GeTeMed VG 3100 User Manual

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VitaGuard® VG 3100

Apnea, heart, and SpO2 monitor

Operating instructions

Who should read which sections in these operating instructions?

The sections 3 to 8 colored blue at the top of the page and in the table of contents are intended specifically for caregivers without medical background knowledge.

The other sections are intended in particular for doctors and qualified medical staff.

1 General view and list of accessories 2 Intended use

3 Safety 4 Description 5 Steps before and after monitoring 6 Preparing for SpO2 monitoring 7 Preparing for heart rate and apnea monitoring 8 Alarms, displays, and views during monitoring

9 Alarm and monitor settings 10 Information for the doctor and qualified medical staff 11 Algorithms and measuring principles 12 Evaluating stored data on a PC 13 Specifications 14 Table of figures

NOTE Words and passages in small capitals in these operating instructions also appear on the display.

Table of contents

1 General view and list of accessories0...............................0011

2 Intended use0............................................................................0014

2.1 Label on the back of the device0...........................................................0014

2.2 Symbols and warnings0 ..........................................................................0015

2.3 Indications0.................................................................................................0016

2.3.1 SpO2 and pulse rate monitor0...............................................0016

2.3.2 Heart rate and apnea monitor0............................................0016

2.4 VitaGuard® modes of operation0.........................................................0017

2.5 Intended use and performance0...........................................................0018

2.6 Limitations on VitaGuard®’s intended use0......................................0019

2.6.1 Obstructive apneas are not detected0................................0019

2.6.2 Limitations of the heart rate and central apnea monitor0 ...0020

2.6.3 Limitations of the SpO2 and pulse rate monitor0............0020

2.7 Information for the doctor on these operating instructions0 .....0021

3 Safety0..........................................................................................0022

3.1 Caregivers’ tasks0......................................................................................0022

3.2 Allergy risks to patients0.........................................................................0024

3.3 Possible external interference to monitoring0................................. 0024

3.3.1 Installation and environment0 .............................................0025

3.3.2 Noise risks to monitoring0..................................................... 0025

3.3.3 Electrostatic interference0 .....................................................0026

3.3.4 Electromagnetic interference0 .............................................0026

3.4 Safety with approved accessories only0.............................................0027

3.5 Handling patient cables0........................................................................0028

3.6 Power supply reliability0 .........................................................................0029

3.6.1 Battery voltage indicator0......................................................0030

3.6.2 Interruptions to the power supply0.....................................0031

3.6.3 Using the rechargeable block battery0...............................0031

3.7 Safety with proper maintenance only0 ..............................................0032

3.7.1 Cleaning VitaGuard® and accessories0..............................0032

3.7.2 Checking and cleaning the battery terminals0................ 0033

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

accessories0.................................................................................................0034

Table of contents

4 Description0...............................................................................0035

4.1 Power supply0............................................................................................ 0036

4.1.1 Power failure with inserted batteries0............................... 0037

4.1.2 Power failure without batteries0......................................... 0037

4.1.3 Replacing batteries0 ................................................................ 0038

4.1.4 Using the automobile power supply adapter0................ 0039

4.2 VitaGuard® connections0.......................................................................0040

4.2.1 Patient cable for SpO2 sensors0............................................ 0040

4.2.2 Patient cable for electrodes0................................................. 0041

4.2.3 Power adapter0 ......................................................................... 0041

4.2.4 Sound outlet (no socket)0 ...................................................... 0041

4.2.5 USB port0..................................................................................... 0042

4.2.6 AUX port0.................................................................................... 0042

4.3 Membrane key panel0 ............................................................................. 0043

4.3.1 Direction keys0 .......................................................................... 0044

4.3.2 <Enter> key0 ............................................................................... 0044

4.3.3 <Esc> key0.................................................................................... 0044

4.4 Color LEDs (Light Emitting Diodes)0.................................................... 0045

4.4.1 Alarm LED0.................................................................................. 0045

4.4.2 Heart and respiration LEDs0.................................................. 0045

4.4.3 Power supply and battery LEDs0.......................................... 0046

4.5 The display0 ................................................................................................ 0046

5 Steps before and after monitoring0.................................0048

5.1 Summary of steps before monitoring0 .............................................. 0048

5.2 Switching on0............................................................................................. 0049

5.3 Switching off0............................................................................................ 0050

5.4 Summary of steps after monitoring0.................................................. 0050

6 Preparing for SpO2 monitoring0........................................0051

6.1 Safety instructions for SpO2 monitoring0......................................... 0051

6.2 Operation of SpO2 sensors0...................................................................0052

6.3 SpO2 sensor adapted to the patient’s size and weight0................ 0053

6.4 Choosing the sensor site0....................................................................... 0053

6.5 Repositioning or replacing the sensor0..............................................0054

6.6 Reasons for unconvincing SpO2 values0 ............................................0054

Table of contents

6.7 Why the pulse rate is not displayed0...................................................0055

6.8 Attaching the SpO2 sensor to an infant’s foot0 ...............................0055

6.9 Attaching the SpO2 sensor to an adult’s finger0..............................0056

6.10 Connecting the SpO2 sensor and patient cable0 .............................0058

6.11 Connecting the SpO2 patient cable to VitaGuard®0....................... 0058

6.12 Disconnecting the SpO2 sensor from the patient cable0 ..............0059

6.13 Disconnecting the SpO2 patient cable from VitaGuard®0............0059

6.14 Reusing and refastening SpO2 sensors0.............................................0059

7 Preparing for heart rate and apnea monitoring0.........0061

7.1 Safety information when monitoring heart rate and apnea0.....0061

7.2 Connecting electrodes, the patient cable, and VitaGuard®0.......0064

7.3 Technical alarm from the electrode contact monitor0..................0064

7.4 Determining the optimal electrode configuration0 .......................0065

7.4.1 ECG lead, electrode color coding0........................................0065

7.4.2 Optimizing the heart and respiration signals – signal

amplitudes in View 10.............................................................0066

7.5 Checking the basal impedance0...........................................................0067

8 Alarms, displays, and views during monitoring0..........0069

8.1 Alarm test0.................................................................................................. 0069

8.2 Heart rate values based on age groups0 ..........................................0069

8.3 Alarm message priorities in the status line0.....................................0070

8.4 Physiological and technical alarms0....................................................0070

8.5 Differentiating physiological and technical alarm signals0.........0071

8.6 Acoustic information signals0...............................................................0072

8.6.1 Information signals from the alarm unit next to

the display0.................................................................................0072

8.6.2 Information signals from the sound aperture

between the sockets0..............................................................0072

8.7 The visual alarm signals0........................................................................0073

8.8 Status line displays0 .................................................................................0073

8.9 SpO2 monitor alarms0..............................................................................0074

8.9.1 Physiological SpO2 alarms0....................................................0074

8.9.2 Technical SpO2 alarms0...........................................................0075

8.10 Heart rate and apnea monitoring0 ......................................................0075

8.10.1 Differentiating between heart and pulse rate0...............0075

Table of contents

8.10.2 Heart and pulse rate alarms0................................................ 0076

8.10.3 Apnea alarms0........................................................................... 0077

8.10.4 Technical heart rate and apnea alarms0 ...........................0077

8.11 Alarm messages – meanings and other information0 .................. 0077

8.11.1 Order of equal-priority alarm conditions0 ........................ 0078

8.11.2 Table of physiological alarm messages0 ........................... 0078

8.11.3 Table of technical alarm messages0................................... 0081

8.12 Table of information messages0.......................................................... 0084

9 Alarm and monitor settings0..................................................... 0085

9.1 Safety instructions for the alarm settings0....................................... 0085

9.2 Summary of views and menus0............................................................ 0086

9.3 Additional views0...................................................................................... 0086

9.3.1 View 2 – Large data presentation and waveforms0....... 0087

9.3.2 View 3 – Smaller data presentation and waveforms0 .. 0087

9.4 Changing the settings0........................................................................... 0087

9.5 System menu – general settings0........................................................0089

9.5.1 \ Screen saver (Off/ On)0 .....................................................0089

9.5.2 \LCD brightness0....................................................................0089

9.5.3 \LCD contrast0........................................................................ 0089

9.5.4 \ Signal beep tone0 ................................................................. 0090

9.5.5 \ Alarm tone pitch0................................................................ 0090

