Wetling W200 User manual

WETLING W200
USER GUIDE
Wireless Micro Current Stimulators - Version: 2019-2

1Wetling W200 User Guide | Wireless Micro Current Stimulators | Ver. 2019-2
Please Read This Before You Begin
This User Guide constitutes the “Instructions for Use” (as per MDD 93/42/EEC
Annex I.13) for the Wetling W200 medical device.
This User Guide (Version 2019-2) covers Wetling W200 devices with the
following serial numbers:
• 275 0000 – 275 9999
The W200 device is delivered in either a cardboard box (order number 610-
11xx) or a hard case that is useful for safe transportation of the device (order
number 610-12xx). The last two digits (“xx”) of the order number indicate the
type of 3-pin power plug that is fitted before delivery (see examples on page
12).
Read this user guide carefully to ensure that the device functions properly.
In the unlikely event that the device does not work properly, power off and
consult this manual. If the problem persists, please contact your local Wetling
service agent.
While every effort has been made to ensure that the data in this manual is
accurate, the information, figures, illustrations and specifications herein are
subject to change without notice.
The manufacturer retains the right to modify the equipment without notice.

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Wetling W200 User Guide | Wireless Micro Current Stimulators | Ver. 2019-2
Contents
Introduction to the WMCS Technology 3
Wetling W200: General Description 4
Wetling W200: Important Safeguards
Intended Purpose 5
Indications for Use 5
Contraindications 5
Side Effects 5
Cautions & Warnings 6
Practical Guidelines:
W200 Related Guidelines 7
Treatment Related Guidelines 8 - 9
Setting up the W200:
Creating an Electrical Circuit 10
Mounting the Console 11
Connecting to Power 12
How to Connect Return Cable & Position Treatment Head 13
Operating the W200:
Control Panel Overview 14
How to Set Microcurrent & Timer 15
How to Set LED Light 16
Starting a Treatment 17
Troubleshooting, Maintenance & Storage 18
The Usage Timer:
How to View the Timer 19
How to Update the Timer 20 - 21
Technical Specifications & Symbol 22
Electromagnetic Compatibility 23 - 24
Declaration of Conformity 25
Warranty & Manufacturer 26

3Wetling W200 User Guide | Wireless Micro Current Stimulators | Ver. 2019-2
Introduction to the Wetling WMCS Technology
The WMCS (Wireless Micro Current Stimulation) technology is invented and
patented by Wetling.
Electrical Stimulation (ES)
WMCS is based on a well-known, scientifically verified method (Oxford CEBM
class 1a evidence); The use of Electrical Stimulation for accelerated wound
healing. However, in spite of its well-established results, historically ES has not
been commonly used due to significant complications in traditional treatment
techniques.
Wireless Micro Current Stimulation (WMCS)
The innovative WMCS technology enables Electrical Stimulation (ES) to be
wirelessly transferred to the wound by using Oxygen's and Nitrogen’s ability
to receive and donate electrons. The radical advantage of WMCS (over
traditional ES), having no physical contact to wound, means that it is very
easy to administer, it significantly improves patients' pain and comfort levels
and it reduces the risk of infections. It also allows for a larger treatment area
per session, thus saving time for both patients and medical staff.
Treatments with Encouraging Results
The WMCS technology produces results that in most cases exceeds the
expectations in conventional wound healing:
• Shorter Healing Times
• Pain Relief
• Reduced Risk of Infections
• Cost Savings
Saving Time & Money
The WMCS technology will shorten healing time, resulting in patient comfort
and reduced nursing costs.

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Wetling W200 User Guide | Wireless Micro Current Stimulators | Ver. 2019-2
Wetling W200: General Description
The Wetling W200 is a medical device providing Wireless Micro Current
Stimulation (WMCS) for wound and tissue healing. The Wetling W200 is
delivered in a box containing:
1. Main W200 device, consisting of
- Treatment head
- Flexible arm
- Power supply box
- Power supply cable
- Return cable
2. Console for table attachment
3. Wetling W200 User Guide (hard copy)
3. USB memory stick with W200 User Guide (soft copy)
Protection Cap for Transportation:
At delivery, the emitter head is protected by a
yellow plastic cap, make sure to remove this before
use.
1
2
3
4

5Wetling W200 User Guide | Wireless Micro Current Stimulators | Ver. 2019-2
Wetling W200: Important Safeguards
Intended Purpose
The Wetling W200 device is intended to be used in professional health care
environment to delivery Wireless Micro Current Stimulation (WMCS) to
patients. Without direct contact to the injured tissue, WMCS will promote
and accelerate wound and tissue healing by attracting the cells of repair,
changing cell membrane permeability, enhancing cellular secretion through
cell membranes and orienting cell structures through the bioelectrical process
of electrotaxis.
Indications for Use
The Wetling W200 device is suitable for adjunct WMCS treatment of most
types of wounds and injuries, both chronic and acute:
• Pressure ulcers
• Arterial ulcers
• Venous stasis ulcers
• Neuropathic diabetic ulcers
• Burns; first, second and third degree
• Surgical wounds
• Traumatic wounds
• Soft tissue injuries
Contraindications
Do not use the Wetling W200 if:
• The patient is pregnant or nursing.
• The patient has a pacemaker or other implanted electrical device(s).
• The patient has a malignancy close to the wound.
• The patient suffers from epilepsy or other neuroexcitatory conditions.
Side Effects
Light itching, tingling and/or redness may occur during and/or after the
treatment.

