GeTeMed VG 310 User Manual
VitaGuard® VG 310
Pulse oximeter
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 SpO2 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 .............................................................................. 14
2.3 Indications .................................................................................................... 16
2.4 Intended use and performance .............................................................. 16
2.5 Limitations on VitaGuard®’s intended use ......................................... 17
2.6 Information for the doctor on these operating instructions ......... 17
3 Safety .......................................................................................................... 18
3.1 Caregivers’ tasks ......................................................................................... 18
3.2 Allergy risks to patients ............................................................................ 19
3.3 Possible external interference to monitoring .................................... 20
3.3.1 Installation and environment ................................................ 20
3.3.2 Noise risks to monitoring ........................................................ 21
3.3.3 Electrostatic interference ........................................................ 21
3.3.4 Electromagnetic interference ................................................. 21
3.4 Safety with approved accessories only ................................................ 23
3.5 Handling patient cables ........................................................................... 23
3.6 Power supply reliability ............................................................................ 24
3.6.1 Battery voltage indicator ......................................................... 25
3.6.2 Interruptions to the power supply ........................................ 26
3.6.3 Using the rechargeable block battery .................................. 26
3.7 Safety with proper maintenance only .................................................. 27
3.7.1 Cleaning VitaGuard® and accessories ................................. 27
3.7.2 Checking and cleaning the battery terminals ................... 28
3.8 Disposing of non-rechargeable batteries, the device, and
accessories .................................................................................................... 29
4 Description .............................................................................................. 30
4.1 Power supply ................................................................................................ 31
4.1.1 Power failure with inserted batteries .................................. 32
4.1.2 Power failure without batteries ............................................ 32
4.1.3 Replacing batteries .................................................................... 33
4.1.4 Using the automobile power supply adapter .................... 34
Table of contents
4.2 VitaGuard® connections .......................................................................... 35
4.2.1 Patient cable for SpO2 sensors ............................................... 35
4.2.2 Power adapter ............................................................................. 36
4.2.3 Sound outlet (no socket) .......................................................... 36
4.2.4 USB port ........................................................................................ 37
4.2.5 AUX port ....................................................................................... 37
4.3 Membrane key panel ................................................................................ 38
4.3.1 Direction keys .............................................................................. 39
4.3.2 <Enter> key ................................................................................... 39
4.3.3 <Esc> key ....................................................................................... 39
4.4 Color LEDs (Light Emitting Diodes) ....................................................... 40
4.4.1 Alarm LED ..................................................................................... 40
4.4.2 Heart LED ...................................................................................... 40
4.4.3 Power supply and battery LEDs ............................................. 41
4.5 The display ................................................................................................... 41
5 Steps before and after monitoring ......................................... 43
5.1 Summary of steps before monitoring .................................................. 43
5.2 Switching on ................................................................................................ 43
5.3 Switching off ............................................................................................... 44
5.4 Summary of steps after monitoring ..................................................... 45
6 Preparing for SpO2 monitoring ................................................. 46
6.1 Safety instructions for SpO2 monitoring ............................................. 46
6.2 Operation of SpO2 sensors ...................................................................... 47
6.3 SpO2 sensor adapted to the patient’s size and weight ................... 48
6.4 Choosing the sensor site .......................................................................... 48
6.5 Repositioning or replacing the sensor ................................................. 49
6.6 Reasons for unconvincing SpO2 values ................................................ 49
6.7 Why the pulse rate is not displayed ..................................................... 50
6.8 Attaching the SpO2 sensor to an infant’s foot .................................. 50
6.9 Attaching the SpO2 sensor to an adult’s finger ................................ 51
6.10 Connecting the SpO2 sensor and patient cable ................................ 53
6.11 Connecting the SpO2 patient cable to VitaGuard® .......................... 53
6.12 Disconnecting the SpO2 sensor from the patient cable ................. 54
6.13 Disconnecting the SpO2 patient cable from VitaGuard® ............... 54
6.14 Reusing and refastening SpO2 sensors ................................................ 54
Table of contents
7 Alarms, displays, and views during monitoring ............ 56
7.1 Alarm test ..................................................................................................... 56
7.2 Pulse rate values based on age groups .............................................. 56
7.3 Alarm message priorities in the status line ........................................ 57
7.4 Physiological and technical alarms ....................................................... 57
7.5 Differentiating physiological and technical alarm signals ............ 58
7.6 Acoustic information signals .................................................................. 58
7.6.1 Information signals from the alarm unit next
to the display ............................................................................... 59
7.6.2 Information signals from the sound aperture
between the sockets ................................................................. 59
7.7 The visual alarm signals ........................................................................... 59
7.8 Status line displays .................................................................................... 59
7.9 SpO2 monitor alarms ................................................................................ 60
7.9.1 Physiological SpO2 alarms ....................................................... 60
