GeTeMed VG 3100 User Manual
VitaGuard® VG 3100
Apnea, heart, and SpO2 monitor
Operating instructions
Who should read which sections in these operating instructions?
The sections 3 to 8 colored blue at the top of the page and in
the table of contents are intended specifically for caregivers
without medical background knowledge.
The other sections are intended in particular for doctors and
qualified medical staff.
1 General view and list of accessories
2 Intended use
3 Safety
4 Description
5 Steps before and after monitoring
6 Preparing for SpO2 monitoring
7 Preparing for heart rate and apnea monitoring
8 Alarms, displays, and views during monitoring
9 Alarm and monitor settings
10 Information for the doctor and qualified medical staff
11 Algorithms and measuring principles
12 Evaluating stored data on a PC
13 Specifications
14 Table of figures
NOTE Words and passages in small capitals in these operating
instructions also appear on the display.
Table of contents
Table of contents
1 General view and list of accessories0...............................0011
2 Intended use0............................................................................0014
2.1 Label on the back of the device0...........................................................0014
2.2 Symbols and warnings0 ..........................................................................0015
2.3 Indications0.................................................................................................0016
2.3.1 SpO2 and pulse rate monitor0...............................................0016
2.3.2 Heart rate and apnea monitor0............................................0016
2.4 VitaGuard® modes of operation0.........................................................0017
2.5 Intended use and performance0...........................................................0018
2.6 Limitations on VitaGuard®’s intended use0......................................0019
2.6.1 Obstructive apneas are not detected0................................0019
2.6.2 Limitations of the heart rate and central apnea monitor0 ...0020
2.6.3 Limitations of the SpO2 and pulse rate monitor0............0020
2.7 Information for the doctor on these operating instructions0 .....0021
3 Safety0..........................................................................................0022
3.1 Caregivers’ tasks0......................................................................................0022
3.2 Allergy risks to patients0.........................................................................0024
3.3 Possible external interference to monitoring0................................. 0024
3.3.1 Installation and environment0 .............................................0025
3.3.2 Noise risks to monitoring0..................................................... 0025
3.3.3 Electrostatic interference0 .....................................................0026
3.3.4 Electromagnetic interference0 .............................................0026
3.4 Safety with approved accessories only0.............................................0027
3.5 Handling patient cables0........................................................................0028
3.6 Power supply reliability0 .........................................................................0029
3.6.1 Battery voltage indicator0......................................................0030
3.6.2 Interruptions to the power supply0.....................................0031
3.6.3 Using the rechargeable block battery0...............................0031
3.7 Safety with proper maintenance only0 ..............................................0032
3.7.1 Cleaning VitaGuard® and accessories0..............................0032
3.7.2 Checking and cleaning the battery terminals0................ 0033
3.8 Disposing of non-rechargeable batteries, the device, and
accessories0.................................................................................................0034
Table of contents
4 Description0...............................................................................0035
4.1 Power supply0............................................................................................ 0036
4.1.1 Power failure with inserted batteries0............................... 0037
4.1.2 Power failure without batteries0......................................... 0037
4.1.3 Replacing batteries0 ................................................................ 0038
4.1.4 Using the automobile power supply adapter0................ 0039
4.2 VitaGuard® connections0.......................................................................0040
4.2.1 Patient cable for SpO2 sensors0............................................ 0040
4.2.2 Patient cable for electrodes0................................................. 0041
4.2.3 Power adapter0 ......................................................................... 0041
4.2.4 Sound outlet (no socket)0 ...................................................... 0041
4.2.5 USB port0..................................................................................... 0042
4.2.6 AUX port0.................................................................................... 0042
4.3 Membrane key panel0 ............................................................................. 0043
4.3.1 Direction keys0 .......................................................................... 0044
4.3.2 <Enter> key0 ............................................................................... 0044
4.3.3 <Esc> key0.................................................................................... 0044
4.4 Color LEDs (Light Emitting Diodes)0.................................................... 0045
4.4.1 Alarm LED0.................................................................................. 0045
4.4.2 Heart and respiration LEDs0.................................................. 0045
4.4.3 Power supply and battery LEDs0.......................................... 0046
4.5 The display0 ................................................................................................ 0046
5 Steps before and after monitoring0.................................0048
5.1 Summary of steps before monitoring0 .............................................. 0048
5.2 Switching on0............................................................................................. 0049
5.3 Switching off0............................................................................................ 0050
5.4 Summary of steps after monitoring0.................................................. 0050
