moorVMS-LDF

V as c u l ar M on i t or in g Sy s t em Laser Doppler Perfusion and Temperature Monitor

User Manual
English

W o r l d w i d e
Moor Instruments Ltd Millwey Axminster Devon EX13 5HU UK Tel: +44 (0)1297 35715 Fax: +44 (0)1297 35716 Web: www.moor.co.uk Email: [email protected]

U n i t e d

S t a t e s
Tel: (302) 798 7470 Fax: (302) 798 7299 Email: [email protected]

Moor Instruments Inc Suite #66 501 Silverside Rd Wilmington DE19809 USA

EC DECLARATION OF CONFORMITY
Moor Instruments Ltd Millwey Axminster Devon EX13 5HU UK Declares that the medical device described hereafter moorVMS-LDF Laser Doppler Monitor is in conformity with the essential requirements and provisions of Council Directive 93/42/EEC and is in conformity with the national standard transposing harmonised standards: IEC 60601-1: 2005 IEC 60601-1-2: 2007 IEC 60825-1: 2007 Is subject to the procedure set out in Annex 2 of Directive 93/42/EEC under the supervision of Notified Body Number 0120, SGS United Kingdom Limited, Unit 202B, Worle Parkway, Weston-Super-Mare, Somerset BS22 6WA, UK Axminster, England 18/09/2008 D. Boggett Managing Director On behalf of Moor Instruments Ltd

___________________________

2009 Moor Instruments Limited, Millwey, Axminster, Devon, EX13 5HU, UK. All rights reserved. Printed in England. Manual Version: moorVMS-LDF User Manual (Version 2.0 English) Revision Date: 14/01/2009 This document may not, in whole or in part, be translated or reproduced by any means without prior consent from Moor Instruments Limited.

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Contents
Safety Notes 1 Introduction
How to use this manual VMS Overview LDF1 Panel Overview LDF2 Panel Overview Measurement Units Making Accurate Measurements 7 7 8 9 10 11

Operation Guide
Setting Up System Buttons System Menus Probes Using Probes on Subjects Calibration Analogue Outputs 12 13 13 15 16 18 20

Maintenance
General Cleaning System Servicing Probe Care Probe Cleaning 21 21 22 23

A Accessories B Troubleshooting C Basic Theory D System Specifications

Warranty and Service Policy Returns, Decontamination and Disposal Index

26 28 29 30
33 34 35

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Safety Notes
General Safety
a) The moorVMS-LDF must be installed and put into service according to the instructions given in this manual. b) If the moorVMS-LDF malfunctions or appears to exhibit an abnormal or unexpected behaviour it should immediately be withdrawn from use and returned for repair. c) DANGER - EXPLOSION HAZARD. Equipment not suitable for use in the presence of a flammable mixture with air or with oxygen or with nitrous oxide. d) Operating personnel should not remove instrument covers. Access to Class 3R and Class 3B invisible laser radiation and live parts of circuits are possible with instrument covers removed. Component replacement and internal adjustments MUST be left to an authorised Moor Instruments service centre where the appropriate laser safety precautions should be adopted, in particular, the use of suitable laser protective eyewear. e) Servicing should only be performed by an authorised Moor Instruments Service centre. f) Exercise caution in handling the moorVMS-LDF. Do not drop it or immerse in fluids. g) WARNING: To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. h) All external equipment connected to the moorVMS-LDF must be compliant with IEC 60950 and the system of equipment must be configured to comply with IEC 60601-1. i) When making connections to the power supply, USB or analogue interfaces, do not touch the patient and parts of either the connecting leads or mating sockets at the same time. j) Ensure that the cooling fan on the rear panel and vents on the bottom cover are free from obstruction and that air is free to circulate around them. k) WARNING: No modification of this equipment is allowed.

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Electrical Safety Labels/Identifying Marks

Symbol: CE Mark Location: Rear panel Explanation: This product is in conformity with the essential requirements and provisions set out in Annex 2 of Council Directive 93/42/EEC under the supervision of Notified Body Number 0120, SGS United Kingdom Limited. Symbol: Type BF Applied Part Location: Front probe sockets / Rear panel Explanation: The equipment has a floating applied part, which is for intentional external application but NOT for direct cardiac application. Symbol: Caution Label Location: Rear panel Explanation: Warning! To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. Symbol: Read Operating Instruction before use Location: Rear panel Explanation: Please refer to operating instructions for correct operation. Symbol: Laser Hazard Warning Location: Front panel Explanation: Laser in operation, observe safety precautions. Symbol: Wheelie bin (WEEE Directive) Location: Rear panel Explanation: Dispose of unit in accordance to WEEE directive. Return unit to manufacturer or distributor for proper disposal. Label: Class 1 laser product (moorVMS-LDF1/moorVMS-LDF2 only) Location: Top case Explanation: This explains that this product contains a class 1 laser.

CLASS 1 LASER PRODUCT IEC 60825-1:2007

INVISIBLE LASER RADIATION AVOID DIRECT EYE EXPOSURE CLASS 3R LASER PRODUCT IEC 60825-1:2007 MAX OUTPUT 20mW, 785nm

Label: Class 3R laser product (moorVMS-LDF1-HP only) Location: Top case Explanation: This explains that this product contains a class 3R laser.

LASER APERTURE AT PROBE TIP

Label: Laser Notice No. 50 (USA only) Location: Top case Explanation: This explains that this product complies with FDA performance standards for laser products.

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Laser Safety
CAUTION! Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure.

USA only: Canada only:

Complies with FDA performance standards for laser products except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007 This instrument must be installed and operated according to CAN/CSA-Z38601: Laser Safety in Health Care Facilities.

The moorVMS-LDF system is available with two alternative laser outputs. The standard moorVMSLDF1 and moorVMS-LDF2 monitors have low power (2.5mW maximum) Class 1 lasers and are suitable for general blood flow measurement applications. The moorVMS-LDF1-HP has a high power (20mW maximum) Class 3R laser and is designed for applications requiring greater measurement depth using probes with wide fibre separations. It is important to identify the system in use and take the appropriate safety precautions.

Standard monitors
CLASS 1 LASER PRODUCT

WARNING! The laser is automatically turned on when switching on the monitor. The laser can be on without probes being connected!

IEC 60825-1:2007

The standard moorVMS-LDF1 and moorVMS-LDF2 monitors are classified as Class 1 laser products according to IEC 60825-1:2007. Class 1 laser products are generally regarded as non-hazardous and laser safety goggles are not required to be worn by the patient or operator, however, care should still be exercised when taking measurements around the eye to avoid unnecessary viewing of the beam. The moorVMS-LDF is not intended to be used for measurement on the eye itself.

High power monitors

CLASS 3R LASER PRODUCT The high power moorVMS-LDF1-HP monitor is classified as a Class 3R IEC 60825-1:2007 MAX OUTPUT 20mW, 785nm laser product according to IEC 60825-1:2007. Invisible laser radiation is emitted from the probe tip. The probe connector incorporates an interlock LASER APERTURE AT PROBE TIP which turns the laser off when no probe is connected, preventing laser radiation being emitted directly from the front panel. The laser output is safe for skin exposure but potentially hazardous to the eye and care should be taken to avoid direct viewing. This may require protective laser eyewear to be used by the patient and/or operator. INVISIBLE LASER RADIATION AVOID DIRECT EYE EXPOSURE

Protective eyewear (for use with moorVMS-LDF1-HP) For maximum safety the patient and operator should wear the protective laser goggles supplied with the system whilst the laser is turned on. The laser goggles should have an optical density (OD) of at least 2 (or a scale number of at least L2) at a wavelength of 785nm and be suitable for a power density of at 3 2 least 10 W/m . The laser goggles should allow the yellow LASER indicator on the front panel to be seen clearly. Replacement goggles can be ordered from Moor Instruments. Laser radiation is emitted from the probe tip as a diverging beam and the laser hazard reduces as the distance from the probe tip is increased. The level of accessible laser radiation is generally below the maximum permissible exposure for the eye at distances of greater than 200mm from the probe tip. As a result, if all of the following conditions are satisfied then protective laser goggles may not be required: The probe is securely positioned before the laser is turned on. The measurement site is at least 200mm from the eye. There is no risk of direct viewing of the beam by the patient or operator. The laser is turned off before the probe is removed or moved to another site.

