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Summary of Contents for Ningbo BIO-06A
- Page 1 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., Ltd...
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Page 2: Table Of Contents
Table of Contents Company information ............................1 Indications for Use .............................. 1 Safety warnings and precautions ........................1 Chapter 1 PelPal device and accessories ......................3 1.1 List of included parts ..........................3 1.2 Key components ............................3 1.3 Biofeedback probe ............................ 4 1.4 Wireless charging cradle ........................... - Page 3 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.com/products/PEL...
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Page 4: Company Information
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. - Page 5 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.
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Page 6: Indications For Use
Safety warnings and precautions Precautions for use Please read this manual carefully first and always follow the operating instructions. Please stay away from children and pets; Don't use in lint, dust, bright light (including sunlight), etc; • Children or people with disabilities need special supervision to use this instrument; •... - Page 7 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; •...
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Page 8: Chapter 1 Pelpal Device And Accessories
Chapter 1 PelPal device and accessories 1.1 List of included parts Part name Quantity Biofeedback probe Wireless charging cradle USB charging cable USB power adapter Purchased separately Instructions for Use 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. -
Page 9: Biofeedback Probe
Biofeedback protective probe 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. -
Page 10: Android App
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. - Page 11 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. — 6 —...
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Page 12: Chapter 2 Directions For Use
Chapter 2 Directions For Use 2.1 Preparing the device for the first use ● Open the product package, remove the product and accessories; ● open Biofeedback Protective cover on the wireless charging cradle, clean and stick the fixed probe and the auxiliary sticker on the charging box; ●... -
Page 13: Charging The Device
● 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; ●... - Page 14 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 ●...
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Page 15: Turning The Device On And Off
◆ 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 ●... -
Page 16: Initiating The Biofeedback Training
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. - Page 17 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.
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Page 18: Performing The Biofeedback Training
● 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"... - Page 19 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.
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Page 20: Chapter 3 Product Maintenance
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. -
Page 21: Waste Disposal
◆ 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. -
Page 22: Chapter 4 Fault Analysis And Troubleshooting
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... -
Page 23: Chapter 5 Therapy Scope, Indications, And Contraindications
Chapter 5 Therapy scope, indications, and contraindications Therapy scope The device is suitable for the treatment of functional constipation or fecal incontinence. — 18 —... -
Page 24: Indications
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. 5.3 Contraindications ● Patients have recently undergone colon, rectal and anal surgery; ●... - Page 25 Purchase Date User Notice: 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. (User can hold invoice or complete warranty card) 3． Any one of the following conditions is not covered by the warranty, but can be repaired for a fee: the ●...
- Page 26 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.com — 21 —...
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Page 27: Chapter 7 Electromagnetic Compatibility
Chapter 7 Electromagnetic compatibility Below cables information are provided for EMC reference. Max. cable length, Cable Cable Number classification Shielded/unshielded USB data cable shielded 1 Set DC Power Important information regarding Electro Magnetic Compatibility (EMC) This electrical medical equipment needs special precautions regarding EMC and put into service according to the EMC information provided in the user manual;... - Page 28 Table 1 - Emission Phenomenon Compliance Electromagnetic environment CISPR 11 RF emissions Home healthcare environment Group 1, Class B IEC 61000-3-2 Harmonic distortion Home healthcare environment Class A IEC 61000-3-3 Voltage fluctuations Home healthcare environment and flicker Compliance EMS Compliance Table (Table 2-4) Table 2 - Enclosure Port Immunity test levels Home healthcare environment...
- Page 29 Home healthcare environment Immunity test levels Test frequency Band (MHz) 380-390 (MHz) Pulse modulation 18Hz, 27V/m 430-470 FM, ±5kHz deviation, 1kHz sine, 28V/m 704-787 Pulse modulation 217Hz, 9V/m 800-960 Pulse modulation 18Hz, 28V/m 1720 1845 1700-1990 Pulse modulation 217Hz, 28V/m 1970 2450 2400-2570...
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Page 30: Chapter 8 Technical Specifications
IEC 61000-4-11 0% U 250/300 cycles Chapter 8 Technical Specifications Name PelPal Biofeedback 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 included) Battery life 300 Charge Cycles (≥80% Nominal capacity) - Page 31 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...
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Page 32: Chapter 9 Fcc Statement
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. - Page 33 This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. — 28 —...
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