GeTeMed VG 300 User Manual

Page 1
SpO2-average:
Defines the period for SpO2-Measurement. The algo­rithm uses a data block from the LNOP®-sensor of a length defined here. The data block is organised as a ring memory, where the oldest data is overwritten by the actual data.
LCD power save:
Enables the message 'LCD power-save Mode' (seeFig. 4 on page 11) to be displayed.
LCD brightness:
Defines the brightness of the LCD display.
only available in expert mode:
Wave display: Buzzer frequency: Delete memory:
Defines, if graphs can be displayed or not. Defines the frequency (tone) of the monitor buzzer. Immediately deletes the alarm episode memory. This
cannot be revoked! You should consider transferring the data to a PC before selecting this option. After completion of the command this setting is reset to 'NO'.
Pre-alarm time:
Defines the duration of the pre-alarm period to be stored.
Post-alarm time: Memory mode:
Defines the post-alarm period. See 'Pre-alarm period'. Defines, if data is stored only on alarms ('Event') or per-
manent. The permanent storage mode might be of inter­est for physicians. In permanent mode the monitor
stores episodes of 2.5 minutes one after the other.
Overwrite mode:
Defines, how the monitor handles an out-of-memory­problem. It can overwrite the oldest episodes or stop writing. At every start-up this is set to 'Overwrite'.
Factory setting:
Reactivates the factory default settings. Caution: All individual settings will be overwritten!
Date/time settings
Day (num.): Month: Year: Hour: Minute:
Correction of the day in the internal clock. Correction of the month in the internal clock Correction of the year in the internal clock Correction of the hour in the internal clock Correction of the minute in the internal clock
Expert mode
Expert mode:
GeTeMed mode:
Activates the expert mode after entering the correct password. When activated, the menus 'Monitor Settings' and 'System Settings' are extended to include functions primarily designed for clinicians e.g. activation of silent alarms and settings controlling the data memory.
Only for internal purposes of GeTeMed.
Ordering information
Complete system
The complete system consists of the following items:
1 VitaGuard®VG300 monitor
1 SpO2patient cable PC08, 1 LNOP®SpO2sensor
1 mains power adapter NA2000-2, 1 set of batteries
1 pouch with straps
1 user manual, 1 license agreement
Accessories
Please quote the following order numbers when ordering replacements.
Item Order
VitaGuard®Monitor VG 300 (complete system with Masimo SET®)
Power adapter NA2000-2 Pouch with straps Masimo SpO2 patient cable PC08 (2,44m) Masimo SpO2 patient cable PC12 (3,66m) Masimo LNOP®-Neo sensor (neonates < 10kg) Masimo LNOP®-NeoPt sensor (pre-term neo-
nates < 1kg) Masimo LNOP®-Pdt sensor (paediatric sensor
10 – 50kg) User manual (English) Alarm chart (English) User manual (German) Alarm chart (German) Alarm chart (Turkish) VitaGuard® packaging External alarm unit EA1000 External alarm connector cable (10m) Car adapter NAK1500
Tab. 9 Ordering information for accessories to Vita-
number
72022
72126 72186 70257 70258 70251 70250
70252
72312 70321 72311 70320 70322 72902 70003 70004 72127
Guard®VG 300.
40 Appendix Operator manual VitaGuard® VG 300
Operator manual VitaGuard® VG 300 Appendix 41
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Ordering address
Place your order at your local dealer or contact GeTe­Med:
GeTeMed GmbH Oderstr. 59, D-14513 Teltow, Germany Telephone +49 3328 3942-0 Fax +49 3328 3942-99 E-Mail info@getemed.de Web www.getemed.de
play structure' on page 12ff, the values and factory de­faults are given in 'Integrated menus' on page 23ff and in Tab. 2 to Tab. 4.
The following explanations are given in the order of their appearance in the menu.
Monitor settings
Lower HR limit:
Upper HR limit:
Tone (Pulse)
Lower SpO2 limit:
Upper SpO2 limit:
only available in expert mode:
The so called 'Expert mode' can be activated by entering the right password. When activated, the 'Monitor Settings' menu and the 'System Settings' menu are extended to include functions primarily designed for clinicians e.g. activation of silent alarms and settings controlling the data memory.
Silent lower HR:
Silent upper HR: Silent lower SpO2: Silent upper SpO2: Bradycardia delay:
Tachycardia delay: SpO2 lower delay: SpO2 upper delay:
Lower limit for the pulse rate, that, if fallen below, gen­erates an alarm.
Upper limit for the pulse rate, that, if exceeded, gener­ates an alarm.
Defines, if an acoustic signal is given at every recog­nised pulse.
Lower limit for SpO2, that, if fallen below, generates an alarm.
Upper limit for SpO2, that, if exceeded, generates an alarm.
Ditto like lower HR limit, but this generates a silent alarm, if exceeded. Silent alarms save, if programmed,
data like a real alarm, but do not generate a user alarm –so being ‘silent’. This kind of alarm can be of interest for the clinician.
See ‘upper HR limit’, but generates a silent alarm. See ‘lower SpO2 limit’, but generates a silent alarm. See ‘upper SpO2 limit’, but generates a silent alarm. Delay between recognition of a bradycardia (pulse rate
to low) and generation of the appropriate alarm. Ditto like tachycardia (pulse rate to high). Ditto for falling below the lower SpO2limit. Ditto for exceeding the upper SpO2limit.
42 Appendix Operator manual VitaGuard® VG 300
System settings
Clear trends
SpO2perfusion:
Operator manual VitaGuard® VG 300 Appendix 39
Immediately clears the trend memory. This cannot be revoked! After completion of the command this setting
is reset to 'NO'. Defines the algorithm to estimate SpO2. There is a nor-
mal and a special mode for patients with low Perfusion.
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V. Appendix
Special function - Immediate data storage
Press both <INFO/> and <GRAPHIC/> simultane­ously. Data will automatically be stored for two minutes. The resulting episode will contain data for one minute prior to pressing the buttons and one minute thereafter. The following data will be stored:
Date and time of the event.
Monitor setup at time of the event (lower and upper
limits.)
SpO2- and pulse rate (minimal, medium and maximal
Value in the alarm period)
Plethysmogram
Compliance log
The compliance memory has room for 256 events. The oldest events are automatically removed to make room for new ones. The following events are registered:
Monitor on /off.
SpO2monitoring on/ off.
System reset from key panel.
System reset from PC.
Episodes removed (Number of deleted episodes).
Error events from VitaGuard®VG 300’s internal Ma-
simo SpO2module (MS-3 board).
The following data is stored with each event:
The time and date of the event.
Monitoring settings (upper and lower limits).
The log can be examined on the monitor by pressing <IN­FO/> once followed by pressing <GRAPHIC/> twice. To scroll, press <INFO/>. The error codes delivered by the SpO2module are listed in 'Error codes' on page 45.
Explanation of the menu settings
Following you’ll find an explanation of all menu settings in the monitor VitaGuard®VG 300 in the menu structures order. Explanations to the menu structure itself and on how to operate the menus can be found in 'Monitor dis-
Masimo SET technology
Principle of operation
Masimo's SET®(SET – Signal Extraction Technology®) pulse oximeter is based on three principles:
1. Oxyhaemoglobin and deoxyhaemoglobin have differ­ent red and infrared light absorption (spectrophotome­try).
2. The arterial blood volume in tissue and the light ab­sorbed by the blood changes during the pulse (ple­thysmography).
3. Arterio-venous shunting is highly variable and fluctu­ating absorbency by venous blood is a major compo­nent of noise during the pulse.
The Masimo SET®pulse oximeter as well as traditional pulse oximetry determine SpO2by passing red and infra­red light into a capillary bed and measure changes in light absorption during the pulsatile cycle. Red and infrared light emitting diodes (LEDs) in oximetry sensors serve as light sources, a photodiode serves as the photodetector.
Traditional pulse oximeters (TPO)
Traditional pulse oximetry assumes that all pulsations in the light absorbance signal are caused by oscillations in the arterial blood volume. This assumes that the blood flow in the sensor region passes entirely through the cap­illary bed rather than through any arterio-venous shunts. The traditional pulse oximeter calculates the ratio of pul­satile absorbance (AC) to the mean absorbance (DC) at each of two wavelength, 660 nm and 940 nm:
S(660) = AC(660)/DC(660) S(940) = AC(940)/DC(940)
The oximeter then calculates the ratio of these two arte­rial pulse-added signals:
R = S(660)/S(940)
This value of R is used to find the saturation SpO2in a look-up table build into the oximeter's software. The val­ues in the look-up table are based upon human blood studies against a laboratory co-oximeter on healthy adult volunteers in induced hypoxia studies.
38 Appendix Operator manual VitaGuard® VG 300
Operator manual VitaGuard® VG 300 Appendix 43
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Masimo SET®pulse oximeter
The Masimo SET®pulse oximeter assumes that the arte­rio-venous shunting is highly variable and that fluctuating absorbance by venous blood is the major component of the noise during the pulse. The SpO2module (MS-3 board) decomposes S(660) and S(940) into an arterial signal plus a noise component and calculates the ratio of the arterial signals without the noise:
S(660) = S1 + N1 S(940) = S2 + N2 R = S1/S2
Again, R is the ratio of two arterial pulse-added absorb­ance signals and its value is used to find the saturation SpO2in an empirically derived equation in the oximeter's software. The values in the empirically derived equation are based upon human blood studies against a laboratory co-oximeter on healthy adult volunteers in induced hy­poxia studies. The above equations are combined and a noise reference (N') is determined:
N' = S(660) – R * S(940)
If there is no noise N' = 0: then S(660) = R * S(940) which is the same relationship for TPO.
The equation for the noise reference N' is based on the value of R, the value being seeked to determine the SpO2. The MS-3 software sweeps through possible values of R that correspond to SpO2values between 1 % and 100 % and generate an N' value for each of these R values. The S(660) and S(940) signals are processed with each possi­ble N' noise reference through an adaptive correlation canceller (ACC) which yields an output power for each possible value of R (i.e. each possible SpO2from 1 % to 100 %). The result is a Discrete Saturation Transform (DST™) plot as shown in Fig. 15, where R corresponds to SpO2= 97%.
The DST plot has at least one peak, caused by the arterial pulse. This peak shows, that at the associated SpO2value the effective noise cancellation was especially effective, because a well defined source of noise, the arterial pulse variation, was identified.
The DST plot may show more peaks with even higher peak values, caused by other sources of noise (e.g. ve­nous variations of light absorbance). But because venous
Guarantee conditions
We provide the following guarantee for VitaGuard®:
1. GeTeMed guarantees that all VitaGuard®devices with the exception of all consumables such as SpO2­sensors, batteries and packaging material are free from faults for one year after delivery. This guarantee is provided in addition to the statutory warrantee.
2. If a fault develops in the VitaGuard®monitor within the first year after delivery, GeTeMed will repair or replace – as GeTeMed decides – the defective monitor free of charge. The customer must to prove that the fault showed up within the first year after delivery.
3. To process the guarantee, the customer or distributor must send the monitor accompanied with the invoice to GeTeMed. GeTeMed will test the monitor. If no fault is discovered under the scope of this guarantee, than the purchaser takes responsibility for the costs of transport and testing. If GeTeMed decides to replace a defective device or part of it, then the ownership of the defective device or component is transferred to GeTeMed.
4. Intrusions and attempts to repair shall be executed only by GeTeMed or authorised third parties that have been certified to do so by GeTeMed. Any warrantee claim is void if such attempts by non-authorised per­sons have been performed. The warrantee is also void if the VitaGuard®monitor or its components have been improperly handled.
44 Appendix Operator manual VitaGuard® VG 300
Operator manual VitaGuard® VG 300 Safety and Accuracy 37
Page 5
Loss of the pulse signal can occur if the patient has
No communication with MS
hypotension, severe vasoconstriction, severe anaemia or hypothermia.
Loss of pulse signal can occur if there is an arterial
occlusion proximal to the sensor.
Loss of pulse signal can occur if the patient is in car-
diac arrest or is in shock.
Cleaning
Disconnect sensors and cables from the patient and the
monitor, before cleaning them. Use a damp cloth to clean both the monitor and the cables. Use cleaning solution sparingly. Excessive solution can flow into the monitor and cause damage to internal components.
Do not use aggressive solvents or cleaning agents such
as petroleum-based or acetone solutions to clean the monitor. These substances attack the device’s materi­als and device failure may result.
Do not use alcohol to clean the monitor or cables as
this hardens the cables.
Do not touch, press or rub the display panel or casing
with abrasive cleaning compounds, instruments, brushes, rough-surfaced materials, or bring them into contact with anything that could scratch them.
Do not autoclave, pressure sterilise or gas sterilise the
monitor or any of its components.
Regulatory information
VitaGuard®VG 300 complies with the requirements
of the Medical Device Directive 93/42/EEC.
VitaGuard®VG 300 fulfils the EMC requirements laid
out under the directive 89/336/EWG and EN60601-1­2 1/May 1993, part 1.2; EN55011 class B: 1991; DIN VDE 0875 part 11/07.92.
VitaGuard®VG 300 is a class IIa devices according to
the Medical Device Directive 93/42/EEC (MDD).
blood or tissue has ALWAYS a lower SpO2level these peaks are always at lower SpO2values.
Fig. 15 DST plot of output power vs. SpO2value
In reverse, The arterial SpO2value is always given at the peat with the highest SpO2.
This entire sequence is repeated every 0.4 seconds on the most recent eight (can be varied between six and 16) sec­onds of raw data. The MS-3 SpO2therefore corresponds to a running average of arterial saturation of arterial hae­moglobin saturation that is updated every 0.4 seconds.
Error codes
The Masimo SpO2module (MS-3 board) incorporated in VitaGuard®VG 300 communicates with VitaGuard®via a serial port. Should a failure occur on the module, an ap­propriate error code is passed to VitaGuard®. These codes are registered in the compliance log. Should no commu­nication take place between VitaGuard®and the MS-3 module, then code 31 is registered.