6 Preparing for SpO2 monitoring0........................................0051
6.1 Safety instructions for SpO2 monitoring0......................................... 0051
6.2 Operation of SpO2 sensors0...................................................................0052
6.3 SpO2 sensor adapted to the patient’s size and weight0................ 0053
6.4 Choosing the sensor site0....................................................................... 0053
6.5 Repositioning or replacing the sensor0..............................................0054
6.6 Reasons for unconvincing SpO2 values0 ............................................0054
Table of contents
6.7 Why the pulse rate is not displayed0...................................................0055
6.8 Attaching the SpO2 sensor to an infant’s foot0 ...............................0055
6.9 Attaching the SpO2 sensor to an adult’s finger0..............................0056
6.10 Connecting the SpO2 sensor and patient cable0 .............................0058
6.11 Connecting the SpO2 patient cable to VitaGuard®0....................... 0058
6.12 Disconnecting the SpO2 sensor from the patient cable0 ..............0059
6.13 Disconnecting the SpO2 patient cable from VitaGuard®0............0059
6.14 Reusing and refastening SpO2 sensors0.............................................0059
7 Preparing for heart rate and apnea monitoring0.........0061
7.1 Safety information when monitoring heart rate and apnea0.....0061
7.2 Connecting electrodes, the patient cable, and VitaGuard®0.......0064
7.3 Technical alarm from the electrode contact monitor0..................0064
7.4 Determining the optimal electrode configuration0 .......................0065
7.4.1 ECG lead, electrode color coding0........................................0065
7.4.2 Optimizing the heart and respiration signals – signal
amplitudes in View 10.............................................................0066
7.5 Checking the basal impedance0...........................................................0067
8 Alarms, displays, and views during monitoring0..........0069
8.1 Alarm test0.................................................................................................. 0069
8.2 Heart rate values based on age groups0 ..........................................0069
8.3 Alarm message priorities in the status line0.....................................0070
8.4 Physiological and technical alarms0....................................................0070
8.5 Differentiating physiological and technical alarm signals0.........0071
8.6 Acoustic information signals0...............................................................0072
8.6.1 Information signals from the alarm unit next to
the display0.................................................................................0072
8.6.2 Information signals from the sound aperture
between the sockets0..............................................................0072
8.7 The visual alarm signals0........................................................................0073
8.8 Status line displays0 .................................................................................0073
8.9 SpO2 monitor alarms0..............................................................................0074
8.9.1 Physiological SpO2 alarms0....................................................0074
8.9.2 Technical SpO2 alarms0...........................................................0075
8.10 Heart rate and apnea monitoring0 ......................................................0075
8.10.1 Differentiating between heart and pulse rate0...............0075
Table of contents
8.10.2 Heart and pulse rate alarms0................................................ 0076
8.10.3 Apnea alarms0........................................................................... 0077
8.10.4 Technical heart rate and apnea alarms0 ...........................0077
8.11 Alarm messages – meanings and other information0 .................. 0077
8.11.1 Order of equal-priority alarm conditions0 ........................ 0078
8.11.2 Table of physiological alarm messages0 ........................... 0078
8.11.3 Table of technical alarm messages0................................... 0081
8.12 Table of information messages0.......................................................... 0084
9 Alarm and monitor settings0..................................................... 0085
9.1 Safety instructions for the alarm settings0....................................... 0085
9.2 Summary of views and menus0............................................................ 0086
9.3 Additional views0...................................................................................... 0086
9.3.1 View 2 – Large data presentation and waveforms0....... 0087
9.3.2 View 3 – Smaller data presentation and waveforms0 .. 0087
9.4 Changing the settings0........................................................................... 0087
9.5 System menu – general settings0........................................................0089
9.5.1 \ Screen saver (Off/ On)0 .....................................................0089
9.5.2 \LCD brightness0....................................................................0089
9.5.3 \LCD contrast0........................................................................ 0089
9.5.4 \ Signal beep tone0 ................................................................. 0090
9.5.5 \ Alarm tone pitch0................................................................ 0090
9.5.6 \RS232 format0........................................................................ 0090
9.5.7 \ Settings protection On, Limited, Off0.......................... 0091
9.6 SpO2 display and menu0 ......................................................................... 0092
9.6.1 SpO2 view0.................................................................................. 0092
9.6.2 SpO2 menu – alarm settings
(Settings protection Limited)0...........................................0093
9.7 Heart rate display and menu0.............................................................0094
9.7.1 Heart rate display0.................................................................. 0095
9.7.2 Heart rate menu – alarm settings
(Settings protection Limited)0...........................................0095
9.8 Respiration display and menu0........................................................... 0096
9.8.1 Respiration display0................................................................0097
9.8.2 Respiration menu – alarm settings
(Settings protection Limited)0...........................................0098
