DL-3000 Operating Instructions sw ver 10533MIE Issue C

Manufactured by: Viamed Ltd., 15 Station Road, Crosshills, Keighley, West Yorkshire, BD20 7DT. United Kingdom.

Tel: Fax:

+44 (0)1535 634542. +44 (0)1535 635582.

Web site: www.viamed.co.uk. E-mail: [email protected].

Quality Standards Accreditations: BS EN ISO 9001/2000 & ISO 13485/2003

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Instructions for the use with DL3000 SpO2 simulators: Software Version: 10533M1E. Motherboard Issue: C.

This publication is protected by copyright and all rights are reserved. No part of this manual may be reproduced or transmitted in any form or by any means electronic or mechanical, including photocopying and recording for any purpose other than the purchasers personal use, without the written permission of Viamed Ltd. Information within this document is subject to change. Changes will be made without notice and incorporated in further issues. DL-3000 is a registered trademark of Viamed Ltd and patent number GB2280024A applies to this product. Viamed Ltd, recognises all trademarks and products of manufacturers mentioned. © Copyright 2003. Viamed Ltd.

Contents. Section.

Page.

Introduction.

3.

Pulse Oximetry.

3.

Introducing the DL-3000 SpO2 Simulator.

4.

Connections and Selectors. Simulator, Oximeter and Finger Probe Setup.

5. 5.

Operating the DL-3000.

6.

Pulse Oximeter Selection. Modes of Operation Overview : Simulation, Engineering, Artifact, Evaluation. Simulation Mode. Table A : Selection of Pulse Oximeter Manufacturers and Models. Table B : SpO2 values and heart rates. Artifact Mode. Evaluation Mode.

6. 7. 7. 8. 10. 11. 12.

Cross Reference Tables.

14.

Table 1 - Ohmeda 3700e, rev Q and below : SpO2 value / Probe resistor value. Table 2 - Ohmeda 3700e, rev Q and above : SpO2 value / Probe resistor value. Table 3 - Ohmeda 3740 : SpO2 value / Probe resistor value. Table 3 - Ohmeda 3800 / 3900 ‘Func’ : SpO2 value / Probe resistor value. Table 4 - Ohmeda 3800 / 3900 ‘Frac’ : SpO2 value / Probe resistor value.

15. 16. 17. 18. 19.

DL-3000 Compatibility - R-Curve Table.

20.

Technical Specification.

21.

Electromagnetic Conformity.

22.

Glossary of Terms.

23.

Product Descriptions and Part Numbers.

24.

Appendices.

A: Engineering Mode. B: Procedure change if oximeter pick up becomes intermittent.

Supplements.

Available seperately.

25. 30.

Calibration of the DL-3000 SpO2 Simulator. Module Support : The DL-3000M/ES SpO2 Probe Analyser Module.

Introduction. The DL-3000 SpO2 simulator provides a facility to test and assess Pulse Oximeters and probes from a wide range of manufacturer’s. Pulse Oximetry. The principle behind SpO2 measurement is very simple: the colour of blood changes depending on the oxygen saturation of the haemoglobin. SpO2 monitoring relies on the fact that oxygenated and deoxygenated haemoglobin absorb varying amounts of different types of light. The amount absorbed varies dependent on the wavelength or colour of light used. Red and infrared light sources are normally selected, giving the greatest difference in absorption levels. An SpO2 finger probe contains a red and infrared light source on one side of the clip, normally in the form of a dual LED package. Immediately opposite, lies a detector; a photodiode. The pulse Oximeter activates the two light sources in an alternating sequence. In timing the pulses, the Oximeter can determine the level of red and infrared light absorbed through the patients’ tissue. Some pulse Oximeters have a period when both light sources are off which is used to assess the level of ambient light falling on the detector. The SpO2 value of interest is that of the arterial blood supply. The pulse of arterial blood during the heartbeat varies the level of light absorption. The detector produces a voltage dependent on the amount of light falling on it. There are two components of its output; an AC signal, due to arterial blood flow and a DC signal, due to tissue, bone and venous blood. The pulse oximeter then derives the ‘R ratio’ =

