AccuMed AP112 Pulse Massager Quick Start Guide

Electrotherapy Muscle Stimulator AP112 Quick Start Guide  

AP112 is a portable and DC 3.7V battery-powered multi-function device, offering Transcutaneous Electrical Nerve Stimulation (TENS) qualities in one device. AP112 has 12 operation modes, which can deliver certain electrical pulses through the electrode adhesive pads to the area of the body where the electrodes are placed. The electronic stimulatory module has an ON/OFF Switch, Display screen, Mode Selection key, Intensity Modification keys, Timing key, Pause key, Output socket, and USB port for battery charging. The display screen can show the battery power, selected mode, current intensity, time remaining of an application mode, and indication of a pause. The device is equipped with accessories: electrode pads, electrode cables, a battery charger, and one USB cable. The electrode cables are used to connect the pads to the device; the USB cable is used to connect the charger to the built-in lithium battery. All accessories, including USB cables, electrode pads, electrode cables, chargers can only be changed or replaced by a qualified person. The electrodes are interchangeable. The application area of electrode pads must be larger than the smaller electrode pads. The electrode pads are provided.

 

Specifications and Essential Performance: 

- Power supply: DC 3.7V 

- Output voltage: 42V@500Ω 

- Output current: 84mA@500Ω 

- Consumed current: 40mA 

- Pulse width: 100µS 

- Frequency: 1~110Hz 

- Smallest are of electrode pad: 4cm²

- Timer: 10~60 minutes 

- Strength level adjustment: 20 grades 

- Charger:  

  Input: 100-240V 50/60Hz 0.18A Max; 

  Output: DC5V 250mA; 

  Class II, not applied part, not suitable for use in the presence of a flammable gases, with oxygen or nitrous oxide, or for continuous operation..

 

Features

- Large, easy to read LCD display 

- Adjustable timer 

- 12 Modes 

- Rechargeable Lithium Battery

Two key points for Operations: 

1) Locate the exact location of the pain: Apply the pads (electrodes) to the muscle area where you are experiencing pain, stiffness, or soreness. 

2) Intensity: The intensity should be gradually increased until you reach the highest setting before it becomes uncomfortable.

 

Accessories

Included in this package: 

1 x Controller

2 x Pairs of electrodes [510(k) cleared] 

2 x Output electrode cables 

1 x USB cable 

1 x  Charger 

1 x User's manual 

1 x Plastic holder

Warnings 

1) The long-term effects of chronic electrical stimulation are unknown. 

2) Do not use stimulation over the main arteries around your neck. 

3) Do not use stimulation over the neck or mouth. Severe spasm of muscles may occur and the contractions may be strong enough to close the airway or cause difficulty in breathing. 

4) Do not apply stimulation directly to the heart area across the chest or on the chest. 

5) Do not use stimulation on your head or across your head. 

6) Do not use stimulation over swollen, infected, or inflamed areas or skin eruptions, e.g., phlebitis, thrombophlebitis, varicose veins. 

7) Do not use stimulation over, or in proximity to, cancerous lesions. 

8) Do not use stimulation when charging the device.

Precautions 

1) Do not use the muscle stimulator during pregnancy. 

2) Do not use if you have heart problems. 

3) Do not use if you have epilepsy. 

4) Do not use the device in the presence of the following: a. When there is a tendency to hemorrhage following an acute trauma or fracture; b. Following recent surgical procedures when muscle contraction may disrupt the healing process; c. Over the menstruating or pregnant uterus; d. Over areas of the skin which lack normal sensation. 

5) Do not use the products near the heart; it may cause a fast or irregular heartbeat. 

6) Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical conductive medium. The irritation can usually be reduced by using an alternate conductive medium (like gel), or alternate electrode placement. 

7) AP112 must be kept out of the reach of children. 

8) AP112 should be used only with the leads and electrodes recommended for use by the manufacturer. 

9) Never apply the pads to your skin with the power on, which will result in sudden shock. If, during application, you want to move the pads to another body part, please shut down the device first, and then move the pads to the place that you want to stimulate. 

10) Never use this product near the following devices: pacemakers or any other embedded electronic medical devices, heart-lung machine and any other life keeping electronic medical devices, electrocardiograph and any other medical screening and monitoring devices. Simultaneous use of the AP112 and any of the above devices will cause malfunctions and can be very dangerous to the users. 