Error
code
Meaning
31 32 DSP: Checksum Failure. 33 DSP: Program Memory Test Failure. 34 DSP: Data Memory Test Failure. 35 DSP: Detector ADC Interrupt Failure. 36 DSP: MCU Interrupt Failure.
-3 board.
36 Safety and Accuracy Operator manual VitaGuard® VG 300
Operator manual VitaGuard® VG 300 Appendix 45
Page 6
Tab. 10 Explanation of the error codes used within Vita-
These error codes are intended for maintenance purposes by qualified personnel only.
Patent information
The following is a (possibly incomplete) table of U.S. is­sued Patents and Applications and Patent Markings.
Error
Meaning
code
37 DSP: Diag Queue Overrun. 38 DSP: Hardware Status Failure. 39 DSP: Raw (Data) Queue Overrun. 40 DSP: MCU Watchdog Failure. 63 Diagnostic Failure.
Guard®VG 300.
No USA
Patent
1 5.337.744Low Noise Finger Cot Probe 2 5.452.717Low Noise Finger Cot Probe 3 5.482.036Signal Processing Apparatus and Method 4 5.490.505Signal Processing Apparatus 5 5.632.272Signal Processing Apparatus 6 5.638.818Improved Low Noise Optical Probe 7 5.645.440Patient Cable Connector 8 5.685.299Signal Processing Apparatus
9 5.758.644Manual and Automatic Probe Calibration 10 5.769.785Signal Processing Apparatus and Method 11 5.782.757Low Noise Optical Probes 12 D393.830Patient Cable Connector 13 5.823.950Manual and Automatic Probe Calibration 14 pending Improved Low Noise Optical Probe 15 pending Patient Cable Connector 16 pending Improved Signal Processing Apparatus 17 pending Signal Processing Apparatus 18 pending Shielded Medical Connector 19 pending Signal Processing Apparatus 20 pending Signal Processing Apparatus
Tittle
Accuracy and factors effecting the SpO2measurement
If you doubt the accuracy of any measurement, first
check the patient’s vital signs by alternate means and check that the monitor is functioning correctly.
Inaccurate measurements may be caused by incorrect
sensor application or use.
Inaccurate measurements or loss of the pulse signal
may be caused by exposure to excessive illumination such as surgical lamps (especially ones with Xenon light sources), bilirubine lamps, fluorescent lights, in- frared heating lamps, or direct sunlight. Expose to excessive illumination can be corrected by covering the sensor with a dark or opaque material.
Inaccurate measurements may be caused by placing
the sensor on an extremity with a blood pressure cuff, arterial catheter or intravascular line.
Loss of the pulse signal can occur if the LNOP®sen-
sor is too tight.
Use only Masimo LNOP®sensors for SpO2measure-
ments. Other sensors may cause improper perform­ance.
Information for the handling paediatrician
A pulse oximeter should be considered an early warn-
ing device. As a trend towards patient deoxygenation is indicated, blood samples should be analysed by a laboratory co-oximeter to completely understand the patients condition.
Inaccurate measurements may be caused by signifi-
cant levels of dysfunctional haemoglobin (e.g. Car­boxyhaemoglobin or Methaemoglobin). Carboxy­haemoglobin may erroneously increase SpO2readings. The level of increase is approximately equal to the amount of Carboxyhaemoglobin present.
Dyes (e.g. Indocyanine green or methylene blue) or
any substance containing dyes that change the usual arterial pigmentation may cause erroneous readings or inaccurate measurements.
Inaccurate measurements may be caused by venous
pulsation
46 Appendix Operator manual VitaGuard® VG 300
Operator manual VitaGuard® VG 300 Safety and Accuracy 35
Page 7
Electrical shock hazard: Never open or tamper with
Non
your patient!
the power adapter. Do not use the power adapter if it has fallen.
Do not operate the power adapter from an electrical
outlet controlled by a wall switch or dimmer.
The mains power adapter should not be operated in
damp environments (e.g. bathroom or utility room).
Remove the batteries when storing the monitor for
longer periods.
You can check the battery status by pressing
<INFO/ > multiple times. Please follow the proce­dure explained in 'Battery replacement' on page 22.
Safety precautions - Sensor and cable
Only use the SpO2patient cable delivered with the
monitor.
Connect the SpO2sensor to the SpO2patient cable
(PC08 or PC12) only.
Only use Masimo SpO2sensors that have been veri-
fied and delivered by GeTeMed or its agents. Care­fully read the sensors 'Directions for Use' information.
Carefully route the cables to reduce the risk of patient
entanglement or strangulation! If necessary, affix the cables with a plaster or tape.
Tissue damage can be caused by incorrect application
or use of an LNOP®sensor, for example, by wrapping the sensor too tightly. Inspect the sensor site as di­rected in 'Directions for use of LNOP®sensors' on page 50 to ensure skin integrity and correct position­ing and adhesion of the sensor. Detailed instructions for the different sensor types are given for the LNOP sensors DC1 on page 51, Adt on page 55, Pdt on page 59, Neo on page 64 and NeoPt on page 68.
Do not use damaged LNOP®sensors or cables. Do not
immerse in water, solvents or cleaning agents. Detach the sensor from the patient before bathing it.
Do not attempt to sterilise by any means. Do not use
alcohol to clean the cables as this may harden the ca­ble isolation.
Patent Marking:
No USA
Patent
21 pending Method and Apparatus for Demodulating 22 pending Manual and Automatic Probe Calibration 23 pending Method and Apparatus for Demodulating 24 pending Improved Signal Processing Apparatus 25 pending Low Noise Optical Probes 26 pending Signal Processing Apparatus and Method 27 pending Signal Processing Apparatus 28 pending Signal Processing Apparatus 29 pending Photodiode Detector with Integrated Shielding 30 pending Pulse Oximetry Sensor Adapter 31 pending 32 pending Patient cable sensor Switch
The Masimo-Device incorporated in VitaGuard®is covered under one or more of the following U.S.A. patents: 5.482. 036, 5.490.505, 5.632.272, 5.685.299, 5.758.644, 5.769.785 and int. equivalents. U.S.A. and international patents pending.
Tab. 11 The most important patents on pulse oximetry is-
Tittle
-Protruding Optoelectronic Lens
sued in the U.S. for Masimo Corp.
External alarm unit EA1000
Operation
The external alarm unit can be connected to VitaGuard to amplify the integrated alarm generator. It is intended for situations where your home is such that you may not hear the integrated alarm generator reliably.
®
Do not cover the speaker!
Verify in your actual situation, if you can hear a possible alarm, independently of what you are doing. Think of ac­tivities like housecleaning, watching TV etc.
Caution: Due to the ex­treme volume of EA 1000 you should leave it at least 3 m off
Make sure the alarm speakers of VitaGuard®or EA 1000 are not blocked by anything placed on them. You cannot
react properly to an alarm if you cannot hear it! Make sure you can react to an alarm within a few seconds! Remember: YOU, the caretaker, must react on an alarm! The monitor cannot react for you! Refer
also to 'EMERGENCY SITUATION' on page 1 and 'Operation' on page 8.
®
34 Safety and Accuracy Operator manual VitaGuard® VG 300
Operator manual VitaGuard® VG 300 Appendix 47
Page 8
Function elements
The unit has a trimmer to regulate the alarm volume. Once it is connected to VitaGuard®using the cable sup­plied, it is automatically activated. The three light emit­ting diodes (LED's) on the unit have the following func­tions:
LED Meaning
'Monitoring active' (green, flashing)
'Change bat­teries' (red, flashing)
'Alarm' (red, flashing)
If none of the LEDs are active, then the monitor is not switched on or there is no monitor connected at all.
Technical data
item Value
Battery:
Connection cable:
Operation period:
Tab. 12 Technical data of the external alarmunit EA 1000.
Safety with the external alarm unit
Caution: Keep the external alarm unit at least 3m
away from the patient to prevent damage from the high alarm volume of the EA 1000.
Pay attention to the polarity when replacing the bat-
tery!
Caution: Do not puncture the speaker because you
could damage it.
VitaGuard is activated and the EA 1000 is ready. Green flashing = system status OK! The flashing frequency is independent from the rhythm of the LEDs on Vita­Guard®.
The battery is weak and should be ex­changed. The remaining capacity at start of flashing is typically sufficient for about two days. Pay attention to the polarity of the new battery!
The monitor generated an alarm. A loud flashing tone is generated, which volume can be varied within some limits.
9 V Battery Alkaline Type 6LR61 or 6AM6
7,5 m (standard)
On average about two month
This can easily happen if operated in a tent. If conden­sation accumulates, wait at least 2 hours before using the monitor.
Keep the monitor away from devices that produce
strong electromagnetic fields such as televisions, walkie-talkies, radio transmitters (as found in cordless telephones and paging transmitters, radio controlled toys, security equipment in many shops, wireless communication links for computers and peripherals, etc.), fluorescent lamps, microwave ovens and so on.
Do not use VitaGuard®near MRI units (magnetic
resonance imaging). Induced currents could poten­tially cause burns. Also, VitaGuard®may affect the MRI image and the MRI unit may affect the accuracy of the VitaGuard®readings.
Do not operate in connection with HF-surgical equip-
ment, defibrillators, TENS units or pacemakers. Should, however, the monitor still be connected to the patient during defibrillation, the readings may be inac­curate for a short period afterwards.
While monitoring patients do not connect VitaGuard
to any devices (e.g. evaluating PC) other than those delivered with the monitor. Other devices may not have the required isolation and cause excessive leak­age currents (>100uA) to flow through the patient. This may damage the patient and/or the monitor.
Static electricity from fabrics (e.g. curtains or rugs)
may cause damage to the patient and the monitor or may reduce the reliability of the monitoring function. Always touch the patient’s bed or a wall before touch­ing the patient or the monitor. Try to use fabric sof­tener when washing the patient’s clothes to reduce static electricity.
Do not operate VitaGuard®when travelling by air.
Switch the monitor off and remove the batteries before packing the monitor into your luggage. Pressure due to other luggage my otherwise switch the monitor on during the flight causing the monitor to generate a technical alarm.
Safety precautions - Power supply
Only use the mains power adapter NA 2000-2 or the
car power adapter NAK1500.
®
48 Appendix Operator manual VitaGuard® VG 300
Operator manual VitaGuard® VG 300 Safety and Accuracy 33
Page 9
VitaGuard’s MDD ap-
proval is bound
proved accessories!
to ap-
Electrical shock hazard: Never open or dismantle the
monitor or any other items delivered with the monitor e.g. mains power adapter, cable connectors, etc.
Do not lift VitaGuard®by the power supply cord or
any of the patient cables.
Do not place VitaGuard®or its power adapter in a po-
sition that might cause it to fall onto the patient.
Do not press heavily on the monitor (press buttons
lightly).
Do not use damaged components, sensors or cables.
Do not immerse VitaGuard®or any of its components
in liquids. Detach all sensors from the patient before bathing.
VitaGuard®and the authorised accessories can only be
purchased through authorised agents. Order new sen­sors before you run out! Never use accessories from other sources!
Maintenance repairs may only be carried out by
authorised persons.
Check the acoustic alarm on a weekly basis.
If an alarm condition occurs while the alarm silence
period is activated (e.g. after pressing a button), the only alarm indication is the visual red alarm LED.
Send the monitor back to the manufacturer or agent
for environmental friendly disposal.
Safety precautions - Environment
Do not operate in the vicinity of explosive gases. Do
not use in the presence of flammable anaesthetics or other flammable substances in combination with air, oxygen-enriched environments, or nitrous oxide.
Do not use in extreme temperatures (below 10°C or
above 40°C). Do not place VitaGuard®near heat sources such as radiators, ventilators, ovens, etc. and do not expose it to direct sunlight.
Neither the monitor nor any of its accessories may be
immersed into liquids. Detach the sensor from the pa­tient before bathing it.
Do not expose the monitor to sudden temperature or
humidity variations. Humidity changes should not re­sult in condensation accumulating on the monitor.
Avoid penetration of moisture into the unit. Pay also attention to the safety precautions for Vita-
Guard®on page 31ff! These precautions are valid for the external alarm also!
Car adapter NAK 1500
Operation
The car adapter NAK 1500 can be used to operate a Vi­taGuard®monitor from the 12V car supply. NAK 1500 is connected instead of the mains adapter NA 2000-2. It is fitted with a safety universal plug (DIN ISO 4165), that fits alternatively into the cigarette lighter or the normal car socket outlet. A green LED signalises operation from the car power.
Technical data
item Value
Input 12 V car power supplies. Output +5V DC max. current 600 mA Operational
temperature. Connectors: VitaGuard®: 2pin socket
Cable: 3 m
Tab. 13 Technical data of the Car adapter NAK 1500.
Safety with the adapter NAK 1500
Caution: Operate only on 12V car power supplies!
To avoid condensation, do not leave the car adapter in
the car overnight.
The car adapter can be fixed in the car with the at-
tached Velcro tape. It should not be exposed to direct sunlight or warm air from the cars heating system.
10 .. 50 °C (50 .. 122 °F)
Car: safety universal plug
32 Safety and Accuracy Operator manual VitaGuard® VG 300
Operator manual VitaGuard® VG 300 Appendix 49
Page 10
VI. Directions for use of LNOP®sen-
IV. Safety and Accuracy
sors
Sensor selection
LNOPNeoPt
LNOPNeo
LNOPPdt
Following you'll find help in deciding what type of sensor to use. Following, an adapted copy of the material ac­companying every economy-sized package of different LNOP®sensors is printed.
GeTeMed offers five different types of LNOP®sensors: LNOP®-DC1, LNOP®-Adt, LNOP®-Pdt, LNOP®-Neo and LNOP®-NeoPt.
Selection plan
Following you'll find a scheme that might help you to de­cide what type of sensor to choose:
Patient weighing
< 30
kg
?
Yes No
Patient weighing
< 1
kg
?
Yes
No
Patient weighing
< 10
kg
?
Yes
No
Fig. 16 Plan to choose the optimal sensor type.
LNOPAdt
LNOPDC1
LNOPAdt
After choosing the right sensor you may read the appro­priate sensor instructions. You'll find the manuals for the LNOP®DC1 hereafter, for the LNOP®Adt on page 55, for the LNOP®Pdt on page 59, for the LNOP®Neo on page 64 and for the LNOP®NeoPt on page 68.
long-term
monitoring?