Table of contents
10 Information for the doctor and qualified medical staff0 ..0099
10.1 Safety instructions0..................................................................................0099
10.1.1 Preparing for a new patient0.................................................0099
10.1.2 Connections to the USB and AUX ports0...........................0101
10.1.3 VitaGuard® and other medical devices0............................0101
10.1.4 Safety instructions for the doctor –SpO2 monitor0........0102
10.2 Info display0...............................................................................................0103
10.2.1 \ Last status messages0.........................................................0103
10.2.2 \ General0...................................................................................0103
10.2.3 \ Measurements: SpO20..........................................................0104
10.2.4 \ Measurements: Pulse rate0 ..............................................0105
10.2.5 \ Measurements: HR & Resp.0...............................................0105
10.2.6 \ Settings: Oximeter0............................................................. 0106
10.2.7 \ Settings: Heart rate0...........................................................0107
10.2.8 \ Settings: Apnea monitor0 .................................................0107
10.2.9 \ Memory/ Internet0 ..............................................................0107
10.2.10 \Versions0.................................................................................0108
10.3 Settings in the System menu (Settings protection Off)0...........0109
10.3.1 Changing multiple-component settings0 .........................0109
10.3.2 \Operating area: Home or Clinic0......................................0110
10.3.3 \Admit new patient – restoring factory settings0 ........0110
10.3.4 \Pre- and Post-alarm time0................................................. 0112
10.3.5 \ Alarm mute time0 .................................................................0112
10.3.6 \Date/time0 ..............................................................................0112
10.3.7 \ Language0 ...............................................................................0113
10.3.8 \Analog input 1 + 20.............................................................. 0113
10.3.9 \ Interval recording0 ............................................................0113
10.3.10 \Show PR/HR0.........................................................................0113
10.4 Data storage functions0..........................................................................0113
10.5 Event storage0 ...........................................................................................0114
10.5.1 Silent alarm limits0................................................................0116
10.5.2 Manual data storage or Transmit data0.......................0116
10.5.3 Summary of stored Events0 ..................................................0117
10.6 Trend storage0 ..........................................................................................0118
10.7 Long term storage over eight hours0.................................................0119
Table of contents
10.8 Protocol storage of operating and device data0.......................... 0119
10.9 Summary of stored signals and data0 ................................................ 0120
10.10 Settings in the SpO2 menu (Settings protection Off)0 ............... 0121
10.11 Settings in the Heart rate menu (Settings protection Off)0 ...0123
10.12 Changing the ECG lead for signal optimization0............................... 0127
10.13 Settings in the Respiration menu (Settings protection Off)0... 0129
10.14 Combining apnea alarms with heart rate and SpO2 alarms0...... 0130
10.15 Table of operating modes0 .................................................................... 0131
11 Algorithms and measuring principles0............................... 0133
11.1 Alarm condition and report delays0.................................................... 0133
11.1.1 Alarm condition delay for the heart rate0......................... 0133
11.1.2 Alarm condition delay for oxygen saturation0................ 0134
11.1.3 Alarm condition delay for respiration0 .............................. 0134
11.1.4 Alarm report delays0................................................................ 0134
11.2 Measuring principle for the SpO2 monitor0...................................... 0135
11.3 Measuring principle for the heart rate monitor0............................0138
11.4 Measuring principle for the apnea monitor0 ................................... 0139
12 Evaluating stored data on a PC0 ..............................................0141
13 Specifications0 ..................................................................................... 0143
13.1 General0....................................................................................................... 0143
13.2 SpO2 monitor0............................................................................................ 0145
13.3 Heart rate monitor0 ................................................................................. 0146
13.4 Apnea monitor0......................................................................................... 0146
13.5 Intervals for calculating average values in the Info mask0 .........0147
13.6 Memory0...................................................................................................... 0147
13.7 Ports0 ............................................................................................................0147
13.8 Miscellaneous0 .......................................................................................... 0148
13.9 Selection of applied standards0............................................................ 0149
14 Table of figures0.................................................................................. 0151
General view and list of accessories 11
1 General view and list of accessories
The general view shows the monitoring system’s most important
components.
SpO
sensor
VitaGuard®
monitor
2
SpO
2
cable
patient
External
power adapter
ECG
ECG
patient cable
electrodes
Fig. 1 General view of the monitoring system
12 General view and list of accessories
The accessories listed in the following can be used together with
VitaGuard® and can be ordered with the specified article numbers
from getemed AG or authorized dealers. Please consult getemed AG
or your authorized dealer for other approved accessories.