9.5.6 \RS232 format0........................................................................ 0090

9.5.7 \ Settings protection On, Limited, Off0.......................... 0091

9.6 SpO2 display and menu0 ......................................................................... 0092

9.6.1 SpO2 view0.................................................................................. 0092

9.6.2 SpO2 menu – alarm settings

(Settings protection Limited)0...........................................0093

9.7 Heart rate display and menu0.............................................................0094

9.7.1 Heart rate display0.................................................................. 0095

9.7.2 Heart rate menu – alarm settings

(Settings protection Limited)0...........................................0095

9.8 Respiration display and menu0........................................................... 0096

9.8.1 Respiration display0................................................................0097

9.8.2 Respiration menu – alarm settings

(Settings protection Limited)0...........................................0098

Table of contents

10 Information for the doctor and qualified medical staff0 ..0099

10.1 Safety instructions0..................................................................................0099

10.1.1 Preparing for a new patient0.................................................0099

10.1.2 Connections to the USB and AUX ports0...........................0101

10.1.3 VitaGuard® and other medical devices0............................0101

10.1.4 Safety instructions for the doctor –SpO2 monitor0........0102

10.2 Info display0...............................................................................................0103

10.2.1 \ Last status messages0.........................................................0103

10.2.2 \ General0...................................................................................0103

10.2.3 \ Measurements: SpO20..........................................................0104

10.2.4 \ Measurements: Pulse rate0 ..............................................0105

10.2.5 \ Measurements: HR & Resp.0...............................................0105

10.2.6 \ Settings: Oximeter0............................................................. 0106

10.2.7 \ Settings: Heart rate0...........................................................0107

10.2.8 \ Settings: Apnea monitor0 .................................................0107

10.2.9 \ Memory/ Internet0 ..............................................................0107

10.2.10 \Versions0.................................................................................0108

10.3 Settings in the System menu (Settings protection Off)0...........0109

10.3.1 Changing multiple-component settings0 .........................0109

10.3.2 \Operating area: Home or Clinic0......................................0110

10.3.3 \Admit new patient – restoring factory settings0 ........0110

10.3.4 \Pre- and Post-alarm time0................................................. 0112

10.3.5 \ Alarm mute time0 .................................................................0112

10.3.6 \Date/time0 ..............................................................................0112

10.3.7 \ Language0 ...............................................................................0113

10.3.8 \Analog input 1 + 20.............................................................. 0113

10.3.9 \ Interval recording0 ............................................................0113

10.3.10 \Show PR/HR0.........................................................................0113

10.4 Data storage functions0..........................................................................0113

10.5 Event storage0 ...........................................................................................0114

10.5.1 Silent alarm limits0................................................................0116

10.5.2 Manual data storage or Transmit data0.......................0116

10.5.3 Summary of stored Events0 ..................................................0117

10.6 Trend storage0 ..........................................................................................0118

10.7 Long term storage over eight hours0.................................................0119

Table of contents

10.8 Protocol storage of operating and device data0.......................... 0119

10.9 Summary of stored signals and data0 ................................................ 0120

10.10 Settings in the SpO2 menu (Settings protection Off)0 ............... 0121

10.11 Settings in the Heart rate menu (Settings protection Off)0 ...0123

10.12 Changing the ECG lead for signal optimization0............................... 0127

10.13 Settings in the Respiration menu (Settings protection Off)0... 0129

10.14 Combining apnea alarms with heart rate and SpO2 alarms0...... 0130

10.15 Table of operating modes0 .................................................................... 0131

11 Algorithms and measuring principles0............................... 0133

11.1 Alarm condition and report delays0.................................................... 0133

11.1.1 Alarm condition delay for the heart rate0......................... 0133

11.1.2 Alarm condition delay for oxygen saturation0................ 0134

11.1.3 Alarm condition delay for respiration0 .............................. 0134

11.1.4 Alarm report delays0................................................................ 0134

11.2 Measuring principle for the SpO2 monitor0...................................... 0135

11.3 Measuring principle for the heart rate monitor0............................0138

11.4 Measuring principle for the apnea monitor0 ................................... 0139

12 Evaluating stored data on a PC0 ..............................................0141

13 Specifications0 ..................................................................................... 0143

13.1 General0....................................................................................................... 0143

13.2 SpO2 monitor0............................................................................................ 0145

13.3 Heart rate monitor0 ................................................................................. 0146

13.4 Apnea monitor0......................................................................................... 0146

13.5 Intervals for calculating average values in the Info mask0 .........0147

13.6 Memory0...................................................................................................... 0147

13.7 Ports0 ............................................................................................................0147

13.8 Miscellaneous0 .......................................................................................... 0148

13.9 Selection of applied standards0............................................................ 0149

14 Table of figures0.................................................................................. 0151

General view and list of accessories 11

1 General view and list of accessories

The general view shows the monitoring system’s most important components.

SpO sensor

VitaGuard® monitor

SpO

cable

patient

External power adapter

ECG

ECG patient cable

electrodes

Fig. 1 General view of the monitoring system

12 General view and list of accessories

The accessories listed in the following can be used together with VitaGuard® and can be ordered with the specified article numbers from getemed AG or authorized dealers. Please consult getemed AG or your authorized dealer for other approved accessories.

Product .............................................................................. Article no. / REF

VitaGuard® VG

3100 Monitor (with Masimo SET®),

complete system ............................................................................ 7311 2012

1 VitaGuard® VG 3100 monitor 1 ECG patient cable, 9 neonatal electrodes 1 PC08 SpO2 patient cable 1 SpO2 LNOP Neo sensor incl. spare adhesive strip 1 NA3000-2 external power adapter 1 rechargeable block battery 1 device bag 1 operating instructions, 1 quick reference Transport case

3000-2 external power adapter

V–240 V~ / 50–60 Hz) ............................................................ 7344 1101

(110

3000-2 automobile power supply adapter ................... 7344 1201

NAK

Rechargeable block battery ......................................................... 7344 2201

PK1-8P ECG patient cable ............................................................ 7341 1001

Kitty Cat™ neonatal electrodes (PU = 30 pcs) ................................ 70222

Masimo PC08 SpO

patient cable (2.44 m) ..................................... 70257

Masimo LNOP® NeoPt SpO

sensor (PU = 20 pcs)

(for one patient use only, infants < 1 kg) ......................................... 70250

Masimo LNOP® Neo SpO

sensor (PU = 20 pcs)

(for one patient use only, infants < 10 kg) ...................................... 70251

Masimo LNOP® Pdt SpO

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.

2.1 Label on the back of the device

The device label serves as a unique identifier for VitaGuard®. In addition, the label bears important cautionary information.

On the device label you will find the manufacturer’s name and address as well as the product and model name. The serial number of your device is given next to SN.

Fig. 2 Device label on the bottom of the device

Intended use 15

2.2 Symbols and warnings

This symbol warns you that failure to observe these operating instructions can cause death or injury to the patient.

The book symbol means that you must not use the device when you are not familiar with the information contained in these operating instructions.

With this CE label and the CE approval number 0197 getemed AG confirms that VitaGuard® complies with all the pertinent regulations and in particular the requirements in Annex I of the Medical Devices Directive 93/42/EWG and that this has been approved by a notified body (TÜV Rheinland Product Safety).

This symbol means that the VitaGuard®’s ECG socket is a type CF (cardio floating) application part and that it is protected against the effects of defibrillation.

This symbol means that the VitaGuard®’s SpO a type BF (body floating) application part that is protected against the effects of defibrillation.

The factory symbol shows the year of manufacture.

Note the warnings on the device label.

Do not use in explosive atmospheres!

socket is

Use the NA 3000-2 power adapter only! Warning: Do not connect to an electrical socket controlled by a wall

switch! Only new alkaline batteries (LR6 or AA) must be used when the

device is powered by non-rechargeable batteries! Note the polarity!

16 Intended use

2.3 Indications

VitaGuard® can be used to monitor patients with, for example, the following symptoms or treatment:

 unstable respiration  oxygen therapy  life-threatening cardiac dysrhythmia  conspicuous sleep laboratory findings  facial and/ or cervical and thoracic dysmorphia  distinct gastro-esophageal reflux  ataxia

2.3.1 SpO2 and pulse rate monitor

The SpO2 and pulse rate monitor with the attached accessories is suitable for the permanent, non-invasive monitoring of arterial blood oxygen saturation (SpO SpO %SpO

sensor. The functional blood oxygen saturation displayed as

is determined exclusively from the measurements of oxygen-

ated and deoxygenated hemoglobin. The SpO

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.

