GeTeMed VG 2100 User Manual
VitaGuard® VG 2100
Apnea and Heart Rate Monitor
Operating instructions
Who should read which sections in these operating instructions?
The sections 3 to 7 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 heart rate and apnea monitoring
7 Alarms, displays, and views during monitoring
8 Alarm and monitor settings
9 Information for the doctor and qualified medical staff
10 Algorithms and measuring principles
11 Evaluating stored data on a PC
12 Specifications
13 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 accessories ...................................... 11
2 Intended use .......................................................................................... 14
2.1 Label on the back of the device .............................................................. 14
2.2 Symbols and warnings .............................................................................. 15
2.3 Indications .................................................................................................... 16
2.4 VitaGuard® modes of operation ............................................................ 16
2.5 Intended use and performance .............................................................. 17
2.6 Limitations on VitaGuard®’s intended use ......................................... 18
2.6.1 Obstructive apneas are not detected ................................... 18
2.6.2 Limitations of the heart rate and central apnea
monitor ......................................................................................... 18
2.7 Information for the doctor on these operating instructions ......... 19
3 Safety .......................................................................................................... 20
3.1 Caregivers’ tasks ......................................................................................... 20
3.2 Allergy risks to patients ............................................................................ 22
3.3 Possible external interference to monitoring .................................... 22
3.3.1 Installation and environment ................................................ 22
3.3.2 Noise risks to monitoring ........................................................ 23
3.3.3 Electrostatic interference ........................................................ 24
3.3.4 Electromagnetic interference ................................................. 24
3.4 Safety with approved accessories only ................................................ 25
3.5 Handling patient cables ........................................................................... 26
3.6 Power supply reliability ............................................................................ 26
3.6.1 Battery voltage indicator ......................................................... 28
3.6.2 Interruptions to the power supply ........................................ 28
3.6.3 Using the rechargeable block battery .................................. 29
3.7 Safety with proper maintenance only .................................................. 30
3.7.1 Cleaning VitaGuard® and accessories ................................. 30
3.7.2 Checking and cleaning the battery terminals ................... 31
3.8 Disposing of non-rechargeable batteries, the device, and
accessories .................................................................................................... 31
Table of contents
4 Description .............................................................................................. 33
4.1 Power supply ............................................................................................... 34
4.1.1 Power failure with inserted batteries .................................. 35
4.1.2 Power failure without batteries ............................................ 35
4.1.3 Replacing batteries .................................................................... 36
4.1.4 Using the automobile power supply adapter ................... 37
4.2 VitaGuard® connections .......................................................................... 38
4.2.1 Patient cable for electrodes .................................................... 38
4.2.2 Power adapter ............................................................................. 39
4.2.3 Sound outlet (no socket) .......................................................... 39
4.2.4 USB port ........................................................................................ 40
4.2.5 AUX port ....................................................................................... 40
4.3 Membrane key panel ................................................................................ 41
4.3.1 Direction keys .............................................................................. 42
4.3.2 <Enter> key ................................................................................... 42
4.3.3 <Esc> key ....................................................................................... 42
4.4 Color LEDs (Light Emitting Diodes) ....................................................... 43
4.4.1 Alarm LED ..................................................................................... 43
4.4.2 Heart and respiration LEDs ..................................................... 43
4.4.3 Power supply and battery LEDs ............................................. 44
4.5 The display ................................................................................................... 44
5 Steps before and after monitoring ......................................... 46
5.1 Summary of steps before monitoring .................................................. 46
5.2 Switching on ................................................................................................ 47
5.3 Switching off ............................................................................................... 48
5.4 Summary of steps after monitoring ..................................................... 48
6 Preparing for heart rate and apnea monitoring ........... 49
6.1 Safety information when monitoring heart rate and apnea ........ 49
6.2 Connecting electrodes, the patient cable, and VitaGuard® .......... 52