Product .............................................................................. Article no. / REF
VitaGuard® VG
3100 Monitor (with Masimo SET®),
complete system ............................................................................ 7311 2012
1 VitaGuard® VG 3100 monitor
1 ECG patient cable, 9 neonatal electrodes
1 PC08 SpO2 patient cable
1 SpO2 LNOP Neo sensor incl. spare adhesive strip
1 NA3000-2 external power adapter
1 rechargeable block battery
1 device bag
1 operating instructions, 1 quick reference
Transport case
NA
3000-2 external power adapter
V–240 V~ / 50–60 Hz) ............................................................ 7344 1101
(110
3000-2 automobile power supply adapter ................... 7344 1201
NAK
Rechargeable block battery ......................................................... 7344 2201
PK1-8P ECG patient cable ............................................................ 7341 1001
Kitty Cat™ neonatal electrodes (PU = 30 pcs) ................................ 70222
Masimo PC08 SpO
patient cable (2.44 m) ..................................... 70257
2
Masimo LNOP® NeoPt SpO
sensor (PU = 20 pcs)
2
(for one patient use only, infants < 1 kg) ......................................... 70250
Masimo LNOP® Neo SpO
sensor (PU = 20 pcs)
2
(for one patient use only, infants < 10 kg) ...................................... 70251
Masimo LNOP® Pdt SpO
sensor (PU = 20 pcs)
2
(for one patient use only, pediatric/ slender finger 10–50 kg) . 70252
General view and list of accessories 13
Masimo LNOP® Adt SpO2 sensor (PU = 20 pcs)
(for one patient use only, adult > 30 kg) .......................................... 70253
Masimo LNOP® DCI reusable sensor (> 30 kg) ............................... 70254
Masimo LNOP® DCIP reusable sensor (10–50 kg) ......................... 70264
Other models are available in addition to the SpO2 sensors listed here.
Operating instructions (English) ................................................ 7381 2021
Alarm chart (English) ..................................................................... 7383 1021
Operating instructions (German) .............................................. 7381 2011
Alarm chart (German) ................................................................... 7383 1011
Operating instructions (Turkish) ................................................ 7381 2081
Alarm chart (Turkish) ..................................................................... 7383 1081
Device bag ........................................................................................ 7345 1001
VitaGuard® transport case (for the complete system) ........ 7391 0001
AUX 01 RS232 cable for connecting VitaGuard®
to a serial PC port ............................................................................ 7341 2002
AUX-02 modem cable for connecting a
modem to VitaGuard® .................................................................. 7341 3001
AUX-03 cable for connecting an external alarm unit
to VitaGuard® ................................................................................ 7341 5001
AUX-04 cable for connecting VitaGuard®
to a nurse call system with 4 kV isolation ............................... 7341 5011
AUX-06 cable for connecting two external signal sources
to VitaGuard® .................................................................................. 7341 6001
14 Intended use
2 Intended use
This section provides information on the intended use of VitaGuard®
and the limitations of this intended use.
CAUTION Do not attempt to use VitaGuard® for detecting obstructive apneas. Obstructive apneas, i.e. respiratory arrest following an
occluded respiratory tract, are not detected by VitaGuard®. Food
debris or vomit, for example, can occlude the respiratory tract.
The doctor treating the patient is responsible for the application of
VitaGuard®. The specific “Information for the doctor and qualified
medical staff” can be found on page 99.
getemed AG recommends qualified training for the caregivers in
potentially necessary resuscitation techniques. Clearing the respiratory tract and the resuscitation of babies and infants require particular know-how that the treating doctor should communicate to the
caregivers.
2.1 Label on the back of the device
The device label serves as a
unique identifier for VitaGuard®.
In addition, the label bears important cautionary information.
On the device label you will
find the manufacturer’s name
and address as well as the
product and model name. The
serial number of your device is
given next to SN.
Fig. 2 Device label on the bottom of the device
Intended use 15
2.2 Symbols and warnings
This symbol warns you that failure to observe these operating instructions can cause death or injury to the patient.
The book symbol means that you must not use the device when you are not familiar with the information contained in these operating instructions.
With this CE label and the CE approval number 0197
getemed AG confirms that VitaGuard® complies with all
the pertinent regulations and in particular the requirements in Annex I of the Medical Devices Directive
93/42/EWG and that this has been approved by a notified body (TÜV Rheinland Product Safety).
This symbol means that the VitaGuard®’s ECG socket is a
type CF (cardio floating) application part and that it is
protected against the effects of defibrillation.
This symbol means that the VitaGuard®’s SpO
a type BF (body floating) application part that is protected against the effects of defibrillation.
The factory symbol shows the year of manufacture.
Note the warnings on the device label.
Do not use in explosive atmospheres!
socket is
2
Use the NA 3000-2 power adapter only!
Warning: Do not connect to an electrical socket controlled by a wall
switch!