) and of the pulse rate as measured with the

2.3.2 Heart rate and apnea monitor

The heart rate and apnea monitor is suitable for adult, pediatric, and infant patients at home or in rooms used for medical purposes.

Intended use 17

The apnea monitor is specifically intended for monitoring central apneas. Successful apnea monitoring requires a stable underground and a patient that lies quietly without moving.

2.4 VitaGuard® modes of operation

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

 SpO

monitoring

 heart or pulse rate monitoring  apnea monitoring

The doctor can deactivate the apnea monitor in the Respiration menu, or combine the apnea monitor alarms with the heart rate and oxygen saturation monitor. In this case, apnea alarms are triggered only when, after detecting apnea, the device also detects deviations from particular average values in the monitored heart rate and/ or the monitored SpO alarms.

When VitaGuard® is to be used to monitor heart rate and respiration only, the doctor can deactivate the SpO

In addition to the fixed alarm limits for the heart or pulse rate moni-

. This combination helps to reduce false apnea

monitor in the SpO2 menu.

tor and the SpO

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 explana-

tions they may need in the following sections:

 “Settings in the SpO

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 SpO

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.

2.5 Intended use and performance

The intended use of VitaGuard® is to detect central apneas when the patient is completely immobile on a stable underground and to monitor the heart or the pulse rate as well as the oxygen saturation. VitaGuard® is designed for applications at home and in rooms used for medical purposes. VitaGuard® has no therapeutic effect.

VitaGuard® emits an acoustic and visual alarm when no respiration or movement is detected within a set period, when the measured heart rate and/or oxygen saturation values violate the set alarm limits for a period also set by the operator, and/or when no heartbeat has been detected for a set period. The alarm limits can be set within particular values specified by VitaGuard®.

Respiration and heart rate are monitored with adhesive ECG electrodes and blood oxygen saturation and pulse rate with an SpO

sensor suitable to the patient’s age and weight. VitaGuard® determines the heart rate from the ECG signal detected

by the electrodes and the pulse rate from the signal detected by the SpO

sensor. The doctor can choose whether the pulse or the heart

rate is used for alarm triggering.

Intended use 19

VitaGuard® features an impedance monitor that triggers a technical alarm when an electrode exhibits impedance values that are not compatible with proper operation. This is the case, for example, when an electrode has become detached.

When the signal registered by the SpO

sensor is inadequate for the

reliable measurement of values, a message appears on the display. Physiological data measured for a set period before and after an

alarm are stored and can afterwards be evaluated and documented. VitaGuard® can be operated with the NA3000-2 power adapter (9 V),

the NAK3000-2 automobile power adapter (e.g. in the cigarette lighter), four non-rechargeable batteries, or a rechargeable block battery. Non-rechargeable batteries or the rechargeable block battery serve above all to safeguard the monitor’s functions during a power failure and to continue monitoring the heart rate and oxygen saturation when patients are in transit.

2.6 Limitations on VitaGuard®’s intended use

Even when operated in accordance with its intended use, VitaGuard® cannot detect all life-threatening situations under certain unfavorable conditions.

2.6.1 Obstructive apneas are not detected

Obstructive apneas are not detected by VitaGuard®. The caregiver may have to remove food debris from the patient’s oral cavity.

When an obstructive apnea at the same time triggers a bradycardia alarm (heart rate too low) or an oxygen saturation alarm (SpO too low), resuscitation measures may need to be taken.

value

20 Intended use

2.6.2 Limitations of the heart rate and central apnea monitor

VitaGuard® could misinterpret movements as respiration, e.g. in ambulances, cars, and prams or when a child is held in the arms. For this reason central apneas can be detected only when the patient is sleeping or is lying still, does not move, and is not being moved.

The heart rate can be monitored with electrodes also when the patient is moving, but sudden, vigorous movements can adversely affect the measuring accuracy.

A false heart rate is displayed during ventricular fibrillation or when the heart rate exceeds 270 beats per minute.

2.6.3 Limitations of the SpO2 and pulse rate monitor

The monitoring of SpO2 and pulse rate is adversely affected when the patient moves vigorously or is vigorously moved.

When the sensor is not attached correctly, ambient light can falsify measurements. One remedy is to cover the sensor with a dark or opaque material.

The monitor operates properly only when the SpO attached.

sensor is correctly

Intended use 21

2.7 Information for the doctor on these operating instructions

In full knowledge of these operating instructions, the treating doctor must decide:

 whether the caregivers have to be trained in the performance of

resuscitation measures,

 how the caregivers can be best prepared for monitoring and

above all for the measures that must be taken in the event of an alarm,

 which view should be displayed

Information on Settings protection that sets the display modes and user configurations can be found on page 91.

“Information for the doctor and qualified medical staff” is found on page 99.

22 Safety

3 Safety

The doctor decides whether the caregivers are able to use VitaGuard® for monitoring and whether they can implement appropriate measures in the event of an alarm.

3.1 Caregivers’ tasks

With “caregivers” we mean those persons who are responsible during monitoring for the monitored patient’s well-being, for example:

 parents or other members of the family,  babysitters, when they too have been thoroughly prepared for the

situation,

 nurses and other medically trained staff.

Observe in particular the information in those sections of the operating instructions that, like here, address you directly.

Observe the extensive safety instructions at the beginning of the section “Preparing for SpO2 monitoring” on page 51.

Observe the extensive safety instructions at the beginning of the section “Preparing for heart rate and apnea monitoring” on page 61.

VitaGuard® has no therapeutic effect. You may have to implement resuscitation measures in the event of an alarm.

The potential applications of VitaGuard® for high-risk patients are so many and diverse that we are unable to give any specific instructions on procedure in the event of an alarm. It is the doctor’s task to inform high-risk patients and their caregivers in detail on the correct procedure in this case.

An alarm chart is available from getemed AG when monitoring children. This alarm chart presents a sequence of activities that are considered suitable by many medical specialists and pediatricians.

Safety 23

Do not attempt to use VitaGuard® on more than one patient at a time.

Never modify settings without consulting the responsible doctor. Only the doctor knows the correct alarm limits and monitor configuration for each patient.

Never leave the patient’s room without first making sure that the LEDs for heart and respiration are flashing.

Make absolutely sure that you can react to an alarm within a few seconds. Move away from patients only so far that you can reach them within ten seconds.

When you are not sure that VitaGuard® is in perfect operating order, check the patient’s vital functions. Under no circumstances should you use VitaGuard® when you suspect a device defect.

In the event of ANY suspected VitaGuard® malfunction, continue to observe the patient until you can use a replacement monitor, or VitaGuard® has been examined by the doctor or authorized dealer.

Stop using VitaGuard® after the servicing interval of eighteen months has expired. Before the end of this period, make an appointment with your authorized dealer to check the safety and operability of your device.

Test the acoustic alarm unit every time you switch on VitaGuard®. This is explained in the section “Alarm test” on page 69.

CAUTION! When attaching the electrodes make sure that the plugs do not touch any other electrically conducting parts. Make sure that there can also be no contact with other electrically conducting parts when the electrodes become detached during monitoring.

Treat all leads and connections with particular care, and never use the connecting cables to lift VitaGuard®.

Switch off VitaGuard® before boarding an aircraft. When you want to transport VitaGuard® in your luggage, you should remove the batteries. This prevents other pieces of luggage from switching on

24 Safety

the device by accident. An activated, but disconnected VitaGuard® will generate acoustic alarm signals.

3.2 Allergy risks to patients

Attach ECG electrodes and SpO So that the permanent contact with the electrodes does not put too

much of a strain on the patient’s skin, the electrodes can be placed in the vicinity of the optimal site.

All materials that are used with VitaGuard® and can come into contact with patient or caregivers during normal operations are free of latex and are non-toxic in accordance with the standard ISO 10993-1.

getemed AG recommends replacing the adhesive electrodes used to monitor heart rate and apnea as soon as they start to lose their adherence. The special gel for the electrodes has been developed to avoid skin irritation, even after several months’ monitoring on newborns.

sensors to intact areas of skin only.

