PelPal Biofeedback 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 Device Co.
Table of Contents Company information ......................................................................................................................................... 1 Indications for Use .............................................................................................................................................. 1 Safety warnings and precautions ........................................................................................................................
Dear Customers: Thank you for choosing our product. For your convenience, please read the instructions carefully and follow all instructions. If you experience any problems during the device use, please contact us by phone or mail, 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 Email: PELservice@medkinetic.com Website: www.medkinetic.
Company information The customer service center at Ningbo MedKinetic Medical Device Co., Ltd can provide help to customers who encountered problems while using the product. Please go to http://www.medkinetic.com for support. In addition, customers can keep up-to-date with the latest product developments through the website of Ningbo MedKinetic Medical Device Co., Ltd. and download the required technical documents from the download center.
Indications for Use The PelPal biofeedback therapy device is an Over-The-Counter Class II medical device intended to treat constipation and fecal incontinence. It is to be used by adults only. This manual will introduce the performance, operation methods and other 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.
Safety warnings and precautions Precautions for use Please read this manual carefully first and always follow the operating instructions.
• • • • • • • • When the power cord is damaged, please do not dismantle and replace it privately, please contact the dealer or qualified professional to replace and repair Do not use in strong electromagnetic radiation environments, such as portable communication equipment other than mobile phones used in conjunction with this product; Do not use in an oxygen-rich environment; Do not use it at an altitude of more than 3000 meters; Do not forcefully pinch or break the biofeedback probe; The product can
Chapter 1 PelPal device and accessories 1.1 List of included parts Part name Quantity Biofeedback probe 1 Wireless charging 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 biofeedback probe, a wireless charging cradle with a protective cover and a USB data cable, an APP. as shown in Figure 1.1.
Biofeedback probe protective cover wireless charging cradle USB data cable Figure 1.1 Composition of PelPal device 1.3 Biofeedback probe The biofeedback probe consists of a handle with sensors. The probe sensors 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. Probe sensors Probe indicator Hall switch Probe handle Figure 1.2 Biofeedback Probe 1.
use, as shown in Figure 1.3. Biofeedback probe Hall swith Probe wireless charging placement slot Probe switch activation slot wireless charging cradle Figure 1.3 Wireless charging cradle 1.5 Android App The app needs to be installed by the user on a smartphone with Android operating system. The app is used to provide data interactive interface for subjects during biofeedback training.
If 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 training.
Chapter 2 Directions For Use 2.
● power the probe, by placing it in the slot on wireless charging cradle for about 5 seconds; after activation, the probe indicator lights green; ● subject prepares before training; ● launch the Biofeedback application on the smartphone; ● register a username (first use), and logs in; ● in the selected training mode, connect the probe Bluetooth, And began to record the data and set the data to zero; ● biofeedback probe is inserted into the anorectum, with the subject adjusting the posture; ● tr
Figure 2.1 Placing the probe into the charging slot on the wireless charging cradle. ● Insert the charger plug into the 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 hours to fully charge the battery. After the battery is fully charged, the charging indicator on the probe is steady green.
Caution ◆ The device does not work during charging ◆ Use only the provide medical-grade power adapter ◆ Do not bend or twist the power cord ◆ Keep the probe in the charging box to maintain its battery capacity 2.3 Turning the device on and off ● The physical switch of the probe is a magnetic switch, which is located at the end of the probe handle, as shown in the "magnetic switch" position.
Probe indicator Hall swith Probe switch activation slot Figure 2.4 The position of the activated magnetic switch is shown on the left. Theright is placed ● sensor is turned off when the. The operation mode is the same as when the probe is turned on. When the probe is turned off, the indicator on the probe is off. Caution ◆ Do not pinch the probe to avoid damaging the sensors ◆ After use, turn off the device to prevent depleting the battery 2.
Click training to select dual channels (constipation) 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 requires 30 obstacles,which takes about 30 minutes.
● Hold the probe handle, slowly insert the sensor part of the probe sensor into your anus, and leave the probe handle outside the body. Please insert the sensor part of the probe completely (if you feel discomfort when inserting, please use water-soluble lubricating fluid), fix it, adjust the proper posture of the lying or sitting position, and then click the "start game" button. ● Choose the right exercise position: Most people prefer sitting exercises, holding your phone at your knees.
the birds and fish pass the obstacle, please relax and rest until the next time the birds and fish are reminded 3, 2, 1 again, and then do a simulated defecation action. ● Anus contraction training (fecal incontinence rehabilitation training) If you choose the fecal incontinence rehabilitation training module, you need to do anal clamping (anal lift) during training. The game bird on the mobile phone represents anal pressure, and the height of the bird flying represents training. Anal clamping pressure.
