GeTeMed VG 3100 User Manual

VitaGuard® VG 3100

Apnea, heart, and SpO2 monitor

Operating instructions

Who should read which sections in these oper-

ating 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

2Intended use

3Safety

4Description

5 Steps before and after monitoring

6Preparing for SpO2 monitoring

7 Preparing for heart rate and apnea monitoring

8 Alarms, displays, and views during monitoring

9Alarm and monitor settings

10Information for the doctor and qualified medical staff

11Algorithms and measuring principles

12Evaluating stored data on a PC

13Specifications

14Table 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
	2.3.1 SpO2 and pulse rate monitor ...............................................		16
	2.3.2 Heart rate and apnea monitor ............................................		16
2.4	VitaGuard® modes of operation .........................................................		17
2.5	Intended use and performance ...........................................................		18
2.6	Limitations on VitaGuard®’s intended use ......................................		19
	2.6.1 Obstructive apneas are not detected ................................		19
	2.6.2	Limitations of the heart rate and central apnea monitor ...	20
2.7	2.6.3 Limitations of the SpO2 and pulse rate monitor ............		20
	Information for the doctor on these operating instructions .....		21
3	Safety	..........................................................................................	22
3.1	Caregivers’ tasks ......................................................................................		22
3.2	Allergy risks to patients .........................................................................		24
3.3	Possible external interference to monitoring .................................		24
	3.3.1	Installation and environment .............................................	25
	3.3.2 Noise risks to monitoring .....................................................		25
	3.3.3	Electrostatic interference .....................................................	26
	3.3.4	Electromagnetic interference .............................................	26
3.4	Safety with approved accessories only .............................................		27
3.5	Handling patient cables ........................................................................		28
3.6	Power supply reliability .........................................................................		29
	3.6.1	Battery voltage indicator ......................................................	30
	3.6.2 Interruptions to the power supply .....................................		31
	3.6.3 Using the rechargeable block battery ...............................		31
3.7	Safety with proper maintenance only ..............................................		32
	3.7.1 Cleaning VitaGuard® and accessories ..............................		32
	3.7.2 Checking and cleaning the battery terminals ................		33

3.8Disposing of non-rechargeable batteries, the device, and

accessories .................................................................................................

34

Table of contents

4	Description ...............................................................................		35
4.1	Power supply ............................................................................................		36
	4.1.1 Power failure with inserted batteries ...............................		37
	4.1.2 Power failure without batteries .........................................		37
	4.1.3	Replacing batteries ................................................................	38
	4.1.4 Using the automobile power supply adapter ................		39
4.2	VitaGuard® connections .......................................................................		40
	4.2.1 Patient cable for SpO2 sensors ............................................		40
	4.2.2 Patient cable for electrodes .................................................		41
	4.2.3	Power adapter .........................................................................	41
	4.2.4 Sound outlet (no socket) ......................................................		41
	4.2.5	USB port .....................................................................................	42
	4.2.6	AUX port ....................................................................................	42
4.3	Membrane key panel .............................................................................		43
	4.3.1	Direction keys ..........................................................................	44
	4.3.2	<Enter> key ...............................................................................	44
	4.3.3	<Esc> key ....................................................................................	44
4.4	Color LEDs (Light Emitting Diodes) ....................................................		45
	4.4.1	Alarm LED ..................................................................................	45
	4.4.2 Heart and respiration LEDs ..................................................		45
	4.4.3 Power supply and battery LEDs ..........................................		46
4.5	The display ................................................................................................		46
5	Steps before and after monitoring .................................		48
5.1	Summary of steps before monitoring ..............................................		48
5.2	Switching on .............................................................................................		49
5.3	Switching off ............................................................................................		50
5.4	Summary of steps after monitoring ..................................................		50
6	Preparing for SpO2 monitoring ........................................		51
6.1	Safety instructions for SpO2 monitoring .........................................		51
6.2	Operation of SpO2 sensors ...................................................................		52
6.3	SpO2 sensor adapted to the patient’s size and weight ................		53
6.4	Choosing the sensor site .......................................................................		53
6.5	Repositioning or replacing the sensor ..............................................		54
6.6	Reasons for unconvincing SpO2 values ............................................		54

	Table of contents
6.7	Why the pulse rate is not displayed ...................................................	55
6.8	Attaching the SpO2 sensor to an infant’s foot ...............................	55
6.9	Attaching the SpO2 sensor to an adult’s finger ..............................	56
6.10	Connecting the SpO2 sensor and patient cable .............................	58
6.11	Connecting the SpO2 patient cable to VitaGuard® .......................	58
6.12	Disconnecting the SpO2 sensor from the patient cable ..............	59
6.13	Disconnecting the SpO2 patient cable from VitaGuard® ............	59
6.14	Reusing and refastening SpO2 sensors .............................................	59
7	Preparing for heart rate and apnea monitoring .........	61