Nevertheless, patients with sensitive skin may suffer allergic reactions in the form of reddened skin and blistering that in serious cases may look like burns. When the skin exhibits such changes, you must immediately inform the doctor. A change of electrode type may help.

The use of SpO when the patient develops an allergy to adhesive tape or similar.

sensors with adhesive materials may cause problems

3.3 Possible external interference to monitoring

Please bear in mind the possibility of other risks that are not listed here that can be caused by your specific monitoring environment.

Safety 25

3.3.1 Installation and environment

We recommend hanging VitaGuard® in the delivered bag at a place where the display can be easily viewed.

Check, as described in the section “Alarm test” on page 69, that you can hear alarms and where you can hear them. Think also of the activities that cause noises, for example showering or vacuuming. Think before you raise the volume of your television or stereo. Also, the VitaGuard®’s alarm outlet should not be obstructed by any objects that absorb sound.

Never place VitaGuard® or the power adapter such that they could fall on the patient. For example, the power adapter could become detached from an overhead socket when the cable is pulled.

Do not immerse either VitaGuard® or the accessories in liquids. Variations in temperature and air humidity could lead to condensation

forming in and on VitaGuard®. Wait for at least two hours after VitaGuard® has visibly dried on the outside before using it for monitoring.

Do not operate VitaGuard® in environments containing explosive gases, flammable substances, nitrous gases, or highly oxygen-enriched atmospheres. Do not use VitaGuard® at extreme temperatures below 5 °C or above 40 °C. Do not place VitaGuard® near heat sources such as radiators, ovens, etc. Do not expose it to direct sunlight.

Always lay all cables and in particular any extension cables so that nobody can trip over them.

Do not place VitaGuard® directly next to the patient’s head: risk of hearing damage!

3.3.2 Noise risks to monitoring

When the alarm cannot be set to a volume that is sufficiently above the prevailing ambient noise levels, you must keep VitaGuard® and

26 Safety

its display within view. The visual signals from the alarm LED and display must then be relied upon to recognize critical situations.

You can also use the external alarm unit available from getemed AG that raises the volume of the alarm signals from VitaGuard®.

Information on the alarm signal types and volumes can be found in “Alarms, displays, and views during monitoring” on page 69. The alarm pitch is set as explained in the section “System menu – general settings” on page 89.

3.3.3 Electrostatic interference

Electrostatic build-up that, for example, a person can pick up on certain carpets must not discharge through the VitaGuard® connector sockets or the electrodes’ electrically conducting parts.

For this reason, avoid touching the electrically conducting parts, or discharge any electrostatic build-up beforehand by, for example, touching an earthed water pipe or heater.

3.3.4 Electromagnetic interference

VitaGuard® is not designed for applications near strong electromagnetic fields. These interference fields are frequently emitted by devices with large electric power consumptions. Keep a good distance from e.g. washing machines, computers, microwaves, vacuum cleaners, power tools, etc.

The device and the system can be used in the home and in all other environments that public utilities supply directly.

Bear in mind that portable and mobile HF communication devices, e.g. cellular phones, radio equipment, walkie-talkies, etc., can interfere with the monitor and influence its operability.

Bear in mind that non-approved accessories can amplify emitted interference and reduce the device’s immunity.

Safety 27

Do not place the monitor directly next to other electrical equipment, and do not stack monitors on top of each other.

When the monitor has to be placed next to or on other equipment, check that the monitor operates as designed in this environment. We recommend you to check at regular intervals:

– that the displayed signals are not disrupted when the patient is not moving, – whether the same technical alarm messages are repeatedly dis played.

When you discover disruptions: – if possible, switch off the interfering equipment or move this equipment to another site.

VitaGuard® uses high-frequency signals exclusively for its internal functions. As a result, its emitted interference is very low, and disruption to neighboring electronic equipment is unlikely.

False diagnoses are possible when monitored values are corrupted by interference from electric or electromagnetic fields and this escapes the doctor’s attention. Every time you analyze stored data, consider the possibility of interference from electric or electromagnetic fields.

VitaGuard®’s emitted interference and immunity to external interference are within the limits for life-supporting systems stipulated in the standard EN 60601-1-2.

3.4 Safety with approved accessories only

Use VitaGuard® only with the delivered or approved accessories and in accordance with the information contained in these and the accessories’ operating instructions.

Electrodes, SpO

sensors, cables, and power adapters can be ordered

from your authorized dealer or directly from getemed AG. The telephone number of your authorized dealer was given to you during

28 Safety

your training on how to operate the device, or it is found on a label your authorized dealer has attached to VitaGuard®.

Bear in mind that monitoring can continue without interruption only as long as the required consumables are available. In emergencies of this nature you can call your authorized dealer, who provides 24-hour emergency services. Please try, however, to avoid unnecessary stress for both yourself and your authorized dealer, and order your consumables in good time.

The modem used to transfer monitoring data must comply with the requirements under the German and European standard DIN EN 60950 “Safety of IT Equipment” with the amendments A1–A4. These details are found in the modem’s operating instructions.

3.5 Handling patient cables

Always lay patient cables at a good distance from the patient’s head and neck. Lay each patient cable inside the clothing, and secure it in place in such a way that no harm can come to the patient or cable (strangulation, twisting).

Make sure when laying and securing patient cables that these cannot kink (kinking causes damage).

For hygiene reasons, always use the same patient cable on the one patient. Disinfect patient cables before using them on a new patient.

When more than one monitor is used in the one environment, each monitor should always be connected to the same patient cables and the same power adapter. Faults can therefore be located and remedied faster.

Safety 29

3.6 Power supply reliability

Before first using VitaGuard® for monitoring, familiarize yourself with the section “Power supply” on page 36. Monitoring is safeguarded only when the power supply is in perfect operating order.

CAUTION: Danger of electric shock! Never open the external power adapter or the connecting cable.

Exclusively the NA 3000-2 approved for VitaGuard® must be used as the external power adapter.

VitaGuard® is usually delivered with the external power adapter for European supply networks. For other supply networks, use only the plug adapters available from getemed AG.

Do not use the external power adapter in sockets that can be switched off or dimmed.

When the VitaGuard® external power adapter is plugged into a multiple socket outlet, only the modem may be connected to this outlet simultaneously.

When an extension cable is used with a multiple socket outlet, this outlet must not lie on the floor. Otherwise water may penetrate the outlet and damage the monitor.

The external power adapter and the power outlet must be free of damage.

Never use the external power adapter’s cable to lift VitaGuard®. Stop using the external power adapter when it has fallen or been

dropped. Do not operate the external power adapter in a damp environment

(e.g. in the bathroom). Always leave the batteries in VitaGuard®, even when this is oper-

ated through the external power adapter.

30 Safety

VitaGuard® operates with batteries: either non-rechargeable batteries or a rechargeable block battery. VitaGuard® must be operated only with the rechargeable block battery available from getemed AG or new alkaline non-rechargeable 1.5 V batteries (LR6 or AA), e.g. VARTA UNIVERSAL ALKALINE. Bear in mind that cheaper nonalkaline non-rechargeable batteries can have a considerably reduced operating lifetime, in some cases only 10–15% of the brand name batteries we recommend.

Do not under any circumstances use single rechargeable batteries available on the market.

Never use a non-rechargeable battery and a rechargeable battery together in the device, and never mix old and new batteries.

To prevent leaking batteries from damaging health and property, remove non-rechargeable batteries from VitaGuard® when it is not used for longer than a week. Information on “Replacing batteries” can be found on page 38.

3.6.1 Battery voltage indicator

When VitaGuard® is powered only by non-rechargeable batteries, check the battery voltage indicator on the display every hour. At least one quarter of the battery symbol must be black.

Fig. 3 Battery voltage indicator

When VitaGuard® is powered from the supply network and commercially available non-rechargeable batteries are inserted, check the battery voltage indicator on the display every day. Even when the device is powered from the supply network, you must replace the non-rechargeable batteries as soon as one quarter of the battery symbol on the display is black.

If necessary, a display message will prompt you to insert new nonrechargeable batteries or to recharge the block battery.

Safety 31

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.

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.

32 Safety

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, the electrodes, 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 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.

Safety 33

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 38.

34 Safety

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 electrodes and 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 electrodes and sensors in a plastic bag before disposing of them in household waste.

Please do not send us any used electrodes or sensors.

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.

