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Table 1 - Emission

Phenomenon

Compliance

Electromagnetic environment

RF emissions

CISPR 11

Group 1, Class B

Home healthcare environment

Harmonic distortion

IEC 61000-3-2

Class A

Home healthcare environment

Voltage fluctuations

and flicker

IEC 61000-3-3

Compliance

Home healthcare environment

EMS Compliance Table (Table 2-4)

Table 2 - Enclosure Port

Phenomenon

Basic EMC

standard

Immunity test levels

Home healthcare environment

Electrostatic

Discharge

IEC 61000-4-2

±8 kV contact
±2kV, ±4kV, ±8kV, ±15kV air

Radiated RF EM field

IEC 61000-4-3

10V/m
80MHz-2.7GHz
80% AM at 1kHz

Proximity fields from

RF wireless

communications

equipment

IEC 61000-4-3

Refer to table 3

Table 3 – Proximity fields from RF wireless communications equipment

Содержание BIO-06A

Страница 1: ...feedback Therapy Device Biofeedback Probe Model BIO 06A Wireless Charging Cradle Model MWCC 01A Instructions for use 2020 07 01 revised Version V1 4 Document No MD E1 04 Ningbo MedKinetic Medical Devi...

Страница 2: ...rging the device 8 2 3 Turning the device on and off 10 2 4 Initiating the biofeedback training 11 2 5 Performing the biofeedback training 13 Chapter 3 Product Maintenance 15 3 1 Cleaning 15 3 2 Devic...

Страница 3: ...using the information below Contact Us Name of Registrant Ningbo MedKinetic Medical Device Co Ltd Address Lushan West Road 167 8 Ningbo Free Trade Zone South 315806 Ningbo China Phone 86 574 86808886...

Страница 4: ...gh the website of Ningbo MedKinetic Medical Device Co Ltd and download the required technical documents from the download center The conventions about the icons in the manual are as follows Tip This i...

Страница 5: ...ther safety information of the PelPal device in detail This is the best starting point for new users to start using and master the use of BIO series biofeedback therapy devices The following symbols w...

Страница 6: ...arger and product charging are dry When the product or charger may be submerged in water it can not be used for charging Do not use other therapeutic instruments while using this machine Do not use th...

Страница 7: ...e of flammable anesthetic gas mixed with air or flammable anesthetic gas mixed with oxygen or nitrous oxide The probe is scrapped The probe contains lithium batteries Please recycle according to the s...

Страница 8: ...harging cradle 1 USB charging cable 1 USB power adapter Purchased separately Instructions for Use 1 Android application software Downloaded by user 1 2 Key components The PelPal device consists of a b...

Страница 9: ...s are inserted in the subject s anorectal area to detect the pressure of the rectum and anal sphincter when the subject is performing a simulated defecation or clamping the anus as shown in Figure 1 2...

Страница 10: ...a smartphone with Android operating system The app is used to provide data interactive interface for subjects during biofeedback training The app provides two training modes which are suitable for th...

Страница 11: ...you need to know the past training achievements you can browse the historical data on the app software and watch the entire training process which can provide you with rich information for the next tr...

Страница 12: ...neatly placed At this time the charging function is performed between the biofeedback probe and the wireless charging cradle and the charging status indicator flashes on the handle of the biofeedback...

Страница 13: ...ubject adjusting the posture training was started and the training mode was entered The subject adjusted the anorectal simulation training action according to the mobile app content prompts Training l...

Страница 14: ...AC100 240V 50 60Hz power socket as shown on Figure 2 2 Figure 2 2 Charger and USB data cable connection Once the charger is powered on the charge indicator on the probe will light up It takes about 2...

Страница 15: ...switch activation slot Figure 2 3 Base of the wireless charging cradle Turning on the probe of the Close the magnetic switch at the end of the probe handle to the probe switch activation slot on the b...

Страница 16: ...robe is off 2 4 Initiating the biofeedback training When the probe is turned on press the BioFeedback icon to proceed to the biofeedback training login interface For first time use you need to registe...

Страница 17: ...ion and click to start parameters are default Click the recording baseline and click Start Figure 2 5 Sequence of operations Figure 2 6 Training screen You could complete one training by default which...

Страница 18: ...anorectal coordination training functional constipation rehabilitation training You can inhale deeply and feel that the lower part of the thorax slowly expands to both sides Relax the abdominal muscle...

Страница 19: ...g training The game bird on the mobile phone represents anal pressure and the height of the bird flying represents training Anal clamping pressure The goal of enzyme washing training to control the cl...

Страница 20: ...and wipe the probe Let the probe dry completely before placing it in the charging case 3 2 Device storage Put the device in the cradle and put it in a safe place Please do not place heavy objects on t...

Страница 21: ...um battery and electronic components The charging box has a charging coil It is recommended to dispose of it as a general medical device waste 3 4 Expected service life 3 years 3 5 Application Envirom...

Страница 22: ...ed probe not properly seated in the probe is placed flat probe wirelessthe charging tank phone can not connect is not on the probe the probe opening magnetic switch is not turnedBluetooth phone to ope...

Страница 23: ...18 Chapter 5 Therapy scope indications and contraindications 5 1 Therapy scope The device is suitable for the treatment of functional constipation or fecal incontinence...

Страница 24: ...ctal stimulation 5 3 Contraindications Patients have recently undergone colon rectal and anal surgery patients are allergic to silicone because the biofeedback probe outsourcing material is silicone p...

Страница 25: ...nditions is not covered by the warranty but can be repaired for a fee the warranty period is exceeded the user disassembles the machine by himself and the structure of the machine is artificially dama...

Страница 26: ...any name Ningbo MedKinetic Medical Device Co Ltd Company address Lushan West Road 167 8 Ningbo South Free Trade Zone 315806 Ningbo Telephone 86 574 86808886 Fax 86 574 86808885 website http www medkin...

Страница 27: ...t adjacent to or stacked with other equipment should be avoided because it could result in improper operation If such use is necessary this equipment and the other equipment should be observed to veri...

Страница 28: ...nce Home healthcare environment EMS Compliance Table Table 2 4 Table 2 Enclosure Port Phenomenon Basic EMC standard Immunity test levels Home healthcare environment Electrostatic Discharge IEC 61000 4...

Страница 29: ...28V m 1845 1970 2450 2400 2570 Pulse modulation 217Hz 28V m 5240 5100 5800 Pulse modulation 217Hz 9V m 5500 5785 Table 4 Input a c power Port Phenomenon Basic EMC standard Immunity test levels Home he...

Страница 30: ...ofeedback Therapy Device Model BIO 06A Power supply Power Internal battery Battery type 3 7V Lithium Polymer Battery 200mAh Wireless charging with cradle DC5V 500mA custom USB charging cable is includ...

Страница 31: ...Pa Electric shock Internally Powered Equipment type BF Applied Parts IP Rating IP27 Classification of safety levels Not suitable for is in the presence of flammable mixtures No Ap apg Running mode Con...

Страница 32: ...e reasonable protection against harmful interference in a residential installation This product generates uses and can radiate radio frequency energy and if not installed and used in accordance with t...

Страница 33: ...28 This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment...

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