Ningbo BIO-06A, Instructions For Use Manual

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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