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SIS M200 Technical Operating Manual

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SIS MACHINES
TECHNICAL OPERATING MANUAL_v7.5_M200
This operating manual is downloadable from http://www.siselectromed.com/
CAUTION: 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.
Page 1.
SIS MANUFACTURING LTD, NZ. MAY 2017.

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  • Page 1 This operating manual is downloadable from http://www.siselectromed.com/ CAUTION: 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. Page 1. SIS MANUFACTURING LTD, NZ. MAY 2017.

  • Page 2: Table Of Contents

    SIS MACHINE M200 MODEL OPERATING MANUAL CONTENTS DELIVERY AND UNPACKING _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _3 WARNING FOR BIOLOGICAL APPLICATIONS _ _ _ _ _ _ _ _ _ 3...

  • Page 3: Delivery And Unpacking

    Please unpack the shipping package carefully and inspect contents immediately on receipt. You must 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.

  • Page 4: Operational Mode

    AUGUST 2016 ONWARDS: For a 3.5mm type connector, insert the harness connector plug directly into the SIS machine connection socket. 2.2. ELECTRODE HARNESS POLARITY It is usually easier to position and secure the SIS electrodes to the body or to Page 4 SIS MANUFACTURING LTD, NZ. MAY 2017.

  • Page 5: Keypad Controls

    • harness is the SIS Return Electrode. ! NOTE: The silver-nylon side of an SIS electrode is the active surface that contacts the body. 2.3. CONNECTION OF ELECTRODE HARNESS TO SIS ELECTRODES Insert the two gold metal 'banana plugs' at the ends of the SIS electrode harness into the two white plastic connectors at the ends of the SIS electrode wires;...

  • Page 6: Application Instructions

    Diagrams of SIS electrode applications for some common infections are available from http://www.siselectromed.com/ applications/ ! NOTE: The SIS machine M200 can be targeted at almost any infected tissue. However, the device cannot determine the type of microbe(s) present; standard diagnostics and differentiating information based on anatomical location, clinical signs, presentation and laboratory testing must be applied.
  • Page 7 SIS electrodes.* Secure electrode to body. *This electrode positioning configuration focuses silver ion flow into the target organ or tissue between the two SIS electrodes. 'Wasted' current flow through the skin between the electrodes is thereby prevented or minimized. Page 7...
  • Page 8 SIS MACHINE M200 MODEL OPERATING MANUAL 4.6. ELECTRODE SKIN CONTACT The contact of the entire surface of an SIS electrode positioned onto normal intact (i.e. non-damaged) skin should be as uniform as possible to surface anatomy geometry. The lower end of dry, intact skin electrical resistance (R), measured in units of 'Ohms' (Ω), is approximately 50kiloohms (kΩ).

  • Page 9: Constant Ultra-Low Output Current

    (7.5microamperes). 5.2. ELECTRODE MONITORING SELECTION Monitoring (MNT) of the contact of the SIS or other electrode(s) with the body for in vivo applications, or with the stimulation target or circuit interface for in vitro applications can be user enabled or disabled.

  • Page 10: Water Treatment

    (not supplied with the SIS machine). If SIS electrodes are used, the rate of silver ion introduction into the water will depend on the SIS electrode size; larger electrode size will give a faster rate of silver ion production, and vice versa.

  • Page 11: Audio And Visual Alerts

    Effective or physical CIRCUIT BREAK. NO CALI NO CALIBRATION possible. BATT LOW BATTERY LOW charge. MNT OFF CIRCUIT MONITORING OFF. VOLT ALERT High Output VOLTAGE ALERT. Table 2: Displayed M200 audio-visual alert abbreviations. Page 11 SIS MANUFACTURING LTD, NZ. MAY 2017.
  • Page 12 SIS MACHINE M200 MODEL OPERATING MANUAL M200 M100-IP model CORRECTIVE ACTION VISUAL VISUAL ALERT TYPE AUDIO AUDIO OLED DISPLAY OPERATIONAL MODE INITIALIZATION ─ Operational mode [MODE NAME] 1 BEEP 1 BEEP ─ ─ is programmed. Unhighlighted ─ Calibrating to body.
  • Page 13 SIS MACHINE M200 MODEL OPERATING MANUAL M200 M100-IP model CORRECTIVE ACTION VISUAL VISUAL ALERT TYPE AUDIO AUDIO OLED DISPLAY ─ Circuit break All applications CIRC BREAK 10 BEEPS (consecutive Open • Check for loose connections or breaks FLASHING 5 SEC INT Loads).
  • Page 14 SIS MACHINE M200 MODEL OPERATING MANUAL M200 M100-IP model CORRECTIVE ACTION VISUAL VISUAL ALERT TYPE AUDIO AUDIO OLED DISPLAY ─ Charge low for BATT LOW • Replace batteries, follow instructions: correct operation. FLASHING ◦ 1.1. Inserting AAA Batteries. BATTERY 5 SEC INT...

  • Page 15: Electrode Contact Monitoring Setting

    The CIRCUIT MONITORING audio-visual alerts are based on real-time updating statistical and algorithmic analysis of Total Circuit Resistance measurements due to any changes of the contact of the SIS electrodes with the body or with their in vitro interfaces. This complex monitoring system ensures reliable delivery of the pre- and user-programmed target Output Currents and Output Voltages with extended, continuous use.

  • Page 16: Electrode Harness Check

    SIS MACHINE M200 MODEL OPERATING MANUAL 7.3. Electrode Harness Check This procedure tests the integrity of the SIS electrode harness for non-visible internal core breaks: 1. Power off the device. 2. Follow 2.1. CONNECTION OF ELECTRODE HARNESS TO SIS MACHINE instructions. Do not connect electrodes to the harness.

  • Page 17: Contraindications And Safety

    SIS MACHINE M200 MODEL OPERATING MANUAL 8. 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 18: 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 19: Maintenance

    ) has been used, do not tear off the tape from the electrode. Cut the tape back to the SIS electrode size and shape, leaving the tape as a layer permanently stuck to the non-stimulation white foam surface of the electrode.

  • Page 20: Warranty

    SIS MACHINE M200 MODEL OPERATING MANUAL 11. WARRANTY Each new SIS machine (“the Device”) carries a 3 year limited Warranty for defects in materials, components, assembly and operation of its electronic hardware. This Warranty is subject to all of the following exclusions and conditions. The Device enclosure is not opened except the battery compartment nor tampered with in any manner.

  • Page 21: Returns, Disposal

    If a device is found to be faulty, we will honor this Warranty as quickly and efficiently as we can and either repair or replace the defective device at our discretion. We will return to you a fully functional SIS machine that meets all of its design and functional specifications perfectly, as speedily as possible.

  • Page 22: Device Specifications

    SIS MACHINE M200 MODEL OPERATING MANUAL 14. DEVICE SPECIFICATIONS Additional Parameter Unit Minimum Typical Maximum Accuracy Notes Input Battery Voltage Output Measured Voltage in across Current 6.91 ±10mV 30kΩ 0.1% Stimulation Sense Mode(s) Resistor † Measured across Output ±100nA (1uA-20uA) 30kΩ...

  • Page 23: Manufacturer's Declaration

    SIS MACHINE M200 MODEL OPERATING MANUAL 15. MANUFACTURER'S DECLARATION RADIATED EMISSIONS CONFORMITY AS/NZS CISPR 11: 2011 (CISPR 11: 2010 Ed 5.1) Industrial, scientific and medical (ISM) radio-frequency equipment EN 60601-1-2 FCC15B FCC STATEMENT This device complies with part 15 of the FCC Rules. Operation is subject to...
  • Page 24 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.

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