card is removed during recording, you will lose all the data for the current session.TappingLike using a mouse on a computer screen the MyoTrac Infiniti allows you to use your finger or a stylus to tap the buttons directly on the screen. The first time you start your handheld unit, or if the power has been disconnected for a while, you will be guided through a set of welcome screens including calibration, time and date setting. The calibration aligns the internal circuitry of theencoder with its touch sensitive screen so that when you tap a button on the screen, the handheld unit can detect exactly which button is being pressed. It is recommended to use a stylus when calibrating the device as it will provide a more accurate calibration than using a finger.Note:Always use a finger or stylus for tapping the screen. Never use a pen, pencil or othermarking or sharp object on the screen.Damage resulting from misuse of the screen is notcovered by the warranty.The software is designed so that once the screen has been calibrated it is possible to use all the buttons with a finger. In many cases the touch sensitive area is greater than the graphicalconstraints of the button allowing for easier operation using a finger. As necessary wipe screen with a dry cloth to clean. Screen protectors are available from good stationary suppliers and are a good way to extending the life of your screen.Connection to the ClientDepending on the type of session you are going to record there are different ways to connect the two channels to the client. Either plug the extender cable into the device directly and connect to the client with EMG electrodes, or plug them into the pre-amplifier and the pre-amplifier into the MyoTrac Infiniti.Attention: When you insert the extender cable (lead wire) into the electrode connector, MAKE SURE THAT NO BARE METAL OF THE PINS IS EXPOSED.Before applying electrodes, be sure the skin surface is cleaned and dried. Make sure theelectrodes are placed firmly to the skin and make good contact between the skin and electrodes.Please consult the clinical guide for information on electrode selection for different placements. The illustration below shows the division of the body into six areas of treatment.Arms and ShouldersHead and NeckAbdominalsBack and ButtocksLegs and HipsWhen connecting a sensor or extender cables, be sure to properly line up the guiding dot on the top of the plug with the notch in the encoder's input socket. Forcing the plug into the jack in any other position may damage your equipment.Using the MyoTrac Infiniti with AC Power Adapter or Connected to a PCThe MyoTrac Infiniti is designed for safe operation on ungrounded AC power sources. However, if you are using the MyoTrac Infiniti while it is connected to an ungrounded AC power source, for best results you may need to follow some simple guidelines for skin preparation and electrode placement. These measures will help to avoid falsely elevated EMG readings while the muscle is at rest.If you notice elevated resting EMG levels not related to the patient’s condition, and if this occurs only when the unit is connected to AC power (directly via the supplied AC adapter or indirectly via a USB connection to the PC), and if it is necessary to run the MyoTrac Infiniti on ungrounded power(i.e. no 3rd ground pin on the AC wall socket or on the PC power supply), try the followingtechniques to improve the readings.First, if you are using a PC with only 2 prongs on the wall plug and you have a grounded outlet (3 pin wall sockets with a working ground), plug the ac adapter into the MyoTrac-Infiniti and into the grounded outlet to provide a ground for the system.If you have no opportunity to ground either the PC or the AC adapter, use the following electrode placement tips:•If the EMG site is located on an extremity or limb, be sure to place the REF (black colored) electrode more proximally (on or closer to the trunk of the body) than the sense electrodes(yellow and blue), and at least ten centimeters away from either sense electrode.•Prepare the skin under all three electrodes, using a product designed for skin preparation prior to electrode application (mild abrasives such as NuPrep are effective).•If you are using Ag/AgCl (silver/silver chloride) electrodes, put some conductive electrode paste or cream on them before applying them to the skin, or try using gel-type rather than dry Ag/AgCl electrodes.Resting EMG readings will not be affected by connection to AC power, in the following cases:•Running the MyoTrac Infiniti stand-alone, with no AC power adapter and no connection to the PC (only on its rechargeable batteries).。