Yes
No
Important – Intended Use:
VitaGuard®is designed to monitor pulse rate and oxygen saturation. Should a bradycardia alarm (low pulse rate) or a drop in the arterial oxygen saturation occur, then artifi­cial respiration and cardiopulmonary resuscitation (CPR) measures may need to be taken. Therefore, allow a trained person to demonstrate to you how you should per­form these measures..
Safety precautions
Safety precautions - Usage
YOU must act on alarms!
Stay near your patient!
Important!
VitaGuard has no therapeutic intentions. YOU, the
Never leave the patient alone until you have veri-
Never continue operating a damaged or unreliable
Verify that you can hear a possible alarm independent
Make sure you can act on an alarm within a few
VitaGuard®must be demonstrated to you by a quali-
Allow your doctor to set the alarm limits and monitor-
VitaGuard®may not be used for other purposes other
caregiver, must act in the event of an emergency.
fied that the monitor is working properly!
monitor! Immediately check the vital signs of the pa­tient! Send the monitor back to the manufacturer or agent for inspection! Watch the patient yourself until you got another monitor or your handling physician advises you to stop monitoring.
of where you are and what you are doing. Make sure that VitaGuard’s alarm speaker is not blocked by any­thing laid on top of the monitor. You cannot act
promptly to an alarm if you do not hear it!
seconds!
fied person. Do not operate the monitor until you have been made familiar with its usage by a trained person and have read and understood this manual and all other documentation provided.
ing parameters suitable for your patient.
than the intended purpose laid out in 'Intended use of VG 300' on page 5.
50 Directions for use of LNOP® sensors Operator manual VitaGuard® VG 300
Operator manual VitaGuard® VG 300 Safety and Accuracy 31
Page 11
Pulse oximetry
Miscellaneous
Item Value range
Pulse rate 25 – 240 BPM Lower alarm limit 25, 30, 35, ... 175, 180 BPM Upper alarm limit 100, 105, 110, ... 235, 240 BPM Pulse rate accuracy:
(± 1 Std. Dev.)
SpO2range 1 – 100 % SpO2accuracy:
(± 1 Std. Dev.)
* Testing based on adult volunteers in induced hypoxia stud­ies with LNOP®-Adt sensors in the range 70 – 100% SpO against a laboratory co-oximeter and ECG monitor.
Tab. 7 Pulse rate monitor properties of VitaGuard
VG 300.
± 3 digits during no motion condi-
*
tions ± 5 digits during motion condi­tions
Range above 70 % - ± 3 digits on
*
neonates during motion. Range 0 % - 69% unspecified
®
Item Value range
MDD classification IIa Safety classification
Operating tempera­ture
Humidity 0 – 90 %, non condensing
Tab. 8 Miscellaneous properties of VitaGuard®VG 300.
BF (IEC 601-2-25) IP41 (IEC 601-1)
10 - 40 Celsius
LNOP®DC1 - Directions for use
Fig. 17 Instructions for LNOP®DC1 SpO2sensors.
These sensors are intended for multiple use on different patients weighing > 30 kg. They are non sterile and latex free and can not be sterilised.
2
INDICATIONS/CONTRAINDICATIONS
The LNOP DC1, Reusable Adult Sensor is indicated for either “spot check” or continuous non-invasive monitor­ing of arterial oxygen saturation (SpO2) and pulse rate for patients weighing >30 kg. It is for use only with instru­ments containing Masimo SET oximetry or licensed to use LNOP sensors. Consult individual instrument manu­facturer for compatibility of particular instrument and sensor models. Each instrument manufacturer is respon­sible for determining whether its instruments are com­patible with each sensor model.
The LNOP DC1 is contraindicated for use on mobile pa­tients or for prolonged periods of use. It is not intended for long-term monitoring. It must be removed and reposi­tioned to a different monitoring site at least every four (4) hours. If extended monitoring is required, use of a LNOP Adt adhesive sensor is recommended.
30 Technical Data Operator manual VitaGuard® VG 300
INSTRUCTIONS
A) Site Selection
Choose a site that is well perfused and least restricts a
conscious patient’s movements. The ring finger of the non-dominate hand is preferred.
Alternatively, the other digits on the non-dominate
hand may be used. Always choose a site that will completely cover the sensor’s detector window. The great toe or long toe (next to the great toe) may be
Operator manual VitaGuard® VG 300 Directions for use of LNOP® sensors 51
Page 12
used on restrained patients or patients whose hands are unavailable.
Site should be cleaned of debris prior to sensor place-
ment.
B) Attaching the Sensor to the Patient
1. Open the sensor by pressing on hinge tabs. Place the selected digit over the sensor window of the LNOP DC1. The fleshiest part of the digit should be covering the detector window in the lower half of the sensor. The top half of the sensor is identified by the cable. On finger sites, the tip of the finger should touch the raised digit stop inside the sensor. If the fingernail is long, it may extend over and pass the finger stop (Fig.
18).
Fig. 18 DC1 sensor placement
2. The hinged tabs of the sensor should open to evenly distribute the grip of the sensor along the length of the finger (Fig. 19). Check position of sensor to verify correct positioning. Complete coverage of the detector window is needed to ensure accurate data.
III. Technical Data
General
Item Value range
Weight 750g (with batteries) Dimensions (13,5 x 19 x 4,5) cm Batteries 4 x 1,5 V (Type LR6, AA), alkaline Battery operation min. 2 hours*with SpO2monitoring Key panel Washable buttons Battery indicator Flashing message Battery exhaustion Warn tone Mains supply
Display elements LED's and LCD graphical display Patient cable
Test and mainte­nance period
*
Only with batteries VARTA ALKALINE Extra Longlife!
Tab. 5 General properties of VitaGuard®VG 300.
Memory
3
External power adapter NA 2000-2 with FRIWO FW1299 (5Volt, 900 mA, DC)
Masimo patient cable PC08, length
2.44m A maintenance procedure
is required every 18 months. The end of the maintenance period is marked with a sticker.
Fig. 19 Orientation of emitter and detector
3. Orient the sensor so that the cable will be running to­wards the top of the patient’s hand (as shown in Fig.
20). Connect the LNOP DC1 connector to a patient cable.
52 Directions for use of LNOP® sensors Operator manual VitaGuard® VG 300
Item Value range
Capacity 200 episodes Duration approx. 7 hours Storage mode Event or permanent Pre-alarm storage 10 - 60 seconds Post-alarm storage 10 - 60 seconds Interface RS232 interface Software option VitaGuard®for Windows – Software
program for evaluation of stored data
Tab. 6 Memory properties of VitaGuard®VG 300.
Operator manual VitaGuard® VG 300 Technical Data 29
Page 13
Monitor log:
patient bulletin.
Easy but complex documentation for the
In VitaGuard®for Windows one can display an Over­view over the monitoring period (Monitor log: (Fig. 13). Here the monitoring took place only during the night with short interrupts around midnight and in the early morning.
The main screen (Fig. 14) shows the context of the actual episode for the pulse frequency and the plethysmogram.
Fig. 13 VitaGuard®for Windows: Monitor protocol
VitaGuard®for Windows supports the documentation of the monitoring behaviour and results. One can gener­ate and print many overviews and tables.
Fig. 20 Correctly attached sensor
NOTE: With smaller digits, in order to completely cover the detector window, the digit might not need to be pushed all the way to the stop. The sensor is not intended for use on the thumb or across a child’s hand or foot.
C) Attaching the Sensor to the Patient Cable
1. Orient the connecting tab so that the “shiny” contacts are facing up and mate the logo to the logo on the pa­tient cable (Fig. 21). Insert the LNOP DC1 connector over the patient cable connector until there is a tactile or audible click of connection.
Fig. 14 Main screen of VitaGuard®for Windows; Brady-
cardia-episode
28 Operating VitaGuard® Operator manual VitaGuard® VG 300
Fig. 21 Connecting patient cable and sensor
2. Gently tug on the connectors to ensure a positive con­tact. Tape may be used to secure the cable to the pa­tient for ease of movement.
D) Disconnecting sensor and patient cable
1. Place thumb and index finger on grey buttons on ei­ther side of the patient cable connector (Fig. 22).
2. Press firmly on the grey buttons and pull to remove the sensor.
CLEANING
To clean the sensor, first remove it from the patient and disconnect it from the patient cable. You my then clean the LNOP DC1 by wiping it with a 70% isopropyl alco­hol pad. Allow the sensor to dry prior to placement on a patient.
Operator manual VitaGuard® VG 300 Directions for use of LNOP® sensors 53
Page 14
Caution: Do not soak or immerse the cable in any liquid
solution. Do not attempt to sterilise.
Fig. 22 Disconnecting patient cable and sensor
WARNINGS
The site must be checked and changed at least every
four (4) hours NOTE: Exercise extreme caution with poorly per­fused patients; skin erosion and pressure necrosis can be caused when sensors are not frequently moved. As­sess the site at least every two (2) hours with poorly perfused patients.
If the sensor is damaged in any way, discontinue use
immediately.
To prevent damage, do not soak or immerse the sensor
in any liquid solution. Do not attempt to sterilise.
Intravascular dyes may lead to inaccurate SpO2 meas-
urements.
Elevated levels of Carboxyhaemoglobin (COHb) may
lead to inaccurate SpO2 measurement.
Elevated levels of Methaemoglobin (MetHb) will lead
to inaccurate SpO2 measurements.
Failure to apply the LNOP DC1 properly may cause
incorrect measurements.
Do not use the LNOP DC1 during MRI scanning.
Avoid placing the LNOP DC1 on any extremity with
an arterial catheter or blood pressure cuff.
The pulsation’s from intra-aortic balloon support can
be additive to the pulse rate on the oximeter pulse rate display. Verify pulse rate against an ECG heart rate.
Avoid bending and distorting the sensor cable, be-
cause this may damage the sensor.
Hint: If the monitor displays pulse rate and SpO2not constantly than check the sensor placement and reposition
Episode memory and PC interface
Integrated memory for 100 alarm episodes.
Event mode is default!
Stored data can be re­viewed on a PC.
VitaGuard®is fitted with a solid-state memory for storing alarm episodes. The pulse rate, SpO2and plethysmograph are stored as a function of time. Up to approx. 7 hours of data (or 200 episodes) can be stored with the standard memory.
There are two storage modes possible - event mode or permanent mode. When, in event mode, an alarm occurs, both time and date as well as the signal curves for a pro­grammable period prior to the alarm (usually 50s), during the alarm phase and for a programmable period after the alarm (usually 20s) are stored together as an alarm epi­sode. In the permanent mode of operation, all the signals are continuously stored in blocks of approx. 2.5 minutes, regardless of whether an alarm occurs or not.
When the monitor is switched on, it always assumes event mode storage. To change to permanent storage mode, enter the expert mode and change the memory mode option under the 'System settings' menu. Refer also to 'System settings main menu:' on page 24.
In both modes, the memory operates as a loop memory i.e. when the memory is full (200 episodes), the oldest episodes are automatically deleted to make room for new ones. This ensures that the most actual stored episodes are available.
The actual memory usage is displayed during start-up of the monitor. It can be reviewed by pressing <INFO/ > multiple times.
The data from the monitor can be transferred to a stan­dard PC over the serial RS232 interface and evaluated with a Windows based programme developed by GeTe­Med. The PC programme can also be used to set the monitor internal clock
GeTeMed developed the Software VitaGuard®for Windows to support the evaluation of the saved protocols and alarm episodes. VitaGuard®for Windows runs on Windows 95, 98, NT 4.0 or higher. It is sold only to authorised dealers and to physicians that supervise users of VitaGuard®.
54 Directions for use of LNOP® sensors Operator manual VitaGuard® VG 300
Operator manual VitaGuard® VG 300 Operating VitaGuard® 27
Page 15
Bradycardia Tachycardia SpO2low SpO2high SpO2
Silent
Silent Brady. Silent Tachy. Permanent Manual Combination
post-alarm period (usually 20s) to elapse before you can view the information about an alarm that has just oc­curred. The actual process of saving is displayed.
Alarm types
The following alarm types can be displayed under status information:
Pulse rate below the set alarm limit. Pulse rate above the set alarm limit. SpO2below the set alarm limit. SpO2above the set alarm limit. Episode with an overrun of both SpO2limits.
Silent alarm where the SpO2lay outside either of the si­lent alarm limits.
Pulse rate below the silent alarm limit. Pulse rate above the silent alarm limit. Episode without an alarm stored in permanent mode. Episode manually initiated. Episode with more than one alarm cause e.g. SpO2and
bradycardia together.
it, if necessary. If this does not help than change the sen­sor. Hint: Sensors being used for a long period tend to re­duced performance. A sensor should be replaced, if pulse rate and SpO2become questionable.
SPECIFICATIONS
When used with Masimo SET pulse oximetry monitors or with licensed Masimo SET pulse oximetry modules, us­ing PC Series patient cabled, during no motion, the accu­racy of the LNOP DC1 from 70% to 100% SpO2 is ± 2 digits (± 1 Std. Dev.).
Please see also 'Miscellaneous Warnings and Hints' on page 73ff!
LNOP®Adt - Directions for use
26 Operating VitaGuard® Operator manual VitaGuard® VG 300
Fig. 23 Instructions for LNOP®Adt SpO2sensors.
These sensors are intended for multiple use on only one patient weighing > 30 kg. They are non sterile and latex free and can not be sterilised.
INDICATIONS/CONTRAINDICATIONS
The LNOP Adt, adult Adhesive Sensor is indicated for single-patient use for the continuous non-invasive moni­toring of arterial oxygen saturation (SpO2) and pulse rate for patients weighing >30 kg. The LNOP Adt is or use only with instruments containing Masimo SET oximetry or licensed to use LNOP sensors. Consult individual oxi­metry system manufacturer for compatibility of particular instrument and sensor models. Each instrument manufac­turer is responsible for determining whether its instru­ments are compatible with each sensor model.
