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SIS W250 Operating Manual

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SIS MACHINES
TECHNICAL OPERATING MANUAL_W250_v1.5
This operating manual is downloadable from http s ://www.siselectromed.com/
Due to periodic revisions, always check that you are reading the most up to
date version of this manual.
PLEASE READ THIS MANUAL CAREFULLY BEFORE USING THE SIS
EQUIPMENT FOR CORRECT AND SAFE OPERATION.
Page 1.
SIS MANUFACTURING LTD, NZ. JANUARY 2019.

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Summary of Contents for SIS SIS W250

  • Page 1 This operating manual is downloadable from http s ://www.siselectromed.com/ Due to periodic revisions, always check that you are reading the most up to date version of this manual. PLEASE READ THIS MANUAL CAREFULLY BEFORE USING THE SIS EQUIPMENT FOR CORRECT AND SAFE OPERATION. Page 1.

  • Page 2: Table Of Contents

    SIS MACHINE W250 MODEL OPERATING MANUAL CONTENTS SECTION PAGE DELIVERY AND UNPACKING_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 3 WARNING FOR BIOLOGICAL APPLICATIONS_ _ _ _ _ _ 3 DEVICE DESCRIPTION_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 4...

  • Page 3: Delivery And Unpacking

    Please unpack the shipping package carefully and inspect contents immediately on receipt. Check that all ordered equipment is included in the shipping box and notify SIS Manufacturing Ltd New Zealand immediately of any missing items from your order. Visible damage or tampering to shipping boxes must be recorded before signing the delivery receipt.

  • Page 4: Device Description

    SIS MACHINE W250 MODEL OPERATING MANUAL DEVICE DESCRIPTION The SIS machine model W250 is designed for electromedical low intensity (amperage) direct current stimulation and silver iontophoresis for a surface wound or ulcer, electromedical measurement, and supplementation or replacement of endogenous wound bioelectrics, and stimulation of surface or internal tissue fibroblast and other cell modifications and transdifferentiations.

  • Page 5: Keypad Controls And Operation

    SIS MACHINE W250 MODEL OPERATING MANUAL 3. KEYPAD CONTROLS AND OPERATION POWER Power device on, 2 seconds hold. Power device off, 5 seconds hold. ON OFF Main Operational MODE displayed. Operating STATUS displayed. Screen PROGRAM Access Main Menu  scroll...

  • Page 6: Applications

    The LED is not under user control. 3.1. ELECTRODE STIMULATION EFFICIENCY (ESE) MONITORING The W250 monitors the contact of the SIS or other electrode(s) with the body, both in real-time and statistically via complex measurement, logging and assessment algorithms with self-adaptive AI aspects. The highly summarized logged ESE data are shown in the STATISTICS screen.
  • Page 7 ROTATIONAL (+)POSITIVE ELECTRODE POSITIONING For a larger superficial wound, depending on the limitations of wound location and geometry, each time the SIS (+)Positive Electrode is replaced, it can be advantageous to re-position the (+)electrode at a different o'clock location around the wound edges, for example in the repeating sequence: 3-6-9-12 o'clock, in order to distribute stimulation evenly to the entire wound, over time.
  • Page 8 Cover the SIS (+)Positive Electrode with saline/sterilizing liquid-rinsed gauze or other non-adherent moisture-holding wound dressing if available. Position the SIS (-)Return Electrode onto intact skin as much as possible directly behind the center of the wound on the opposite anatomical surface of the injured body part.
  • Page 9 Insert the two gold metal 'banana plugs' at the ends of the electrode cable into the two white plastic connectors at the ends of the SIS electrode wires; insert the 'banana plugs' all the way in until they are no longer visible.
  • Page 10 SIS MACHINE W250 MODEL OPERATING MANUAL NOTE: Do not tape the connections of the electrode cable to the electrode wires as doing so can cause excessive mechanical force on the cable connection to the electro-stimulator. 4.5. OPERATIONAL MODE Select WOUND operational mode. Follow on-screen alert messages.
  • Page 11 Refer to the ELECTROTHERAPY ELECTRODE↔SKIN CONTACT section of this manual for further information. Position the SIS (+)Positive and (-)Return Electrodes on opposite sides across the wound as close as possible to the wound edges; position the (+)Positive Electrode closest to the most infected side of the wound.