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1 Introduction
How to use this manual
This manual is intended for the standard moorVMS-LDF1 (Single channel), moorVMS-LDF2 (Dual channel) and the high power moorVMS-LDF1-HP (Single channel) laser Doppler perfusion and temperature monitors. Within this manual you will find setting up and operational guides, safety and maintenance information. For PC software information, please consult the accompanying moorVMS-PC software manual (if purchased). User Assistance Information: In case of difficulties that cannot be solved easily within this manual, please contact your distributor or Moor Instruments directly. Quote the instrument serial number and moorVMS-PC software version (if used).

VMS Overview
Welcome to the moorVMS-LDF, an instrument designed for the measurement of blood flow within the microvasculature by using laser Doppler techniques. Part of a set of instruments belonging to the moorVMS system, the moorVMS-LDF can be used on its own or combined with other moorVMS modules to create a flexible system to aid your research and clinical applications.

Overview of features
Available in 1 or 2 channel configurations. Modules are stackable, saving work-space for multi-channel systems. High resolution LCD for clear measurement readings. Connect to a PC via USB to display, record and analyse your measurements. (Only available with moorVMS-PC software) 2 analogue voltage outputs per channel for connecting to analogue data acquisition units. Probes used with the moorVMS-LDF have an integrated memory chip to save calibration constants (any probe can be used with any moorVMS-LDF module of the same power without recalibrating). Module with high power laser output (moorVMS-LDF1-HP) available for deeper penetrations applications.

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LDF1 Panel Overview Front panel

1 2 3 4 5

moor instruments
LASER

moorVMS-LDF1
LASER

Laser Doppler Perfusion and Temperature Monitor

POWER

10
1 2 3 4 5

9
Probe socket Laser warning symbol Laser on / off button LCD display Menu up button 6 7 8 9

8
Menu/Enter button Power on / off LED Menu down button Laser on / off LED

10 Type BF label

Rear panel

11 EU WEEE directive symbol 12 Power on / off switch 13 AC mains inlet 14 Analogue outputs 15 Caution symbol 16 Read documentation symbol

17 USB, port for PC connection 18 Manufacturer / Model details 19 Power rating 20 CE marking 21 Type BF applied part symbol

Warning! All external equipment connected to the moorVMS-LDF must be compliant with IEC 60950 and the system of equipment must be configured to comply with IEC 60601-1.

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LDF2 Panel Overview Front panel

2
1

5 6

moor instruments

LASER

moorVMS-LDF2
LASER

Laser Doppler Perfusion and Temperature Monitor

POWER

10
1 2 3 4 5

9
Probe sockets Laser warning symbol Laser on / off button LCD display Menu up button 6 7 8 9

8
Menu/Enter button Power on / off LED Menu down button Laser on / off LED

10 Type BF labels

Rear panel

11 EU WEEE directive symbol 12 Power on / off switch 13 AC mains inlet 14 Channel 1 analogue outputs 15 Channel 2 analogue outputs 16 Caution symbol

17 Read documentation symbol 18 USB, port for PC connection 19 Manufacturer / Model details 20 Power rating 21 CE marking 22 Type BF applied part symbol

Warning! All external equipment connected to the moorVMS-LDF must be compliant with IEC 60950 and the system of equipment must be configured to comply with IEC 60601-1.

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Measurement Units
The moorVMS-LDF provides continuous measurements of LD tissue blood flow (Flux), moving blood volume (Conc), light intensity (DC), and temperature (Temp). Flux LD Blood flow is related to the product of average speed and concentration of moving blood cells in the tissue sample volume. It is the parameter most widely reported in laser Doppler publications. LD concentration relates to the number of moving blood cells in the tissue sample volume. Indicates the backscattered laser light intensity. It can be used to check the function of the laser Doppler probes. Indicates the skin temperature when used with appropriate skin probes.

Conc

DC

Temp

Flow Units
Because of the nature of the blood flow in capillaries, connecting small blood vessels and the effect of varying skin colour and structure, researchers and manufacturers generally agree that it is not appropriate to use absolute flow units for laser Doppler such as ml/minute/100g of tissue. To justify the use of absolute units, it is necessary to calibrate for the particular tissue type and site of the measurement. This is impractical except in very special circumstances and is not appropriate for normal day to day measurements. Perfusion units (PU) are used for Flux and arbitrary units (AU) are used for Conc and DC in Moor Instruments monitors (in common with most other manufacturers). PU (Perfusion Units) To provide consistent measurements for all tissue types, measurements must be taken using a probe that has been calibrated using the motility standard supplied with the moorVMS-LDF. The motility standard consists of a low concentration of polystyrene microspheres in water undergoing thermal motion (Brownian motion). The calibration constants are stored on the probe memory chip. PU is the laser Doppler blood flow unit. Note: Calibration standardises the performance of probes of the same type; equivalent performance cannot be assumed for probes with different optical fibre geometries.

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Making Accurate Measurements

Precautions should be taken to standardise conditions under which blood flow measurements are made, as a number of factors can affect the subjects blood flow or measured blood flow.

The following factors may influence the laser Doppler flux measurement:

External Factors
External lighting such as spot lamps and sunshine can affect LD measurements. To see if the lighting is suitable under experimental conditions, turn the lighting off and on, or cover/uncover the tissue site while reading the Flux and DC measurements. External lighting that causes a noticeable change of Flux and/or DC should be avoided or the tissue shielded from it. Moving the probe tip or tissue during measurement will produce movement artefacts, causing the flux measurement to give an artificially increased blood flow reading. Secure the probe head to the measurement site (e.g. using the supplied skin probe holders) and secure probe leads to avoid movement. The physical force applied to tissue by a probe tip will reduce blood flow. Try to apply minimal pressure when taking measurements. Using probe holders helps you to get stable and accurate measurements. The ambient temperature and humidity of the room used for measurements can affect blood flow. Try to conduct measurements in a room maintained at a constant temperature and humidity. Allow the subject to acclimatise for 15 minutes or longer in the room before a test.

Internal Factors
A subjects mental state before and during a measurement will affect blood flow; ensure a quiet, relaxed and comfortable environment during acclimatisation and measurements. Measurements on different parts of the body will have different blood flow characteristics. Try to keep the measurements in a particular area of interest. Allow the subject to breathe normally during measurement. A deep breath can significantly affect blood flow. Subjects should not talk during measurements because this alters breathing and causes movement. Subjects should refrain from vigorous exercise, meals or stimulants (e.g. caffeine, nicotine, alcohol) for several hours before any measurements. Measurement Tips Laser Doppler monitors sample blood flow in a small volume of tissue. To obtain a representative measurement of the area under investigation, measure at several local sites on the tissue. Averaging or use of a large area probe can reduce variance. It is recommended that users measure flux changes relative to a reference baseline. Laser Doppler is most powerful when using a test that produces a dynamic response. Blood flux changes can then be expressed as a percentage change from a baseline and this change may be used to measure the status of the tissue blood flow system. In addition to single absolute flux levels and responses, the spontaneous fluctuations of flow with time contain significant information: i.e. vasomotion amplitudes and frequencies.