Operator manual VitaGuard® VG 300 Directions for use of LNOP® sensors 55
Page 16
The LNOP Adt is contraindicated for patients who ex-
page
<MODE/Esc> to exit the
hibit allergic reactions to adhesive tape. The sensor must be removed and the site inspected at least every eight (8) hours and, if indicated by circulatory condition or skin in­tegrity, reapplied to a different monitoring site.
INSTRUCTIONS
A) Site Selection
Choose a site that is well perfused and least restricts a
conscious patient’s movements. The ring or middle finger of the non-dominate hand is preferred.
Alternatively, the other digits on the non-determinate
hand may be used. Always choose a site that will completely cover the detector window. The great toe or long toe (next to the great toe) may be used on re­strained patients whose hands are unavailable.
The site should be cleaned of debris and dry prior to
sensor placement.
B) Attaching the Sensor to the Patient
1. Open the pouch and remove the sensor. Holding the sensor with the printed side down, bend the sensor backward and remove the backing. Orient the sensor so the detector can be placed first (Fig. 24). Press the detector onto the fleshly part of the finger near the tip of the finger. Press down the “T” shaped adhesive ends of the sensor onto the finger (Fig. 25).
Fig. 24 Sensor placement; detector on the finger tip
Time/Date main menu:
See also 'Explanation of the menu settings' on
38!
These settings can be changed using <MODE/Esc>. Re­fer also to 'Monitor display structure' and 'Monitor menu structure' on pages 12 and 13. The different settings are explained in detail in 'Explanation of the menu settings' on page 38.
Item Value range
Day (num.) 1, 2, ... 29, 30 (31). Month January, February, March etc. Year 1998, 1999, etc. Hour 0, 1, ... 22, 23. Minute 0, 1, ... 58, 59.
Tab. 4 Value range for the time settings main menu
Status memory function
Using <STATUS/En­ter>, the stored episodes can be examined in chronological order. By pressing the key once, information about the last stored episode is dis­played. Using the arrow buttons, other episodes can be addressed. To ob­tain more information about a particular epi­sode, press <STATUS/­Enter> again. After the alpha-numerical information you will see the stored signals. Press
episode information mode.
Standard display 1
<ALARM/Stop>
<Status>
Episode number / count
Type of episode
Date and time
Duration
<Status>
Settings at the alarm
<Status>
Pulse oximeter settings
and SpO2 limits
at the alarm
<Status>
Heart rate informa-
tion at the alarm
<Status>
Plethysmogram
at the alarm
Standard display 2
<∆> / <∇>
to choose
Fig. 25 Fixing of the detector
56 Directions for use of LNOP® sensors Operator manual VitaGuard® VG 300
Fig. 12 Scheme on how to review stored data
Remember that you need to wait for the programmed
Operator manual VitaGuard® VG 300 Operating VitaGuard® 25
Page 17
See also 'Explanation of
page
page
the menu settings' on
38!
See also 'Explanation of the menu settings' on
38!
System settings main menu:
These settings can be changed using <MODE/Esc>. Re­fer also to 'Monitor display structure' and 'Monitor menu structure' on pages 12 and 13. The different settings are explained in detail in 'Explanation of the menu settings' on page 38.
The factory defaults are shown in large bold font:
Item Value range
Clear trends SpO2perfusion Low_Perfusion On /
SpO2average LCD power save LCD brightness
Only available in expert mode:
Wave display Silent alarms Buzzer frequency Delete memory Pre-alarm time Post-alarm time Memory mode Ring memory Load defaults
Tab. 3 Value range for the items in the system settings
main menu
No / yes
Low_Perfusion Off 6, 8 ... 14, 16 seconds Off / On Level 1, 2, 3, 4
Off / On
No / Yes
2048 Hz / 4096 Hz
No / Yes
10, 20, ... 50, 60 seconds 10, 20, ... 50, 60 seconds
Event / Permanent
No / Yes
No / Yes
Expert mode main menu:
The expert mode can be activated using <MODE/Esc>. Refer also to “Monitor display structure” and “Monitor menu structure” on pages 12 and 13.
2. Next, wrap the sensor with the emitter (*) and finger design over the fingernail and secure the wings down one at a time around finger (Fig. 26). When properly applied, the emitter and the detector should be verti­cally aligned as shown (Fig. 27). Check position of sensor to verify correct positioning and reposition if necessary. Complete coverage of the detector window is needed to ensure accurate measurements.
Fig. 26 Fixing of the emitter
Fig. 27 Correctly attached sensor: emitter and detector
are aligned!
3. The connector tab is now oriented on the top side of the patient’s finger so that the “shiny” contacts are facing up. Mate the logo on the sensor to the logo on the patient cable. Insert the patient cable into the sen­sor tab until there is a tactile or audible click of con­nection (Fig. 28). Gently tug on the connectors to en­sure a positive contact. If required, tape may be used to secure the cable to the patient.
Item Value range
Code word Enter code word
24 Operating VitaGuard® Operator manual VitaGuard® VG 300
Fig. 28 Connecting patient cable and sensor
Operator manual VitaGuard® VG 300 Directions for use of LNOP® sensors 57
Page 18
C) Reattachment
page
The sensor may be reapplied to the same patient if the emitter and detector windows are clear and the adhesive still adheres to the skin.
NOTE: Prior to reattachment or rejuvenation, disconnect the sensor from the sensor cable.
The adhesive can be partially rejuvenated by wiping
with a 70% isopropyl alcohol pad and allowing the sensor to thoroughly air dry prior to replacement on the patient.
If the adhesive can not be adequately rejuvenated, use
a new sensor.
D) Disconnecting Sensor and Patient Cable
1. Place thumb and index finger on grey buttons on ei­ther side of the patient cable (Fig. 29).
Fig. 29 Disconnecting patient cable and sensor
2. Press firmly on the grey buttons and pull to remove the sensor.
WARNINGS
The site must be checked and changed at least every eight (8) hours NOTE: Exercise extreme caution with poorly per­fused patients; skin erosion and pressure necrosis can be caused when sensors are not frequently moved. As­sess the site at least every two (2) hours with poorly perfused patients.
If the sensor is damaged in any way, discontinue use immediately.
To prevent damage, do not soak or immerse the sensor in any liquid solution. Do not attempt to sterilise.
Intravascular dyes may lead to inaccurate SpO2 meas­urements.
Integrated menus
See also 'Explanation of the menu settings' on
38!
The monitor settings and stored alarm episodes are not lost when changing the batteries. Refer also to 'Technical Data' on page 29 for battery operation lifetime.
Mains adapter
Only use the mains adapter NA 2000-2 provided with the monitor. Other mains adapters may not fulfil the
necessary safety standards and could cause serious dam­age to both the patient and the monitor. When Vita­Guard®is operated from the mains adapter, the display backlight is automatically switched on.
Monitor settings main menu:
These settings can be changed using <MODE/Esc>. Re­fer also to 'Monitor display structure' and 'Monitor menu structure' on pages 12 and 13. The different settings are explained in detail in 'Explanation of the menu settings' on page 38.
The factory defaults are shown in large bold font:
Item Value range
Lower HR limit Upper HR limit Lower SpO2limit Upper SpO2limit
only available in expert mode:
Silent lower HR Silent upper HR Silent lower SpO Silent upper SpO Bradycardia delay Tachycardia delay SpO2lower delay SpO2upper delay
Tab. 2 Value range for the items in the monitor settings
main menu
30, 35, ... 80, ... 175, 180 BPM 100, 105, ... 220, ... 255, 260 BPM 50, 51, ... 88 ... 99, 100 % 50, 51, ... 99, 100 %
30, 35, ... 50, ... 175, 180 BPM
100, 105, ... 255, 260 BPM
2
50, 51, ... 88 ... 99, 100 %
2
50, 51, ... 99, 100 % 4, 5, 6, ... 14, 15 seconds 4, 5, ... 15, ... 23, 24 seconds 1, 2, ... 6, ... 19, 20 seconds 1, 2, ... 6, ... 19, 20 seconds
58 Directions for use of LNOP® sensors Operator manual VitaGuard® VG 300
Operator manual VitaGuard® VG 300 Operating VitaGuard® 23
Page 19
Important! Check bat-
ALKALINE Extra
teries with active SpO module!
Replacing batteries:
Please pay attention to the polarity of the bat­teries as shown on the bottom of the battery compartment.
fore, always insert batteries, even if you use the mains adapter supplied with the monitor.
Battery replacement
Switch the monitor off before replacing the batteries.
To test that the batteries in the battery compartment are charged enough for SpO2operation, carry out the follow
2
steps:
Remove the external power adapter so that the device is powered from batteries.
Wait 30 seconds and then press <INFO/> a number of times until you reach the battery information.
If the state of the batteries is not good, replace them immediately with good-quality alkaline batteries such as VARTA alkaline Extra Longlife. It is recommen­ded that you always keep at least two spare sets handy.
Slide open the battery compartment at the back of the monitor. Pay attention to the polarity of the batteries when inserting the new ones(Fig. 11).
Elevated levels of Carboxyhaemoglobin (COHb) may
lead to inaccurate SpO2 measurement.
Elevated levels of Methaemoglobin (MetHb) will lead
to inaccurate SpO2 measurements.
Failure to apply the LNOP Adt properly may cause in-
correct measurements.
Do not use the LNOP Adt during MRI scanning.
Avoid placing the LNOP Adt on any extremity with
an arterial catheter or blood pressure cuff.
The pulsation’s from intra-aortic balloon support can
be additive to the pulse rate on the oximeter pulse rate display. Verify pulse rate against an ECG heart rate.
Avoid bending and distorting the sensor cable, be-
cause this may damage the sensor.
Hint: If the monitor displays pulse rate and SpO2not constantly than check the sensor placement and reposition it, if necessary. If this does not help than change the sen­sor. Hint: Sensors being used for a long period tend to re­duced performance. A sensor should be replaced, if pulse rate and SpO2become questionable.
SPECIFICATIONS
When used with Masimo SET pulse oximetry monitors or with licensed Masimo SET pulse oximetry modules, us­ing PC Series patient cabled, during no motion, the accu­racy of the LNOP Adt from 70% to 100% SpO2 is ± 2 digits (± 1 Std. Dev.).
Please see also 'Miscellaneous Warnings and Hints' on page 73ff!
Fig. 11 Bottom of the monitor with partially opened Battery
compartment.
GeTeMed recommends
Only use new, good-quality alkaline LR6 (AA) 1,5V bat­teries. Change the whole set of batteries. Never use new
Longlife Batteries.
Hint:
and old batteries together! Cheap non-alkaline batteries may lead to a drastic reduc-
tion in the battery operation time. Some batteries only have 10-15% of the capacity of good batteries.
22 Operating VitaGuard® Operator manual VitaGuard® VG 300
LNOP®Pdt - Directions for use
Fig. 30 Instructions for LNOP®Pdt SpO2sensors.
Operator manual VitaGuard® VG 300 Directions for use of LNOP® sensors 59
Page 20
These sensors are intended for multiple use on only one
Attention: Monitoring
module is automatically
power supply!
patient weighing between 10 and 50 kg. They are non sterile and latex free and can not be sterilised.
Bear in mind that you should be able to reach your patient within 10 seconds in order to react promptly to a critical situation!
INDICATIONS/CONTRAINDICATIONS
The LNOP Pdt, Paediatric/Slender Digit Adhesive Sensor is indicated for single patient use for the continuous non­invasive monitoring of arterial oxygen saturation (SpO2) and pulse rate for patients weighing between 10 and 50 kg. It is for use only with instruments containing Masimo SET oximetry or licensed to use LNOP sensors. Consult individual instrument manufacturer for compatibility of particular instrument and sensor models. Each instrument manufacturer is responsible for determining whether its instruments are compatible with each sensor model.
The LNOP Pdt is contraindicated for patients who exhibit allergic reactions to adhesive tape. The sensor must be removed and site inspected at least every eight (8) hours and, if indicated by circulatory condition or skin integrity, reapplied to a different monitoring site.
INSTRUCTIONS FOR USE
A) Site Selection
Choose a site that is well perfused and least restricts a conscious patient’s movements. The ring or middle finger of the non-dominate hand is preferred.
Alternatively, the other digits on the non-dominate hand may be used. Always choose a site that will completely cover the sensor’s detector window. The great toe or second toe (next to the great toe) may be used on restrained patients or patients whose hands are unavailable.
The site should be cleaned of debris and dry prior to sensor placement.
B) Attaching the Sensor to the Patient
1. Open the pouch and remove the sensor. Holding the sensor with the tan printed side downward, bend the sensor backward and remove the backing from the sensor. Orient the sensor so the detector can be placed first (Fig. 31). Press the detector onto the fleshly part of the finger near the tip of the finger. Press down the “T” shaped adhesive ends of the sensor onto the finger (Fig. 32).
Battery operation
Important Hint:
is aborted when batter­ies are weak!
With low batteries you should firstly restore
VitaGuard®can be operated either with four LR6 alkaline batteries or with an external power adapter (NA 2000-2 or NAK 1500; see 'Power supply' on page 6). The moni­tor also has an internal battery that always powers the in­ternal memory and clock chip. Should the power adapter be suddenly removed from the monitor during operation and no batteries are installed, then the internal battery is used to generate a warn tone. This should be avoided!
The monitor must be returned to the manufacturer if the internal battery becomes weak.
Battery supervision
Once the installed batteries become weak, the monitor displays an appropriate message. This message is dis­played after the initialisation phase when VitaGuard®is switched on and can be checked at any time using <INFO/>. When the batteries become very weak, a message is repeatedly displayed for 2 seconds every 16 seconds informing you to replace them.
If the external power adapter is not connected and the batteries become weak, the SpO switched off. The monitor generates a technical alarm to warn the clinician and displays an appropriate message. Once new batteries have been inserted into the unit or the external power adapter is reconnected, the SpO2module is automatically restarted and monitoring is continued.
Bear in mind, that without monitoring, critically situations may not be brought to your attention!
You should replace the batteries as soon as possible hav­ing seen the message on the display. GeTeMed recom-
mends that you always have at least two spare sets of batteries at hand!