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Wetling W200 User Guide | Wireless Micro Current Stimulators | Ver. 2019-2
Wetling W200: Important Safeguards
Cautions & Warnings
• Only operate the W200 according to the guidelines in this User Guide
(Instructions for Use).
• Do not operate the W200 near shortwave or microwave therapy
equipment.
• Do not simultaneously connect the W200 and any high-frequency
equipment to the patient.
• Do not take the W200 apart, as this can cause electrical shocks.
• Do not use the W200 if there is visible damage to the housing, power box
or cables.
• Patients should not use cellular phones or other communication devices
while during the W200 treatment.
WARNINGS
Use of other equipment adjacent to this 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 verify that they are operating
normally.
Portable RF communications equipment (including
peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 Inches) to any part
of the unit, including cables specified by the manufacturer.
Otherwise, degradation of the performance of this equipment
could result.

7Wetling W200 User Guide | Wireless Micro Current Stimulators | Ver. 2019-2
Practical Guidelines
Wetling W200 Related Guidelines
The Wetling W200 Beeping Signal
Do not proceed with a treatment if the Wetling W200 emits a continuous
beeping sound (for more information, see pages: 10, 13 & 18).
The Positioning of the Return Cable
The return cable should be kept away from the treated area; otherwise this
may affect the electrical transfer and reduce the efficiency of the treatment.
Cleaning of the Device
Use no other cleaning agents or disinfectants aside from 60–70% isopropyl
alcohol. Other cleaning liquids may leave a residue on the device that could
attract the negative ions and cause the W200 device to malfunction. Be
careful while cleaning not to damage the tiny emitter threads (see picture on
page 18).
Temperature & Humidity
The working temperature for the W200 should be between 15–30 °C and
the humidity should be kept between 30–60%. Extreme humidity may
negatively affect the treatment. Also avoid using the W200 in dusty or windy
environments.
The W200 LED Light
The LED light can be used to serve as visual indication that a treatment is in
progress, and may have a calming effect on some patients.
How to Setup & Operate the W200
For instructions on setting up and operating the W200, see pages 10–17.
Recommended Treatment Settings
Under normal circumstances, the recommended current is 1.5 µA and the
recommended treatment time is 45–60 min. Treatments should typically be
administered 2–3 times a week. In severe cases such as hospitalized burn
patients, treatments may be administered daily.
Interrupting a W200 Treatment
If a treatment needs to be interrupted, push the red OFF button once, which
will pause the treatment. Remove the return cable from the electrode or the
limb clamp. To continue the treatment, refit the return cable, reposition the
treatment head over the wound and push the green 'ON' button.
Refer all service calls to your local Wetling service agent.

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Wetling W200 User Guide | Wireless Micro Current Stimulators | Ver. 2019-2
Practical Guidelines
Treatment Related Guidelines
• Inspect the wound regularly, following the procedure recommended by
the prescribing physician.
• If the wound shows signs of infection, treat the wound according to the
instructions of the prescribing physician.
• In the case of malignancy (cancer), any signs of accelerated deterioration
should be followed up with the prescribing physician.
• Consult the prescribing physician if:
- deterioration of the wound occurs or is suspected
- there is excessive scar tissue at the wound sit
- the patient has a major heart disease, uncontrolled bleeding
disorders, or a metallic implant
- the patient's wound has over-granulation (rough) tissue
Wound Size Capacity
When applying the recommended parameters for use (1.5 µA at a distance
of 10–12 cm from the wound), the area of treatment with the W200 device is
approximately 300 cm2 .
Under favourable conditions (temperature, humidity & patient), the treatment
area can be increased to approximately 400 cm2 by increasing the distance
to the wound in small increments. The W200 device will start to beep
continuously when the distance from the wound is too great for the current
conditions. Note that by increasing the distance from the wound, the electrical
charge is distributed over a larger area, causing the energy density per cm2 to
decrease (See page 13, "How to Position the Treatment Head".)
If the wound area is larger than what is stated above, divide the entire area
into smaller sections and apply a full treatment for each. Overlapping sections
impose no risk.

9Wetling W200 User Guide | Wireless Micro Current Stimulators | Ver. 2019-2
Practical Guidelines
Use of Conventional Dressings
WMCS is typically applied as adjunct treatment together with conventional
wound care practice.
When treating most wounds, dressings should be removed before any WMCS
treatment. For chronic wounds it is recommended that WMCS should be
applied over the exposed wound in combination with regular dressing change,
typically 2–3 times per week.
For burns, the first treatment should be given before the initial dressing
is applied. This will generate a thin layer of new skin over the wound. A
recommended primary dressing for burns should then be applied, which can
remain on the wound during subsequent WMCS treatments and only removed
when full epithelialization has occurred. This avoids painful dressing changes
for burns patients at the same time as it reduces nursing costs and the risk of
infections or permanent scarring. (Secondary dressings, such as gauze, should
be removed to allow the ions to reach the wound.) For severe burn patients
who are typically hospitalized, daily WMCS treatments are recommended.
Other acute wounds (such as surgical wounds or wounds caused by trauma)
should preferably have the first WMCS treatment as soon as possible after
the surgery or injury. The wound will then heal faster with less swelling
and reduced risk of infections. Also, the risk of permanent scarring and
pigmentation changes is reduced.
When using wound care products that contain metal ions (e.g. silver
dressings) a temporary darkening of the skin may occur.
Visible Results & Pain Relief
In some cases (e.g. burns) there will be visible results and pain relief already
after the first treatment.