Description 35

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

36 Description

4.1 Power supply

VitaGuard® is usually delivered with the power adapter for European supply networks. For other supply networks, contact getemed for the appropriate plug adapter. Observe the information in “Power supply reliability” on page 29.

Fig. 6 Power adapter socket

VitaGuard® is normally supplied by the power adapter (Fig. 7, left) in the 230 V/50 Hz supply network.

The NAK

3000-2 automo-

bile power supply adapter (Fig. 7, right) for vehicle dashboards can be inserted in this socket.

Fig. 7 Power adapter for 230 V/ 50 Hz supply network and automobile power supply

When VitaGuard® is supplied by the external power adapter, the green LED lights up next to the power adapter symbol. In addition, the display backlight is activated when VitaGuard® is switched on.

When VitaGuard® is supplied by the power adapter only, without inserted batteries, a display message will prompt you to insert batteries.

When VitaGuard® is supplied by the power adapter, charging of the inserted rechargeable block battery is activated. The LED next to the battery symbol illuminates.

Description 37

4.1.1 Power failure with inserted batteries

VitaGuard® automatically switches to battery mode when the external power supply fails or the power adapter is disconnected. In this event a technical alarm is permanently emitted until the power supply has been reinstated or the <Esc> key pressed.

When the supply network LED is off, but you can still see the usual monitor displays, VitaGuard® is being supplied by the batteries.

4.1.2 Power failure without batteries

VitaGuard® is fitted with an internal battery. This provides the voltage for an acoustic signal that is emitted when monitoring cannot be continued during a power failure.

The acoustic alarm from the internal battery does not stop until VitaGuard® has been switched back on after the power adapter has been reconnected or batteries have been inserted.

A power failure jeopardizes monitoring when

 the batteries in the VitaGuard® are nearly depleted or  no batteries have been inserted and VitaGuard® is disconnected

from the external power adapter.

To stop the power draw on the internal battery, it is important that non-rechargeable batteries are inserted as quickly as possible or, better, the power adapter is reconnected.

VitaGuard® must not be used for monitoring when the internal battery is depleted. This status appears on the display.

A new internal battery can be installed at getemed AG only, so you must continue monitoring with a replacement device until the internal battery has been displaced.

38 Description

4.1.3 Replacing batteries

Switch off VitaGuard® before replacing batteries.

Push back the catch and lift off the battery cover to open the battery compartment. Insert either four non-rechargeable batteries or the rechargeable block battery.

Fig. 8 Opening the battery compartment

Make sure that the + symbols on the batteries and in the compartment match before inserting non-rechargeable batteries.

Fig. 9 Opened battery compartment and polarity

Observe the following instructions when you use the rechargeable block battery.

 Never use force to insert the block battery.  The bottom of the block battery has a guide groove that prevents

the battery from being inserted the wrong way. Make sure when inserting the block battery that the labeled side is on the top and the metal terminals point to the device label.

Description 39

 You will feel a slight

pressure from the terminal spring connections when inserting the block battery.

Fig. 10 The arrows show how the block battery is correctly inserted.

4.1.4 Using the automobile power supply adapter

Use only the NAK 3000-2 automobile power supply adapter to operate VitaGuard® from a vehicle’s dashboard.

Do not leave the automobile power supply adapter overnight in the vehicle (particularly during the cold season). Otherwise condensation may form on and in the device.

The NAK 3000-2 automobile power supply adapter is connected to the VitaGuard® power adapter socket. NAK 3000-2 features a universal safety plug (DIN ISO 4165) for the dashboard lighter. Automobile power supply mode is indicated on VitaGuard® by the green LED beside the power adapter symbol.

The specifications of the automobile power supply adapter are as follows:

Input .............................................. Automobile voltage supply at 12–24 V

Output ......................................................................................................... 9 Vdc

Max current ......................................................................................... <

500 mA

Operating temperature ............................................................. +5 to +50 °C

Connection to VitaGuard® ........................................................... 3-pin plug

Connection to automobile supply .... Universal safety plug (DIN ISO 4165)

Connecting cable length .......................................................... 2 m ± 20 cm

40 Description

4.2 VitaGuard® connections

Fig. 11 Overview of VitaGuard® connections

For safety reasons, only those accessories that getemed AG has delivered or approved must be connected to VitaGuard®.

Hold VitaGuard® firmly with one hand when connecting and disconnecting plugs.

Never use force when connecting and disconnecting cables. Always insert and remove the plugs parallel to the sockets to prevent damage to the sensitive contacts.

Only the doctor, in full knowledge of the information under “Connections to the USB and AUX ports” on page 101, must decide which devices are connected to the USB and AUX ports.

4.2.1 Patient cable for SpO2 sensors

Fig. 12 SpO2 socket

The patient cable for the SpO2 sensors is connected to the SpO2 socket.

Description 41

4.2.2 Patient cable for electrodes

Fig. 13 Electrode socket

The patient cable for the electrodes for heart rate and apnea monitoring is connected to this socket.

4.2.3 Power adapter

Fig. 14 Power adapter socket

The external power adapter socket is for connecting the NA 3000-2 exter- nal power adapter or the NAK

3000-2 automobile power supply adapter.

4.2.4 Sound outlet (no socket)

Fig. 15 Sound aperture

The outlet in the figure is not a socket, but a sound hole for the internal system monitor buzzer.

42 Description

This outlet emits a pulsating sound when the external power adapter is disconnected from the monitor and no batteries are inserted.

The sound outlet is located between the cable sockets so that it cannot be covered by objects such as cushions or curtains.

4.2.5 USB port

Fig. 16 USB port

The USB (universal serial bus) port serves to read out stored data and to modify the VitaGuard® settings via a PC.

4.2.6 AUX port

Fig. 17 AUX port

The AUX (auxiliary) port can take the following connections:

 Two analog inputs  Modem for communicating data  Nurse call unit  External alarm unit

Description 43

VitaGuard® cannot confirm whether an alarm signal has been reported by a nurse call unit. As explained in the section “Alarm test” on page 69, check each time you switch on the device that an alarm signal is really transferred and the alarm reported.

Measure the time it takes for an alarm to be reported and the time needed to reach the patient. No more than ten seconds must pass between these times. Observe the operating instructions for the nurse call unit.

4.3 Membrane key panel

Do not apply excess pressure to the keys.

VitaGuard® recognizes key presses only when the keys have been pressed for about one second.

There are six membrane keys on the top side of VitaGuard®.

Fig. 18 Keys on the top side

44 Description

4.3.1 Direction keys

With the direction keys you navigate from one window to the next.

The direction keys also allow you to navigate within the menu structure.

4.3.2 <Enter> key

Fig. 19 Direction keys

 The <Enter> key switches VitaGuard® on and off.  The <Enter> key also lets you confirm changes to

the monitor settings.

Fig. 20 <Enter> key

4.3.3 <Esc> key

 When an alarm is triggered, the <Esc> key serves to deactivate the

acoustic alarm signal for a set alarm mute time. During an alarm condition the red alarm LED and the violated alarm limit flash. The acoustic alarm is again emitted if the alarm condition persists after the alarm mute time has expired. Pressing the <Esc> key during the alarm mute time a second time reactivates the acoustic alarm.

Fig. 21 <Esc> key

 Also when an alarm has automatically ended (because the vital

functions have restabilized by themselves) the alarm LED and the violated alarm limit continue to flash until you press the <Esc> key. The alarm LED, however, flashes slower than during an alarm.

Description 45

 The <Esc> key cancels unsaved changes to the monitor settings or

moves back to the next-higher menu.

4.4 Color LEDs (Light Emitting Diodes)

When VitaGuard® is switched on, all LEDs light up for a short time so that you can see they work properly. During this time, the alarm LED first lights up red and then yellow.

4.4.1 Alarm LED

 In the event of a higher-priority alarm, i.e. a

physiological alarm, the alarm LED flashes red.

 In the event of a medium-priority alarm, i.e. a

technical alarm, the alarm LED flashes yellow.

Fig. 22 Alarm LED

4.4.2 Heart and respiration LEDs

The LED with the heart symbol flashes with every heartbeat of the patient. In other words, this LED flashes as fast as the heart beats.

The LED with the lungs symbol lights up with every detected breath of the patient when the patient does not move and is not moved. In other words, this LED flashes as fast as the patient breathes.