Only new alkaline batteries (LR6 or AA) must be used when the
device is powered by non-rechargeable batteries! Note the polarity!
16 Intended use
2.3 Indications
VitaGuard® can be used to monitor patients with, for example, the
following symptoms or treatment:
unstable respiration
oxygen therapy
life-threatening cardiac dysrhythmia
conspicuous sleep laboratory findings
facial and/ or cervical and thoracic dysmorphia
distinct gastro-esophageal reflux
ataxia
2.3.1 SpO2 and pulse rate monitor
The SpO2 and pulse rate monitor with the attached accessories is
suitable for the permanent, non-invasive monitoring of arterial blood
oxygen saturation (SpO
SpO
%SpO
sensor. The functional blood oxygen saturation displayed as
2
is determined exclusively from the measurements of oxygen-
2
ated and deoxygenated hemoglobin.
The SpO
and pulse rate monitor is suitable for adult, pediatric, and
2
infant patients, in mobile or stationary indoor and outdoor applications
, including patients with weak blood flow and those in hospitals
and other institutions.
) and of the pulse rate as measured with the
2
2.3.2 Heart rate and apnea monitor
The heart rate and apnea monitor is suitable for adult, pediatric, and
infant patients at home or in rooms used for medical purposes.
Intended use 17
The apnea monitor is specifically intended for monitoring central
apneas. Successful apnea monitoring requires a stable underground
and a patient that lies quietly without moving.
2.4 VitaGuard® modes of operation
Depending on the risk group and the latest diagnosis, VitaGuard®
allows the treating doctor to combine three monitoring parameters:
SpO
monitoring
2
heart or pulse rate monitoring
apnea monitoring
The doctor can deactivate the apnea monitor in the Respiration
menu, or combine the apnea monitor alarms with the heart rate and
oxygen saturation monitor. In this case, apnea alarms are triggered
only when, after detecting apnea, the device also detects deviations
from particular average values in the monitored heart rate and/ or
the monitored SpO
alarms.
When VitaGuard® is to be used to monitor heart rate and respiration
only, the doctor can deactivate the SpO
In addition to the fixed alarm limits for the heart or pulse rate moni-
. This combination helps to reduce false apnea
2
monitor in the SpO2 menu.
2
tor and the SpO
monitor, the doctor or the qualified medical staff
2
can also configure percentage deviations as alarm conditions.
The doctor or the qualified medical staff can find all other explana-
tions they may need in the following sections:
“Settings in the SpO
menu (Settings protection Off)” on page
2
121,
“Settings in the Heart rate menu (Settings protection Off)” on
page 123,
18 Intended use
“Settings in the Respiration menu (Settings protection Off)” on
page 129,
“Combining apnea alarms with heart rate and SpO
alarms” on
2
page 130,
“Table of operating modes” on page 131.
In the event of electrode allergies it may prove convenient, after
consultation with the treating doctor, to dispense with the electrodes entirely for a time and to operate the device as a pulse oximeter. The display then shows the Pulse rate monitored by the
SpO2 sensor instead of the Heart rate.
2.5 Intended use and performance
The intended use of VitaGuard® is to detect central apneas when the
patient is completely immobile on a stable underground and to
monitor the heart or the pulse rate as well as the oxygen saturation.
VitaGuard® is designed for applications at home and in rooms used
for medical purposes. VitaGuard® has no therapeutic effect.
VitaGuard® emits an acoustic and visual alarm when no respiration or
movement is detected within a set period, when the measured heart
rate and/or oxygen saturation values violate the set alarm limits for a
period also set by the operator, and/or when no heartbeat has been
detected for a set period. The alarm limits can be set within particular
values specified by VitaGuard®.
Respiration and heart rate are monitored with adhesive ECG electrodes and blood oxygen saturation and pulse rate with an SpO
2
sensor suitable to the patient’s age and weight.
VitaGuard® determines the heart rate from the ECG signal detected
by the electrodes and the pulse rate from the signal detected by the
SpO
sensor. The doctor can choose whether the pulse or the heart
2
rate is used for alarm triggering.
Intended use 19
VitaGuard® features an impedance monitor that triggers a technical
alarm when an electrode exhibits impedance values that are not
compatible with proper operation. This is the case, for example, when
an electrode has become detached.
When the signal registered by the SpO
sensor is inadequate for the
2
reliable measurement of values, a message appears on the display.
Physiological data measured for a set period before and after an
alarm are stored and can afterwards be evaluated and documented.