生物反馈仪生物反馈仪生物反馈仪（Biofeedback）是一种测量和反馈生理信号并调节身体反应的治疗性技术，能够帮助人们通过训练来增强身体和心理的自我调节能力，治疗多种疾病和症状，如焦虑、压力、头痛、高血压、失眠、肌肉紧张等。

生物反馈仪通过感知和监测人体内部活动，如心率、呼吸、肌肉张力、皮肤电阻等生理变化，将这些变化以可视化或听觉形式呈现出来，反馈给被训练者，从而使其更好地掌握和管理自身的生理状态。

生物反馈仪的使用生物反馈仪有多种形式，包括电动机反馈、心电图反馈、肌肉张力反馈、皮电反应反馈等，可以在医院、家庭或者办公室等多种环境下使用，且操作简单、无需手术等副作用，不仅能够帮助治疗疾病，而且对身体健康和心理健康的保护，也有一定的作用。

常见的生物反馈仪包括电动机反馈仪和心率变异反馈仪。

电动机反馈仪电动机反馈仪（EMG）主要用于减缓肌肉紧张和疼痛缓解，在一些骨科、神经病学等临床治疗中得到广泛应用。

EMG反馈仪可以监测肌肉收缩和放松的程度，通过电极贴附在肌肉表面，将肌肉的收状况反馈给使用者，促进其改变肌肉的紧张和放松程度，达到减轻疼痛和肌肉紧张的目的。

心率变异反馈仪心率变异反馈仪（HRV）主要用于调节身心紧张及应对压力，在生理、心理、康复等方面得到应用。

HRV反馈仪可以测量人体自主神经系统对心率的控制，通过呈现心跳率的波动，引导使用者通过平静的呼吸和放松的心态来达到心跳率的平稳，进而减轻压力和焦虑，促进身体和心理的平静。

生物反馈仪的优缺点优点生物反馈仪治疗具有以下优点：1. 非侵入性：生物反馈仪治疗不需要手术或使用药物，不会产生副作用和不良反应，治疗过程安全无害。

2. 自我调节：生物反馈仪训练可以帮助人们增强自身的调节能力，通过练习，训练人们自我调节身体和心理反应，使其保持平稳。

3. 针对性强：生物反馈仪训练可以根据个人实际情况进行调整，实现针对性治疗。

缺点生物反馈仪治疗也有一定的缺点：1. 训练周期较长：生物反馈仪训练的效果需要通过长时间的训练才能够得到体现，在训练过程中需要大量的精力和时间投入。

ASE1000型（便携式）生物功能反馈仪1.1设备操作前的准备工作及通电初始化在接通工作电源之前，应确定机器内置电池有足够的电量。

如果电池不足时，请使用随机附件交流电源适配器给电池充足电，电源适配器使用的交流电源应符合以下规格： AC(220±22) V 、（50±1）Hz 。

把信号导联电缆线插头与治疗仪后盖板上CH 插座相连接。

1.1.1 松开裤带，露出腹外斜肌部分，先进行必要的皮肤清洁处理。

建议采用如下方法：●如有需要，可剃掉电极片粘贴处的毛发。

●使用医用酒精彻底将电极片粘贴处皮肤擦干净。

（有条件最好使用肥皂水擦洗后用清水擦干，因为使用乙醚或纯酒精会增加皮肤表面的电阻，降低信号灵敏度）。

●用力擦干，以增加组织中的毛细血液流动并去除皮肤屑与油。

注意：腹肌电极片与心电图机一次性使用电极片相同，为一次性使用的附件，使用后应作为医学废物妥善处理。

然后把腹肌电极片依次粘贴在腹外斜肌皮肤表面，相互距离大至均匀（位置见上图10），并用手轻轻按压，以保持三个电极片与皮肤表面接触完好。

电极导联线按图10所示颜色红、黑、白分别与电极片搭扣扣紧。

注意：排列顺序为黑色居中，红、白两个电极在上、下两侧对称排列。

图10、腹肌电极片粘贴示意图1.1.2将经2%戊二醛消毒液浸泡30分钟后的肛直肠肌电极用生理盐水冲洗，均匀涂敷医用润滑剂（医用石蜡油），把该肛直肠肌电极与肛电极插头连接好（见肛电极防水插座连接示意图11），然后把肛电极轻轻插入肛门内见图13。