7.1Safety information when monitoring heart rate and apnea ..... 61

7.2	Connecting electrodes, the patient cable, and VitaGuard® .......		64
7.3	Technical alarm from the electrode contact monitor ..................		64
7.4	Determining the optimal electrode configuration .......................		65
	7.4.1	ECG lead, electrode color coding ........................................	65

7.4.2Optimizing the heart and respiration signals – signal

	amplitudes in View 1 .............................................................	66
7.5	Checking the basal impedance ...........................................................	67

8	Alarms, displays, and views during monitoring ..........		69
8.1	Alarm test ..................................................................................................		69
8.2	Heart rate values based on age groups ..........................................		69
8.3	Alarm message priorities in the status line .....................................		70
8.4	Physiological and technical alarms ....................................................		70
8.5	Differentiating physiological and technical alarm signals .........		71
8.6	Acoustic information signals ...............................................................		72
	8.6.1	Information signals from the alarm unit next to
		the display .................................................................................	72
	8.6.2	Information signals from the sound aperture
		between the sockets ..............................................................	72
8.7	The visual alarm signals ........................................................................		73
8.8	Status line displays .................................................................................		73
8.9	SpO2 monitor alarms ..............................................................................		74
	8.9.1	Physiological SpO2 alarms ....................................................	74
8.10	8.9.2	Technical SpO2 alarms ...........................................................	75
	Heart rate and apnea monitoring ......................................................		75
	8.10.1	Differentiating between heart and pulse rate ...............	75

Table of contents

	8.10.2 Heart and pulse rate alarms ................................................	76
	8.10.3 Apnea alarms ...........................................................................	77
	8.10.4 Technical heart rate and apnea alarms ...........................	77
8.11	Alarm messages – meanings and other information ..................	77
	8.11.1 Order of equal-priority alarm conditions ........................	78
	8.11.2 Table of physiological alarm messages ...........................	78
	8.11.3 Table of technical alarm messages ...................................	81
8.12	Table of information messages ..........................................................	84

9	Alarm and monitor settings .....................................................		85
9.1	Safety instructions for the alarm settings .......................................		85
9.2	Summary of views and menus ............................................................		86
9.3	Additional views ......................................................................................		86
	9.3.1 View 2 – Large data presentation and waveforms .......		87
	9.3.2	View 3 – Smaller data presentation and waveforms ..	87
9.4	Changing the settings ...........................................................................		87
9.5	System menu – general settings ........................................................		89
	9.5.1 \ Screen saver (Off/ On) .....................................................		89
	9.5.2	\ LCD brightness ....................................................................	89
	9.5.3	\ LCD contrast ........................................................................	89
	9.5.4 \ Signal beep tone .................................................................		90
	9.5.5 \ Alarm tone pitch ................................................................		90
	9.5.6	\ RS232 format ........................................................................	90
	9.5.7 \ Settings protection On, Limited, Off ..........................		91
9.6	SpO2 display and menu .........................................................................		92
	9.6.1	SpO2 view ..................................................................................	92

9.6.2SpO2 menu – alarm settings

		(Settings protection Limited) ...........................................	93
9.7	Heart rate display and menu .............................................................		94
	9.7.1	Heart rate display ..................................................................	95
	9.7.2 Heart rate menu – alarm settings
		(Settings protection Limited) ...........................................	95
9.8	Respiration display and menu ...........................................................		96
	9.8.1	Respiration display ................................................................	97

9.8.2Respiration menu – alarm settings

(Settings protection Limited) ...........................................

98

Table of contents

10	Information for the doctor and qualified medical staff ..		99
10.1	Safety instructions ..................................................................................		99
	10.1.1 Preparing for a new patient .................................................		99
	10.1.2 Connections to the USB and AUX ports ...........................		101
	10.1.3 VitaGuard® and other medical devices ............................		101
10.2	10.1.4 Safety instructions for the doctor –SpO2 monitor ........		102
	Info display ...............................................................................................		103
	10.2.1 \ Last status messages .........................................................		103
	10.2.2	\ General ...................................................................................	103
	10.2.3	\ Measurements: SpO2 ..........................................................	104
	10.2.4 \ Measurements: Pulse rate ..............................................		105

10.2.5\ Measurements: HR & Resp. ............................................... 105