11) Two pads should be used together as a pair. Always peel off the protective film on the pads before use. To avoid an electrical short, do not connect two pads to each other. 

12) Do not apply pads to the same spot for over 60 minutes at a time. 

13) Do not use the AP112 while driving, operating machinery, or during any activity in which involuntary muscle contractions may put the user at undue risk of injury. 

14) Do not use the product in bathroom or a moist environment. Do not use while bathing. 

15) Do not use the product in the condition of air mixed with flammable gases. 

16) Never use this product in concurrence with high frequency surgical equipment; it may result in burns at the site of the stimulator electrodes and possible damage to the control unit. 

17) Never use this product near a microwave oven, or other high frequency equipment. 

18) Never use this product while it is being charged. 

19) Do not operate the product in close proximity (e.g. 1m/3ft) to shortwave therapy equipment as it may produce instability in stimulator output.

Contraindication 

1) Do not use this device on patients who have a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device, because this may cause electric shock, burns, electrical interference, or death. 

2) Do not use this device on patients whose pain syndromes are not diagnosed. 

3) Do not use this device during pregnancy. 

4) Do not use this device on babies or infants who cannot express themselves.

Adverse Reactions 

1) Patients may experience skin irritation and burns beneath the stimulation electrodes applied to the skin. 

2) Patients may experience headache and other painful sensations during or following the application of electrical stimulation. 

3) Patients should stop using the device and should consult with their physicians if they experience adverse reactions from the device.

Indications for Use 

TENS: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. 

 

Mode Description

We suggested that you initially experiment using each of the 12 modes. The mode that gives you the most desirable sensations and comfort is the most appropriate one to use for your current condition. 

1) Intensity should be set at a level where you will feel some muscular vibration and involuntary muscle movements. It should be set to give a comfortable feeling and should not be painful. 

2) Timing of application should be at least 10 to 20 minutes. 

3) Frequency of the application should be at least one to three times per day.

Direction for Use

General Operation Guidance 

1) The AP112 unit needs to be charged for up to 10 hours before the first use. 

2) Connect the electrode cables to the output sockets at the bottom of the unit. 

3) Connect the pads to the cables by snapping them on. 

4) Use a damp towel to wipe the skin where you intend to put the pads, so as to remove any body oil, cosmetics, or dirt. Remove the protective film and place the pads on the area making sure that both pads are on the skin and not overlapping. Warning: To avoid an electrical short, never put two electrode pads together. 

5) Turn on the unit by sliding the On/Off switch from Off to On. Warning: Do not move pads or touch them with your hands during use, it may cause strong stimulation. 

6) When you turn on the unit, the LCD display will automatically show Mode 1. The "T" (Timer) will automatically choose the time duration of 20 minutes. 

7) To change the modes, press the M (Mode) button. The unit's A & B channels are independent. Once you have selected a mode, gradually increase the intensity by pressing the "+" button, and to decrease the intensity by pressing the "-" button. When the intensity "A" mark on the display flashes, the intensity of "A" is adjusted by pressing the + / - button. You can press the Pause Key to change the Intensity of "B". The chosen power output depends on your comfort level. The intensity should be chosen as high as possible for the best effect but still feel comfortable. 

8) To set the time of use, press the T button. The default time is 20 minutes. Each press of the T button increases the time by 10 minutes. After the time runs out the device turns off automatically, and it can be restarted if treatment needs to be continued. 

9) Sit back and enjoy the deep soothing sensations! Notes: The AP112 unit is very safe, the output intensity increases only by pushing the + key. Even if the intensity is increased to the maximum, it is within the safe range, but may feel uncomfortable. When the user switches the mode, the intensity will automatically go down to the minimum for safety reasons. 

10) If you need to turn off the device during stimulation, slide the On/Off switch to "OFF". 

11) Before storing the TENS use the protective film to cover the electrode pads. 

Notes: 

Never connect this product with a common headphone. 

Please do not touch the USB port when using the device. The USB port is only used to connect the charger. Do not connect other devices. 

The charger supplied by the manufacturer must in compliance with IEC/EN 60601-1, the use of unauthorized chargers can impair the safety or damage the device. 

The battery needs to be charged for up to 10 hours before the first use.