7.9.2 Technical SpO2 alarms .............................................................. 61
7.10 Pulse rate alarms ........................................................................................ 61
7.11 Alarm messages – meanings and other information ...................... 62
7.11.1 Order of equal-priority alarm conditions ............................ 62
7.11.2 Table of physiological alarm messages ............................... 62
7.11.3 Table of technical alarm messages ....................................... 64
7.12 Table of information messages .............................................................. 66
8 Alarm and monitor settings ........................................................ 67
8.1 Safety instructions for the alarm settings .......................................... 67
8.2 Summary of views and menus ............................................................... 68
8.3 Additional views ......................................................................................... 68
8.3.1 View 2 – Large data presentation and waveforms .......... 69
8.4 Changing the settings ............................................................................... 69
8.5 System menu – general settings ............................................................ 70
8.5.1 \ Screen saver (Off/ On) ......................................................... 71
8.5.2 \LCD brightness ....................................................................... 71
8.5.3 \LCD contrast ........................................................................... 71
8.5.4 \ Signal beep tone ..................................................................... 71
8.5.5 \ Alarm tone pitch .................................................................... 72
8.5.6 \RS232 format ........................................................................... 72
Table of contents
8.5.7 \ Settings protection On, Limited, Off ............................. 72
8.6 SpO2 display and menu ............................................................................ 73
8.6.1 SpO2 view ..................................................................................... 74
8.6.2 SpO2 menu – alarm settings (Settings
protection Limited) .................................................................. 75
8.7 Pulse rate display and menu ................................................................. 76
8.7.1 Pulse rate display ...................................................................... 76
8.7.2 Pulse rate menu – alarm settings (Settings
protection Limited) .................................................................. 76
9 Information for the doctor and qualified
medical staff
9.1 Safety instructions ..................................................................................... 78
9.1.1 Preparing for a new patient .................................................... 78
9.1.2 Connections to the USB and AUX ports .............................. 79
9.1.3 VitaGuard® and other medical devices ............................... 80
9.1.4 Safety instructions for the doctor – SpO2 monitor .......... 81
9.2 Info display .................................................................................................. 81
9.2.1 \ Last status messages ............................................................ 82
.......................................................................................... 78
9.2.2 \ General ...................................................................................... 82
9.2.3 \ Measurements: SpO2 ............................................................ 83
9.2.4 \ Measurements: Pulse rate ................................................. 84
9.2.5 \ Settings: Oximeter ................................................................ 84
9.2.6 \ Settings: Pulse rate .............................................................. 85
9.2.7 \ Memory/ Internet ................................................................. 85
9.2.8 \Versions .................................................................................... 85
9.3 Settings in the System menu (Settings protection Off) .............. 86
9.3.1 Changing multiple-component settings ............................ 86
9.3.2 \Operating area: Home or Clinic ......................................... 87
9.3.3 \Admit new patient – restoring factory settings ........... 87
9.3.4 \Pre- and Post-alarm time .................................................... 89
9.3.5 \ Alarm mute time .................................................................... 89
9.3.6 \Date/time ................................................................................. 90
9.3.7 \ Language .................................................................................. 90
9.3.8 \Analog input 1 + 2 ................................................................ 90
9.3.9 \ Interval recording ............................................................... 90
Table of contents
9.4 Data storage functions ............................................................................. 90
9.5 Event storage .............................................................................................. 91
9.5.1 Silent alarm limits ................................................................... 93
9.5.2 Manual data storage or Transmit data .......................... 93
9.5.3 Summary of stored Events ...................................................... 94
9.6 Trend storage .............................................................................................. 95
9.7 Long term storage over eight hours .................................................... 95
9.8 Protocol storage of operating and device data ............................... 95
9.9 Summary of stored signals and data .................................................... 96
9.10 Settings in the SpO2 menu (Settings protection Off) ................... 97
9.11 Settings in the Pulse rate menu (Settings protection Off) ....... 99
10 Algorithms and measuring principles ..................................102
10.1 Alarm condition and report delays ........................................................102
10.2 Alarm report delays ....................................................................................102
10.3 Measuring principle for the SpO2 monitor .........................................103
11 Evaluating stored data on a PC .................................................107
12 Specifications ........................................................................................109
12.1 General ..........................................................................................................109
12.2 SpO2 and pulse rate monitor ..................................................................111
12.3 Intervals for calculating average values in the Info mask .............112
12.4 Memory .........................................................................................................112
12.5 Ports ................................................................................................................113
12.6 Miscellaneous ..............................................................................................113
12.7 Selection of applied standards ...............................................................114
13 Table of figures .....................................................................................115
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.
SpO
2
sensor
SpO
2
cable
patient
VitaGuard®
monitor
External
power adapter
Fig. 1 General view of the monitoring system
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.