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2 Operation Guide
Setting Up
Your basic moorVMS-LDF box should contain: moorVMS-LDF User manual *Software *Software manual USB cable AC power cable *Probe Box

Calibration Flux Standard

Calibration Calibration Post Base Skin probe holders & probe cleaning tissues

Probe & PAD (Spare adhesives for probe holder) * Optional

moorVMS-LDF kit

Probe box

Quick Start Guide

The following provides a quick reference on how to set up the moorVMS-LDF. (Please ensure that the probes are properly checked and clean before use)

1. Plug in the AC power cable.

2. Switch on the unit at the rear of the VMS.

3. Open the dust cap, align the markers and plug in the probe.

4. (For optional moorVMS-PC Software) Plug the USB cable into the USB port at the rear of the instrument and into your USB port on your PC. 5. Run Measurement Mode from the moorVMS-LDF menu (see page 13 for information). 6. Turn the laser on (For moorVMS-LDF1-HP only)

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System Buttons
The 4 front panel buttons are used to control the moorVMS-LDF. By using the up (+), down (-) and menu buttons (), you can access the measurement, calibration and analogue output setups.

Up (+) / Down (-) Use these buttons to scroll the menus. Menu / Enter In measurement mode, use this button to return to the main menu. In menu mode, use this to select menus and settings.

LASER

LASER On / Off Use this button to switch the laser on or off. The LASER LED will illuminate when the laser is on. Standard systems The laser is automatically turned on when switching on the monitor. The laser can be on without probes being connected. High Power systems The laser must be turned on manually and can only be used when a probe is connected and will automatically turn off when a probe is disconnected.

System Menus
The user can access features on the moorVMS-LDF by the menu. The main menu enables access to 3 modes: Measurement Mode Probe Calibration Analogue Output Setup
Main menu
1. Measurement Mode 2. Probe Calibration 3. Analogue Output Setup

Select the mode required by highlighting with the +/- keys and then press the Enter key. Note: The following sections contain screenshots from the LDF2. The LDF1 display is smaller in height but has equivalent functionality.

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Measurement Mode
Flux, DC and temperature (depending on probe type) measurement readings are displayed and updated once per second (1 Hz). Flux, DC, Conc and Temp measurements are sent out to the PC via the USB port 40 times per second (40 Hz).
1 Flux DC
PU

Temp
AU

Measurement mode: During measurements, the parameters are displayed (from left to right) Flux, DC, and Temp. Channel 1 is displayed on the top half (LDF2).

300.0
2 Flux

300.0
DC

37.9
Temp

300.0

PU

300.0

AU

37.9

Measurement mode

Note: All flux measurements are displayed as (PU) perfusion units.

Probe Calibration
This menu lets you calibrate your probes. Follow the onscreen instructions during the calibration procedure. (For information on the probe calibration procedure see page 18) Calibrate channel probe: Select the channel the probe is connected to. Note: A warning message appears if the probe is not connected.
Probe calibration menu
1. Return 2. Calibrate channel 1 probe 3. Calibrate channel 2 probe

Analogue Output Setup

The analogue output setup menu allows you to set the output voltage range and scales for Flux and DC/Temp measurements (See page 20 for information on analogue outputs). Analogue output setup: Select either Flux or DC/Temp to change the output settings for that output type and channel.
1. Return 2. Flux1 3. Flux2 4. DC/Temp1 5. DC/Temp2 Time const 0.1s Time const 0.1s Temperature Temperature 2.5V=1000PU 5.0V= 500PU 5.0V= 50C 5.0V= 50C

Analogue output setup

Flux setup: Change the time constant and scaling for the flux output. Flux output settings Time Constant: Flux Scaling (PU): 0.0 / 0.1 / 0.5 / 1.0 / 3.0 seconds 5.0V = 100 5.0V = 500 5.0V = 1000 2.5V = 1000

1. Return 2. Time Constant 3. Scaling

0.1s 2.5V=1000PU

Flux output setup

DC/Temp setup: Set the output to either DC or Temp and scaling type for that parameter. Aux output settings Parameter: DC Scaling (AU): DC/Temp 5.0V = 100 5.0V = 500 5.0V = 1000 2.5V = 1000 Temp Scaling: 2.5V = 50C 5.0V = 50C

1. Return 2. Parameter 3. Scaling

Temperature 5.0V=50C

DC/Temp output setup

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Probes
Probes supplied for the moorVMS-LDF have an embedded memory chip that is used to store calibration constants. Probes can be used on either channel on the same machine or on another moorVMS-LDF without being recalibrated, providing consistent results between channels. All probes have a probe tip, which is generally positioned in gentle contact with a tissue surface during measurement. Probes transmit low power laser light (typically 0.5 to 1.2mW for standard systems and 5 to 12mW for high power (HP) versions) to the tissue surface via a flexible glass optic fibre. Some of the light scattered from the tissue and moving blood cells is collected and transmitted back to the moorVMS-LDF by one or more optic fibres. You should check the probes before use, ensuring that they are clean and not damaged. A basic check is to see that light is transmitted from the probe connector to the probe tip. (Further probe instructions on cleaning and testing can be found on page 22 under Probe Care) Caution! Probes are only suitable for use with the moorVMS-LDF. Use of probes with other instruments may result in increased electromagnetic emissions or decreased immunity. Caution! Optic fibres will break if mishandled. Do not bend the leads through small angles (radii of less than 20mm). Do not pull or apply pressure on the leads with heavy objects or sharp edges.

Inserting and removing probes

Note: Standard and High power moorVMS-LDF require the right probe type to be connected, if the wrong probe type is connected a warning message will appear.

Precautions to take during Insertion/Removal of probes:

Do not drop the probe; this may permanently impair probe performance. Do not force the probe plug into the socket, it will insert only one way. Do not obstruct the socket with foreign material while plugging the probe in. Do not allow the dust cap to stay open for long periods without a probe inserted as dust will collect inside the socket, degrading optical performance. Pull on the ridged segment of the probe plug when removing; doing otherwise will damage the probe.

1. Open dust cap: Swing the dust cap towards the left and hold in position while connecting the probe.

2. Inserting the probe: Line up the red marker on the probe to the red marker on the probe socket. Plug the probe in until it is fully inserted.

3. Removing the probe: Hold the ridged area on the probe handle and pull away from the socket. The dust cap will spring shut once the probe is removed.

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Using Probes on Subjects Skin and other external surfaces

There are several types of probes for measurements of skin: Skin probes (e.g. VP1/T, VP2, VP1T/7) are attached with a probe holder and double-sided adhesive discs. Probes attached this way do not apply pressure to the skin; pressure would reduce the skin blood flow. The ideal choice of probe holder depends on the application: PH1-V2 is a flexible PVC probe holder that holds the probe tight and secure; this is appropriate for long-term monitoring to obtain responses from exactly the same site. The flexibility of the PH1-V2 enables adherence to curved surfaces (using a PAD adhesive disc, see below).

PH1-V2F is a hard plastic probe holder that gives a sliding fit for the probe so that it can be removed or replaced; this enables measurements at many sites (using separate probe holders) and also enables rotation of the probe within the probe holder so that a local average of measurements, with lower variance, can be obtained. The PH1-V2F is not suitable for highly curved surfaces such as fingers.

PAD adhesive discs are pressure sensitive; to obtain a secure bond with the skin and probe holder, apply gentle pressure for 15 to 20 seconds. Do not apply pressure during measurements. Attaching Skin Probes with PAD adhesive discs 1. Peel the PAD from the packaging and attach the adhesive side of the PAD underneath the probe holder, pressing firmly.