ACRED x DCINFRARED ACINFRARED DCRED

In many pulse Oximeters, when the calculation for R ratio equals 1.00, the value of SpO2 is 85%. When the R ratios for all SpO2 readings are put together, practically from 60% to 100%, the ‘R-curve’ is formed. The R-curve relates the SpO2 reading displayed to the value of blood oxygenation obtained by blood gas analysis. R curve values are dependent on several factors; the LED wavelengths used, the method of calculation or software algorithm employed and the data obtained by the manufacturer. ‘Functional’ SpO2 measurement is the oxygenated haemoglobin expressed as a percentage of haemoglobin capable of carrying oxygen. ‘Fractional’ SpO2 is the percentage of oxygenated haemoglobin when compared to all types of haemoglobin. Most pulse Oximeters measure functional SpO2 however some are capable of relating detector returns to fractional SpO2. SpO2 is the percentage haemoglobin saturation with oxygen, either functional orfractional, as measured by a pulse Oximeter and displayed as a percentage.

Introducing the DL-3000 SpO2 Simulator. The DL-3000 simulates the levels of returns from the two light sources, in order to test the Oximeter and probe, at SpO2 values across the clinical range. The simulation facilities provided could be utilised during research & development, production, quality assurance, evaluation / servicing of monitors, hardware / software algorithm generation or training staff. It is primarily for use with reusable SpO2 probes, but can also be used with different models and types of probes i.e. multi-site ‘Y’ probes and disposables. It is compatible with most manufacturers technologies and LED drive configurations. It is easy to use however operation may vary due to model, type, design, materials used, style and performance (specification / possible degradation) of opto-electronics. Some probes may also contain additional active or passive components. In some cases, passive components may be used to identify probe type / model or wavelength of LEDs (red and / or infrared). The unit operates in conjunction with a unique, physiologically designed test finger, which does not require adapter cables for use with different manufacturer’s Oximeters. The test finger functions with most pulse oximeters using transmission of light to measure SpO2. Correct alignment of the finger probe clip on the test finger is indicated on the DL-3000 facia. The test finger accepts a wide range of probes types and designs. All external parts of the DL-3000 should be cleaned using isopropyl-alcohol. The DL-3000 should not be operated, sited or stored in extremes of temperature or humidity. The DL-3000 uses one of four modes; Simulation, Engineering, Artifact or Evaluation. It provides a facility to simulate SpO2 value, heart rate and ECG waveform, and is capable of introducing patient artifact and change in patient characteristics or probe component degradation. The unit is capable of interfacing with a wide selection of pulse Oximeters and probe combinations and those not preprogrammed may be user set through engineering mode. It does not test the wavelength of the probes emitters, only the optical integrity of the probe. When the optional DL-3000M/ES module is used, the emitters’ intensities can be quantified. The unit is operated, by a simple to use, scrolling menu, requiring only five selectors. The display has an upper and lower readout line. The upper line shows the current option. The lower line shows labels for selectors F1 to F4 or the next selection option. Selectors labelled ‘up’ & ‘down’, allow the user to cycle through the menu options, shown on the upper and lower readout lines. Selectors annotated with upper case labels indicate rapid increase / decrease of the variable, lower case labels indicate single increments. Enter, “ ←| “, selects the option on the upper readout line and progresses to the next menu.

R-curves are pre-installed, matching Oximeter models from leading manufacturers. The unit as supplied, accepts a total of 84 R-curves and could accept further R-curves if necessary. Note. The DL-3000 requires an understanding of pulse Oximetry and experience in Oximeter testing / SpO2 simulation, to fully benefit from all the facilities provided. Further information or explanation on the DL-3000 operation can be obtained from Viamed Ltd. Unless ‘R’ curves are verified and authorised by the respective pulse Oximeter manufacturer, the DL-3000 should only be used as a simulator. Connections and Selectors. The DL-3000 is a compact, robust unit with integral carrying handle. All connections to the unit are made through the rear panel, except the test finger, which connects on the facia (the red dot on the plug aligns with the red dot on the socket). The unit is portable and can be powered via the internal battery or the supplied mains adapter. The unit has been designed to be simple and uncluttered. The facia consists of the display panel, red & infrared alignment indicators, test finger connector and five tactile user selectors.

The rear of the unit accepts connection of a 5 lead ECG cable, the system interface connector and AC/DC adapter lead. Also located here is the on/off switch & control for display contrast.