If the batteries are not replaced and are used further, the monitor will generate a technical alarm tone forcing you to replace the batteries (See Switching VitaGuard®on and off' on page 11).
Remember that the system can only operate in the event of a mains power failure if batteries are inserted. There-
2
60 Directions for use of LNOP® sensors Operator manual VitaGuard® VG 300
Operator manual VitaGuard® VG 300 Operating VitaGuard® 21
Page 21
YOU must react to
ype of alarm. The alarm
is deactivated and a message 'monitoring
alarms!
System check
Important Hint:
ing of all settings is explained in 'Explanation of the menu settings' on page 38.
Alarms
The monitor generates an alarm if the detected pulse rate falls for at least a given period below the lower limit or rises above the upper limit. Then the red LED flashes ac­companied by a loud acoustic warning. The LCD dis­plays a message about the actual t can be stopped by pressing <ALARM/Stop>. Go to your patient immediately and verify the situation! Both the alarm setting and the alarm LED will flash in intervals of 1 second to indicate that an alarm has occurred. If no alarm occurs or if no button is pressed for 5 minutes, the standard display activated' will appear. The alarm LED will keep flashing to indicate that an alarm had occurred and will stop once <ALARM/Stop> is pressed. To obtain information about the alarm, press <STATUS/Enter>.
Should two alarms occur within the period of one minute, the alarm will not automatically cease. To stop the acous­tic alarm, press <ALARM/Stop>.
Alarm generator
Approximately 4 seconds after switching on the monitor, the monitor generates a short acoustic signal. Remember to listen for this tone each time you switch the monitor on. Should this signal not occur, return the monitor im­mediately to the manufacturer for inspection. Contact your supplier to get a replacement monitor. Never con­tinue to use a faulty device!
Baby phone
Before relying on any form of external system for trans­mitting the alarm tone to another room (e.g. Baby phone), ensure that the VitaGuard®alarm tone is transmitted clearly.
To amplify the alarm signal over a greater distance, we recommend that you use the external alarm unit EA 1000. This unit also checks that the monitor is switched on.
Fig. 31 Sensor placement; detector on the finger tip
Fig. 32 Fixing of the detector
2. Next, wrap the sensor with the emitter (*) and finger design over the fingernail and secure the wings down one at a time around finger (Fig. 33). When properly applied, the emitter and the detector should be verti­cally aligned as shown in (Fig. 34). Check position of sensor to verify correct positioning and reposition if necessary. Complete coverage of the detector window is needed to ensure accurate measurements.
Fig. 33 Fixing of the emitter
Fig. 34 Correctly attached sensor: emitter and detector
are aligned!
20 Operating VitaGuard® Operator manual VitaGuard® VG 300
Operator manual VitaGuard® VG 300 Directions for use of LNOP® sensors 61
Page 22
3. The connector tab is now oriented on the top side of
properly connected to the monitor. In this case, a message
the patient’s finger so that the “shiny” contacts are facing up. Mate the logo on the sensor to the logo on the patient cable. Insert the patient cable into the sen­sor tab until there is a tactile or audible click of con­nection (Fig. 35). Gently tug on the connectors to en­sure a positive contact. If required, tape may be used to secure the cable to the patient.
C) Reattachment
The sensor may be reapplied to the same patient if the emitter and detector windows are clear and the adhesive still adheres to the skin.
Fig. 35 Connecting patient cable and sensor
NOTE: Prior to reattachment or rejuvenation, disconnect the sensor from the sensor cable.
The adhesive can be partially rejuvenated by wiping
with a 70% isopropyl alcohol pad and allowing the sensor to thoroughly air dry prior to replacement on the patient.
If the adhesive can not be adequately rejuvenated, use
a new sensor.
D) Disconnecting Sensor and Patient Cable
3. Place thumb and index finger on grey buttons on ei­ther side of the patient cable (Fig. 36).
4. Press firmly on the grey buttons and pull to remove the sensor.
Fig. 36 Disconnecting patient cable and sensor
Technical alarm and common reasons:
Pulse rate alarm limits:
Important:
LED will flash in intervals of 1 second to indicate that an alarm has occurred.
Should two alarms occur within the period of one minute, the alarm will not automatically cease. To stop the acous­tic alarm, press <ALARM/Stop>.
The upper alarm limit can be deactivated by setting the upper limit value to 100%.
A technical alarm will be generated if the sensor is not
is displayed telling the cause of the alarm. The SpO
2
value is zeroed out until the problem has been resolved. The main causes of technical alarms are:
Bad positioning of the sensor (emitter and detector not
placed across from each other).
Sensor has fallen off the patient or the patient cable is
not connected to the monitor.
Excessive movement.
Too much ambient light or electrical interference from
an external source.
Batteries are too weak for SpO2operation. The LNOP®-sensors as well as the SET®-Technology are
specially invented to handle those problematic situations. In normal domestic situations the most common source of technical alarms is bad sensor placement.
Pulse rate
The standard pulse rate alarm limit settings are:
Lower limit: 80 BPM Upper limit: 220BPM
Those settings are suitable for children. When monitor­ing adults, consult your clinician for appropriate values. Do not change the alarm limits without prior consulta­tion.
The selected values are displayed on the monitor LCD. If the pulse rate rises above the upper limit or falls below the lower limit, then an alarm will be generated. The de­lays before an alarm is generated are programmable. Generally, the upper limit needs to be exceeded for at least 15 seconds and the lower limit for at least 6 seconds before an alarm takes place.
For instructions on how to change the alarm parameters refer to 'Monitor display structure' on page 12. The mean-
62 Directions for use of LNOP® sensors Operator manual VitaGuard® VG 300
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Page 23
Monitoring
an appropriate
Having connected the SpO2sensor and ensured that all connections are secure, switch on the monitor using the <ON/OFF>-button.
If problems arise you may reposition the sen­sor!
If false alarms occur you must check the sensor place­ment and the quality of the used sensor.
Do not change any alarm limits to combat alarms without prior consultation with your clinician!
Setting alarm parameters
Important:
SpO2alarm limits:
YOU must act on alarms!
Ask your doctor to set the alarm limits that suit the patient. Do not change the alarm limits without prior consultation.
SpO2parameters
The standard SpO2alarm limits are:
Lower limit: 88 % Upper limit: 100 %
To change the alarm limits, press <MODE> to enter the main menu structure. Select the 'Monitor settings' menu using <STATUS/Enter>. Move to the SpO2alarm limit menus with the arrow keys and select the required menu using <STATUS/Enter>. Remember to hold <ALARM/Stop> when selecting the new value. Press <STATUS/Enter> to accept the new value or <MODE/Esc> to reject. The limits may be adjusted be­tween 50% and 100%. Refer to 'Monitor display struc­ture' on page 12. The meaning of all settings is explained in 'Explanation of the menu settings' on page 38.
Should excessive false alarms occur, check that the sen­sor is properly connected. Allow a nurse or doctor to show you how to apply the sensor properly.
Alarms
If the displayed SpO2value falls below the lower alarm limit or rises above the upper alarm limit, VitaGuard VG 300 will generate an alarm and display message. You should go immediately to the patient and check its condition. If the SpO2value moves back within the set limits, the alarm will automatically cease. The ex­ceeded alarm limit on the LCD display and the alarm
WARNINGS
The site must be checked and changed at least every
eight (8) hours NOTE: Exercise extreme caution with poorly per­fused patients; skin erosion and pressure necrosis can be caused when sensors are not frequently moved. As­sess the site at least every two (2) hours with poorly perfused patients.
If the sensor is damaged in any way, discontinue use
immediately.
To prevent damage, do not soak or immerse the sensor
in any liquid solution. Do not attempt to sterilise.
Intravascular dyes may lead to inaccurate SpO2 meas-
urements.
Elevated levels of Carboxyhaemoglobin (COHb) may
lead to inaccurate SpO2 measurement.
Elevated levels of Methaemoglobin (MetHb) will lead
to inaccurate SpO2 measurements.
Failure to apply the LNOP Pdt properly may cause in-
correct measurements.
Do not use the LNOP Pdt during MRI scanning.
Avoid placing the LNOP Pdt on any extremity with an
arterial catheter or blood pressure cuff.
The pulsation’s from intra-aortic balloon support can
be additive to the pulse rate on the oximeter pulse rate display. Verify pulse rate against an ECG heart rate.
Avoid bending and distorting the sensor cable, be-
cause this may damage the sensor.
Hint: If the monitor displays pulse rate and SpO2not constantly than check the sensor placement and reposition it, if necessary. If this does not help than change the sen­sor. Hint: Sensors being used for a long period tend to re­duced performance. A sensor should be replaced, if pulse rate and SpO2become questionable.
®
SPECIFICATIONS
When used with Masimo SET pulse oximetry monitors or with licensed Masimo SET pulse oximetry modules, us­ing PC Series patient cabled, during no motion, the accu-
18 Operating VitaGuard® Operator manual VitaGuard® VG 300
Operator manual VitaGuard® VG 300 Directions for use of LNOP® sensors 63
Page 24
racy of the LNOP Pdt from 70% to 100% SpO2 is ± 2
finger!
sensor package and remove the sensor. Hold
tail so that it is pointed away from the patient. Position
the connector to ensure
digits (± 1 Std. Dev.).
Please see also 'Miscellaneous Warnings and Hints' on page 73ff!
Detector on fleshy side of foot, hand, toe or
Attaching the sensor to the patient:
Open the
the sensor along the length of the 'Y' and remove the backing from sensor and bandage. Orient the sensor
LNOP®Neo - Directions for use
Fig. 37 Instructions for LNOP®Pdt SpO2sensors.
These sensors are intended for multiple use on only one patient weighing < 10 kg. They are non sterile and latex free and can not be sterilised.
INDICATIONS/CONTRAINDICATIONS
The LNOP Neo, Neonatal Adhesive Sensor is indicated for single-patient use for the continuous non-invasive monitoring of arterial oxygen saturation (SpO2) and pulse rate for patients weighing < 10 kg (10,000 grams). The LNOP Neo is for use only with instruments containing Masimo SET oximetry or licensed to use LNOP sensors. Consult individual oximetry system manufacturer for compatibility of particular instrument and sensor models. Each instrument manufacturer is responsible for deter­mining whether its instruments are compatible with each sensor model.
The LNOP Neo is contraindicated for patients who ex­hibit allergic reactions to adhesive tape. The sensor must be removed and the site inspected at least every eight (8) hours and, if indicated by circulatory condition or skin in­tegrity, reapplied to a different monitoring site.
INSTRUCTIONS FOR USE
A) Site Selection
Neonates: The preferred site is a foot. Alternatively, across the palm and back of the hand can be used. For
Emitter exactly on the opposite side! Wrap both with tape to fix it.
Connect sensor and ca­ble properly and attach it to the child.
Connecting the patient cable to VitaGuard®.
The skin must be checked regularly!
Use one of the adhesive sensors for long-term monitoring!
Switch the monitor off before detaching the sensor!
the detector onto the fleshy part of the sole of the foot aligned with the fourth toe.
Orient the emitter window on top of the extremity di-
rectly opposite to the detector. Wrap the bandage or plaster around to maintain proper alignment of detec­tor and emitter windows. Check position of sensor to verify correct positioning and reposition if necessary. Complete coverage of the detector window is needed to ensure accurate data.
Orient the connector tab to match the logos on the
sensor tab and the patient cable. Insert the patient ca­ble to the sensor tab until there is a tactile or audible click of connection. Gently tug on the connectors to ensure a positive contact. Tape may be used to secure the cable to the patient for ease of movement.
By holding the connector of the patient cable so that
the logo is pointing up, connect it to the VitaGuard monitor. Again, an audible or tactile click will con­firm connection. Gently tug on a positive contact with the monitor. Avoid excessive bending of the patient cable!
The site should be checked at least every eight (8), on in­fants with poor skin integrity every two (2) hours, to en­sure proper adhesion, skin integrity and alignment.
The LNOP®-DC1 sensor is not intended for long term monitoring. On patients with poor perfusion or when monitoring is needed for more than 8 hours don't use the DC1 sensor, but the appropriate adhesive sensor instead.
Disconnecting the sensor
Before you detach the sensor from the patient you should switch the monitor off and disconnect the sensor and the patient cable. Press firmly on the grey buttons on either side of the patient cable connector and pull to remove the sensor connector. Now you may detach the sensor from the patient.
®
64 Directions for use of LNOP® sensors Operator manual VitaGuard® VG 300
Operator manual VitaGuard® VG 300 Operating VitaGuard® 17
Page 25
Fig. 6 Placing the LNOP®- DC1 SpO2sensors
neonates with poor skin integrity, use of the LNOP NeoPt is recommended.
Infants: For infants between 3 and 10 kg or with fat or
oedematous feet, use of the LNOP Neo sensor on the big toe is recommended. Follow instructions shown with sensor detector on fleshy part (underside) of big toe. Alternative site would be the thumb.
Paediatric patients: For infants or paediatric patients
above 10 kg, use of the LNOP Pdt is recommended.
Always choose a site that is well perfused and will
completely cover the sensor’s detector window.
Site should be cleaned of debris and dry prior to sen-
sor placement.
Fig. 7 Placing the LNOP®-Adt SpO2sensors
Fig. 8 Placing the LNOP®-Pdt SpO2sensors
Fig. 9 Placing the LNOP®-Neo SpO2sensors
B) Attaching the Sensor to the Patient
1. Open the pouch and remove the sensor. Holding the sensor along the length of the “Y”, remove the back­ing from the sensor and bandage. Orient the sensor tail so that it is pointed away from the patient. Position the detector onto the fleshly part of the sole of the foot aligned with the fourth toe (Fig. 38).
Fig. 38 Sensor placement; detector on the sole of the foot
2. Orient emitter window on top of foot directly opposite the detector. Wrap the bandage around the foot to maintain proper alignment of the detector and emitter windows (Fig. 39). Check position of sensor to verify correct positioning and reposition if necessary. Com­plete coverage of the detector window is needed to en­sure accurate data (Fig. 40).