2. For the flexible PH1-V2, press probe into probe holder on a clean surface (e.g. lens tissue), remove cover paper and press the holder onto the skin for 15-20 sec. 3. The PH1-V2F can be attached first to visually target the exact site. Remove PAD cover paper and press onto skin for 1520 seconds. Turn probe as required.

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Low-profile Probes (e.g. VP8c and VP11sc) are attached by taping over the skin; they can also be used under a pressure cuff. Low profile probes can be influenced by direct laser reflection from the skin so it is advised to use an optical coupling gel between probe and skin (to provide refractive index matching); only a thin film is TM required; KY and ultrasound gels are suitable.

Internal use
Endoscopic Probes Endoscopic probes are intended for use in cavities and internal orifices, introduced alone or via the accessory port of an endoscope, colonoscope, laparoscope or similar devices. Probes should be tested for free movement within an endoscope accessory port before any in vivo measurements commence. It is essential that the tip of an endoscope probe is in good optical contact with the tissue. This will normally be achieved with the moisture of normal body fluids, but where it is not sufficient the probe tip will need to be bathed in sterile saline or similar, in-situ (a high DC light level indicates poor optical contact; the level drops when there is good contact). Probe positioning should be done with visual observation if tactile assessment is not possible. This is to avoid excess probe-tissue pressure altering blood flow or causing tissue damage. Embedded Probes Good optical contact is essential (see Endoscopic Probes section, above). Various probes can be embedded but the easiest to remove at the end of measurements are the endoscopic probes (front and side-viewing) and the low-profile VP11sc probe. If re-exploration is anticipated, some probes can be sutured in place (e.g. VP8 series and VP11sc) and later removed. Needle Probes Needle probes are blunt-ended and should not be used to puncture holes in tissue; a standard sharp needle of similar diameter to the probe should be used to form the access hole or insert probe within a larger sharp needle. An end-view needle probe should be inserted to the full extent of the access hole to avoid loss of flux signal due to excess blood from needle puncture bleeding. When needle probes are used for surface measurements, shade the tissue surface from bright room lighting which can be transmitted through adjacent tissue and distort the flux signal. Single-fibre Probes Good optical contact between the single fibre probe and the master probe is essential. It is also essential to have good optical contact between the single-fibre tip and the tissue. An instruction note regarding techniques and observation of DC light levels is supplied with each probe.

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Calibration
The optical properties of probes may change over time due to probe cleanliness and handling. These factors can influence your blood flow measurements. Regular calibration helps to ensure your readings are consistent over time. When to calibrate? Probes should be calibrated monthly. A warning will be displayed if a probe has not been calibrated in over 6 months. Probes that are to be sterilised should be calibrated after washing (then re-washed prior to sterilisation). What to do before calibrating? Probe Check that the optical surfaces of the probe tip and probe connector are clean. Clean with a soft non-abrasive cloth or lens tissue. Remove any dust or particles from the probe connector. Do not rub the polished probe tip or connectors. Motility Standard Check that the motility flux standard is within the expiration date. A new flux standard can be ordered from Moor Instruments if the expiration date has passed (Order code = PFS). Ensure the flux standard is at a stable temperature. Generally this is done by leaving the vial of motility standard liquid in a laboratory/room for several hours. Ideally the room temperature should be between 20C and 24C. Before using the standard, shake the vial gently for 10 seconds and then allow the standard to rest for 2 minutes before starting the calibration procedure. Environment Avoid strong ambient lighting during calibration as this may cause errors when calibrating. Check to see if the ambient lighting conditions will affect calibration by checking the DC levels with the laser off. Suitable lighting should only give a DC value rise of 2 units or less. Ensure that there is no source of knocks or vibrations during calibration. Checks between calibration times Leave the probe in the flux standard and watch the flux readings in measurement mode for a few minutes. If the flux reading appears erratic or unstable, check that the probe is positioned correctly in the standard and that there is no movement (particularly the probe lead and probe tip) or vibration (particularly from adjacent machines). If the flux is stable and between 200 220 PU, then no extra calibration is required. High power probes The high power moorVMS-LDF1-HP requires dedicated probes with increased fibre separation for reliable measurement. Although standard probes can be used with the high power monitor and high power probes used with standard monitors, probes must be recalibrated before use in this way.

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Calibration procedure
Your probe box should contain all the necessary parts for calibration: Calibration base, post and clamp Calibration flux standard Warning! Failure to adhere to the calibration procedures as described may result in inaccurate measurements. 1. Assemble the calibration stand (see picture on right) 2. Remove the flux standard container from the probe box and allow it to reach room temperature (e.g. 30 minutes). This may take longer if the container has been stored in a cold place. 3. Once the container has reached room temperature, shake it gently for 10 seconds and leave to rest for 2 minutes. 4. Unscrew the top and position the container in the middle of the calibration base. 5. Adjust the clamp for maximum height and secure the probe in the clamp with the probe tip/head pointing downwards towards the container (see pictures on right). 6. Re-position the container so that the flux standard is directly underneath the probe head. 7. Slowly drop the clamp down until the probe tip/head is correctly submerged in the flux standard (see pictures on right). 8. Access the calibration menu on the moorVMS-LDF and select the channel of the probe to be calibrated. Then follow the onscreen instructions. 9. Following a successful calibration, a Calibration successful message is displayed on the monitor. If a problem occurred during calibration, a Calibration failed message will be displayed. Check that the probe is correctly positioned and not subjected to disturbance during calibration Note: If the probe is dirty or damaged during the calibration, a warning will be displayed Probe characteristics have changed on the moorVMS-LDF. Check the condition of the probe and clean or replace the probe if necessary. The probe will still be calibrated.
How to position needle probe tip Assembled calibration stand

How to position skin probe tip

Important Information
The flux standard must be in thermal equilibrium with its surroundings so there are no convection currents within the fluid; if the fluid has been stored in a cold place, it is important to allow at-least 30 minutes for thermal equilibration to occur before calibration. The thermal energy of the microspheres (and hence their average speed) and water viscosity are temperature dependent. Ideally calibration should always be performed at the same temperature. An increased temperature of 1C will result in an increased in flux signal of about 1%.

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Analogue Outputs
The moorVMS-LDF provides you with 2 analogue outputs per channel at the rear of the monitor, for use with data acquisition units and chart plotters. The outputs provide Flux and DC/Temp voltages. A Time Constant (TC) can be applied to the flux output giving a low-pass filtered output eliminating problems such as spurious spikes caused by the rapid movement of the probe tip or tissue. Note that the cardiac pulse wave will also be reduced with increased TC and it will not be easy to recognise noise due to movement. The analogue outputs will always transmit analogue data even if the monitor is not in measurement mode and can be used simultaneously with the optional moorVMS-PC software. You must use the correct BNC type cabling when using the analogue outputs. The cable has been designed to meet stringent EMC standards. Setting up the analogue outputs is performed via the system menu (see page 14). The maximum voltage range for each output is 0 to 5 volts. Each flux unit is scaled to a voltage value depending on the settings chosen. e.g. A flux output setting of 5.0V = 1000 will give a flux unit value (1.0 PU) output of 5mV (millivolts). A flux value of 0 would give 0 volts and values of 1000 give 5 volts. Analogue output settings

Flux settings Flux output (PU) 5.0V = 100 5.0V = 500 5.0V = 1000 2.5V = 1000 Time const (Seconds) 0.0 (unfiltered), 0.1, 0.5, 1.0, 3.0

DC/Temp settings DC output (AU) 5.0V = 100 5.0V = 500 5.0V = 1000 2.5V = 1000 OR Temp output (C) 2.5V = 50 5.0V = 50

Note: Cabling should conform to the specification listed on page 31. Suitable cables can be ordered from Moor Instruments; refer to the accessories section for details (see page 26). Warning! All external equipment connected to the moorVMS-LDF must be compliant with IEC 60950 and the system of equipment must be configured to comply with IEC 60601-1.