  • Page 12: Device↔Wound Calibration

    Position the SIS (-)Return Electrode onto intact skin on the opposite anatomical surface of the body to the SIS (+)Positive Electrode so that the target infected organ or other anatomical structure is aligned bet ween the two SIS electrodes.
  • Page 13 CURRENT is automatically scaled to the user-programmed surface area size of the SIS (+)Positive Electrode, as shown below and in real-time in the STIM DATA screen. The smallest electrode that can be programmed is 1.5 cm²; the maximum size of any electrode shape is 50 cm²: If a standard 4.75cm (1.87") ⌀diameter Small circular SIS electrode is used,...
  • Page 14 6.1.6. TOTAL CIRCUIT RESISTANCE OPERATING LIMITS The total circuit resistance operating limit of the W250 for all possible user- programmed SIS (+)Positive Electrode sizes is shown in the table below; the actual measured total circuit resistance is shown in real-time in the STIM DATA screen as RES.
  • Page 15 6.2.2. OPERATIONAL MODE Select REGEN operational mode. 6.2.3. (+)POSITIVE ELECTRODE SIZE There is no user selection of SIS (+)Positive Electrode size. The output voltage self-adaptively scales to the injured tissue's bioelectric properties. Page 15 SIS MANUFACTURING LTD, NZ. JANUARY 2019.

  • Page 16: Audio And Visual Alerts

    SIS MACHINE W250 MODEL OPERATING MANUAL 7. AUDIO AND VISUAL ALERTS Alert Message Meaning / Notes Action Required STANDBY CALIBRATING Device is calibrating to Wait. wound or internal tissue target pathway. STATUS: OK Device is operating within None. normal limits. Electrode contact is established.
  • Page 17 SIS MACHINE W250 MODEL OPERATING MANUAL NO WOUND No wound detected from electrode placement. Wait for device to power off. CANNOT CALIBRATE Device cannot calibrate Re-check appropriate due to alerted, uncorrected application instructions. If in electrode contact problem. WOUND operational mode,...

  • Page 18: Electrotherapy Electrode↔Skin Contact

    SIS MACHINE W250 MODEL OPERATING MANUAL 8. ELECTROTHERAPY ELECTRODE↔SKIN CONTACT Electrical resistance, which is part of total electrical impedance to the flow of electric current, is measured in units of Ohms (Ω): 1 megaOhm (MΩ) = 1000 kiloOhm (kΩ) = 1,000,000Ω...

  • Page 19: Contraindications And Safety

    SIS MACHINE W250 MODEL OPERATING MANUAL 9. CONTRAINDICATIONS AND SAFETY DO NOT POSITION ELECTRODES OVER THE BRAIN. CONSULT WITH A SPECIALIST HEALTHCARE PROFESSIONAL BEFORE APPLICATION. DO NOT POSITION ELECTRODES OVER THE HEART (CENTRAL AND LEFT SIDE OF CHEST). CONSULT WITH A SPECIALIST HEALTHCARE PROFESSIONAL BEFORE APPLICATION.

  • Page 20: Medical Disclaimer

    Nothing in this medical disclaimer will limit any of the liabilities of SIS Manufacturing Ltd NZ in any way that is not permitted under applicable law, or exclude any of its liabilities that may not be excluded under applicable law.

  • Page 21: Maintenance

    Store the device in a dry place away from heat-generating sources. 10.3. SIS ELECTRODES The silver-nylon stimulation surface of an SIS electrode that has been applied only to normal intact skin can be cleaned by gently wiping with a clean damp cloth or cotton wool (use tap/other clean water) to remove dead skin cells, sweat and electro-chemical debris.

  • Page 22: Warranty

    Warranty. If a non-SIS electrode harness is used with the Device this warranty shall be void. This Warranty is expressly limited solely to the original purchaser of the SIS equipment and does not extend to any transferee or temporary user of the Device.

  • Page 23: Returns, Disposal

    Please keep your proof of purchase. 12.2. Disposal In case of replacement of any SIS machine part due to repair, exchange or future upgrade, we will optimally recycle the SIS equipment. Page 23...

  • Page 24: Device Specifications

    SIS MACHINE W250 MODEL OPERATING MANUAL 13. DEVICE SPECIFICATIONS Parameter Unit Minimum Typical Maximum Tolerance Additional Notes 3 x 1.5V AAA Batteries Alkaline Duracell Ultra Battery Life Hours Alkaline recommended Output Voltage in Measured across Current 11.8 30kΩ 0.1% Sense †...

  • Page 25: Manufacturer's Declaration

    SIS MACHINE W250 MODEL OPERATING MANUAL 14. MANUFACTURER'S DECLARATION The device is pending testing for EMC conformity to EN 60601-1-2 edition 4.0, AS/NZS CISPR 11, FCC 15B, ICES-001. Page 25 SIS MANUFACTURING LTD, NZ. JANUARY 2019.
  • Page 26 The specifications, descriptions and data within this document are subject to change without notice. This publication supersedes all previous publications on this subject. The SIS machines, SIS electrodes and SIS technology are patent pending devices. The SIS machine logo and “SIS” letters are Registered Trade Marks.

This manual is also suitable for:

W250

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