Fig. 10 Placing the LNOP®-NeoPt SpO2sensors
16 Operating VitaGuard® Operator manual VitaGuard® VG 300
Operator manual VitaGuard® VG 300 Directions for use of LNOP® sensors 65
Page 26
Important:
p
Attention: Most se
performance.
Automatic storage of all
arameters.
The alarm is always deactivated for 20 seconds after pressing a button.
All monitor settings are stored and reappear automati­cally when the monitor is switched back on again. This is also true when replacing the batteries.
Fig. 39 Orientation of emitter and detector
Fig. 40 Correctly attached LNOP®Neo Sensor
3. Orient the LNOP Neo’s connector tab so that the top site of the “shiny” contacts are facing up. Mate the logo on the sensor tab to the logo on the patient ca­ble. Insert the patient cable to the sensor tab until there is a tactile or audible click of connection (Fig. 41). Gently tug on the connectors to ensure a positive con­tact. Tape may be used to secure the cable to the pa­tient for ease of movement.
Fig. 41 Connecting patient cable and sensor
C) Reattachment
The sensor may be reapplied to the same patient if the emitter and detector windows are clear and the adhesive still adheres to the skin.
NOTE: Prior to reattachment or rejuvenation, disconnect the sensor from the sensor cable.
The adhesive can be partially rejuvenated by wiping with a 70% isopropyl alcohol pad and allowing the
Alarms are shown in the display.
Sensors
n­sors are 'Single­Patient'!
LNOP®-Neo-Sensors must be handled prop­erly to achieve their full
Alarm information
When an alarm occurs, a message related to the cause of the alarm appears on the display. <STATUS/Enter> can be used to obtain more information about the alarm. This information is available approx. 1 minute after the alarm has stopped.
Handling LNOP®- sensors
The LNOP®-sensors offered with VitaGuard®are dispos­able ones, intended for single-patient use and only with instruments containing Masimo SET®oximetry. They can be used several times, but prolonged use of the same sensor may lead to reduced performance if the sensor be­comes dirty or the plaster no longer sticks properly. The only exception is the LNOP®-DC1 sensor, that can be used with different patients.
If you are not sure what type of sensor to choose, than read 'Sensor selection' on page 50. In the subsequent sec­tions of 'Directions for use of LNOP®sensors' on page 50ff you'll find detailed instructions on how to use the different sensor types. Here the descriptions are limited to global instructions.
Before using a particular type of sensor, refer to the de­tailed instructions starting on page 50. Always choose a site that is well perfused and will completely cover the sensor’s detector window. The skin should be dry and clean prior to sensor placement. For infants with poor skin integrity, use of the LNOP NeoPt is recommended.
Place the actual LNOP®sensor as shown in the appropri­ate figure. Use only sensors provided by GeTeMed or its authorised dealers.
66 Directions for use of LNOP® sensors Operator manual VitaGuard® VG 300
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Page 27
Interrupted monitoring
protection!
120 seconds
result in a vertical line in the trend curve!
Important: Clear the old trend curves when changing the patient!
Information about stored episodes.
Important – Controls
Safety measure:
The trend display shows a horizontal line if monitoring was interrupted. Such interrupts are typically caused by switching off the monitor.
To display trend curves VitaGuard stores older data. When changing the patient, this could cause wrong data being used in the trend curves. Clear the trend curves
whenever you finally finish monitoring a specific pa­tient! More information on how to clear the trend curves
can be found in “System settings main menu:” on page
24. After displaying the last signal curve, the display reverts
back to the selected standard display
Status (<STATUS/Enter>)
<STATUS/Enter> is used to view information on stored episodes. Once activated, the actual episode of interest can be selected with <INFO/> and <GRAPHIC/>. Once the episode of interest is selected, the information about the episode can be viewed with <STATUS/Enter>. Each time it is pressed, a new page of information is dis­played. Once the last page is reached, the plethys­mograph curves can be viewed.
Changing parameters
Select the parameter that needs to be modified using the arrow buttons <INFO/> or <GRAPHIC/>. Enter the selected parameter by pressing <STATUS/Enter>. By keeping <ALARM/Stop> pressed, use the arrow buttons to move the cursor to the required position. Once selec­ted, accept the value by pressing <STATUS/Enter>. To leave the menu structure and reject any changes made, press <MODE/Esc>.
Note that parameters can only be changed by simulta­neously pressing <ALARM/Stop>. This is necessary to avoid any parameters from being unintentionally changed by siblings or small children or due to lightly touching or rubbing the monitor. Also remember that the buttons need to be held pressed for approximately ½ a second be­fore they react. If any button is pressed for > (depending on the button), an acoustic warning is gener­ated. This feature ensures that the alarm function cannot be deactivated by placing a heavy object on the monitor or if a key becomes defect.
sensor to thoroughly air dry prior to replacement on the patient.
If the adhesive can not be adequately rejuvenated, use
a new sensor.
D) Disconnecting Sensor and Patient Cable
1. Place thumb and index finger on grey buttons on ei­ther side of the patient cable (Fig. 42).
2. Press firmly on the grey buttons and pull to remove the sensor.
Fig. 42 Disconnecting patient cable and sensor
WARNINGS
The site must be checked and changed at least every eight (8) hours NOTE: Exercise extreme caution with poorly per­fused patients; skin erosion and pressure necrosis can be caused when sensors are not frequently moved. As­sess the site at least every two (2) hours with poorly perfused patients.
If the sensor is damaged in any way, discontinue use immediately.
To prevent damage, do not soak or immerse the sensor in any liquid solution. Do not attempt to sterilise.
Intravascular dyes may lead to inaccurate SpO2 meas­urements.
Elevated levels of Carboxyhaemoglobin (COHb) may lead to inaccurate SpO2 measurement.
Elevated levels of Methaemoglobin (MetHb) will lead to inaccurate SpO2 measurements.
Failure to apply the LNOP Neo properly may cause incorrect measurements.
Do not use the LNOP Neo during MRI scanning.
Avoid placing the LNOP Neo on any extremity with
an arterial catheter or blood pressure cuff.
14 Operating VitaGuard® Operator manual VitaGuard® VG 300
Operator manual VitaGuard® VG 300 Directions for use of LNOP® sensors 67
Page 28
The pulsation’s from intra-aortic balloon support can
or 25 minutes, or
be additive to the pulse rate on the oximeter pulse rate display. Verify pulse rate against an ECG heart rate.
High oxygen concentrations may predispose a prema-
ture infant to retinopathy. Therefore, the upper alarm limit for the oxygen saturation must be carefully se­lected in accordance with accepted clinical standards.
Circulation distal to the sensor site should be checked
routinely.
Avoid bending and distorting the sensor cable, be-
cause this may damage the sensor.
Hint: If the monitor displays pulse rate and SpO2not constantly than check the sensor placement and reposition it, if necessary. If this does not help than change the sen­sor. Hint: Sensors being used for a long period tend to re­duced performance. A sensor should be replaced, if pulse rate and SpO2become questionable.
SPECIFICATIONS
When used with Masimo SET pulse oximetry monitors or with licensed Masimo SET pulse oximetry modules, us­ing PC Series patient cabled, during no motion, the accu­racy of the LNOP Neo from 70% to 100% SpO2 is ± 3 digits (± 1 Std. Dev.).
Please see also 'Miscellaneous Warnings and Hints'
on page 73ff
LNOP®NeoPt - Directions for use
Fig. 43 Instructions for LNOP®NeoPt SpO2sensors.
These sensors are intended for multiple use on only one patient weighing < 1 kg and having poor skin integrity.
Configuration of the monitor.
Information about the monitor settings.
Signal curves and trends.
Monitor menu structure
The monitor possesses three menu levels. The first menu level is activated with <MODE/Esc>. Use <INFO/> or <GRAPHIC/> to highlight the required selection. To enter the selected menu, press <STATUS/Enter>.
Settings (<Modus>)
There are four submenus available, that can be selected with <INFO/ > or <GRAPHIC/ > and activated with <STATUS/Enter>:
Monitor settings: All parameters governing alarm limits, settings and signals are grouped here.
System settings: These include parameters such as scaling the displayed waves, power-save mode and settings for the SpO2monitor.
Time/Date: The time and date of the internal clock can be adjusted using this menu.
Expert mode: The expert mode can be activated upon entering a password. When activated, the 'Monitor Settings' menu and the 'System Settings' menu are ex­tended to include functions primarily designed for cli­nicians e.g. activation of silent alarms and settings controlling the data memory.
Upon entering one of these menus, the parameter of in­terest can be selected using <INFO/> or <GRAPHIC/>. Once highlighted, the individual menu can be entered by pressing <STATUS/Enter>.
Info (<INFO/ >)
Information about the monitor settings, cardio and SpO settings, as well as battery and memory information can be viewed by pressing this key. Each time it is pressed, a new information window appears. After displaying all available information, the display reverts back to the se­lected standard display.
Graphic (<GRAPHIC/ >)
By pressing this key you can review the plethysmograph signal curves and some trend curves. The trends of pulse rate and SpO2are shown for the last 2.5 the last 2.5 or 24 hours.
Pressing <ALARM/Stop> rewrites the trend display.
2
68 Directions for use of LNOP® sensors Operator manual VitaGuard® VG 300
Operator manual VitaGuard® VG 300 Operating VitaGuard® 13
Page 29
VitaGuard®can only be switched off using the key panel.
Important: Self tests are performed at start to ensure functionality
Always switch the monitor off using the key panel. Do not try to switch it off by unplugging the power adapter as this will only cause VitaGuard®to switch to battery mode. If, however, batteries are not inserted, an acoustic warning will be generated, which can only be deactivated by reinserting the power adapter and switching the moni­tor back on. Once the monitor has been switched off properly, you may remove the power adapter.
After power is applied to the monitor, a series of tests are performed. The monitor type and the battery condition is displayed. All the LED's are activated and a short acous­tic alarm is generated to verify that the alarm speaker op­erates correctly. Should this acoustic signal not be gen-
erated, send the monitor for inspection to the manu­facturer immediately.
They are non sterile and latex free and can not be steril­ised.
INDICATIONS/CONTRAINDICATIONS
The LNOP NeoPt, Neonatal Adhesive Sensor is indicated for single-patient use for the continuous non-invasive monitoring of arterial oxygen saturation (SpO2) and pulse rate for patients weighing < 1 kg (1,000 grams), and with poor skin integrity. The LNOP NeoPt is for use only with instruments containing Masimo SET oximetry or licensed to use LNOP sensors. Consult individual oximetry system manufacturer for compatibility of particular instrument and sensor models. Each instrument manufacturer is re­sponsible for determining whether its instruments are compatible with each sensor model.
Monitor settings System settings
Datum/Uhrzeit
Expert mode
<∆> / <∇>
to choose
<Mode>
<Enter>
<Enter>
<Enter>
<Enter>
Monitor settings
System settings
Date/time
Expert
mode
Monitor display structure
Monitor information can be viewed using the four buttons <MODE/Esc>, <INFO/>, <GRAPHIC/> and <STATUS/Enter> as shown in Fig. 5. The four main menu paths will be explained next. For information on the individual monitor settings, refer to 'Explanation of the menu settings' on page 38ff.
browse
with <Info>
<ALARM/Stop>
Graphic displayInformationdisplay
Plethysmogram
<Graphic><Info>
<Graphic>
<Graphic>
Trends
Standard Display 2
<Status>
Episode number / count
Type of episode
Date and time
Duration
<Status>
Settings at the alarm
<Status>
Pulse oximetersettings
at the alarm
SpO2 limits at the
alarm
<Status>
Heart rate informa-
tion at the alarm
<Status>
Plethysmogram
at the alarm
Standard Display 1
<Graphic>
<Graphic>
<Info>
Operationmode
<Info>
Pulse oximeter
settings
<Info>
common settings
<Info>
Memory settings
<Info>
Version information
Monitoring log
Fig. 5 Menu structure of VitaGuard®VG 300
<∆> / <∇>
to choose
The LNOP NeoPt is contraindicated for patients who ex­hibit allergic reactions foam rubber products and/or adhe­sive tape.. The sensor must be removed and the site in­spected at least every eight (8) hours and, if indicated by circulatory condition or skin integrity, reapplied to a dif­ferent monitoring site.
INSTRUCTIONS FOR USE
A) Site Selection
The preferred site is a foot. Alternatively, across the palm and back of the hand can be used.
Always choose a site that is well perfused and will completely cover the sensor’s detector window.
Site should be cleaned of debris and dry prior to sen­sor placement.
B) Attaching the Sensor to the Patient
1. Open the pouch and remove the sensor. Holding the sensor along the length of the “Y”, remove the back­ing from the sensor. Orient the sensor tail so that it is pointed away from the patient. Position the detector onto the fleshly part of the sole of the foot aligned with the middle toe (Fig. 44).
12 Operating VitaGuard® Operator manual VitaGuard® VG 300
Operator manual VitaGuard® VG 300 Directions for use of LNOP® sensors 69
Page 30
Fig. 44 Sensor placement; detector on the sole of the foot
Attention! Read '
or how to react in
2. Orient emitter window on top of foot directly opposite the detector. Wrap the sponge wrap around the foot with the white detector fitting into the pre-punched opening on the foam wrap. Be careful to maintain proper alignment of the detector and emitter windows and attach the 'Velcro' strap to secure (Fig. 45)! Check position of sensor to verify correct positioning and re­position if necessary. Complete coverage of the detec­tor window is needed to ensure accurate data (Fig.
46).
Standard Display 3 (power-save mode)
Fig. 4 Standard Display 3 (power-save mode)
Standard Display 3
This mode just indicates that the patient is being moni­tored and reverts automatically back to standard display 1 or 2 when an alarm occurs or a button is pressed. This mode is recommended for home use.
To switch between standard display 1 and 2, press <ALARM/Stop>. Display 3 appears automatically after 5 minutes if no button is pressed and the power-save setting is activated. See also 'System settings' on page 39
II. Operating VitaGuard
®
Fig. 45 Orientation of emitter and detector
Fig. 46 Correctly attached LNOP®Neo Sensor
Fig. 47 Connecting patient cable and sensor
70 Directions for use of LNOP® sensors Operator manual VitaGuard® VG 300
Operation
Safety and Accuracy' on page 31!