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3 Maintenance
General Cleaning
The instrument must first be disconnected from the mains power supply. Note: The instrument case is not sealed so great care must be taken to prevent the ingress of fluids such as water or alcohol cleaner. The exterior enclosure of the moorVMS-LDF should be cleaned with a soft, dry cloth, or if stains are to be removed, by an alcohol wipe. If the instrument is being returned for servicing or repair, the instrument and optic probes (if being returned) may need to be decontaminated. The user should consult the infection control officer of his/her establishment or their local hospital where necessary (For additional information see page 23 for probe cleaning and page 34 for information regarding contamination status).

System Servicing
There are no user serviceable parts inside the instrument case. All servicing should be carried out only by Moor Instruments approved service personnel. The probe recalibration feature allows the instrument to be easily recalibrated by the user. However it is recommended that the moorVMS-LDF is returned for yearly servicing. If the monitor has suffered a large knock it may be necessary to check the power output of the laser from a probe tip. Should the power have fallen significantly, the monitor will need to be returned to Moor Instruments for servicing. The basic 3 year warranty supplied with the monitor is extended to 5 years if the instrument is serviced annually (For additional information see page 33). Circuit diagrams and parts lists will be made available to approved service personnel upon request.

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Probe Care
All probes emit a near-infrared beam at the probe tip. To identify the active area, before connection to the moorVMS-LDF, hold the connector towards a bright light and inspect the probe head for points of light. For most probes, the active area is at the probe tip. Side delivery probes have an active area a few mm from the tip. Do not stare into the active area of the probe. Probes normally consist of two or more optic fibres contained within a PVC, nylon or silicone rubber sleeving. Typical fibre lengths are 2m for skin and needle probes and 3m for endoscopic probes. The fibres themselves have a silica glass core (typical diameters 100 or 200m), a hard cladding of thickness approximately 20m and a plastic acrylate coating which approximately doubles the overall diameter of the fibre. Prior to use, the probe should be inspected; if there are any signs of damage, do not use. Signs of damage include: unintended rough surfaces, sharp edges or protrusions which may cause a safety hazard.

IMPORTANT: The optic probes are not implantable devices. moorVMS-LDF optic probes cannot be autoclaved.

Caution! Handle probes with care to avoid breaking the optic fibres, scratching the polished ends, or separating the probe ends or connectors from the fibres. Optic fibre is flexible and can be bent; however minimum bending radii are recommended to avoid damage or complete breakage. A typical minimum bending radius is 20mm. Endoscope Probes Warning! There is a risk of tissue puncture with endoscope probes. Where there is a risk of tissue puncture, probes should only be moved into place under visual inspection, with or without use of an endoscope. To obtain appropriate LD output values, it is important that the probe is calibrated. It should be cleaned or sterilised and held, without movement, in contact with the tissue. Prior to use within the inspection port of an endoscope or prior to independent use, the probe should be inspected; if there are any signs of damage, do not use. Signs of damage include: unintended rough surfaces, sharp edges or protrusions which may cause a safety hazard. Probes to be used within an endoscope inspection port should be tested for free movement within the port before clinical use. The minimum instrument channel width recommended for use is 1.5 times the diameter of the LD probe (e.g. for a VP6a probe the minimum instrument channel width is 1.5 x 2.1mm = 3.15mm). During use, it may be necessary to turn off endoscope illumination to avoid interference to the LD signal. Turn illumination on and off during LD measurement to test for interference; if the flux signal changes when illumination is turned off, it should be left off during measurements.

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Needle Probes Warning! Handle needle probes with care to avoid accidental tissue puncture during preparations for use and during cleaning. The needle probe should be stored in its original packaging. Needle probes should be used only by trained and competent personnel. To obtain appropriate LD output values, it is important that the probe is calibrated. It should be cleaned or sterilised prior to use. Prior to use the needle probe should be inspected visually; if there are any signs of damage do not use. During surface measurements, it should be held, without movement, in contact with the tissue. For invasive measurements with smaller needle probes, it might be necessary to puncture the tissue first with a pilot hole using a sharpened hypodermic needle to facilitate probe entry. Pooling of blood at the tip of the probe could impair the LD signal. This can be avoided by inserting to the full depth of the entry hole. During measurement on exposed tissue, it may be necessary to turn off room lighting to avoid interference to the LD signal. Turn illumination on and off during LD measurement to test for interference; if the flux signal changes when illumination is turned off, it should be left off during measurements.

Probe Cleaning
The method of cleaning and the need for sterilisation will depend on the planned measurements and the situations in which the probe will be used. Risk Type Intermediate

Probe Usage (Non-invasive) On intact skin where no infection is suspected. (Invasive) In the mouth with no visible lesions and no infection suspected. Application of probes to broken/infected areas in the mouth or on the skin. Insertion of probes into the nasal cavity or the ear canal. Insertion of probes via endoscopes into stomach, duodenum, colon, rectum, bronchi trachea. Insertion of probes into normally sterile sites, e.g. a joint. Application of probe to an internal organ during an operative procedure, e.g. liver.

Low

High

For INTERMEDIATE RISK and HIGH RISK applications the hospital infection control officer must be consulted and his/her advice on cleaning, disinfecting and sterilisation adhered to.

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LOW RISK

Non invasive
Note: In all cases only the probe head and sleeving should be washed, care should be taken to avoid wetting the connector during the washing process. A new probe as supplied by the manufacturer The probe head, sleeving and connectors will be wiped with an alcohol impregnated cloth prior to packing in its probe box and despatch to the customer. It is recommended that the probe head and probe holder (if being used) is wiped with an alcohol impregnated cloth prior to use, e.g. using a Medi-Wipe (manufacturer Smith & Nephew). After use and before using on a new patient Visually inspect the probe head, sleeving and connectors. If it is free of particles and has no obvious soiling the probe head and sleeving should be wiped using an alcohol impregnated cloth, e.g. Medi-Wipe. If the probe is soiled or has particles attached, the particles should be removed by rubbing with an alcohol impregnated cloth. If necessary the probe should be washed in running water to remove dirt and grime. After washing, excess water should be gently shaken off the probe connectors and probe end and the probe dried with a clean paper towel. When dry, the probe end should be wiped with a clean alcohol impregnated cloth.

Invasive
Note: Under some circumstances the user or the infection control officer will treat the introduction of a probe into the mouth as an Intermediate Risk.

Medical establishments such as hospitals will have approved cleaning/washing protocols to be followed. Where these are not in place the following is recommended:
Probe heads and sleeving should be cleaned in warm clean water with a neutral or enzymatic detergent, e.g. Neutracon (manufacturer Decon). Cleaning should be sufficiently thorough to leave the probe external surfaces visually clean and free of particles. Carefully rubbing with a clean cloth and/or clean brush may be necessary. Probe heads and sleeving should be rinsed in cold or warm running water.

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INTERMEDIATE RISK
Note: In all cases only the probe head and sleeving should be disinfected, care should be taken to avoid wetting the connector during the disinfection process.

Medical establishments such as hospitals will have approved cleaning/washing protocols to be followed. Where these are not in place the following is recommended:
Probe heads and sleeving should be cleaned in warm clean water with a neutral or enzymatic detergent, e.g. Neutracon (manufacturer Decon). Cleaning should be sufficiently thorough to leave the probe external surfaces visually clean and free of particles. Carefully rubbing with a clean cloth and/or clean brush may be necessary. Probe heads and sleeving should be rinsed in cold or warm running water. Disinfection of Probes All probe types (after washing and cleaning) can be disinfected by immersion of the probe head and sleeving in Cidex OPA (manufacturer Johnson & Johnson) for 5 minutes followed by rinsing in sterile water. With care, probes can be expected to withstand 5 disinfection cycles.