图11、肛电极防水插座连接图注意：肛电极防水插座上带有定位槽，肛电极插头带有锁扣，在插拔肛电极插头时要按住锁头按钮对准定位槽插拔，否则可能会损坏插头。

图12、肛电极插入肛门的位置1.1.3、按下面板上的电源开关键，接通电源，电源指示灯亮，显示屏上出现下图所示开机界面。

图13、开机界面 图14、设定训练参数1.2 参数设定显示屏上出现开机界面3秒后，显示屏上出现图14设定训练参数界面，按“OK ”键进入图15主菜单界面。

生物反馈治疗仪（多功能神经康复诊疗系统）技术参数
数量：2台预算：6.4万元
1、嵌入式计算机系统、医用隔离电源（4000V隔离安全标准）
2、嵌入式彩色液晶显示器
3、内置扬声器
★4、EMG放大器灵敏度：2～1000μV
5、刺激波形：方波
6、输出电流：0mA～50mA可调，恒流且安全锁定；
7、刺激频率：1Hz～250Hz
8、脉冲宽度：50～600μs
9、最大刺激持续时间：60S
10、多媒体语音系统
11、支持人工外触发功能
12、具有自动检测、自动报警功能
★13、六种治疗模式，包括：
（1）PBF1、PBF2模式（小肌群，大肌群）
（2）NBF模式（多媒体生物反馈）
（3）TENS1模式（感觉型障碍及神经促通治疗）
（4）TENS2模式
（5）ESFN（小脑顶核仿生电刺激，又称脑循环治疗）
14、可通过NBF模式分析表面肌电峰值、平均值及面积，方便对训练过程效果进行观察及评
估
15、训练中采用柱状图指引，以0-200分级表达，增加训练者参与的趣味性
16、治疗过程包括休息、用力、刺激、维持（功能位）四种状态构成的“闭环”显示及治疗
过程的时间进度条，使整个治疗过程更加目标化
★17、支持处方预置及后台设置系统，可避免仪器使用中的误操作
18、资质要求：所投设备具有医疗器械注册证，投标商具有医疗器械经营许可证或医疗器械生产许可证。

19、整机保修期≥2年
20、提供耗材及零配件供货价格供业主参考
21、供货期：合同签订后10日以内。

一多参数生物反馈治疗仪1套一、多参数生物反馈治疗仪1套信号采集器参数：脑电（EEG）、肌肉（EMG）、皮温(ST/BT)、心电(ECG)、心率(HR)、呼吸(RESP)、血氧饱和度(SpO2)、皮电（SC）八个参数1、脑电(EEG):1)电压测量：电压测量误差应不超过±10%范围。