Operator manual VitaGuard® VG 300 Operating VitaGuard® 11
Before using VitaGuard®for the first time, read and un­derstand this manual carefully. Pay particular attention to “Safety precautions” on page 31ff. If you have questions about monitoring, handling VitaGuard the event of an emergency, ask your clinician or moni-
tor dealer!
®
Switching VitaGuard®on and off
VitaGuard®is switched on using <ON/OFF>. To switch the monitor off, press <ON/OFF> for a couple of seconds and follow the instructions on the monitor display. After switching the monitor off, wait at least two seconds be­fore switching it back on again.
Page 31
Standard Display 1:
Standard Display 1 (numbers and alarm limits)
Fig. 2 Standard Display 1 (only numbers)
This display mode gives an overview of the measured values along with the associated alarm limits.
Standard Display 2 (graphic and numbers)
3. Orient the connector tab so that the “shiny” contacts are facing up. Mate the logo on the sensor tab to the logo on the patient cable. Insert the patient cable into the sensor tab until there is a tactile or audible click of connection (Fig. 47). Gently tug on the connectors to ensure a positive contact.
C) Reattachment
The sensor may be reapplied to the same patient if the emitter and detector windows are clear and the adhesive still adheres to the skin.
NOTE: Prior to reattachment or rejuvenation, disconnect the sensor from the sensor cable.
The adhesive can be partially rejuvenated by wiping with a 70% isopropyl alcohol pad and allowing the sensor to thoroughly air dry prior to replacement on the patient.
If the adhesive can not be adequately rejuvenated, use a new sensor.
D) Disconnecting Sensor and Patient Cable
1. Place thumb and index finger on grey buttons on ei­ther side of the patient cable (Fig. 48).
2. Press firmly on the grey buttons and pull to remove the sensor.
Fig. 3 Standard Display 2 (graphic and numbers)
Standard Display 2:
The measured values for pulse rate and SpO2are also shown in this mode. The graphical part of the display shows the plethysmograph, thus giving a good indication of the condition of the patient and the placement of the SpO2sensor.
10 General Information Operator manual VitaGuard® VG 300
Fig. 48 Disconnecting patient cable and sensor.
WARNINGS
The site must be checked and changed at least every eight (8) hours NOTE: Exercise extreme caution with poorly per­fused patients; skin erosion and pressure necrosis can be caused when sensors are not frequently moved. As­sess the site at least every two (2) hours with poorly perfused patients.
If the sensor is damaged in any way, discontinue use immediately.
Operator manual VitaGuard® VG 300 Directions for use of LNOP® sensors 71
Page 32
To prevent damage, do not soak or immerse the sensor
in any liquid solution. Do not attempt to sterilise.
Intravascular dyes may lead to inaccurate SpO2 meas-
urements.
Elevated levels of Carboxyhaemoglobin (COHb) may
lead to inaccurate SpO2 measurement.
Elevated levels of Methaemoglobin (MetHb) will lead
to inaccurate SpO2 measurements.
Failure to apply the LNOP Neo properly may cause
incorrect measurements.
Do not use the LNOP Neo during MRI scanning.
Avoid placing the LNOP Neo on any extremity with
an arterial catheter or blood pressure cuff.
The pulsation’s from intra-aortic balloon support can
be additive to the pulse rate on the oximeter pulse rate display. Verify pulse rate against an ECG heart rate.
High oxygen concentrations may predispose a prema-
ture infant to retinopathy. Therefore, the upper alarm limit for the oxygen saturation must be carefully se­lected in accordance with accepted clinical standards.
Circulation distal to the sensor site should be checked
routinely.
Avoid bending and distorting the sensor cable, be-
cause this may damage the sensor.
Hint: If the monitor displays pulse rate and SpO2not constantly than check the sensor placement and reposition it, if necessary. If this does not help than change the sen­sor. Hint: Sensors being used for a long period tend to re­duced performance. A sensor should be replaced, if pulse rate and SpO2become questionable.
SPECIFICATIONS
When used with Masimo SET pulse oximetry monitors or with licensed Masimo SET pulse oximetry modules, us­ing PC Series patient cabled, during no motion, the accu­racy of the LNOP Neo from 70% to 100% SpO2 is ± 3 digits (± 1 Std. Dev.).
Please see also the following section!
Key Explanation
Key to enter and exit the menu structure View operating mode
View monitor settings View measurements View memory settings
View plethysmogram and trends View stored episodes
Accept new values when changing parameters Alarm stop
Controls protection button Change between standard display 1 and 2
Monitor on/off This key needs to be pressed for a couple of sec­onds. Follow the instructions on the LCD display.
Tab. 1 Key function in VitaGuard®VG 300
In the following sections keys to be pressed will be written in brackets, for example, <MODE/Esc> means that the mode button must be pressed. All buttons need to be pressed for approximately ½ a second before they react.
Connectors of VitaGuard®VG 300
VitaGuard®VG 300 (Fig. 1) has connectors to accom­modate an external power adapter, the SpO2sensor ca­ble and the external alarm amplifier EA 1000. A PC connector is also available to download data.
Only use cables and sensors delivered by GeTeMed or an authorised distributor.
Important: Use only the external power adapters delivered by GeTeMed!
For safety reasons, only use the mains adapter delivered with the monitor or the car power adapter NAK 1500. Under no circumstances should you connect any other mains adapter or connect the monitor with the 220V mains supply directly.
Failure to comply with the above advice may result in serious health damage or even death.
Monitor displays
72 Directions for use of LNOP® sensors Operator manual VitaGuard® VG 300
VitaGuard®offers three standard display modes as fol­lows:
Operator manual VitaGuard® VG 300 General Information 9
Page 33
Particularly easy op­eration.
VitaGuard®is just a tool. YOU must react!
Caution: Do not cover the speaker!
Key panel
Operation
Operation of VitaGuard®can be learned within minutes. Allow your doctor to demonstrate the monitor to you and to set the alarm limits to suit the patient being monitored.
Remember that YOU, the caregiver, must act in the event of emergencies. Refer to 'Emergency situation' on page i.
In the home environment verify that you can hear the alarm, independent of where you are and what you are doing, for example, when house cleaning, watching TV, listening to radio, shopping, etc.
Make sure VitaGuard®’s alarm speaker is not blocked by anything placed on the monitor. You cannot react prop-
erly to an alarm if you cannot hear it! Make sure you can react to an alarm within a few seconds!
The key panel (Fig. 1) consists of six keys. These keys are explained in Tab. 1 below:
Miscellaneous Warnings and Hints
INSTRUMENT CAPABILITY
LNOP®sensors are intended for use only with instru­ments containing Masimo SET oximetry or pulse oxi­metry monitors licensed to use LNOP®sensors. Each sensor is designed to operate correctly only on the pulse oximetry systems from the original instrument manufac­turer. Use of this sensor with other instruments may result in no or improper performance.
LICENSE
Purchase or possession of this sensor confers no ex­pressed or implied license to use the sensor with any de­vice which is not an authorised device or separately authorised to use LNOP sensors.
Order of a physician
CAUTION: FEDERAL LAW (U.S.A.) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.
Miscellaneous
U.S.A. Patient 5,638,818 and international equivalents. Other U.S.A. and international patents pending.
Masimo SET technology under license from Masimo Corporation.
Manufactured in the U.S.A. Masimo SET logo, LNOP and sensor configuration are
trademarks of Masimo Corporation. © 1998 Masimo Corporation. VitaGuard®is a trademark of GeTeMed GmbH.
SpO2- PC ext. mains ext.
sensor connector adapter alarm unit
Fig. 1 Frontal view and connectors of VitaGuard
VG 300
8 General Information Operator manual VitaGuard® VG 300
®
Licence agreement for end users
THIS DOCUMENT IS A LEGAL AGREEMENT BETWEEN YOU, THE PURCHASERAND GETEMED. IF YOU DO NOT AGREE TO THE TERMS OF THIS AGREEMENT, PROMPTLY RETURN THE ENTIRE PACKAGE, INCLUD­ING ALL ACCESSORIES, IN THEIR ORIGINAL PACKAGE, WITH YOUR SALES RECEIPT TO GETEMED FOR A FULL REFUND.
1. Grant of License. In consideration of payment of the license fee, which is part of the price paid for this product, GeTeMed grants to Purchaser a nonexclusive, non-transferable license,
Operator manual VitaGuard® VG 300 Directions for use of LNOP® sensors 73
Page 34
without right to sublicense, to use the copy of the incorporated
ed. If no batteries are installed, the monitor displays a
abruptly removes
inserting batteries into the device or reapplying the power
software/firmware, and documentation in connection with Pur­chaser's use of the Products for their labelled purpose. GeTeMed reserves all rights not expressly granted to Pur­chaser.
2. Ownership of Software/Firmware. Title to, ownership of, and all rights and interests, in any MASIMO software and/or firm­ware and the documentation, and all copies thereof, remain in all times vested in MASIMO Corporation, licensor to GeTeMed, and they do not pass to Purchaser.
3. Assignment. Purchaser shall not assign or transfer this license, in whole or in part, by operation of law or otherwise, without GeTeMed's prior written consent; any attempt without such consent, to assign any rights, duties or obligations arising here­under shall be void.
4. Copy Restriction. The software/firmware and the accompany­ing materials are copyrighted. Unauthorised copying of the software, including software that has been modified, merged or included with other software, or other written materials is ex­pressly forbidden. You may be held legally responsible for any infringement that is caused or incurred by your failure to abide by the terms of this license. Nothing in this license provides any rights beyond those provided by 17 U.S.C. §117.
5. Use Restriction. As the Purchaser, you may physically transfer the products from one location to another provided that the software/firmware is not copied. You may not electronically transfer the software/firmware from the product to any other device. You may not disclose, publish, translate, release or di s­tribute copies of the software/firmware or accompanying mate­rials to others. You may not modify, adapt, translate, reverse engineer, decompile, disassemble or create derivative works based on the software/firmware. You may not modify, adapt, translate or create derivative works based on the written materi­als without the prior written consent of GeTeMed.
6. Transfer Restrictions. The software/firmware is licensed to the Purchaser, and may not be transferred to anyone, except other end-users, without the prior written consent of GeTeMed. In no event may you transfer, assign, rent, lease, sell, or otherwise dispose of the software/firmware or the products on a tempo­rary basis.
7. Beneficiary. Masimo Corporation is a Beneficiary of this Agreement and has the right to enforce its provisions.
8. U.S. Government Rights: If you are acquiring software (includ­ing the related documentation) on behalf of any part of the United States Government, the following provisions apply: the software is deemed by the 'commercial software' and 'commer­cial computer software documentation,' respectively pursuant to FAR Section 227.7202 FAR 12.212, as applicable. Any use,
become weak. ule will automatically switch off when the batteries be-
come too weak. The monitor generates an appropriate technical alarm to warn the childminder or clinician. To reactivate the SpO2monitor, either replace the batteries or power the device with the external power adapter sup­plied. Once the batteries have been replaced or the power adapter has been connected, the SpO2module switches back on automatically. Remember that monitoring
ceases once the SpO2 module switches off.
Always have fresh bat­teries in the monitor!
When operating VitaGuard®VG 300 with the external power adapter, always ensure that fresh batteries are in­stall message every 16 seconds informing you to do so. The batteries are important to ensure that the device can automatically switch to battery mode in the event of a mains power failure or when somebody the power connector. Should either of these events hap­pen and no batteries are inserted, the monitor generates a permanent alarm tone. This can only be deactivated by
connector and switching the monitor back on.
You should react promptly in the event of such an alarm because your child is no longer being moni­tored. This alarm tone is generated by an internal buffer
battery. If this battery becomes weak, the monitor must be returned to the manufacturer for replacement
Important! Check bat­teries with active SpO module!
To test that the batteries in the battery compartment are charged enough for SpO2operation, carry out the follow
2
steps:
Remove the external power adapter so that the de-
vice is powered from batteries.
Wait 30 seconds and then press <INFO/> a number
of times until you reach the battery information.
If the batteries are weak replace them immediately with good-quality alkaline batteries such as VARTA alkaline Extra Longlife. It is recommended that you always keep at least two spare sets handy.
Display
The large surfaced LCD display and the light emitting diodes (LED's) allow visual control of the monitor. Acoustic signals synchronous with the pulse rate may be activated using the key panel.
74 Directions for use of LNOP® sensors Operator manual VitaGuard® VG 300
Operator manual VitaGuard® VG 300 General Information 7
Page 35
LNOP®-Neo Sensors
for pulse oximetry, e.g.
Carefully route the patient cable to prevent strangulation.
Alarm when batteries
monitoring of pulse and SpO2.
Important:
The optimal SpO2­sensor position depends on the sensor type and the patients weight!
Important: Cable rout­ing!
Sensors
The LNOP®Neo sensor delivered with the VitaGuard VG 300 monitor is a single-patient disposable sensor in­tended to measure the functional oxygen saturation of ar­terial haemoglobin (SpO2) of neonatal patients weighing less than 10 kg. To monitor premature born babies with very fragile skin use the LNOP®-NeoPt sensor with re­duced adhesive area. For larger children between 10 and 50 kg use the LNOP®-Pdt sensor and for patients weigh­ing more than 30 kg use the LNOP®-Adt sensor. Patients exhibiting allergic reactions to adhesive tape may not be able to use these sensors.
The sensor must be removed and the site inspected at least every eight (8) hours (every four (4) hours with DC1 sensor, every two (2) hours on children with poor skin integrity) and, if indicated by circulatory condition or skin integrity, reapplied to a different monitoring site.
®
Sensor application
The sensors delivered with VitaGuard®can be placed on the feet or hands of smaller children, on the big toe or thumb of larger children or on a finger of adult or paedi­atric patients. In choosing the actual site, you have to consider the necessity of obtaining a good signal and the comfort of the child. See also Directions for use of LNOP®sensors' and 'Sensor selection' on page 50ff.
The sensor must be fixed at its site without obstructing the blood flow.