The carrying handle may be employed as a stand to elevate the display. To do this, depress the handle locking buttons, rotate the handle to the required position, release the locking buttons and allow the handle to lock into the closest available position. Simulator, Oximeter and Finger Probe Setup. The Oximeter manufacturer and model is selected (see overleaf for detailed selection procedure) and with the Oximeter switched on, the finger probe of the Oximeter under test is connected onto the DL-3000’s test finger. The finger probe is attached to the

test finger with the probe upside down. The lit red LED aids in visually aligning the LED package with the optical window of the test finger. Ensure that the finger probe is transmitting light through the window of the test finger. When the correct location is achieved the red and infrared alignment LED's on the facia of the simulator will be illuminated. The Oximeter should begin to respond. If the alignment LED's are not lit, reposition the finger probe. Operating the DL3000. The DL-3000 can operate using it’s internal battery or from the mains supply using the AC/DC adapter. (If necessary connect to the mains outlet using the AC/DC adapter, with the tip polarity converter in “tip >< +” position). Switch on the unit and adjust the display contrast control to obtain a readable display. Pulse Oximeter Selection. This is the initial display after switching on. 1. Select Manufacturer. Using F1 and F2 keys, scroll through the list until the required manufacturer (or compatible i.e. original equipment manufacturer or licensee) appears on the upper readout line of the display. Press Enter to select. Selections. Monitor -› up down

Criticare Criticare

F1 & F2: Scroll through the list of Manufacturers. F3 & F4: No function.

F1 F2 F3 F4 ↵ ↓ Enter: Selects choice of Manufacturer (See Page 8 for table of manufacturers & models). Example: Press F1 (up) three times for Datascope followed by Enter.

2. Select Model. Using F1 & F2 keys, scroll through the list until the required model (or compatible) appears on the upper readout line of the display. Press Enter to select. Datascope up down

Accusat Passport

Selections. F1 & F2: Scroll through the list of Models. F3 & F4: No function.

F1 F2 F3 F4 ↵ ↓ Enter: Selects choice of Model (See Page 8 for table of manufacturers & models).

Example: Press F1 (up) or F2 (down) to select Accusat or Passport followed by Enter. The DL-3000 begins to simulate at a value of 97% SpO2 and a heart rate of 80 bpm, based on the selected Manufacturer and Model. (Default values of zero artifact introduction and 100% for pulse / DC levels for light sources apply. See corresponding sections for further details).

3. Select Function. Selections. Sim sel

Artfct eval sel sel

F1 F2 F3 F4 ↵ ↓ Enter: Returns to Select Manufacturer. Modes of Operation Overview.

F1: Select Simulation Mode. F2: Select Engineering Mode (no label). F3: Select Artifact Mode. F4: Select Evaluation Mode.

1. Simulation:

The primary mode for simulation of SpO2 value, ECG waveform & heart rate. SpO2 and heart rate can be adjusted using F1 - F4. A simulated ECG output of 1mVPEAK is available via the 4mm sockets on the rear panel. This output is synchronized with the SpO2 pulse. The ECG output is available whenever Simulation Mode is selected. The DL-3000 can be used as a standalone ECG simulator. Automatic switch from ECG derived to SpO2 derived heart rate can be tested on some patient monitors, when an ECG lead becomes detached.

2. Engineering :

A provision to access and alter all parameters for SpO2 simulation, to create a custom R-curve for a particular oximeter model. (See Appendix A for operation of Engineering Mode). Engineering Mode is accessed from the Select Function menu using F2. This key is purposely not labelled. This mode has been incorporated to provide the ability to access and alter all the parameters for SpO2 simulation, to create a custom Rcurve. The mode should only be used to verify a known calibrated oximeter and probe.

3. Artifact :

A facility for ‘noise’ introduction to assess oximeter sensitivity. SpO2, bpm and artifact levels can all be adjusted. Artifact Mode allows the introduction of monitorable amounts of noise, representing patient movement etc., into the simulation, at set SpO2 / heart rate values. The level of noise introduced is user alterable, from 0 to a maximum of 4000.

4. Evaluation :

A simulation allowing alteration of light returns, to assess the effect of patient variation and / or probe component degradation. Evaluation Mode allows the level of light present at the detector to be altered, to simulate change in patient characteristics such as skin pigmentation, tissue & bone density, size and perfusion volume. These user-derived variations in light source output also simulate degradation of probe components and evaluates their effects on SpO2 determination.

Simulation Mode. This mode is most commonly used and has only one screen display as shown below. Selections. F1 and F2 : Adjust SpO2 level. F3 and F4 : Adjust bpm rate.

spo2 := 97% bpm := 80

up down up

down

↵ F1 F2 F3 F4 ↓

Enter : Returns to Select Manufacturer.