6.3 Technical alarm from the electrode contact monitor ..................... 52
6.4 Determining the optimal electrode configuration .......................... 53
6.4.1 ECG lead, electrode color coding ........................................... 53
6.4.2 Optimizing the heart and respiration signals –
signal amplitudes in View 1 ................................................... 54
Table of contents
6.5 Checking the basal impedance .............................................................. 55
7 Alarms, displays, and views during monitoring ............ 57
7.1 Alarm test ..................................................................................................... 57
7.2 Heart rate values based on age groups .............................................. 57
7.3 Alarm message priorities in the status line ........................................ 58
7.4 Physiological and technical alarms ....................................................... 58
7.5 Differentiating physiological and technical alarm signals ............ 59
7.6 Acoustic information signals .................................................................. 60
7.6.1 Information signals from the alarm unit next to the
display ............................................................................................ 60
7.6.2 Information signals from the sound aperture
between the sockets ................................................................. 60
7.7 The visual alarm signals ........................................................................... 60
7.8 Status line displays .................................................................................... 60
7.9 Heart rate and apnea monitoring ......................................................... 62
7.9.1 Heart rate alarms ....................................................................... 62
7.9.2 Apnea alarms ............................................................................... 62
7.9.3 Technical heart rate and apnea alarms ............................... 63
7.10 Alarm messages – meanings and other information ...................... 63
7.10.1 Order of equal-priority alarm conditions ............................ 63
7.10.2 Table of physiological alarm messages ............................... 63
7.10.3 Table of technical alarm messages ....................................... 65
7.11 Table of information messages .............................................................. 67
8 Alarm and monitor settings ........................................................ 68
8.1 Safety instructions for the alarm settings .......................................... 68
8.2 Summary of views and menus ............................................................... 69
8.3 Additional views ......................................................................................... 69
8.3.1 View 2 – Large data presentation and waveforms .......... 70
8.3.2 View 3 – Smaller data presentation and waveforms ...... 70
8.4 Changing the settings ............................................................................... 70
8.5 System menu – general settings ............................................................ 72
8.5.1 \ Screen saver (Off/ On) ......................................................... 72
8.5.2 \LCD brightness ....................................................................... 72
8.5.3 \LCD contrast ........................................................................... 72
8.5.4 \ Signal beep tone ..................................................................... 73
Table of contents
8.5.5 \ Alarm tone pitch ................................................................... 73
8.5.6 \RS232 format ........................................................................... 73
8.5.7 \ Settings protection On, Limited, Off ............................. 74
8.6 Heart rate display and menu ................................................................ 75
8.6.1 Heart rate display ..................................................................... 75
8.6.2 Heart rate menu – alarm settings (Settings
protection Limited) .................................................................. 75
8.7 Respiration display and menu .............................................................. 77
8.7.1 Respiration display ................................................................... 77
8.7.2 Respiration menu – alarm settings (Settings
protection Limited) .................................................................. 78
9 Information for the doctor and qualified medical staff ..... 79
9.1 Safety instructions ..................................................................................... 79
9.1.1 Preparing for a new patient .................................................... 79
9.1.2 Connections to the USB and AUX ports .............................. 81
9.1.3 VitaGuard® and other medical devices ............................... 81
9.2 Info display .................................................................................................. 82
9.2.1 \ Last status messages ............................................................ 82
9.2.2 \ General ...................................................................................... 83
9.2.3 \ Measurements: HR & Resp. .................................................. 84
9.2.4 \ Settings: Heart rate .............................................................. 85
9.2.5 \ Settings: Apnea monitor .................................................... 85
9.2.6 \ Memory/ Internet ................................................................. 86
9.2.7 \Versions .................................................................................... 86
9.3 Settings in the System menu (Settings protection Off) .............. 87
9.3.1 Changing multiple-component settings ............................ 87
9.3.2 \ Operating area: Home or Clinic ........................................ 88
9.3.3 \Admit new patient – restoring factory settings ........... 88
9.3.4 \Pre- and Post-alarm time .................................................... 90
9.3.5 \ Alarm mute time .................................................................... 90
9.3.6 \Date/time ................................................................................. 90