If necessary route the cable within the clothing and fix it with a plaster.
modification, reproduction, release, performance, display or disclosure of the software (including the related documentation) by the U.S. Government or any of its agencies shall be govered solely by the terms of this Agreement and shall be prohibited except to the extend permitted by the terms of this agreement.
Note: In the event that any of the provisions of this agreement shall be held by a court or other tribunal of competent jurisdi c­tion to be unenforceable or unlawful, such provisions shall be deleted from this agreement and the remaining portions of this agreement shall remain in full force and effect, except where the economic equity of both parties hereto is martially affected by such unenforceability.
Power supply
Automatic switching be­tween battery and mains supply.
6 General Information Operator manual VitaGuard® VG 300
VitaGuard®offers a high level of electrical safety and flexibility and operates with batteries, the car power adapter NAK 1500 or with the mains supply adapter NA 2000-2 provided. When an external power adapter is connected, the LCD backlight is automatically switched on. The monitor switches automatically to battery mode in the event of an external power failure. It is therefore strongly recommended that you always keep batteries in the monitor, even when using external power adapters.
When operating the device with batteries, the SpO2mod-
Operator manual VitaGuard® VG 300 Directions for use of LNOP® sensors 75
Page 36
I. General Information
the oxygen saturation falls below or exceeds preset limits.
Introduction
In this chapter you will find information on the intended purpose of VitaGuard®and some general information on its usage.
Intended use of VG 300
Alarm generation when pulse rate or SpO2are outside of the allowed limits.
Responsibility
Allergies.
VitaGuard®VG 300 is intended to be used for continu­ous, non-invasive monitoring of oxygen saturation and pulse rate of adult, paediatric and neonate patients in hospitals, hospital-type facilities, intra-hospital transport and the home. An alarm is generated if the pulse rate or
The delay times before alarms are generated can be indi­vidually programmed.
VitaGuard®VG 300 is a warning device that gener­ates an alarm. YOU, the caregiver, must act in the event of an emergency.
The manufacturer takes no responsibility for any damages resulting from using the monitor in any way other than the intended use. Remember that Vita­Guard®is a warning device and that YOU must act in the event of an emergency.
The LNOP®Neo and NeoPt sensors are especially de­signed for neonates to allow monitoring over a period of months without causing irritation of the skin. In seldom cases allergic reactions can occur. Should this happen, consult your clinician for advise.
Fig. 49 Approval of the quality management system of
GeTeMed
76 Directions for use of LNOP® sensors Operator manual VitaGuard® VG 300
Compliance with the legal requirements
The product VitaGuard®complies with all legal re­quirements listed in the appendix I (basic requirements on medical products) of the EEC directive on medical products. When applied according to the intended use and observing all the stated warnings there are no safety risks known to be caused by the product.
The monitor must be returned for inspection to the manufacturer, if the operation period printed on the monitor is expired.
Operator manual VitaGuard® VG 300 General Information 5
Page 37
Safety with the adapter NAK 1500 ..............................................................49
VI. Directions for use of LNOP®sensors 50
Sensor selection...............................................................................................50
Selection plan...............................................................................................50
LNOP®DC1 - Directions for use....................................................................51
INDICATIONS/CONTRAINDICATIONS................................................51
INSTRUCTIONS.........................................................................................51
CLEANING.................................................................................................53
WARNINGS................................................................................................54
SPECIFICATIONS......................................................................................55
LNOP®Adt - Directions for use......................................................................55
INDICATIONS/CONTRAINDICATIONS................................................55
INSTRUCTIONS.........................................................................................56
WARNINGS................................................................................................58
SPECIFICATIONS......................................................................................59
LNOP®Pdt - Directions for use ......................................................................59
INDICATIONS/CONTRAINDICATIONS................................................60
INSTRUCTIONS FOR USE.......................................................................60
WARNINGS................................................................................................63
SPECIFICATIONS......................................................................................63
LNOP®Neo - Directions for use.....................................................................64
INDICATIONS/CONTRAINDICATIONS................................................64
INSTRUCTIONS FOR USE.......................................................................64
WARNINGS................................................................................................67
SPECIFICATIONS......................................................................................68
LNOP®NeoPt - Directions for use..................................................................68
INDICATIONS/CONTRAINDICATIONS................................................69
INSTRUCTIONS FOR USE.......................................................................69
WARNINGS................................................................................................71
SPECIFICATIONS......................................................................................72
Miscellaneous Warnings and Hints ................................................................73
INSTRUMENT CAPABILITY...................................................................73
Miscellaneous ..............................................................................................73
Licence agreement for end users.....................................................................73
VII. Glossary 78 VIII. Index 80
4 Operator manual VitaGuard® VG 300
Fig. 50 Covered products of GeTeMeds quality manage-
ment system
Operator manual VitaGuard® VG 300 Directions for use of LNOP® sensors 77
Page 38
VII.Glossary
Alarm Parameters
Limits for monitored data, that, if exceeded, generate alarms.
Asystolie, Asystolea
Complete (at least temporary) stop of the heart beat.
BPM
Beats per minute of the heart.
Bradycardia
Slow heart rate.
(Event) delay
This is the minimal duration an event must last to generate an alarm.
LCD
Liquid Crystal Display: A special kind of a passive, non­luminous display. VitaGuard®employs an LCD to conserve battery power for a longer monitoring p eriod.
®
LNOP
Low Noise Optical Probe; a patented (Masimo Corporation) sensor type to receive noise-reduced optical signals for SpO determination.
2
low Perfusion
here: Special SET®-analysis method employed with patients with low perfusion.
Oxygen Saturation
Ratio of oxygenated haemoglobin to all haemoglobin in arte­rial blood. Abbr.: SpO2– partial saturation of oxygen.
In this manual this term is always used for partial (functional) arterial oxygen saturation, which is the ratio between oxygen­ated to all functional haemoglobin. The normal value for adults is about 98%.
Plethysmograph
Plethysmographs primarily measure variations in limb volume or circumference that are caused by blood flow to and from that limb. VitaGuard®utilises the optical bridge of the LNOP®-sensor to detect the changes in opacity resulting from the periodic filling and emptying of the blood vessels.
Plethysmogram
Display of the results of a plethysmograph, showing the time­course of the blood flow in the observed vessel
Status memory function ..................................................................................25
Alarm types..................................................................................................26
Episode memory and PC interface..................................................................27
III. Technical Data 29
General............................................................................................................29
Pulse oximetry.................................................................................................29
Memory...........................................................................................................29
Miscellaneous..................................................................................................30
IV. Safety and Accuracy 31
Safety precautions...........................................................................................31
Safety precautions - Usage ..........................................................................31
Safety precautions - Environment ...............................................................32
Safety precautions - Power supply ..............................................................33
Safety precautions - Sensor and cable .........................................................34
Accuracy and factors effecting the SpO2measurement..................................35
Cleaning ..........................................................................................................36
Regulatory information...................................................................................36
Guarantee conditions.......................................................................................37
V. Appendix 38
Special function - Immediate data storage...................................................38
Compliance log............................................................................................38
Explanation of the menu settings....................................................................38
Monitor settings...........................................................................................39
System settings.............................................................................................39
Date/time settings ........................................................................................40
Expert mode.................................................................................................40
Ordering information ......................................................................................41
Complete system..........................................................................................41
Accessories ..................................................................................................41
Ordering address..........................................................................................42
Masimo SET technology.................................................................................43
Principle of operation...................................................................................43
Error codes...................................................................................................45
Patent information...........................................................................................46
External alarm unit EA1000 ...........................................................................47
Hints for operation.......................................................................................47
Function elements........................................................................................48
Technical data..............................................................................................48
Safety with the external alarm unit..............................................................48
Car adapter NAK 1500 ...................................................................................49
Hints for operation.......................................................................................49
Technical data..............................................................................................49
78 Glossary Operator manual VitaGuard® VG 300
Operator manual VitaGuard® VG 300 Table of Content 3
Page 39
Table of Content
EMERGENCY SITUATION 1
IMPORTANT – Telephone numbers in an emergency!...................................1
I. General Information 5
Introduction.......................................................................................................5
Intended use of VG 300.................................................................................5
Compliance with the legally relevant requirements ......................................5
Sensors...........................................................................................................6
Sensor application..........................................................................................6
Power supply..................................................................................................6
Display...........................................................................................................7
Operation........................................................................................................8
Key panel...........................................................................................................8
Connectors of VitaGuard®VG 300 ..................................................................9
Monitor displays................................................................................................9
II. Operating VitaGuard
Operation.........................................................................................................11
Switching VitaGuard®on and off................................................................11
Monitor display structure.............................................................................12
Monitor menu structure ...............................................................................13
Changing parameters ...................................................................................14
Alarm information .......................................................................................15
Sensors ............................................................................................................15
Handling LNOP®- sensors...........................................................................15
Monitoring.......................................................................................................18
Setting alarm parameters.................................................................................18
SpO2parameters...........................................................................................18
Pulse rate......................................................................................................19
System check...................................................................................................20
Alarm generator...........................................................................................20
Baby phone..................................................................................................20
Battery operation.............................................................................................21
Battery supervision......................................................................................21
Battery replacement.....................................................................................22
Mains adapter...............................................................................................22
Integrated menus.............................................................................................23
Monitor settings main menu:.......................................................................23
System settings main menu: ........................................................................24
Time/Date main menu: ................................................................................24
Expert mode main menu:.............................................................................24
®
11
Fig. 51 Example of a plethysmogram as displayed on the
VitaGuard®VG 300
®
SET
Signal Extraction Technology: A patented (Masimo Corpora­tion) procedure to determine the arterial SpO2value in noisy environments e.g. due to motion and low perfusion.
Silent Alarms
Special internal alarm limits that cause episodes to be stored without actually generating an acoustic alarm. For example, a silent lower bradycardia limit of 100 BPM may be set. If the pulse rate falls below 100 BPM, then a silent alarm will be stored. If the real alarm limit is set to 80 BPM and the pulse rate falls below this value, then a real alarm with warn tone is generated.
SpO
2
See oxygen saturation.
Tachycardia
Rapid heart rate.
Technical Alarm
A technical alarm is a slow sequence of warning tones that are generated when a technical irregularity is detected, for exam­ple, when the SpO2sensor is not properly connected.
Trend
In this manual: Displaying average values to show and review a longer period of data.
2 Table of Content Operator manual VitaGuard® VG 300
Operator manual VitaGuard® VG 300 Glossary 79
Page 40
VIII. Index
EMERGENCY SITUATION
Accessories 44 Accuracy 12, 38 Alarm 1, 5, 7 – 15, 18 –
21, 23, 25 – 29, 32, 34, 35, 42 – 44, 51, 52, 72, 76, 82, 83
- limits 8, 10, 13, 18, 19, 20, 25, 28, 32, 34, 42, 72, 76, 83
- parameter 82
- technical 7, 8, 19, 20, 22, 23, 36, 83
- test 21
Allergies 5, 6, 60, 64, 68, 73 Batteries 7, 8, 12, 14, 15, 20
– 24, 32, 36, 37, 44, 51, 52, 82
Display 8, 9, 10 – 13, 14,
15, 19, 20, 22, 24, 26, 29, 32, 43, 51, 58, 63, 67, 72, 76, 79, 82
Emergency
- How to act 1, 51
- Telephone numbers 1
Expert mode 13, 25, 26, 29, 42,
43, 44
Handling 16 Intended Use 34 Key panel 8, 9, 12, 14, 15,
27, 43
Memory
- what is stored 9, 14, 15, 23, 27, 28, 29, 33, 42, 43, 83
Menu 13
- changing parameters 9, 15
- controls protection 15
- Expert mode 13, 27, 42, 44
- monitor settings 13, 19, 25, 42
- settings 9, 12– 15, 19, 20, 23 – 27, 12 – 15, 12 – 15, 12 – 15, 12 – 15, 42 – 44
- system settings 11, 13, 14, 25, 29, 43
- time/date settings 26
Monitor
- operation 8, 11, 12, 18, 21, 22, 23, 36, 51, 52, 53
PC interface 29, 36, 43 Power supply 7, 8, 10, 12, 22 –
24, 32, 35, 37, 44, 45, 53
Power-save 11, 13 Safety 12, 34, 35, 37 Safety and accuracy 12, 34
®
SET
SpO2sensors 5 – 11, 16 – 20,
- placement 17, 56, 61, 65, 69,
Technical data 23, 32
- general properties 32
- heart rate properties 33
- memory properties 33
- miscellaneous 33
Trend 9, 14, 26, 43, 83
i, 16, 20, 44, 46, 47, 82, 83
23, 33, 35, 37, 38, 43 – 46, 50, 54 – 77, 82, 83
73, 74
Please ask the handling physician how you should act in the event of an emergency. For baby monitoring pur­poses we offer an alarm chart with instructions on how to act in an emergency. Read those instructions care­fully. If you do not fully understand them, ask your paediatrician or your dealer. Make certain you and all other potential caregivers are ready to respond properly to an alarm. Every caregiver must be able to perform CPR (cardiopulmonary resuscitation) alone or be able to instruct a second person to assist in CPR. We recom- mend to participate in a CPR training course. Reca­pitulate the necessary actions with all potential caregiv­ers regularly, at least once every month!
In the event of an alarm, follow the instructions on page ii.
IMPORTANT – Telephone numbers in an emergency!
Please note the telephone numbers of your doctors in the spaces provided below:
Emergency: Family doctor:
Your address: Name: Street: Postal code:
Telephone:
Keep this manual in a place where it can easily be found by every potential caregiver!
80 Index Operator manual VitaGuard® VG 300
Operator manual VitaGuard® VG 300 1
Page 41
Page 42
GeTeMed GmbH
GeTeMed
Gesellschaft für Technische Medizin mbH Oderstraße 59 14513 Teltow Telefon (0 33 28) 39 42 - 0 Telefax (0 33 28) 39 42 - 99 Email Info@getemed.de Internet www.getemed.de
Operator Manual
®
VitaGuard
(Serial number 0199701 or greater)
VG 300
Pulse oximeter
incorporating Masimo SET®Technology
HighTech made easy
Operator manual VG 300
Version of 25.02.2000 - Subject to changes
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