In this mode, the SpO2 level can be varied using F1 & F2 and likewise bpm rate can be altered using F3 & F4. Pressing Enter exits Simulation Mode and returns to Select Manufacturer. Table A : Selection of Pulse Oximeter Manufacturers and Models.

Manufacturer.

DL-3000 Selected Options. Abbreviated Model.

Actual Model.

Agilent

A1

A1

Criticare.

503. 504. 504DX. Compact TS. Oxyshttl 1. Oxyshttl 2.

503. 504. 504DX. Compact TS. Oxyshuttle I. Oxyshuttle II.

Datex-Ohm

Accusat. Passport. Passport2m. Cardiocap. Cardiocap2. Satlite tr. TuffSat

Accusat. Passport. Passport2 using MasimoSET. Cardiocap. Cardiocap II. Satlite Trans. TuffSat

Dolphin

Voyager

Voyager

Drager Elmed/BCI.

Oxipac Pso 1000. 71000A2. LP28. 2000. 7840. 7850. Eagle 3000. 450SL. Masimo(1).

Oxipac PSO 1000. 71000A2. LP28. 2000. 7840. 7850. Eagle 3000. Tram Module T450SL. Oximeters using licensed MasimoSET technology. Escort PSM. 3i. Pulsox-7. 2B. N-20. N-180. N-185. N-200. N-250. N-3000. NBP- 40. NBP-190. NBP-195. NBP-290. NBP-295. NBP-395. NBP-39XX series.

Critikon.

Datascope.

Datex.

HME. Ivy Biomed(ical). Kontron. Marquette. Masimo. MDE. Minolta. Nascor. Nellcor.

Escort psm. 3i. Pulsox-7. 2B. N-20. N-180. N-185. N-200. N-250. N-3000. NBP- 40. NBP-190. NBP-195. NBP-290. NBP-295. NBP-395. NBP-39XX.

Nonin.

Novametrix. Ohmeda.

Palco. Sensormed(ics). Simed. Space Labs. S&W.

W(elch) Allyn.

NBP-4000. 4600FO. 8500. Onyx. Satchk. 515. 3700e V<Q. 3700e V>Q. 3740. 3770. 3775. 3800 Func. 3800 Frac 3900 Func. 3900 Frac. 340. Sat-Track. S-100e. 90496. Athena. Trav 4053. NT 3050. 52000.

NBP-4000. 4600FO. 8500. Onyx. Satcheck. 515. 3700e, software version before Q. 3700e, software version after Q. 3740. 3770. 3775. 3800 set to functional. 3800 set to fractional. 3900 set to functional. 3900 set to fractional. 340. Sat - Trak. S-100e. 90496. Athena 9140. Diascope Traveller T4053. Diascope NT 3050. 52000.

Viamed Ltd. recognises all trademarks. Note : Oxyshuttle I oximeters can be alternatively labelled as being manufactured by Critikon or Sensormedics. The R curve for this model is therefore installed under Critikon and under Sensormedics. Both R curves are identical.

Table B : SpO2 values and heart rates. % SpO2 values : 60 - 90% at 5% intervals, Heart rate : 40 - 200 at 20 bpm intervals. % SpO2 values : 91 - 100% at 1% intervals, Heart rate : 40 - 200 at 20 bpm intervals. SpO2 (%) 100 100 100 100 100 100 100 100 100 99 99 99 99 99 99 99 99 99 98 98 98 98 98 98 98 98 98 97 97 97 97 97 97 97 97 97

Heart Rate (bpm) 200 180 160 140 120 100 80 60 40 200 180 160 140 120 100 80 60 40 200 180 160 140 120 100 80 60 40 200 180 160 140 120 100 80 60 40

SpO2 (%) 95 95 95 95 95 95 95 95 95 94 94 94 94 94 94 94 94 94 93 93 93 93 93 93 93 93 93 92 92 92 92 92 92 92 92 92

Heart Rate (bpm) 200 180 160 140 120 100 80 60 40 200 180 160 140 120 100 80 60 40 200 180 160 140 120 100 80 60 40 200 180 160 140 120 100 80 60 40

SpO2 (%) 90 90 90 90 90 90 90 90 90 85 85 85 85 85 85 85 85 85 80 80 80 80 80 80 80 80 80 75 75 75 75 75 75 75 75 75