2)共模抑制比：各通道≥80dB。

3)噪声电平应≤5μVp-v。

4)耐极化电压：以峰谷值100μV、周期1s标准方波的幅值为基准，加±300mV 直流耐极化电压后，幅值偏差不超过标准方波的±5％范围。

5)时间间隔：误差不超过±5％范围。

(国家必检项目)6)脑电电极的生物相容性（国家强制性必检项目）：与患者接触的材料应无细胞毒性、迟发型超敏反应和皮内反应。

该材料必须进行生物相容性的试验或评价。

细胞毒性:≤1级。

迟发型超敏反应：无迟发型超敏反应。

皮内反应:试验样品和溶剂对照平均积分之差≤1.0。

2、肌电(EMG):1）测量范围：为1μV～5000μV。

误差不超过±10%范围。

2）输入噪声：小于1μV。

3）共模抑制比：大于100dB。

3、皮电（SC）：1）测量范围：为40kΩ～4MΩ，误差不超过±10%范围。

4、心电（ECG）：1）输入电压范围：≥5mV，误差不超过±10%范围。

2）耐极化电压：加±300mV直流耐极化电压后，幅值偏差不超过标准方波的±5％范围。

3）共模抑制比：大于80dB。

5、心率（HR）：1）范围：为30～250（次/min）；2）误差：为±1%或±1次/min；6、血样氧饱和度（SpO2）：1）测量范围：为0%～100%；2）分辨率：为1%；3）测量误差：在80%～100%范围内精度为±1% ；在80%以下仍能正常显示。

7、皮温(ST/BT)：1）测量范围：为15℃～40℃；2）在15℃～40℃时，精度为±0.1℃；3）反馈时显示分辨率：为0.1℃；4）测温稳定性：不大于±0.1℃。

生物刺激反馈仪要求及技术参数
一、主要功能描述
主要用于产后神经肌肉功能障碍的康复治疗。

满足产后常见症状的治疗，包括：子宫复旧、产后尿潴留、产后下肢水肿、盆腔供血不足、卵巢保养、乳腺疏通、淡化妊娠纹、腹直肌分离、腰背痛、肌肉酸痛等
二、主要技术参数
1.内置彩色触摸屏，可在触摸屏上直接操作
2. 电刺激波形：双向平衡波，刺激舒适，增强患者依从性
3.物理通道数：4独立通道，每个通道可以实现电刺激和生物反馈
4.AD采样率：≥4096Hz
5.刺激强度：0mA～100mA
6.刺激频率：2Hz～100Hz
7.脉冲宽度：50μs～400μs
8.肌电测量范围：1μV～999μV（r.m.s）
9.最高分辨率：小于0.2μV（r.m.s）
10.输入噪声：小于1μV（r.m.s）
11.通频带：30Hz～450Hz
12.差模输入阻抗：大于5MΩ
13.共模抑制比：大于100dB
14.内置电源+外接电源，双供电模式，满足不同临床应用场
15.移动推车+手提箱的完美设计，满足床边和出诊的不同需求
16.多种产康方案，满足产后常见症状的治疗，包括：子宫复旧、产后尿潴留、乳腺疏通、腹直肌分离、腰背痛、肌肉酸痛等。

技术参数产品名称：生物刺激反馈仪产品型号：SA9800产品配置：便携版产品技术要求及参数：一、适用范围（注册证上有说明）：对患者的体表肌电信号进行采集、分析和反馈训练，可以对患者的肌肉施加电刺激来帮助诊断和恢复患者的肌肉功能障碍二、硬件参数：1.进口产品2.EMG灵敏度：0.1uV ；3.输出电流：0－100mA(1KΩ)4.脉冲宽度：50－400uS5.频率：2－100Hz6.上升和下降时间：0－10S7.波形：Balanced Biophasic双相平衡波8.*触摸控制屏9.*两种存储方式（内部存储器、CF卡），两种传输方式（CF卡，CF卡至PC）三、软件参数：1、*内置嵌入式软件Open Session和Script Session两种工作模式，可根据不同的病情设计有效治疗方案2、*内置100种以上的治疗方案，可自定义治疗方案并可储存。