Chapter 3 Product Maintenance 3.1 Cleaning Clean the probe before and after each use. Wipe the surface of the probe thoroughly with soft cloth that is dampened with a warm cleaning solution, such as household soap or mild detergent, which are recommended for cleaning hands and or lightly soiled kitchen items. Do not immerse the probe in a cleaning solution. Finally, rinse the cloth in water, squeeze out the water, and wipe the probe. Let the probe dry completely before placing it in the charging case.
Caution ◆ Do not expose this device to high or extremely low temperature ◆ Do not use this device on children 3.3 Waste Disposal This equipment mainly includes a biofeedback probe and a charging box. The probe contains a polymer lithium 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 Enviroment Home or Hospital.
Chapter 4 Fault analysis and troubleshooting Possible causes approach magneticon / offis not open switch to activate the probeslot on the on / off does not turn the battery runs out charge of the magnetic switchlocation on the probeswitch activation slots, misalignment the aligned position is not plugged is plugged can not be charged probe not properly seated in phone can not connect the probe is placed flat probe wirelessthe charging tank is not on the probe the probe opening magnetic switc
Chapter 5 Therapy scope, indications, and contraindications 5.1 Therapy scope The device is suitable for the treatment of functional constipation or fecal incontinence.
5.2 Indications 4.2.1 Functional defecation disorders; 4.2.2 Fecal incontinence caused by: ● weakened external anal sphincter tone; ● rectal sensory disorders; ● loss of coordination of internal and external anal sphincter responses after stretch rectal stimulation. 5.
Purchase Zip Date User Notice: 1. This product is guaranteed for one year. 2. During the warranty period, if the product has a quality failure, you can directly contact the manufacturer.
Company 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.medkinetic.
Chapter 7 Electromagnetic compatibility Below cables information are provided for EMC reference. Max.
Table 1 - Emission Phenomenon RF emissions Harmonic distortion Voltage fluctuations and flicker Compliance Electromagnetic environment CISPR 11 Home healthcare environment Group 1, Class B IEC 61000-3-2 Home healthcare environment Class A IEC 61000-3-3 Home healthcare environment Compliance EMS Compliance Table (Table 2-4) Table 2 - Enclosure Port Phenomenon Basic EMC standard Electrostatic IEC 61000-4-2 Radiated RF EM field IEC 61000-4-3 Discharge Proximity fields from RF wireless communi
Test frequency Band Immunity test levels (MHz) (MHz) 385 380-390 Home healthcare environment Pulse modulation 18Hz, 27V/m 704-787 Pulse modulation 217Hz, 9V/m 800-960 Pulse modulation 18Hz, 28V/m 1845 1700-1990 Pulse modulation 217Hz, 28V/m 2450 2400-2570 Pulse modulation 217Hz, 28V/m 5500 5100-5800 Pulse modulation 217Hz, 9V/m 450 710 745 780 810 870 930 1720 1970 5240 5785 430-470 FM, ±5kHz deviation, 1kHz sine, 28V/m Table 4 – Input a.c.
0% UT; 0.5 cycle Voltage dips Voltage interruptions At 0º, 45º, 90º, 135º, 180º, 225º, 270º and 315º 0% UT; 1 cycle IEC 61000-4-11 and 70% UT; 25/30 cycles Single phase: at 0º IEC 61000-4-11 0% UT; 250/300 cycles Chapter 8 Technical Specifications Name Model PelPal Biofeedback Therapy Device BIO-06A Power supply Power Internal battery Battery type 3.
Operating/storage/transport temperature 5 to 40℃ Operating/storage/transport humidity 25% to 90% RH Storage/transport atmospheric pressure 70 to 106 kPa 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 Continuous Operation EMC Group 1, Class B Smartphone compatibility Google Android Version 6.0 (or later) with Bluetooth 4.
Chapter 9 FCC Statement This device complies with Part 18 of the FCC Rules. This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) This device must accept any interference received, including interference that may cause undesired operation. Attention that changes or modification not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment.