9.3.7 \ Language .................................................................................. 91
9.3.8 \Analog input 1 + 2 ................................................................ 91
9.3.9 \ Interval recording ............................................................... 91
9.4 Data storage functions ............................................................................. 91
Table of contents
9.5 Event storage .............................................................................................. 92
9.5.1 Silent alarm limits ................................................................... 94
9.5.2 Manual data storage or Transmit data .......................... 94
9.5.3 Summary of stored Events ...................................................... 95
9.6 Trend storage .............................................................................................. 96
9.7 Long term storage over eight hours .................................................... 96
9.8 Protocol storage of operating and device data ............................. 96
9.9 Summary of stored signals and data .................................................... 97
9.10 Settings in the Heart rate menu (Settings protection Off) ....... 98
9.11 Changing the ECG lead for signal optimization ...................................101
9.12 Settings in the Respiration menu (Settings protection Off) .....103
10 Algorithms and measuring principles ..................................105
10.1 Alarm condition and report delays ........................................................105
10.1.1 Alarm condition delay for the heart rate ............................105
10.1.3 Alarm condition delay for respiration ..................................106
10.1.4 Alarm report delays ...................................................................106
10.2 Measuring principle for the heart rate monitor ...................................107
10.3 Measuring principle for the apnea monitor .......................................108
11 Evaluating stored data on a PC .................................................110
12 Specifications ........................................................................................112
12.1 General ..........................................................................................................112
12.2 Heart rate monitor .....................................................................................114
12.3 Apnea monitor ............................................................................................114
12.4 Intervals for calculating average values in the Info mask .............115
12.5 Memory .........................................................................................................115
12.6 Ports ................................................................................................................115
12.7 Miscellaneous ..............................................................................................116
12.8 Selection of applied standards ...............................................................117
13 Table of figures .....................................................................................119
Table of contents
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.
External
power adapter
ECG
patient cable
ECG
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
2100 Monitor
complete system ............................................................................ 7311 1022
1 VitaGuard® VG 2100 monitor
1 ECG patient cable, 9 neonatal electrodes
1 NA3000-2 external power adapter
1 rechargeable block battery
1 device bag
1 operating instructions, 1 quick reference
Transport case
3000-2 external power adapter
NA
(110
V–240 V~ / 50–60 Hz) ............................................................ 7344 1101
NAK
3000-2 automobile power supply adapter ................... 7344 1201
Rechargeable block battery ......................................................... 7344 2201
PK1-8P ECG patient cable ............................................................ 7341 1001
Kitty Cat™ neonatal electrodes (PU = 30 pcs) ................................ 70222
Operating instructions (English) ................................................ 7381 1021
Alarm chart (English) ..................................................................... 7383 1021
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
General view and list of accessories 13
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 79.
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.
The factory symbol shows the year of manufacture.
Note the warnings on the device label.
Do not use in explosive atmospheres!
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
life-threatening cardiac dysrhythmia
conspicuous sleep laboratory findings
facial and/ or cervical and thoracic dysmorphia
distinct gastro-esophageal reflux
ataxia
The heart rate and apnea monitor is suitable for adult, pediatric, and
infant patients at home or in rooms used for medical purposes.
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 two monitoring parameters:
heart rate monitoring
apnea monitoring
The doctor can deactivate the apnea monitor in the Respiration
menu.
In addition to the fixed alarm limits for the heart rate monitor, the
doctor or the qualified medical staff can also configure percentage
deviations as alarm conditions.
The doctor or the qualified medical staff can find all other explanations they may need in the following sections:
Intended use 17
“Settings in the Heart rate menu (Settings protection Off)” on
page 98,
“Settings in the Respiration menu (Settings protection Off)” on
page 103,
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. 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 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. VitaGuard® determines the heart rate from the ECG signal
detected by the electrodes.
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.
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 when patients are in transit.
18 Intended use
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), resuscitation measures may need to be
taken.