VitaGuard® can be operated with the NA3000-2 power adapter (9 V),
the NAK3000-2 automobile power adapter (e.g. in the cigarette
lighter), four non-rechargeable batteries, or a rechargeable block
battery. Non-rechargeable batteries or the rechargeable block battery
serve above all to safeguard the monitor’s functions during a power
failure and to continue monitoring the heart rate and oxygen saturation when patients are in transit.
2.6 Limitations on VitaGuard®’s intended use
Even when operated in accordance with its intended use, VitaGuard®
cannot detect all life-threatening situations under certain unfavorable conditions.
2.6.1 Obstructive apneas are not detected
Obstructive apneas are not detected by VitaGuard®. The caregiver
may have to remove food debris from the patient’s oral cavity.
When an obstructive apnea at the same time triggers a bradycardia
alarm (heart rate too low) or an oxygen saturation alarm (SpO
too low), resuscitation measures may need to be taken.
value
2
20 Intended use
2.6.2 Limitations of the heart rate and central apnea
monitor
VitaGuard® could misinterpret movements as respiration, e.g. in
ambulances, cars, and prams or when a child is held in the arms. For
this reason central apneas can be detected only when the patient is
sleeping or is lying still, does not move, and is not being moved.
The heart rate can be monitored with electrodes also when the
patient is moving, but sudden, vigorous movements can adversely
affect the measuring accuracy.
A false heart rate is displayed during ventricular fibrillation or when
the heart rate exceeds 270 beats per minute.
2.6.3 Limitations of the SpO2 and pulse rate monitor
The monitoring of SpO2 and pulse rate is adversely affected when the
patient moves vigorously or is vigorously moved.
When the sensor is not attached correctly, ambient light can falsify
measurements. One remedy is to cover the sensor with a dark or
opaque material.
The monitor operates properly only when the SpO
attached.
sensor is correctly
2
Intended use 21
2.7 Information for the doctor on these
operating instructions
In full knowledge of these operating instructions, the treating doctor must decide:
whether the caregivers have to be trained in the performance of
resuscitation measures,
how the caregivers can be best prepared for monitoring and
above all for the measures that must be taken in the event of an
alarm,
which view should be displayed
Information on Settings protection that sets the display modes and
user configurations can be found on page 91.
“Information for the doctor and qualified medical staff” is found on
page 99.
22 Safety
3 Safety
The doctor decides whether the caregivers are able to use VitaGuard® for monitoring and whether they can implement appropriate measures in the event of an alarm.
3.1 Caregivers’ tasks
With “caregivers” we mean those persons who are responsible during
monitoring for the monitored patient’s well-being, for example:
parents or other members of the family,
babysitters, when they too have been thoroughly prepared for the
situation,
nurses and other medically trained staff.
Observe in particular the information in those sections of the operating instructions that, like here, address you directly.
Observe the extensive safety instructions at the beginning of the
section “Preparing for SpO2 monitoring” on page 51.
Observe the extensive safety instructions at the beginning of the
section “Preparing for heart rate and apnea monitoring” on page 61.
VitaGuard® has no therapeutic effect. You may have to implement
resuscitation measures in the event of an alarm.
The potential applications of VitaGuard® for high-risk patients are
so many and diverse that we are unable to give any specific instructions on procedure in the event of an alarm. It is the doctor’s task to
inform high-risk patients and their caregivers in detail on the correct
procedure in this case.
An alarm chart is available from getemed AG when monitoring
children. This alarm chart presents a sequence of activities that are
considered suitable by many medical specialists and pediatricians.
Safety 23
Do not attempt to use VitaGuard® on more than one patient at a
time.
Never modify settings without consulting the responsible doctor.
Only the doctor knows the correct alarm limits and monitor configuration for each patient.
Never leave the patient’s room without first making sure that the
LEDs for heart and respiration are flashing.
Make absolutely sure that you can react to an alarm within a few
seconds. Move away from patients only so far that you can reach
them within ten seconds.
When you are not sure that VitaGuard® is in perfect operating order,
check the patient’s vital functions. Under no circumstances should
you use VitaGuard® when you suspect a device defect.
In the event of ANY suspected VitaGuard® malfunction, continue to
observe the patient until you can use a replacement monitor, or
VitaGuard® has been examined by the doctor or authorized dealer.
Stop using VitaGuard® after the servicing interval of eighteen
months has expired. Before the end of this period, make an appointment with your authorized dealer to check the safety and
operability of your device.
Test the acoustic alarm unit every time you switch on VitaGuard®.
This is explained in the section “Alarm test” on page 69.
CAUTION! When attaching the electrodes make sure that the plugs
do not touch any other electrically conducting parts. Make sure that
there can also be no contact with other electrically conducting parts
when the electrodes become detached during monitoring.
Treat all leads and connections with particular care, and never use
the connecting cables to lift VitaGuard®.