Electrode guidelines 

1) Use only the electrodes supplied by the manufacturer; other electrodes may present a risk of unsuitable electrical characteristics with your stimulator. 

2) Do not use the electrodes on different people, otherwise, skin reaction or cross contamination may occur. 

3) Always turn power off before removing or re-positioning the electrodes. 

4) Wash skin thoroughly, and then dry it before applying the electrodes. 

5) Apply the whole surface of the electrodes firmly to the skin. Do not use electrodes that do not stick properly to the skin or only partially stick to the skin. 

6) In case of skin redness under the electrodes after a stimulation session, do not start a new session in the same place if skin redness is still evident.

There are two ways to place the pads in twin or opposed modes:

Fix the two pads from one channel on either side of the pain area, or one electrode on the painful site and the other near the site of pain, but on the same side of body. If you want to use both channels at the same time, make sure that the second pair of electrodes is also fixed near the side of pain on the same side of the body (right under or over the first pair)

Figure 1: Twin mode (this is the correct mode)

Fixing the two or four pads respectively on the opposite sides of the body is not recommended and provides little benefit.

Figure 2: Opposed mode (Not recommended)

Regular TENS Application Methods

Use the device for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arms), and lower extremities (legs) due to strain from exercise or normal household work activities. 

Users can choose Mode 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 or 12 for temporary relief of pain. 

Many people experience immediate relief from muscle pain, while others require several days of regular use to feel the benefits. The results vary and will depend upon your underlying conditions and how often you use the device. If your pain does not improve, you can try to increase the intensity and time or change the mode. 

Note: The charts below are merely a suggestion for where to place the electrodes, what Mode to choose and how long to stimulate, but only after the user has gone through the starting procedure (above) and is familiar with the device.  

1. Pain in Neck


2. Pain in Shoulders


3. Pain in Back

1. Mode 1 (A) for 10-20 minutes, and Mode 3 for 10-20 minutes; twice or 3 times a day.
  * Keep the neck warm and avoid sleeping on a high pillow.

2. Mode 4 (B & C) for 10-20 minutes, and Mode 5 for 10-20 minutes; twice or 3 times a day.
  * Keep the area warm. Avoid sudden movements with the aching shoulders. 

3. Mode 1 for 10-20 minutes, and Mode 5 or 6 for 10-20 minutes; twice or 3 times a day.
  * Avoid working in the same position in the initial phase and change the position at times.
4. Pain in Waist

4. Mode 3 or 6 to stimulate (A) for 10-20 minutes, Mode 8 to stimulate (B and C) for 10-20 minutes; twice or 3 times a day.
5. Elbow/ Arm

5. Mode 1 for 10-20 minutes, and Mode 4 for 10-20 minutes; twice or 3 times a day.
6. Wrist/ Hand

6. Mode 3 for 10-20 minutes, and Mode 4 for 10-20 minutes; twice or 3 times a day.
7. Knee/ Leg

7. Mode 7 for 20 minutes and Mode 3 for 20 minutes; twice or 3 times a day.
8. Ankle/ Foot

8. Mode 4 for 10-20 minutes, and Mode 6 for 10-20 minutes; twice or 3 times a day.
  * Do not use this device directly on the pain area or area of injury. 
     

Battery

Battery information

Capacity: 110mAh 

Voltage: DC 3.7V 

Restriction: 4.2V

Charging the Battery 

1) The Lithium battery can be recharged through both the AC adapter and a computer USB input. 

2) Turn off the unit. 

3) Connect the unit and the charger with the USB cable. Plug charger into any power outlet and a green light shows that it is charging. The charging process will take approximately 1 hour. When charging is finished, the LCD will show a full battery cell. 

4) The battery should be charged for 10 hours or so before the first use.

Notes: Only charge the unit when battery is completely drained the first 2 times. Unplug the charger from power outlet when charging is complete. When stimulation intensity decreases, it indicates that the device needs charging. Recharge it and then continue to use the device. Do not use the device while charging.

Readjustments, Alterations, and Repairs 

1) Do not disassemble, repair or modify the device without authorization. This will void any warranty on the product. 

2) The manufacturer is only responsible for the safety and performance of AP112 when readjustments, alterations, and repairs are carried out by authorized individuals and when the AP112 is used in accordance with the user instructions. 