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.
Intended use 19
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 73.
“Information for the doctor and qualified medical staff” is found on
page 79.
20 Safety
3 Safety
The responsible 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 heart rate and apnea monitoring” on page 49.
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.
Do not attempt to use VitaGuard® on more than one patient at a
time.
Safety 21
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 57.
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
the device by accident. An activated, but disconnected VitaGuard®
will generate acoustic alarm signals.
22 Safety
3.2 Allergy risks to patients
Attach ECG electrodes to intact areas of skin only.
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.
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.
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.
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 57, 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,
Safety 23
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
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 57. The
alarm pitch is set as explained in the section “System menu – general
settings” on page 72.
24 Safety
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.
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.
Safety 25
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, cables, and power adapters can be ordered from your
authorized dealer or directly from getemed AG. The telephone number of your authorized dealer was given to you during 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.
26 Safety
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.
3.6 Power supply reliability
Before first using VitaGuard® for monitoring, familiarize yourself
with the section “Power supply” on page 34. 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.
Safety 27
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.
VitaGuard® operates with batteries: either non-rechargeable batter-
ies 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.
28 Safety
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 36.
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.
3.6.2 Interruptions to the power supply
When the external power adapter is connected VitaGuard® operates
automatically in supply network mode. When the supply network
fails, VitaGuard® switches automatically to battery mode – when
batteries are inserted.
As long as VitaGuard® is powered from the external power adapter or
the automobile power supply, the green LED next to the power
adapter symbol lights up.
Normal voltage fluctuations in the supply network do not adversely
affect monitoring with VitaGuard®. Following a power supply failure,
Safety 29
the current alarm settings are retained for at least thirty days and are
again available when the device is switched back on.
3.6.3 Using the rechargeable block battery
Note the warnings on the rechargeable block battery’s label.
Do not open or short-circuit!
Do not throw into a fire!
Avoid temperatures over 50 °C!
The charging time for the block battery is
at most six hours.
Fig. 4 Rechargeable block battery
Also note the recycling symbol on the label. This means
that the block battery must be recycled when its service life
has expired.
Do not expose the block battery to direct sunlight. For example,
temperatures greater than 50 °C can easily occur on a vehicle’s
dashboard or rear shelf.
When you intend to use VitaGuard® powered from the rechargeable
battery block and disconnected from the supply network, you must
first make sure that the block battery is fully charged. For this reason, check the “Battery charging” LED. The battery is
being charged as long as this LED light is continuously
on. When the LED flashes every second, the battery is
full and compensation charging is activated.
Sometimes the LED will go out for a short time in the interval between battery and compensation charging.
30 Safety
3.7 Safety with proper maintenance only
VitaGuard® can operate safely and reliably over the long term only
when it is subject to proper maintenance and use.
Check visually for any damage on VitaGuard®, the patient cables
including the connections, the external power adapter, and the
electrodes every time you use VitaGuard® for monitoring.
Every eighteen months at the latest VitaGuard® and accessories
must be serviced by getemed AG to comply with safety regulations.
Repairs must be performed by getemed
sary procedure with your authorized dealer.
For the protection of our service personnel, disinfect VitaGuard® and
the patient cables with Virkon®, available as a spray or wiping solution, before sending them to getemed AG.
AG only. Clarify the neces-
3.7.1 Cleaning VitaGuard® and accessories
Before cleaning VitaGuard®, remove the batteries.
Before cleaning VitaGuard®, detach the electrodes and cables from
the monitor and from the patient.
Do not under any circumstances use solvents like ether, acetone, or
benzene. These substances can cause malfunctions and attack the
housing plastic.
Also, do not use any cleaning agents containing abrasive substances
and no coarse brushes or hard objects.
VitaGuard® and accessories can be cleaned any number of times
when the recommended cleaning agents are used.
VitaGuard® and accessories must not be sterilized.
VitaGuard® and the cable plugs must not be immersed or otherwise
penetrated by liquid.
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