Fig. 23 Heart and respiration LEDs

These two flashing green LEDs show you even in complete darkness that monitoring is activated.

46 Description

Also, the System menu lets you switch on and off an acoustic signal that is emitted synchronously with the heartbeat or respiration.

4.4.3 Power supply and battery LEDs

 When the LED with the

power adapter symbol lights up, VitaGuard® is being powered from the supply network or an

Mains supply active Block battery charging

automobile power supply.

Fig. 24 Power supply LEDs

 When the LED with the power adapter symbol does not light up,

but the usual monitor displays are visible, VitaGuard® is being supplied by batteries (four non-rechargeable batteries or the rechargeable block battery).

The light from the LED with the battery symbol is permanently on when the block battery is being charged in VitaGuard®. A depleted block battery takes up to six hours to recharge.

When the block battery is fully charged the LED with the battery symbol flashes every second to indicate that compensation charging is active. The block battery must therefore be fully charged at all times in the event that the power supply from the external power adapter fails.

4.5 The display

Each of the “Alarms, displays, and views during monitoring” are explained on page 69. Pressing the Y key in View 1 takes you to the Info screen with the current information for the doctor. Pressing it again takes you to the System menu for the basic VitaGuard® settings.

After the monitor is switched on it can take up to twenty seconds before the first values are displayed.

Description 47

1 2 2a 2b

3 3a 3b

4 4a 4b 4c

Fig. 25 Current values and alarm limits in View 1

1 The status line at the top of the display shows messages (on the

left) and symbols (on the right) for the external power supply and alarm activation.

2 For all vital functions, as here SpO

vital function [2a] is shown in large digits. Smaller digits to the right show the set alarm limits [2b].

3 In addition to the The Heart rate [3], the quality of the signal am-

plitude [3a] is shown on the left. Pulse rate will be displayed instead of Heart rate [3] and PR [3b] instead of HR if the pulse oxi- meter is selected as the source for the heart rate alarms (rather

[2], the current value for each

than the ECG electrodes). The System menu lets you deactivate the simultaneous display of PR or HR [3b].

4 Respiration [4] shows in addition on the left the quality of the

amplitude [4a] and the basal impedance in ohms [4b]. This term is explained in the section “Checking the basal impedance” on page

67. A respiration bar [4c] moves up and down synchroneously with the patient’s breathing.

48 Steps before and after monitoring

5 Steps before and after monitoring

The following summary shows you all the necessary measures that need to be taken before monitoring. Also read information on how VitaGuard® is switched on and off.

The doctor and the qualified medical staff are responsible for all other important activities when “Preparing for a new patient” (see page 99).

5.1 Summary of steps before monitoring

 Insert the battery or batteries (do not switch on yet!).  Use the external power adapter to connect VitaGuard® to the

supply network (do not switch on yet!).

 Attach the SpO  Connect the SpO  Connect the SpO

sensor to the patient.

patient cable to VitaGuard®.

sensor to the patient cable.

 Connect the ECG patient cable to VitaGuard®.  Attach the ECG electrodes to the patient.  Connect the ECG electrodes to the patient cable.  Switch on VitaGuard® as explained in the next section.  Make sure that after the monitor is switched on the indicator

lamps light up briefly and a short sound is emitted by the alarm buzzers.

 Check that the alarm limits displayed are the same as those

recommended by the doctor.

Steps before and after monitoring 49

5.2 Switching on

Press the <Enter> key for several seconds to switch on VitaGuard®.

In the first minute of operation no acoustic signals are emitted so that you have time to check all cables. The alarm bell is crossed out for this time and the remaining time is shown next to it. Text messages, on the other hand, are shown from the beginning.

When no patient cable is connected, an acoustic reminder signal is emitted as a short tone every twenty seconds after the monitor is switched on. The technical alarms for cable and electrode monitoring are not activated until the patient cable is connected and the first plausible data have been calculated. A text message in the status line reports from the beginning that the cables are being checked.

After the device has been switched on, the following displays and signals show you that the monitoring system is fully operable.

 All indicator LEDs light up briefly. During this time the alarm LED

first lights up red and then yellow.

 A brief tone is emitted to indicate that the acoustic alarm buzzer

is fully operable.

If the alarm buzzer does not emit the acoustic signal after the device has been switched on, you must immediately send VitaGuard® to getemed AG or your authorized dealer for inspection. Please consult your authorized dealer for a replacement device.

Observe the patient carefully until the replacement device arrives. Bear in mind that the patient is not being monitored at this time and that no alarm will be reported in an emergency.

50 Steps before and after monitoring

5.3 Switching off

Always switch off VitaGuard® in the manner described here.

1 Press the <Enter> key and keep this pressed: the message Press

Esc key appears.

2 Briefly press the <Esc> key, still keeping the <Enter> key pressed,

and then release both keys. The switch off command is acknowledged by two short beeps. Data must be stored before the device finally switches off. For this

reason, VitaGuard® needs about another two seconds after the keys are released until it switches off completely.

5.4 Summary of steps after monitoring

 Switch off VitaGuard® as explained in the previous section.  Carefully detach the ECG electrodes from the patient.  Disconnect the ECG electrodes from the patient cable.  Detach the SpO

from the skin.

If the procedure concerning stored data has not been clarified during your training, then please contact your doctor.

sensor, carefully removing the adhesive strip

Preparing for SpO2 monitoring 51

6 Preparing for SpO2 monitoring

The information in this section refers primarily to the use of adhesive strip sensors. Also available, however, are SpO2 sensors that can be disinfected and reused (permanent sensors) for brief examinations and for monitoring patients with allergies.

 LNOP® Neo will be explained as an example SpO

children.

 LNOP® Adt will be explained as an example SpO

adults.

Preparing for SpO

monitoring involves:

sensor for

 attaching the sensors to the patient  laying and securing the patient cable  connecting the SpO

patient cable to VitaGuard®

6.1 Safety instructions for SpO2 monitoring

For hygiene reasons, check that there is no damage to the sensor’s packaging before opening it. Use adhesive strip sensors on the one patient only.

Remove the adhesive sensors no later than every eight hours and permanent sensors no later than every four hours so that you can inspect and, if necessary, clean the attachment sites on the patient’s skin.

When the blood flow or attachment site is not satisfactory, attach the sensor to a different site, and inspect this site more often.

Be particularly careful with patients exhibiting weak blood flow: failing to check the sensors frequently may lead to skin damage and pressure-induced necrosis. Check no later than every two hours in these cases.

52 Preparing for SpO2 monitoring

Connect the SpO2 sensors only to the corresponding patient cable and this only to the corresponding socket on VitaGuard®.

Do not use adhesive strip SpO

sensors on patients exhibiting aller-

gic reactions to adhesive strips or similar. Securing sensors incorrectly, e.g. too tightly, can damage tissue. Do not use damaged sensors. Replace sensors immediately if they

exhibit any damage. Do not immerse the sensors in liquids and do not attempt to sterilize

them. An improperly attached sensor can falsify measurements. Do not attach the SpO

sensor to a limb that has or will have a

catheter or pressure cuff during monitoring. Secure the sensors and cables so that they cannot harm, strangle, or

be swallowed by the patient. Always lay the patient cable at a safe distance from the patient’s head and neck. Lay the patient cable when monitoring small children inside their clothing so that it exits at the foot. On larger children and adults you can, for example, lay the patient cable so that it exits between the trousers and pullover.

To prevent damage, avoid all kinks, folds, and any other unnecessary bends in the sensor cable.

6.2 Operation of SpO2 sensors

SpO2 sensors consist of a transmitter diode (referred to as “transmitter” in the following) and a receiver. The transmitter is identified by the red star symbol on the adhesive strip. The receiver is identified by its round window and the white plastic part on the adhesive strip behind it.

The transmitter emits light, the receiver detects this light. When this light penetrates arterial blood vessels, the composition and intensity of the light picked up by the receiver change.

Preparing for SpO2 monitoring 53

The SpO2 monitor can calculate the percentage level of blood oxygenation from the composition of the light picked up by the receiver. However, it is important that no other light, whether daylight or ambient light, can reach the receiver. More detailed explanations can be found in the section “Measuring principle for the SpO on page 135.

monitor”

6.3 SpO2 sensor adapted to the patient’s size and weight

The following lists a number of SpO2 sensors that are also available.