3、方案化神经肌肉电刺激：按人体肌肉的类型不同分为六大部分上肢、头颈、腹部、背部、下肢、盆底，设定不同的参数，包括频率、波宽、电流通断比时间。

4、方案化的神经肌肉肌电触发电刺激：按人体肌肉的类型不同分为六大部分上肢、头颈、腹部、背部、下肢、盆底，设定不同的参数，包括频率、波宽、电流通断比时间。

5、肌电触发电刺激的模式要求：（3种模式）可进行阈值上刺激也可进行阈值下刺激的参数设置。

A、手动模式：可自主设定阈值，在可随时在治疗中进行阈值的调整。

B、自动模式：阈值在机器检测到表面肌电信号后，智能调整阈值，以适应患者的训练要求。

C、交替式反馈电刺激模式：主动表面肌电反馈训练结合电刺激，二者循环交替。

休息阶段给予电刺激，让患者感觉肌肉产生收缩时真实的感觉。

在工作阶段中，患者需要主动去模仿被动电刺激产生的收缩动作。

通过这种主动和被动结合的反复训练，能够强化肌力，并且让患者重新学习自然的收缩肌肉。

6、可搭配相应的盆底电极进行盆底神经肌肉电刺激和肌电触发电刺激的治疗盆底神经肌肉功能障碍。

生物反馈仪设备技术参数及配置要求1、根据生物反馈原理，适用于焦虑症等神经精神疾病的生物反馈治疗。

用于临床治疗时，无禁忌症。

2、zigbee传输无线型披戴式传感器：披戴式传感器内置锂电池，每次治疗同时集合化采集sEMG信号与BVP两个信号,采用无线传输模块，使用者可不受任何干扰的移动，方便团体训练中成员互动，在100米范围内可随意活动。

3、物理通道信号处理器，同时采集HRV及EMG信号，实时反应心理与身体的压力与放松情况，亦可进行生物反馈训练。

支持升级到20通道，可满足20人同时治疗。

4、可同步监测2人指标；可进行2人的生物反馈治疗。

5、状态指示灯：无线型披戴式传感器具备心理状态指示灯功能，位置位于前额的状态指示灯，便于治疗师通过心理指示灯的不同显示实时的直接观测到每一个使用者即时的心理状态；心理状态指示灯可实时随放松指数的不同变换红、蓝、绿等不同颜色，以直观显示不同的心理状态。

6、AD采样位数：≥14 Bit7、AD采样率：128~256Hz8、sEMG测量范围：1~200μv9、sEMG最高分辨率：≤0.2μv10、sEMG输入噪声：＜1μv11、sEMG通频带：25~450Hz12、表面肌电反馈通道差模输入阻抗：＞5 MΩ13、sEMG共模抑制比：＞100 dB14、阻抗测试：有15、Heart Rate测量范围：40~140bmp，BVP测量范围：0~100%16、无线模块参数：工作电压＋3.3V,工作电流≤20mA17、基线测试，多人同时测试，时间五分钟，自动生成测试数据报告，内置通用参考常模，并可选用标准压力评估等评估形式。

18、技能训练模式：脑呼吸训练、雅克布逊式肌肉放松、意象式音乐治疗、萨提亚式冥想等构成。

19、团体训练模式：2人团体协作式训练方案，使参加团体训练的所有成员，可以保证同一时间互动。

团体训练时，2人同时控制同一训练界面，并可以进行成员互动式训练，即在同一训练界面中拥有竞争式互动或协作式互动。

生物刺激反馈仪技术参数1、*主机：原装进口，包括主机（含嵌入式软件）、上位机软件、电源适配器、USB数据传输线、阴道电极、直肠电极、贴片电极等。

2、*产品适用范围：对患者的体表肌电信号进行采集、分析和反馈训练，可对患者的肌肉施加电刺激来帮助恢复患者的肌肉功能障碍。

同时必须有阴道电极的独立注册证，要求是生物反馈类仪器。

3、硬件要求3.1专用的信号采集及刺激器，既可采集盆底表面肌电（SEMG），也可同时电刺激（Stim），还可进行肌电触发电刺激（EMG Trigger Stim）；3.2具有动态存储功能，表面肌电采集及刺激器支持内置CF卡，支持数据的动态存储；3.3刺激器内置嵌入式软件，采用触摸屏操作方便快捷，并可直接在刺激器中编辑治疗方案；3.4电极接触不良时有自动断电的保护功能；*3.5该系统具有肌电触发—神经肌肉刺激模式（EMG Trigger Stim），来帮助患者提高主动运动的表现，在盆底肌肉障碍中帮助患者进行主动和被动相结合的治疗，重建中枢对盆底肌肉的控制3.6单机也可进行生物反馈训练，对人体的而不同部位的肌肉预置了标准的监测参数和工作流程，用户可以根据需要在列表中选择监测和电刺激部位，并且可以修改训练方案。