Heart Rate (bpm) 200 180 160 140 120 100 80 60 40 200 180 160 140 120 100 80 60 40 200 180 160 140 120 100 80 60 40 200 180 160 140 120 100 80 60 40

SpO2 (%) 65 65 65 65 65 65 65 65 65 60 60 60 60 60 60 60 60 60

Heart Rate (bpm) 200 180 160 140 120 100 80 60 40 200 180 160 140 120 100 80 60 40

96 96 96 96 96 96 96 96 96

200 180 160 140 120 100 80 60 40

91 91 91 91 91 91 91 91 91

200 180 160 140 120 100 80 60 40

70 70 70 70 70 70 70 70 70

200 180 160 140 120 100 80 60 40

Artifact Mode. Artifact Mode is used to introduce ‘noise’ into the simulation procedure. The level of noise introduced is controllable using the ‘Art Value’ variable. This mode can be used to compare monitors from different manufacturers. The level of noise introduced into the simulation can assist in evaluating the ability of the oximeter under test to select the required signal over the level of noise present. The setting of the artifact level can be adjusted between 0 and 4000. When tested, a particular oximeter will possess a given threshold to artifact introduction, at which point it will show intermittent display of SpO2 and pulse. Over time during routine checks, the artifact rejection level can be monitored to verify the ability of the oximeter to maintain similar levels of noise rejection. The first screen display after selection of Artifact Mode is shown below.

Selections. spo2 := 97% bpm := 80

up down up down

F1 and F2 : Adjust SpO2 level. F3 and F4 : Adjust bpm rate.

↵ F1 F2 F3 F4 ↓

Enter : Selects Artifact adjustment.

Selections. Set

0

Art

Value

UP DOWN up

down

↵ F1

F1 & F2 : Rapid change in Artifact level. F3 & F4 : Fine change in Artifact level. (Changes do not need confirming).

F2 F3 F4 ↓

Enter : Return to SpO2 / bpm adjustment.

Selections. Spo2 / bpm

adjust

↵ F1 F2

F1 : Return to SpO2 / Bpm adjust. F2, F3 & F4 : No function.

F3 F4 ↓

Enter : Return to Select Manufacturer.

Evaluation Mode. Oximeters have to be able to cope with varying physical properties from patient to patient. These variables include change in finger diameter and skin pigmentation levels. To cope with these variations, oximeter circuits usually automatically adjust the light source intensity in response to the level of return from the detector. Any degradation of the LED / detector performance may have adverse effects on the accuracy of the oximeter SpO2 reading. The Evaluation Mode of the simulator allows the emulation of variation in patient characteristics such as skin colour, tissue and bone density, size and perfusion volume. The mode may also be used to independently assess probe component degradation. The initial display of the Evaluation Mode is shown below.

Selections. mode

>

Pulse only

up

down

F1 & F2 : Cycle through the menu. F3 & F4 : No function.

DC & Pulse

↵ F1 F2 F3 F4 ↓

Enter : Select option on upper readout line.

The options available are : Pulse off.

No AC component of the detector signal, therefore no patient pulse or SpO2 reading. The oximeter under test should lose both SpO2 and pulse with corresponding alarms.

Pulse only.

Allows an increase / decrease in the AC component of the detector signal. Oximeters with graphical / bar displays show a corresponding change in pulse amplitude.

DC.

Allows an increase / decrease in the DC component of the detector signal. This simulates changeable light levels arriving at the detector due to skin pigmentation levels or finger diameter etc.

DC & Pulse.

Allows an increase / decrease in both the AC and DC components of the signal. Represents simultaneous changes in skin pigmentation levels, finger diameters and pulse amplitude.

Mon.

Returns to the Select Manufacturer menu.

Pulse and DC levels have a default setting of 100% and have a range of between 0 and 200%. Pulse only. Selections. Puls

100%

up

down

↵ F1 F2 F3

F1 & F2 : Fine change in Pulse level. F3 & F4 : No function.

F4 ↓

Enter : Return to Evaluation Mode Select.

DC only. Selections. DC

100%

up

down

↵ F1 F2 F3

F1 & F2 : Fine change in DC level. F3 & F4 : No function.

F4 ↓

Enter : Return to Evaluation Mode Select.

DC & Pulse. Selections. DC&P 100%

up

down

↵ F1 F2 F3 F4

F1 & F2 : Fine change in DC & pulse. F3 & F4 : No function.