Switch off VitaGuard® before boarding an aircraft. When you want
to transport VitaGuard® in your luggage, you should remove the
batteries. This prevents other pieces of luggage from switching on
24 Safety
the device by accident. An activated, but disconnected VitaGuard®
will generate acoustic alarm signals.
3.2 Allergy risks to patients
Attach ECG electrodes and SpO
So that the permanent contact with the electrodes does not put too
much of a strain on the patient’s skin, the electrodes can be placed
in the vicinity of the optimal site.
All materials that are used with VitaGuard® and can come into
contact with patient or caregivers during normal operations are free
of latex and are non-toxic in accordance with the standard ISO
10993-1.
getemed AG recommends replacing the adhesive electrodes used to
monitor heart rate and apnea as soon as they start to lose their
adherence. The special gel for the electrodes has been developed to
avoid skin irritation, even after several months’ monitoring on newborns.
sensors to intact areas of skin only.
2
Nevertheless, patients with sensitive skin may suffer allergic reactions in the form of reddened skin and blistering that in serious cases
may look like burns. When the skin exhibits such changes, you must
immediately inform the doctor. A change of electrode type may help.
The use of SpO
when the patient develops an allergy to adhesive tape or similar.
sensors with adhesive materials may cause problems
2
3.3 Possible external interference to monitoring
Please bear in mind the possibility of other risks that are not listed
here that can be caused by your specific monitoring environment.
Safety 25
3.3.1 Installation and environment
We recommend hanging VitaGuard® in the delivered bag at a place
where the display can be easily viewed.
Check, as described in the section “Alarm test” on page 69, that you
can hear alarms and where you can hear them. Think also of the
activities that cause noises, for example showering or vacuuming.
Think before you raise the volume of your television or stereo. Also,
the VitaGuard®’s alarm outlet should not be obstructed by any
objects that absorb sound.
Never place VitaGuard® or the power adapter such that they could
fall on the patient. For example, the power adapter could become
detached from an overhead socket when the cable is pulled.
Do not immerse either VitaGuard® or the accessories in liquids.
Variations in temperature and air humidity could lead to condensation
forming in and on VitaGuard®. Wait for at least two hours after VitaGuard® has visibly dried on the outside before using it for monitoring.
Do not operate VitaGuard® in environments containing explosive
gases, flammable substances, nitrous gases, or highly oxygen-enriched atmospheres. Do not use VitaGuard® at extreme temperatures
below 5 °C or above 40 °C. Do not place VitaGuard® near heat sources
such as radiators, ovens, etc. Do not expose it to direct sunlight.
Always lay all cables and in particular any extension cables so that
nobody can trip over them.
Do not place VitaGuard® directly next to the patient’s head: risk of
hearing damage!
3.3.2 Noise risks to monitoring
When the alarm cannot be set to a volume that is sufficiently above
the prevailing ambient noise levels, you must keep VitaGuard® and
26 Safety
its display within view. The visual signals from the alarm LED and
display must then be relied upon to recognize critical situations.
You can also use the external alarm unit available from getemed AG
that raises the volume of the alarm signals from VitaGuard®.
Information on the alarm signal types and volumes can be found in
“Alarms, displays, and views during monitoring” on page 69. The
alarm pitch is set as explained in the section “System menu – general
settings” on page 89.
3.3.3 Electrostatic interference
Electrostatic build-up that, for example, a person can pick up on
certain carpets must not discharge through the VitaGuard® connector sockets or the electrodes’ electrically conducting parts.
For this reason, avoid touching the electrically conducting parts, or
discharge any electrostatic build-up beforehand by, for example,
touching an earthed water pipe or heater.
3.3.4 Electromagnetic interference
VitaGuard® is not designed for applications near strong electromagnetic fields. These interference fields are frequently emitted by
devices with large electric power consumptions. Keep a good distance from e.g. washing machines, computers, microwaves, vacuum
cleaners, power tools, etc.
The device and the system can be used in the home and in all other
environments that public utilities supply directly.
Bear in mind that portable and mobile HF communication devices,
e.g. cellular phones, radio equipment, walkie-talkies, etc., can interfere with the monitor and influence its operability.
Bear in mind that non-approved accessories can amplify emitted
interference and reduce the device’s immunity.
Safety 27
Do not place the monitor directly next to other electrical equipment,
and do not stack monitors on top of each other.
When the monitor has to be placed next to or on other equipment,
check that the monitor operates as designed in this environment.
We recommend you to check at regular intervals:
– that the displayed signals are not disrupted when the patient is
not moving,
– whether the same technical alarm messages are repeatedly dis played.
When you discover disruptions:
– if possible, switch off the interfering equipment or move this
equipment to another site.