 The LNOP® Neo delivered with VitaGuard® is an adhesive strip

sensor for measuring the functional arterial blood oxygen saturation (SpO

 Sensors of the type LNOP® NeoPt are available for monitoring

premature infants with sensitive skin.

 The sensor LNOP® Pdt can be used on children weighing between

) of infants weighing up to 10 kg.

10 and 50 kg.

 The sensor LNOP® Adt is suitable for patients over 30 kg.

Information on other sensors can be obtained from getemed AG or your authorized dealer.

6.4 Choosing the sensor site

 Always choose a site that is intact, has good blood flow, and

covers completely the receiver window. Information on choosing the right attachment site can be found on the sensor’s packaging.

 Choose a site such that the sensor’s transmitter and receiver can

lie exactly opposite each other.

 The distance between the transmitter and the receiver should not

be greater than two centimeters.

54 Preparing for SpO2 monitoring

 On infants with thick or swollen feet, the big toe is often better

than the whole foot.

 Clean and dry the attachment site.  Choose a site where the sensor and patient cable can least restrict

the patient’s freedom of movement.

6.5 Repositioning or replacing the sensor

Sensors used for a long time do not adhere as well as new ones.

When VitaGuard® does not display plausible values for the pulse rate and oxygen saturation, the sensor may not be attached to the optimal site or may not be properly secured.

 Check the sensor’s position, and if necessary, move the sensor to a

different site.

 Always replace a sensor when the displayed pulse rate and the

displayed percentage level of oxygen saturation remain unconvincing despite the sensor’s new site.

6.6 Reasons for unconvincing SpO2 values

Clarify with the doctor whether one of the following situations may have arisen:

 the sensor is improperly secured or used (e.g. when the transmit-

ter and receiver do not lie exactly opposite each other),

 the patient moves vigorously,  the sensor picks up bright ambient light, e.g. from powerful

lamps, IR heater lamps, direct sunlight, etc.,

 venous pulsation,  a catheter or pressure cuff has been applied to the same limb as

the sensor,

Preparing for SpO2 monitoring 55

 the blood exhibits appreciable quantities of dysfunctional hemo-

globin, e.g. carboxyhemoglobin or methemoglobin,

 blood dyes have been used such as indocyanine green, methylene

blue, or other substances that contain coloring agents and therefore affect the blood color.

6.7 Why the pulse rate is not displayed

Clarify with the doctor whether one of the following situations may have arisen:

 The sensor is secured too tightly (dangerous for the patient),  Bright ambient light,  Inflated blood pressure cuff on the same limb as the sensor,  Arterial occlusion near the sensor,  Low blood pressure, serious vasoconstriction, anemia, hypother-

mia, cardiac arrest, or shock.

6.8 Attaching the SpO2 sensor to an infant’s foot

Note that the SpO here as an example. The doctor must decide which SpO2 sensor type to use in each case.

LNOP® Neo is an SpO2 sensor for use with one patient only weighing

sensor type LNOP® Neo for infants is described

less than 10 kg.

Fig. 26 Label on the LNOP® Neo SpO2 sensor

LNOP® Neo is free of latex, is not sterile, and cannot be sterilized. The foot is the preferred attachment site on newborns. Alternative

sites are also the palms and backs of the hands.

56 Preparing for SpO2 monitoring

On infants weighing between 3 and 10 kg with thick or swollen feet, the LNOP® Neo sensor can be secured to the big toe. In this case, the following information for the sensor’s receiver does not refer to the sole of the foot, but to the underside of the big toe. An alternative attachment site is also the thumb.

1 Open the packaging and remove the sensor. Hold the sensor at

the stem of the Y and remove the protective cover from both the sensor and the adhesive strip. Align the end of the sensor so that the contacts point away from the patient. Align the receiver along the fourth toe and press it against the sole of the foot (Fig. 27).

2 Align the transmitter window along the

top of the foot directly opposite the receiver. Wrap the adhesive strip around the foot to secure the transmitter and receiver (Fig. 28). Check and if necessary correct the positions.

Fig. 28 Aligning the sensor and receiver

3 The opening in the receiver window

must be completely covered by the foot (Fig. 29).

Fig. 29 Correctly attached LNOP® Neo sensor

Fig. 27 Positioning the sensor

6.9 Attaching the SpO2 sensor to an adult’s finger

Note that the SpO here as an example. The doctor must decide which SpO2 sensor type to use in each case.

sensor type LNOP® Adt for adults is described

Preparing for SpO2 monitoring 57

The LNOP® Adt sensor designed for adults weighing over 30 kg is identified by the label illustrated on the right.

Fig. 30 Label on the LNOP® Adt SpO2 sensor

The preferred attachment sites on adults are the ring and middle fingers of the non-dominant hand. Alternative attachment sites are the other fingers of the non-dominant hand. On immobilized patients or patients whose hands cannot be used as attachment sites, the big or middle toe can be used.

1 Open the packaging and remove the

sensor. Hold the sensor with the printed beige side downwards and bend it back to draw off the rear side. Align the sensor so that the receiver can be attached first (Fig. 31).

2 Now press the receiver on the fingertip

and wrap the adhesive T ends around the finger (Fig. 32).

Fig. 32 Positioning the receiver on the fingertip

3 Next wrap the sensor with the transmit-

ter and the finger design around the fin-

Fig. 31 Positioning the sensor

gernail, and wrap the flaps downwards, one after the other, around the finger (Fig. 33).

Fig. 33 Aligning the sensor and receiver

58 Preparing for SpO2 monitoring

4 When the transmitter and receiver are correctly attached, they

should be exactly opposite each other (Fig. 34). Check and if necessary correct the sensor’s position. The receiver window must be completely covered by the tissue.

Fig. 34 Correctly attached LNOP® Adt sensor

6.10 Connecting the SpO2 sensor and patient cable

Hold the sensor’s contact blade so that the metal contacts are on the top and the two Masimo symbols on the blade and patient cable are opposite each other. Insert the contact blade into the patient cable until it engages (Fig. 35). Pull carefully on the contact blade to check that it has engaged properly. You can now secure the patient cable to the patient with an adhesive strip.

Fig. 35 Connecting the patient cable and sensor contact

6.11 Connecting the SpO2 patient cable to VitaGuard®

Insert the patient cable’s monitor plug into the SpO2 socket on VitaGuard®. The Masimo inscription on the monitor plug must be on top. You should feel the monitor plug engage.

Fig. 36 SpO2 socket

Preparing for SpO2 monitoring 59

6.12 Disconnecting the SpO2 sensor from the patient cable

Use the thumb and index finger of one hand to carefully press the two buttons on the side of the patient cable’s socket (Fig.

37). Carefully pull the end of the sensor to

withdraw it.

Fig. 37 Disconnecting the sensor from the patient cable

6.13 Disconnecting the SpO2 patient cable from VitaGuard®

Using your thumb and index finger, carefully press the two levers in the patient cable’s monitor plug, and carefully pull out the plug.

Fig. 38 Two levers for securing and releasing the patient cable plug

6.14 Reusing and refastening SpO2 sensors

When the SpO2 sensors are treated with care they can be used several times on the same patient as long as the adhesive surfaces still adhere and the transmitter and receiver windows are cleaned at regular intervals.

Disconnect the sensor from the patient cable before you reattach or refresh it.

 There are replacement adhesive strips available for the LNOP®

Neo sensor used on infants.

60 Preparing for SpO2 monitoring

 When sensors have been in use for a short time only, you can

refresh the adhesive surfaces with a cotton swab saturated with a 70% isopropanol solution. Leave the sensor to dry thoroughly in air before reattaching it.

 A sensor can be secured with an adhesive strip on less sensitive

patients. Velcro strips are available for more sensitive patients.

Use a new sensor when the old one can no longer be properly secured.

Preparing for heart rate and apnea monitoring 61

7 Preparing for heart rate and apnea

monitoring

This section is divided into the following parts.

 Safety information when monitoring heart rate and apnea  Connecting electrodes, the patient cable, and VitaGuard®  Technical alarm from the electrode contact monitor  Determining the optimal electrode configuration  ECG lead, electrode color coding  Optimizing the heart and respiration signals –

signal amplitudes in View 1

 Checking the basal impedance

7.1 Safety information when monitoring heart rate and apnea

Observe the following points before monitoring with VitaGuard®.