3、硬件参数要求4.1 内置放大器带宽：30-450 Hz4.2 表面肌电灵敏度：0.2uV4.3 输出电流：0-100 mA4.4 刺激频率：≤100Hz 2-100Hz 可调整4.5 刺激波宽：≤400μs 50-400μs 可调整4.6 具有产妇专用放松训练的SEMG电极，SEMG头带实时采集肌肉紧张及放松度，进行放松训练，采集灵敏度小于0.2uV。

4.7 刺激上升和下降时间：0-10s4.8 波形为平衡生理波，相同的刺激电流强度疼痛感更小。

5、软件配置5.1 专用嵌入式的软件系统，具有开放式训练模式，标准化训练模式，数据库管理模式，单机可以直接进行数据采集，电刺激治疗，生物反馈训练；*5.2 具有专用的盆底表面肌电采集，分析，评估功能，具有国际通用标准的Glazer 评估软件（运营在BioNeuro Infiniti平台上），具有欧洲生物反馈协会（BFE）认可的数据库和授权书；*5.3 具有系统开发工具，可自定义动画、可自行更换音乐，可以根据用户的需求自行定义新的治疗和评估方案，该开发工具包括三个，数据通道编辑软件Channel Editor ，界面编辑软件系统Screen Editor，训练和评估方案编辑系统Scrit Editor；5.4具备多媒体肌电生物反馈训练，可进行音乐反馈和动画反馈，包括肌肉放松训练，肌力增强训练，肌肉协调性训练，肌肉精准性训练、肌肉耐力训练；5.5显示表面肌电原始波形，RMS值，并且对原始波形进行二维和三维频谱图分析；5.6统计表面肌电图的最大值，最小值，标准差，平均值等，进行肌肉的功能状态的评估，记录原始数据。

生物反馈治疗仪（多功能神经康复诊疗系统）技术参数
数量：2台预算：6.4万元
1、嵌入式计算机系统、医用隔离电源（4000V隔离安全标准）
2、嵌入式彩色液晶显示器
3、内置扬声器
★4、EMG放大器灵敏度：2～1000μV
5、刺激波形：方波
6、输出电流：0mA～50mA可调，恒流且安全锁定；
7、刺激频率：1Hz～250Hz
8、脉冲宽度：50～600μs
9、最大刺激持续时间：60S
10、多媒体语音系统
11、支持人工外触发功能
12、具有自动检测、自动报警功能
★13、六种治疗模式，包括：
（1）PBF1、PBF2模式（小肌群，大肌群）
（2）NBF模式（多媒体生物反馈）
（3）TENS1模式（感觉型障碍及神经促通治疗）
（4）TENS2模式
（5）ESFN（小脑顶核仿生电刺激，又称脑循环治疗）
14、可通过NBF模式分析表面肌电峰值、平均值及面积，方便对训练过程效果进行观察及评
估
15、训练中采用柱状图指引，以0-200分级表达，增加训练者参与的趣味性
16、治疗过程包括休息、用力、刺激、维持（功能位）四种状态构成的“闭环”显示及治疗
过程的时间进度条，使整个治疗过程更加目标化
★17、支持处方预置及后台设置系统，可避免仪器使用中的误操作
18、资质要求：所投设备具有医疗器械注册证，投标商具有医疗器械经营许可证或医疗器械生产许可证。

19、整机保修期≥2年
20、提供耗材及零配件供货价格供业主参考
21、供货期：合同签订后10日以内。