VitaGuard® uses high-frequency signals exclusively for its internal
functions. As a result, its emitted interference is very low, and disruption to neighboring electronic equipment is unlikely.
False diagnoses are possible when monitored values are corrupted
by interference from electric or electromagnetic fields and this
escapes the doctor’s attention. Every time you analyze stored data,
consider the possibility of interference from electric or electromagnetic fields.
VitaGuard®’s emitted interference and immunity to external interference are within the limits for life-supporting systems stipulated in the
standard EN 60601-1-2.
3.4 Safety with approved accessories only
Use VitaGuard® only with the delivered or approved accessories and
in accordance with the information contained in these and the
accessories’ operating instructions.
Electrodes, SpO
sensors, cables, and power adapters can be ordered
2
from your authorized dealer or directly from getemed AG. The telephone number of your authorized dealer was given to you during
28 Safety
your training on how to operate the device, or it is found on a label
your authorized dealer has attached to VitaGuard®.
Bear in mind that monitoring can continue without interruption
only as long as the required consumables are available. In emergencies of this nature you can call your authorized dealer, who provides
24-hour emergency services. Please try, however, to avoid unnecessary stress for both yourself and your authorized dealer, and order
your consumables in good time.
The modem used to transfer monitoring data must comply with the
requirements under the German and European standard DIN EN
60950 “Safety of IT Equipment” with the amendments A1–A4. These
details are found in the modem’s operating instructions.
3.5 Handling patient cables
Always lay patient cables at a good distance from the patient’s head
and neck. Lay each patient cable inside the clothing, and secure it in
place in such a way that no harm can come to the patient or cable
(strangulation, twisting).
Make sure when laying and securing patient cables that these cannot kink (kinking causes damage).
For hygiene reasons, always use the same patient cable on the one
patient. Disinfect patient cables before using them on a new patient.
When more than one monitor is used in the one environment, each
monitor should always be connected to the same patient cables and
the same power adapter. Faults can therefore be located and remedied faster.
Safety 29
3.6 Power supply reliability
Before first using VitaGuard® for monitoring, familiarize yourself
with the section “Power supply” on page 36. Monitoring is safeguarded only when the power supply is in perfect operating order.
CAUTION: Danger of electric shock! Never open the external power
adapter or the connecting cable.
Exclusively the NA 3000-2 approved for VitaGuard® must be used as
the external power adapter.
VitaGuard® is usually delivered with the external power adapter for
European supply networks. For other supply networks, use only the
plug adapters available from getemed AG.
Do not use the external power adapter in sockets that can be
switched off or dimmed.
When the VitaGuard® external power adapter is plugged into a
multiple socket outlet, only the modem may be connected to this
outlet simultaneously.
When an extension cable is used with a multiple socket outlet, this
outlet must not lie on the floor. Otherwise water may penetrate the
outlet and damage the monitor.
The external power adapter and the power outlet must be free of
damage.
Never use the external power adapter’s cable to lift VitaGuard®.
Stop using the external power adapter when it has fallen or been
dropped.
Do not operate the external power adapter in a damp environment
(e.g. in the bathroom).
Always leave the batteries in VitaGuard®, even when this is oper-
ated through the external power adapter.
30 Safety
VitaGuard® operates with batteries: either non-rechargeable batteries or a rechargeable block battery. VitaGuard® must be operated
only with the rechargeable block battery available from getemed AG
or new alkaline non-rechargeable 1.5 V batteries (LR6 or AA), e.g.
VARTA UNIVERSAL ALKALINE. Bear in mind that cheaper nonalkaline non-rechargeable batteries can have a considerably reduced
operating lifetime, in some cases only 10–15% of the brand name
batteries we recommend.
Do not under any circumstances use single rechargeable batteries
available on the market.
Never use a non-rechargeable battery and a rechargeable battery
together in the device, and never mix old and new batteries.
To prevent leaking batteries from damaging health and property,
remove non-rechargeable batteries from VitaGuard® when it is not
used for longer than a week. Information on “Replacing batteries”
can be found on page 38.
3.6.1 Battery voltage indicator
When VitaGuard® is powered only by non-rechargeable batteries,
check the battery voltage indicator on the
display every hour. At least one quarter of
the battery symbol must be black.
Fig. 3 Battery voltage indicator
When VitaGuard® is powered from the supply network and commercially available non-rechargeable batteries are inserted, check
the battery voltage indicator on the display every day. Even when
the device is powered from the supply network, you must replace
the non-rechargeable batteries as soon as one quarter of the battery
symbol on the display is black.
If necessary, a display message will prompt you to insert new nonrechargeable batteries or to recharge the block battery.
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