HIGH RISK
Sterilisation by an approved organisation is required. Cleaning, washing and rinsing cycles will be performed by the organisation prior to the sterilisation. The validated method of sterilisation of Moor Instruments optic and temperature probes is the STERRAD METHOD (manufacturer Johnson & Johnson). This uses hydrogen peroxide gas plasma technology at a temperature of approximately 50C and can be applied to the entire probe, including the connector. Note: Probes must not be subjected to temperatures in excess of 90C during the washing and sterilisation process. Durability of the Optic Probes The sterilisation process recommended will not significantly affect the optic properties of the probes; however the frequent washing and handling will increase the likelihood of damage. With care probes can be expected to withstand 5 washing/sterilisation cycles. Probe Integrity After washing or sterilisation, the probe should be visually inspected for damage to sleeving, connector and the probe end. The optical transmission of the fibres can be checked by illuminating one end with light from a lamp, e.g. the probe end and checking that light is transmitted to the connector ends. Where the probe end has more than 2 fibres the check should be repeated illuminating the connector end and viewing the probe end for transmitted light. Damaged probes must not be used! After sterilisation a probe will normally be stored in a double sealed pack as for a surgical instrument. It will generally not be possible to check the light transmission; however it has been established in trials that the STERRAD sterilisation process does not significantly affect the probe function.

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A Accessories
Laser Doppler Blood Flow monitors Skin Heating Applications moorVMS-LDF1 (Single Channel) moorVMS-HEAT moorVMS-LDF2 (Dual Channel) moorVMS-LDF1-HP (High Power Single Channel) Pressure Monitor moorVMS-PRES Mobility MS3b Stand (With battery back-up) Cables VMS-USB-2m (2.0 meter USB cable) VMS-BNC-2m (2.0 meter BNC cable) Accessories PFS PAD PH1-V2 PH1-V2S PH1-V2F PH2 LASER-GOGGLES-785
(Flux Standard 10ml) (Probe Adhesive Discs, Qty: 500) (Moulded white PVC probe holder, use with VP1 and VP1T/7, Qty: 10) (Same as PH1-V2 but with 6 suture holes, Qty: 10) (Tecaform (bio-compatible) probe holder, use with VP1 type probes, Qty: 10) (Probe holder, use with VP2 and VP7a probes, Qty: 10) (Laser goggles for use with moorVMS-LDF1-HP)

Non-Invasive Drug Delivery moorVMS-IONT Software moorVMS-PC Software

Note: Your system is supplied with a modified USB cable. You can order additional cables from Moor Instruments or buy from another supplier (following the requirements on page 31).

Optic Probes Reference

Moor Instruments manufacture a wide range of probes to help you assess blood flow from almost any tissue. Skin probes Available with twin or multi-fibre designs. Multi-fibre designs contain a ring of up to eight collecting fibres around a central delivery fibre providing an averaged signal for a larger tissue area than would otherwise be supplied by the twin fibre model. They can also be used in other applications (e.g. non-human bone or visceral measurements) and with other equipment (e.g. Iontophoresis). Amongst the most versatile designs, needle probes can be used for surface measurements, inserted into tissue or used for single vessel measurements. The compact design helps in measurements from tissues with restricted access, e.g. teeth, conjunctiva and where micromanipulation is required. Used when access is difficult (e.g. oral mucosa) or to reduce application pressure if the probe is to be covered by bandages.

Needle probes

Low profile

Endoscopic probes For internal investigations of blood flow in tissue beds such as colon, bronchus and urethra. The probes are available in a wide range of diameters to fit the biopsy channel of most endoscopes. Master/Single fibre probe system Master probes are twin fibre designs, acting as a link between the monitor and the Slave probe tip. The Master probe connects to the single fibre slave probe tip via an optical in-line connector (order code: PCP).

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Probe Guide 90 right angled probe 180 angled probe Multi collection, large area probe
0.5 8.0

Probe tip diameter (mm) Probe head/needle height (mm) Combined optic/temperature probe Multi collection, small area probe

H
12.5

C F

Fibre separation (mm)

Skin Probes - standard systems

VP1 & VP1b
H
8.0 12.5 0.5 0.25

VP2T & VP2Tb

H
30.0 6.0

C F

0.5

0.25

VP1T & VP1bT

C F H
8.0 12.5 0.5 0.25

VP7a
H
30.0 6.0

1.0

VP1/7 & VP1T/7

H
8.0 12.5 0.5

VP7a/T
C F C F H
30.0 6.0

1.0

VP2 & VP2b

H
30.0 6.0 0.5 0.25

Needle Probes - standard systems

VP3 & VP3b
H
1.5 10-80 0.5 0.25 0.8

VP5bs
H
60-120

VP4 & VP4s

H
0.8 0.25 30-80
0.46

VP7b
H
3.3
30-120

VP5a & VP5b

H
30-80 1.5 0.5 0.8 0.25

VP12 & VP12b

12.7

1.5

0.5

0.25

Low Profile Probes - standard systems

VP8c - Suturable
H
8.0 2.5 2.0

VP11sc
H
30-150

Endoscopic Probes - standard systems

VP6a & VP6b
2.1
1.35

VP6L Rectal
0.25

0.5

VP6asd
2.1 0.25

VP6ds
1.34

Master/Single Fibre Probes - standard systems

P10d DP10M200ST
0.5

P10s-TCG DP10M100ST
0.26

P10k DP10M200ST
H
3.0 1.0

High Power Probes - High power systems

VP1-V2-HP
H
8.0 12.5
4.0

VP7BS-HP
3.3

H
30-150

2.15

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B Troubleshooting
System not powering up when switched on Check to make sure that the AC power cable is connected and switched on at the wall socket/outlet. The fuse within the plug of the AC power cable may have blown, change the fuse with another one of the required rating. Fan speed switching This is perfectly normal. The moorVMS-LDF has been designed with a two speed fan for addition cooling when required. When trying to calibrate, a message appears Probe characteristics have changed If the probe is dirty or damaged during the calibration check, a warning will be displayed Probe characteristics have changed on the moorVMS-LDF. Check the condition of the probe and clean or replace probe if necessary. Probe failed to calibrate - Check the condition of the probe (see page 22). - Check that the calibration procedure has been followed (see page 18). No laser power at probe output or no power detected (Zero DC and/or Flux Readings) - Check the condition of the probe (see page 22). - Check that the laser is switched on (see page 13). Flux value of Zero - Check the condition of the probe (see page 22). - Check to see if the laser is on (see page 13). - Recalibrate probe (see page 18). If flux is not zero (greater than 5 PU) the probe is probably ok. Carefully recalibrate the probe. Note: On some tissue, e.g. cold skin, the flux reading can be very small (10 PU or less). Flux or DC values shown as 1000 or OVER RANGE - Check that tissue and probe movement is kept to a minimum (see page 11 and 16). - Check that the probe is calibrated correctly (see page 18). - Check that external lighting is not affecting measurements (see page 11). - Check that standard probes are not used with the moorVMS-LDF1-HP high power monitor.

If none of the suggestions above have helped solve your problem, then contact moor instruments for assistance: W o r l d w i d e
Moor Instruments Ltd Millwey Axminster Devon EX13 5HU UK Tel: +44 (0)1297 35715 Fax: +44 (0)1297 35716 Web: www.moor.co.uk Email: [email protected]

U n i t e d

S t a t e s
Tel: (302) 798 7470 Fax: (302) 798 7299 Email: [email protected]

Moor Instruments Inc Suite #66 501 Silverside Rd Wilmington DE19809 USA

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C Basic Theory
Laser Doppler flowmetry is a well established method for providing real time measurements of blood flow within local tissue. The schematic below illustrates light scattering in tissue.
Optical fibre transmits laser light to the tissue Optical fibre transmits reflected/scattered laser light to a photo detector

flux = k1 .