	10.2.6	\ Settings: Oximeter .............................................................	106
	10.2.7	\ Settings: Heart rate ...........................................................	107
	10.2.8	\ Settings: Apnea monitor .................................................	107
	10.2.9	\ Memory/ Internet ..............................................................	107
	10.2.10 \ Versions .................................................................................		108
10.3	Settings in the System menu (Settings protection Off) ...........		109
	10.3.1	Changing multiple-component settings .........................	109
	10.3.2	\Operating area: Home or Clinic ......................................	110
	10.3.3	\ Admit new patient – restoring factory settings ........	110
	10.3.4	\ Preand Post-alarm time .................................................	112
	10.3.5	\ Alarm mute time .................................................................	112
	10.3.6	\ Date/ time ..............................................................................	112
	10.3.7	\ Language ...............................................................................	113
	10.3.8	\ Analog input 1 + 2 ..............................................................	113
	10.3.9	\ Interval recording ............................................................	113
	10.3.10 \ Show PR/ HR .........................................................................		113
10.4	Data storage functions ..........................................................................		113
10.5	Event storage ...........................................................................................		114
	10.5.1	Silent alarm limits ................................................................	116
	10.5.2 Manual data storage or Transmit data .......................		116
	10.5.3 Summary of stored Events ..................................................		117
10.6	Trend storage ..........................................................................................		118
10.7	Long term storage over eight hours .................................................		119

Table of contents

10.8	Protocol storage of operating and device data ..........................	119
10.9	Summary of stored signals and data ................................................	120
10.10	Settings in the SpO2 menu (Settings protection Off) ...............	121
10.11	Settings in the Heart rate menu (Settings protection Off) ...	123
10.12	Changing the ECG lead for signal optimization ...............................	127
10.13	Settings in the Respiration menu (Settings protection Off) ...	129
10.14	Combining apnea alarms with heart rate and SpO2 alarms ......	130
10.15	Table of operating modes ....................................................................	131
11	Algorithms and measuring principles ...............................	133
11.1	Alarm condition and report delays ....................................................	133
	11.1.1 Alarm condition delay for the heart rate .........................	133
	11.1.2 Alarm condition delay for oxygen saturation ................	134
	11.1.3 Alarm condition delay for respiration ..............................	134
	11.1.4 Alarm report delays ................................................................	134
11.2	Measuring principle for the SpO2 monitor ......................................	135
11.3	Measuring principle for the heart rate monitor ............................	138
11.4	Measuring principle for the apnea monitor ...................................	139
12	Evaluating stored data on a PC ..............................................	141
13	Specifications .....................................................................................	143
13.1	General .......................................................................................................	143
13.2	SpO2 monitor ............................................................................................	145
13.3	Heart rate monitor .................................................................................	146
13.4	Apnea monitor .........................................................................................	146
13.5	Intervals for calculating average values in the Info mask .........	147
13.6	Memory ......................................................................................................	147
13.7	Ports ............................................................................................................	147
13.8	Miscellaneous ..........................................................................................	148
13.9	Selection of applied standards ............................................................	149
14	Table of figures ..................................................................................	151

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.

VitaGuard® monitor

SpO2 sensor

SpO2 patient	External
cable	power adapter

ECG electrodes

ECG

patient cable

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
(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
Masimo PC08 SpO2 patient cable (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 SpO2 sensor (PU = 20 pcs)
(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.

2.1Label 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

2.2Symbols 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 SpO2 socket is 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!

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

2.3Indications

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 (SpO2) and of the pulse rate as measured with the SpO2 sensor. The functional blood oxygen saturation displayed as %SpO2 is determined exclusively from the measurements of oxygenated and deoxygenated hemoglobin.

The SpO2 and pulse rate monitor 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.

2.3.2 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.

2.4VitaGuard® modes of operation

Depending on the risk group and the latest diagnosis, VitaGuard® allows the treating doctor to combine three monitoring parameters:

SpO2 monitoring

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 SpO2. This combination helps to reduce false apnea alarms.

When VitaGuard® is to be used to monitor heart rate and respiration only, the doctor can deactivate the SpO2 monitor in the SpO2 menu.

In addition to the fixed alarm limits for the heart or pulse rate monitor and the SpO2 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:

“Settings in the SpO2 menu (Settings protection Off)” on page 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 SpO2 alarms” on 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.

2.5Intended 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 SpO2 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 SpO2 sensor. The doctor can choose whether the pulse or the heart 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 SpO2 sensor is inadequate for the 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.

2.6Limitations 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 (SpO2 value too low), resuscitation measures may need to be taken.

20 Intended use

2.6.2Limitations 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 SpO2 sensor is correctly attached.

Intended use

21

2.7Information 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.

3.1Caregivers’ 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.

3.2Allergy risks to patients

Attach ECG electrodes and SpO2 sensors 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.

The use of SpO2 sensors with adhesive materials may cause problems when the patient develops an allergy to adhesive tape or similar.

3.3Possible 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.

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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-en- riched 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

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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.

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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.

3.4Safety 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, SpO2 sensors, 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

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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.

3.5Handling 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.

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3.6Power 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 operated through the external power adapter.

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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.