3) Qualified technicians who are familiar with the technical features of the device have been provided with circuit diagrams, PCB drawings, component lists, and setting instructions by the manufacturer.

Cleaning and Maintenance 

For the control unit: 

1) To keep the controller clean, use a soft, dry cloth for dust or a soft damp cloth for any dirt and smudges. Do not use any cleaning solutions to clean the controller and its pads. 

2) Do not use or store the device where there are magnetic fields or electric waves (near TV set or speakers). 

3) Do not place the devices in areas of high temperature, high humidity, or under direct sunlight. 

4) Keep the device out of reach of children. 

5) All worn accessories should be disposed of according to your local regulations.

For electrode pads

1) Unplug the output cord from the output jack of the controller after each use. Cover both pads with the protective film before storing. Never fold the electrode pads. 

2) Between uses, store the electrodes in the reusable bag in a shady place. Stockroom temperature: +5�C~+27�C (41-80�F) and humidity of 30%~80%. No need to sterilize. 

3) Never apply the pads to any other surface other than your skin. If the pads become soiled or dirty, the adhesiveness may decrease. In this case, moisten the surface of the pads with water and wipe away the dirty portion. This will allow a temporary restoration of the adhesiveness. However, too much water will result in loss of the adhesiveness. 

4) The life of the electrodes varies depending on skin conditions, storage, amount of use, type of stimulation, and stimulation site. Electrode life may be extended by carefully following this Instruction for Use. The expired electrodes are to be recycled to not harm environment. 

Warning: The electrodes are intended for single patient use only!

 

Storage 

Caution: Do not store in a damp area. Dampness may affect the device and cause rust. 

- Normal working ambient temperature: 5°C~40°C (40-104°F) 

- Normal working ambient humidity: ≤80%RH 

- Store and transport ambient temperature: -20°C~55°C (4° -131° F) 

- Store and transport ambient humidity: ≤93%RH

Technical checks 

Technical checks on the device should be performed every 24 months. 

1. Checking to see whether the user instructions and the medical device book are included in the accompanying documentation.

2. Checking the equipment for completeness. 

3. Visual check: - For mechanical damage - For damage to any cables and connections 

4. Functional safety - Checking the output signals with a load resistance of 500Ω real (current and voltage) - Checking the frequency - Checking the pulse width. These technical checks may only be performed by individuals with appropriate training. The results must be noted in the medical device book along with the date and name of the person carrying out the check.

Troubleshooting

PROBLEMS POSSIBLE CAUSES SOLUTIONS
One pad feels stronger than the other This is normal. Different areas of your body will react differently Nothing needs to be done. Make sure the pads are sticky and are making good contact
The intensity is not felt; Very weak intensity level


- Pads are not attached to the body firmly
- The transparent films are still stuck to the pads
- The pads stacked together or overlap
- The cord is not properly connected to the unit
- The intensity setting is getting weak
- The battery capacity is low
- Attach both pads firmly to the skin
- Peel off film on the adhesive surface of pads
- Do not stack pads together or overlap pads
- Connect cord correctly into the jack
- Increase the intensity level
- Charge the battery
The skin turns red or the skin feels irritated - The adhesive surface of pads is dirty or dry.
- The therapy time is too long or the intensity is set too high.
- The electrode pad surface is worn out.
- Wash surface of pads softly with your fingertips for about 3 seconds under slow running water.
- Reduce the application time or reduce the intensity
- Replace electrode pad
No power source; no display in LCD. - The battery capacity is depleted - Charge the battery
Power cut off during use. - The battery is weak
- The cord is broken
- Charge the battery
- Replace the cord
It is difficult to attach the pad to the skin. - Have you removed the transparent film from the pad?
- Was the pad applied immediately after washing?
- Is the adhesive surface of the pad damaged?
- Peel off film on the adhesive surface of pads
- Dry the pad
- Replace the pad
Adhesive surface of pad is not sticky. - Are you using pad when perspiring?
- Were the pads stored under high temperature, high humidity, or direct sunshine?
- Use when not perspiring, in a cool room.

- Replace the pad.
     

Disposal of the Unit 

To dispose of the unit, its accessories, and packing materials, take appropriate actions in accordance with the rules and regulations enforced in your area to prevent adverse ecological effects.

Warranty 

We give a warranty of 1 year from the date of purchase on the AP112. This warranty does not cover cables and electrodes.

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