.P ( ).d
DC 2

noise

conc = k 2 .

P ( ).d noise DC 2
Scaling constants used for calibration.

k1 and k 2
Capillaries 1mm Arterioles & venules

P ( )

Optical power density at Doppler frequency shift

DC

Light intensity. Lower and upper bandwidth limits.

1 and 2
noise

Dark and shot noise components.

Explanation: When laser light is reflected off a moving object such as a blood cell, it undergoes a Doppler frequency shift, the amount of frequency shift is dependent on the speed of the moving object (e.g. a higher speed of blood causes a higher Doppler shift and hence, a higher measured flux value). The laser light used to illuminate the skin tissue is scattered by the static tissue and the moving blood cells. The backscattered light collected by the probe contains a component that has not undergone any frequency shifting and a component that is frequency shifted. Doppler Effect When a wave source (e.g. sound, light) and observer (e.g. photo-detector) are in relative motion to each other, the frequency of the wave changes in relation to the speed of the relative motion. This shift in frequency can be used to calculate speed (e.g. of blood cells) from a reference frequency source (e.g. laser). When two waves mix (e.g. Doppler shifted from blood and non-shifted light from static tissue) the resulting sum of the waveforms has a beat frequency that is equal to the difference between the two original wave frequencies.

Beating

The frequency difference (Doppler shift amount) of these two light components is detected on the surface of a photo detector by a phenomenon called optical Beating. The resulting photocurrent undergoes analogue and digital signal processing (DSP) to produce Flux and Conc parameters relating to the movement and concentration of the blood cells.
Further reading
Nilsson GE, Tenland T and Oberg PA. Evaluation of a Laser Doppler Flowmeter for Measurement of Tissue Blood Flow. IEEE Transactions on Biomedical Engineering, 27 (10), 597-604, 1980. Oberg PA Innovations and Precautions. (Chapter 6). Laser-Doppler Blood Flowmetry edited by A P Shepherd and P A Oberg, published by Kluwer Academic Publishers, 1990. Tenland T, Salerud EG, Nilsson GE and Oberg PA. Spatial and temporal variations in human skin blood flow. Int J Microcirc: Clin Exp 2, 81-90, 1983.

For further information on theory, refer to the Moor Instruments website: www.moor.co.uk/support/theory

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D System Specifications
Measured parameters Flux (tissue perfusion) Range: 0-1000 PU Accuracy: +10% Precision: +3% of measured value DC (intensity) Range: Accuracy: Precision:

0-1000 AU +10% +3% of measured value

Concentration Range: 0-1000 AU Accuracy: +10AU Precision: +5% of measurement value Temperature Range: Accuracy: Precision:

5-50C 0.3C 0.1C

Flux/concentration signal processing Number of measurement channels Analogue outputs

Display Operating environment Storage and transportation environment Power source Dimensions Weight Mode of operation Laser specification

Laser classification of device Electrical safety classification Medical devices classification

Sampling rate (all parameters): 40Hz Raw signal bandwidth: 20Hz - 22kHz (+/- 0.3dB) Software selectable low pass filter settings for flux and concentration processing (Standalone monitoring: 15kHz; PC software: 3kHz, 15kHz, 22kHz) moorVMS-LDF1: 1 x Flux, 1 x DC/Temperature (Selectable) moorVMS-LDF2: 2 x Flux, 2 x DC/Temperature (Selectable) Range: 0-5V Resolution: 12-Bit Number of outputs: LDF1: 2 outputs, LDF2: 4 outputs Connectors: BNC sockets 50 Ohms Graphical LCD with backlight Indoor: e.g. hospital or laboratory use Temperature range: 15 30 oC Temperature range: 0 45 oC Atmospheric pressure: 500-1060kPa Humidity: 0-80%, non-condensing AC mains, 100-230V, 50-60Hz, 30VA LDF1: 235x60x200mm (WxHxD) nominal LDF2: 235x80x200mm (WxHxD) nominal moorVMS-LDF1 (1.4Kg), moorVMS-LDF2 (1.5Kg) Continuous Output power 2.5mW max (moorVMS-LDF1/moorVMS-LDF2) Output power 20mW max (moorVMS-LDF1-HP) Wavelength 785nm + 10nm (moorVMS-LDF1/moorVMS-LDF2) Class 1 per IEC 60825-1:2007 Class 1 per 21 CFR 1040.10 and 1040.11 (moorVMS-LDF1-HP) Class 3R per IEC 60825-1:2007 Class I Type BF applied parts Class IIa Active device for diagnosis

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Laser output
moorVMS-LDF1 / moorVMS-LDF2 Laser Type: Semi-conductor laser diode Wavelength: 785nm + 10nm Maximum Accessible Power: 2.5mW Beam Type: Diverging beam 26 from probe tip moorVMS-LDF1-HP Laser Type: Semi-conductor laser diode Wavelength: 785nm + 10nm Maximum Accessible Power: 20mW Beam Type: Diverging beam 26 from probe tip

Light is emitted as a diverging beam from the optic probe. The power output from this laser aperture is typically 0.5 to 1.2mW for standard monitors and 5 to 12mW for high power versions, with an angular spread of approximately 26 degrees as the numerical aperture of the 200-micron silica glass fibre used is 0.22.

Electromagnetic compatibility
The moorVMS-LDF complies with the requirements of EN60601-1-2:2007 electromagnetic Compatibility of Medical Electrical Equipment. Medical electrical equipment needs special precautions regarding electromagnetic compatibility and needs to be installed and put into service in accordance with the following information. Mobile radio frequency communications equipment can affect medical electrical equipment. The moorVMS-LDF should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the moorVMS-LDF should be observed to verify normal operation in the proposed configuration. The moorVMS-LDF has been tested in a stacked and adjacent configuration with other Moor Instruments products and such use is permitted. Cabling The moorVMS-LDF is compliant with EN60601-1-2:2007 only when used with the following cables. Modification of cables or use of cables other than those supplied may result in increased electromagnetic emissions or decreased electromagnetic immunity of the equipment. The supplied cables are only intended for use with the moorVMS-LDF, use with other equipment may result in increased electromagnetic emissions or decreased electromagnetic immunity of the equipment. If the user wishes to find alternative suppliers other than Moor Instruments for cables, please ensure that they meet the following requirements: Cable type
USB shielded cable (For PC software)

moorVMS-LDF Connector type

USB Type B

User connector type

USB Type A

Length
up to 5 meters

Required Extras
Ferrite clamp (Farnell: 9415700) fitted next to Type B connector with correct inner diameter to fit cable. Ferrite clamp (Farnell: 9415700) with correct inner diameter fitted to each end of the cable.