12 General view and list of accessories
Product ........................................................................................ Article no. / REF
VitaGuard® VG 310 Monitor (with Masimo SET®),
complete system ............................................................................... 7311 3022
1 VitaGuard® VG 310 monitor
1 SpO2 patient cable PC08
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
(110 V–240 V~ / 50–60 Hz) ............................................................... 7344 1101
NAK 3000-2 automobile power supply adapter .................... 7344 1201
Rechargeable block battery ........................................................... 7344 2201
Masimo SpO2 patient cable PC08 (2.44 m) ...................................... 70257
Masimo LNOP® NeoPt SpO2 sensor (PU = 20 pcs)
(for one patient use only, infants < 1 kg) .......................................... 70250
Masimo LNOP® Neo SpO2 sensor (PU = 20 pcs)
(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
Masimo LNOP® Adt SpO
sensor (PU = 20 pcs)
2
(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.
General view and list of accessories 13
Operating instructions (English) ................................................ 7381 3021
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
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.
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 78.
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
2.2 Symbols and warnings
This symbol warns you that failure to observe these operating instructions can cause death or injury to the patient.
Intended use 15
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 SpO
a type BF (body floating) application part that is protected against the effects of defibrillation.
The factory symbol shows the year of manufacture.
Like every electronic device, VitaGuard® and accessories
contain metal and plastic parts that must be disposed of
in such a way that they do not pollute the environment
after their service live. For this reason, the device and accessories may be sent to getemed AG in an adequately
stamped package, when possible in the original packaging, for free and proper disposal.
Note the warnings on the device label.
socket is
2
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
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 of the pulse rate as measured with the
2
and pulse rate moni-
2
tor is suitable for adult, pediatric, and infant patients, in mobile or
stationary indoor and outdoor applications
, including patients with
weak blood flow and those in hospitals and other institutions.
2.4 Intended use and performance
The intended use of VitaGuard® is to monitor 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 the measured pulse rate and/or oxygen saturation values
violate the set alarm limits for a period set by the operator. The alarm
limits can be set within particular values specified by VitaGuard®.
Blood oxygen saturation and pulse rate are monitored with an SpO
2
sensor suitable to the patient’s age and weight. When the signal
registered by the SpO
sensor is inadequate for the reliable meas-
2
urement 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.
Intended use 17
2.5 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.
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
2.6 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 72.
“Information for the doctor and qualified medical staff” is found on
page 78.
18 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 46.
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.
Never leave the patient’s room without first making sure that the
heart LED is flashing.
Safety 19
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.
Never modify settings without consulting the responsible doctor.
Only the doctor knows the correct alarm limits and monitor configuration for each patient.
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 56.
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.
3.2 Allergy risks to patients
Attach SpO
The use of SpO2 sensors with adhesive materials may cause problems
when the patient develops an allergy to adhesive tape or similar.
sensors to intact areas of skin only.
2
20 Safety
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.
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 56, 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.
Safety 21
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 56. The
alarm pitch is set as explained in the section “System menu – general
settings” on page 70.
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.
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 dis-
22 Safety
tance 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 displayed.
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.
Safety 23
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.
SpO
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.
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
sensors, cables, and power adapters can be ordered from your
2
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.
24 Safety
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 31. 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.
Safety 25
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 operated through the external power adapter.
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 33.
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
26 Safety
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,
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.
Safety 27
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 light will go out for a short time in the interval between battery and compensation charging.
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 SpO2
sensor 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 solu-
AG only. Clarify the neces-
tion, before sending them to getemed AG.
3.7.1 Cleaning VitaGuard® and accessories
Before cleaning VitaGuard®, remove the batteries.
28 Safety
Before cleaning VitaGuard®, detach the 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.
Cleaning the exterior is best done with a non-linting cloth moistened
slightly with water or a mild soap solution.
getemed AG recommends disinfecting the device with Virkon®,
available as a spray or wiping solution.
Patient cables can be cleaned with liquid Cable Care or with a 70%
alcohol solution. Baby oil has proved to be effective in removing
residue from adhesive strips.
The VitaGuard® bag can be washed by hand at 30 C. It must not be
put in the laundry dryer.
3.7.2 Checking and cleaning the battery terminals
Check the battery compartment every month for traces of leaking
and for deposits on the battery terminals indicating leaks. Contact
your authorized dealer and clarify further procedures when a battery starts to leak.
The battery compartment and how to replace the batteries are
explained in the section “Replacing batteries” on page 33.
Safety 29
3.8 Disposing of non-rechargeable batteries, the
device, and accessories
getemed AG takes back all of the parts it delivers. For hygiene reasons
these parts do not extend to consumables like sensors that have been
in direct contact with the patient.
The symbol of the crossed-out waste container on the battery packaging is to remind you that under no circumstances must you dispose of batteries in normal household waste. As the end consumer
you are legally obliged to return used batteries or dispose of them
properly. You can return used batteries to us.
Place consumables like sensors in a plastic bag before disposing of
them in household waste.
Please do not send us any used sensors.
30 Description
4 Description
We recommend placing VitaGuard® in the bag provided. This bag protects the monitor and can be hung from a site where it cannot fall.
Fig. 5 VitaGuard® and bag with power and patient cables
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