50 ohm shielded coaxial cable (For analogue outputs)

BNC

Any signal connector type that can supply proper signal and grounding points, e.g. BNC

up to 2 meters

Guidance and manufacturers declaration electromagnetic emissions The moorVMS-LDF is intended for use in the electromagnetic environment specified below. The user of the moorVMS-LDF should ensure that it is used in such an environment.
Emissions Test RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/ flicker emissions IEC 61000-3-3 Compliance Group 1 Class B Not applicable (Power input < 75W) Not applicable (Power input < 75W) Electromagnetic environment guidance The moorVMS-LDF uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The moorVMS-LDF is suitable for use in all establishments, other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

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Guidance and manufacturers declaration electromagnetic immunity For the purpose of electromagnetic immunity, the essential performance of the moorVMS-LDF is defined as maintaining measurement of tissue perfusion and temperature within the accuracy specifications defined in page 30. The moorVMS-LDF is intended for use in the electromagnetic environment specified below. The customer or the user of the moorVMS-LDF should assure that it is used in such an environment.
Immunity test Electrostatic discharge (ESD) IEC 61000-4-2 Electrical fast transient/burst IEC 61000-4-4 Surge IEC 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 IEC 60601 test level +6kV contact +8kV air +2kV for power supply lines +1kV for input/output lines +1kV differential mode +2kV common mode <5% UT(>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 sec 3 A/m Compliance level +6kV contact +8kV air +2kV for power supply lines +1kV for input/output lines +1kV differential mode +2kV common mode <5% UT(>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 sec 3 A/m Electromagnetic environment guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30% Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the moorVMS-LDF requires continued operation during power mains interruptions, it is recommended that the moorVMS-LDF be powered from an uninterruptible power supply.

Power frequency (50/60Hz) magnetic field IEC 61000-4-8

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Portable and mobile RF communications equipment should be used no closer to any part of the moorVMS-LDF, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3

3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz

3 Vrms 3 V/m

d = 1.2 P d = 1.2 P d = 2.3 P

80 MHz to 800 MHz 800 MHz to 2.5 GHz

where P is the maximum power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE1 UT is the a.c. mains voltage prior to application of the test level NOTE2 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE3 these guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the moorVMS-LDF is used exceeds the applicable RF compliance level above, the moorVMS-LDF should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the moorVMS-LDF. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m

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The moorVMS-LDF is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the moorVMS-LDF can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the moorVMS-LDF as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz

d = 1.2 P

d = 1.2 P

d = 2.3 P

0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1 1.2 1.2 2.3 10 3.8 3.8 7.3 100 12 12 23 For transmitters rated at maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80MHz and 800MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Warranty and service policy

We warrant all products manufactured by Moor Instruments Limited to be free from defects in material and workmanship for the following: moorVMS-LDF (all models supplied new): Optic probes (all models supplied new): 3 years from date of delivery (5 years if extended) 6 months from date of delivery

Should a defect occur within the above periods of time we will either replace or repair any defective parts of the equipment free of charge, provided that: (1) (2) The equipment is returned to Moor Instruments Ltd, carriage paid by customer. Our examination discloses to our satisfaction that the part(s) are defective.

This warranty is not applicable to any equipment which has been repaired or altered in any way so as to affect, in our judgement, its operation, stability, and/or reliability, or has been subject to neglect, misuse, abuse, negligence or accident. Neither shall this warranty apply to any instrument that has not been connected and/or operated according to the instructions provided by Moor Instruments Limited. Software programs are supplied without warranty that the functions performed are free from errors, defects or bugs. Software upgrades that fix known bugs will be supplied free of charge, on request, within the warranty period. The 3 year warranty is extended to 5 years provided that the instrument is returned for annual service. Moor Instruments Limited will be pleased to assist you in, and answer all questions pertinent to, the installation and operation of your instrument. Please feel free to contact us at any time. We shall endeavour to provide prompt and useful advice. We will try to diagnose the problem and give instructions on how to proceed. If your problem cannot be resolved through our combined efforts we may prefer to authorise the return of your unit to Moor Instruments Limited.

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Returns Procedure
1. Contact Moor Instruments in advance to inform us of the defective equipment to be returned and Fax the completed Declaration of Contamination Status form to Moor Instruments for inspection. A Moor Instruments returns number can be issued (if required) at this stage for tracking progress. 2. Pack the instrument very carefully, preferably in its original case, to avoid damage in transit. When returning Moor Instruments equipment always return ALL associated leads, flux standard and optic probes being used with the equipment at the same time for checking. 3. It is important that parts are cleaned and, if necessary, decontaminated before return to Moor Instruments. Repairs cannot be started until decontamination has been certified. 4. Include a delivery note to include all parts returned, recording serial numbers of parts (where available). 5. Include a fault report explaining exactly what difficulties or fault you have encountered or other reason for return and action required. 6. Ship to Moor Instruments Limited, carriage paid, marked FRAGILE. 7. If exporting to the UK please return using the appropriate IPR number and clearly mark on all paperwork RETURN FOR REPAIR. Please send to the address: Servicing Department Moor Instruments Ltd Millwey, Axminster, Devon, England, United Kingdom, EX13 5HU

Decontamination
To protect Moor Instruments staff from pathogens, all equipment returned for inspection, service or repair must be decontaminated, if appropriate, before it is sent. The decontamination should be certified by enclosing a completed and signed Declaration of Contamination Status form with packaging documents or faxed separately. Note: No equipment will be handled by Moor Instruments staff unless it is accompanied by a Declaration of Contamination Status form, therefore, to avoid delay in having your equipment serviced or repaired, please ensure that the procedures detailed below are carried out. Note: Do not send the equipment until it has been decontaminated. It is an offence to send contaminated goods by mail or by courier (without prior agreement of all parties). Procedures: A. Decontamination is not required if the equipment has not been in contact with blood, other body fluids, infectious respired gases and pathological samples, chemical substances hazardous to health or other hazards. In this case Box A of the Declaration of Contamination Status form should be ticked. Where equipment has been contaminated with blood, other body fluids, infectious respired gases and pathological samples, chemical substances hazardous to health or other hazards, it should be decontaminated and Box B of the Declaration of Contamination Status form should be ticked and the method of decontamination procedure which has been carried out described.

B.

Disposal
As part of the WEEE directive, the moorVMS-LDF should not be disposed of with other household or commercial waste but should instead be returned to Moor Instruments or your local distributor for recycling.

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Index
A Accessories ........................................................26 Analogue Output Setup ......................................14 Analogue Outputs ...............................................20 AU (Arbitrary Units).............................................10 B Beating ................................................................29 Blood flow measurements ..................................10 C Calibration ...........................................................18 Cleaning ..............................................................21 Conc....................................................................10 D DC .......................................................................10 Decontamination .................................................34 Disposal ..............................................................34 Doppler Effect .....................................................29 E Electrical Safety Labels/Identifying Marks ............ 5 Electromagnetic compatibility .............................31 Embedded probes ..............................................17 Endoscopic probes .............................................17 F Flow Units ...........................................................10 Flux .....................................................................10 G General Cleaning ................................................21 General Safety ...................................................... 4 I Introduction ........................................................... 7 L Laser on/off .........................................................13 Laser output ........................................................31 Laser Safety .......................................................... 6 LDF1 Panel Overview ........................................... 8 LDF2 Panel Overview ........................................... 9 Low-profile probes ..............................................17 M Making Accurate Measurements ........................11 Measurement Mode ........................................... 14 Measurement Units ............................................ 10 N Needle probes .................................................... 17 O Overview of features ............................................ 7 P PAD .................................................................... 16 Probe - Inserting and removing ......................... 15 Probe Calibration ............................................... 14 Probe Care ......................................................... 22 Probe Cleaning .................................................. 23 Probe Guide ....................................................... 27 Probe Holder ...................................................... 16 Probe reference ................................................. 26 Probes ................................................................ 15 PU (Perfusion Units) .......................................... 10 Q Quick Start Guide............................................... 12 R Returns Procedure ............................................. 34 S Safety Notes ........................................................ 4 Setting Up .......................................................... 12 Single-fibre probes ............................................. 17 Skin probes ........................................................ 16 System Buttons .................................................. 13 System Menus ................................................... 13 System Servicing ............................................... 21 System Specification.......................................... 30 T Temperature ...................................................... 10 Theory ................................................................ 29 Troubleshooting ................................................. 28 U Units ................................................................... 10 W Warranty and service policy ............................... 33

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