CAUTION Interference signals can prevent a heart rate alarm from being reported when under certain unfavorable conditions the monitor misinterprets these interference signals as heart signals. Interference signals can originate from the power supply or electrical apparatus in the monitor’s environment. Observe the instructions under “Electromagnetic interference” on page 26.

The doctor can deactivate the Apnea alarms as described in the section “Settings in the Respiration menu (Settings protection Off)” on page 129. The Apnea alarms are then no longer activated and Off is displayed instead of the respiration rate. When a new age

62 Preparing for heart rate and apnea monitoring

group is selected under Admit new patient, the Apnea alarms are reactivated together with the other factory settings.

Use only those electrodes that getemed AG or an authorized dealer has delivered or approved. Other electrodes can, in particular when monitoring apnea, cause malfunctions and in addition cause damage to the patient’s skin. Read and observe the operating instructions for the electrodes.

Do not continue using damaged electrodes or cables. Do not immerse electrodes or cables in water, solvents, or liquid cleaning agents.

Store the electrodes in a cool dry place. Observe the storage instructions on the packaging.

Do not use electrodes after their expiration dates (this date is printed on the packaging, e.g. FEB2006 or 2006-02 = February 2006).

The electrodes provided are designed for short-term applications. Using the same electrodes several times can lead to malfunctions when the adhesive surface fails to adhere properly.

Do not open the electrode’s packaging until shortly before the electrode is to be used. Open the packaging and remove the electrodes. Hold the sides of the electrode and peel off the transparent film. Do not pull on the electrode’s cable. Avoid finger contact with the electrode’s gel-coated surface as much as possible.

If you intend to reuse the same electrode a short time later, carefully reattach them to the transparent film. This helps to prevent the electrode from drying out or becoming soiled.

Use exclusively the ECG patient cable delivered by getemed AG. Connect the ECG electrodes only to the ECG patient cable and this only to the corresponding VitaGuard® socket.

CAUTION Make sure when attaching electrodes that neither the electrodes nor their plug connectors come into contact with other electrically conducting parts. There must also be no contact with

Preparing for heart rate and apnea monitoring 63

other electrically conducting parts when electrodes become detached during monitoring.

Attach the electrodes only to intact areas of skin. Secure the electrodes and cables so that they cannot harm, strangle,

or be swallowed by the patient. Always lay the patient cable at a safe distance from the patient’s head and neck. Lay the patient cable when monitoring small children inside their clothing so that it exits at the foot. On larger children and adults you can, for example, lay the patient cable so that it exits between the trousers and pullover.

Place the gel-coated side of the electrode on the chosen site and carefully press it several times for a good contact.

New electrodes may be reattached several times. Peel them gently from the skin starting at the edge.

When disconnecting the electrodes from the patient cable, do not pull on the electrode’s cable. Pull the plug only.

If necessary, secure the cable with an adhesive strip. The skin should be dry and free of oil and grease.

Make sure when attaching and securing the patient cable that it cannot kink. Kinking can cause damage.

Do not pull on the cable: this is unpleasant for the patient and in addition can damage the electrodes.

64 Preparing for heart rate and apnea monitoring

7.2 Connecting electrodes, the patient cable, and VitaGuard®

Insert the electrode’s plug into the ECG patient cable’s distributor. Note the color coding of the electrodes and the distributor’s sockets.

Fig. 39 Color-coded sockets on the ECG patient cable’s distributor

Insert the plug from the ECG patient cable into the socket marked with the heart and lungs symbol.

Fig. 40 Electrode socket

7.3 Technical alarm from the electrode contact monitor

The electrode contact monitor reports an alarm when:

 the electrodes have become detached,  the electrodes are too dry (e.g. the expiration date has been ex-

ceeded or the electrodes have been used several times), giving rise to too high a value of basal impedance.

When electrodes have become detached or when the electrical resistance between the electrode and skin is too high, the respiration and ECG signals are displayed as a zero line.

Preparing for heart rate and apnea monitoring 65

When new electrodes have become detached you can reattach these by pressing them gently.

You must replace electrodes that have become detached more than once or that exhibit too high a resistance between the electrode and skin. Further explanations can be found in the section “Checking the basal impedance” on page 67.

7.4 Determining the optimal electrode configuration

The respiration and heart signals are detected using the same electrodes. The optimal electrode configuration involves finding good signal amplitudes for both the respiration and the heart signals simultaneously.

getemed AG recommends that the responsible doctor determine the optimal electrode configuration. In most cases this configuration can be retained for the whole period of monitoring.

7.4.1 ECG lead, electrode color coding

Start with the electrode configuration depicted in Fig. 41 (see next page). First arrange

 the electrodes on infants as depicted in Fig. 41 a)

(this electrode configuration has often proved successful because the abdominal wall of infants clearly moves synchronously with the respiration),

 the electrodes on all other patients as depicted in Fig. 41 b)

66 Preparing for heart rate and apnea monitoring

blac

black

ellow

red

a) or b)

Fig. 41 Recommended electrode configuration

If the electrode configuration depicted in Fig. 41 does not yield a good signal quality, you can also try the alternative electrode configuration depicted in Fig. 42.

red

ellow

black

ellow

red

Fig. 42 Alternative electrode configuration for optimizing the heart and respiration signals

7.4.2 Optimizing the heart and respiration signals – signal amplitudes in View 1

The amplitudes of the heart and respiration signals are displayed under the headings Heart rate and Respiration respectively in View 1.

Fig. 43 Electrode signal amplitude in View 1

Preparing for heart rate and apnea monitoring 67

CAUTION When Amplitude: poor is displayed, the values for the monitored heart rate and apnea may be imprecise.

Amplitude ............................. Meaning

poor .......................................... the signal is not or only sporadically

detected

medium ................................... the signal is detected, but interference,

e.g. due to movement, can cause false alarms

good ......................................... a clear signal is detected

A correct Heart rate is detected when the heart LED flashes synchronously with the patient’s heartbeat. When the signal amplitude is good or medium, there should be no deterioration in the detected heart rate when the patient moves normally.

Observe the LED with the lungs symbol and the respiration bar on the VitaGuard® display. Carefully change the positions of the red and yellow electrodes. Whenever possible, try to obtain the largest possible deflections in the respiration bar. Also, the respiration bar must move and the LED flash synchronously with the respiration.

7.5 Checking the basal impedance

The basal impedance is displayed in View 1, the respiration display, and the display Info\Measurements: HR & Resp. The basal impedance is the sum of all impedances in the measuring circuit:

 skin and tissue impedance between the red and the yellow electrode  impedance of the electrode-skin interface  impedance of the electrodes themselves and the patient cable

68 Preparing for heart rate and apnea monitoring

The basal impedance slowly falls for the first few hours after the electrodes have been attached. This is caused by a reduction in the impedance at the electrode-skin interface.

The displayed basal impedance should be less than 1000 Ý. If not, wait for about fifteen minutes. When the basal impedance has still not fallen, you should use new electrodes.

When the displayed basal impedance does not lie within the specified range or when false alarms frequently occur, the doctor or the medical caregivers should observe the instructions in the section “Changing the ECG lead for signal optimization” on page 127.

Alarms, displays, and views during monitoring 69

8 Alarms, displays, and views during

monitoring

Immediately call the emergency services when a patient remains unconscious after being shaken or addressed.

8.1 Alarm test

CAUTION: When beginning monitoring at a new site, make sure that you can clearly hear the alarm signal and quickly reach the patient. For this purpose, deliberately trigger a technical alarm.

When a patient is connected there are two ways you can deliberately trigger an alarm:

1 pull the red electrode plug out of the distributor on the ECG

patient cable or 2 disconnect the SpO

sensor from the SpO2 patient cable.

8.2 Heart rate values based on age groups

Bear in mind that the Heart, Pulse, and Respiration rates drop considerably with increasing age. The doctor must check and, if necessary, adapt the alarm limits for each patient’s age group.

The percentage level of arterial blood oxygenation displayed as %SpO patient’s age group.

The average heart rate of an infant is much higher than that of an adult. Accordingly, the alarm limit e.g. for bradycardia (too low a heart rate) must be set considerably higher for an infant than for an adult patient. As an orientation aid, the following table lists some medically

normally ranges between 97 and 99%, irrespectively of the

70 Alarms, displays, and views during monitoring

acknowledged approximate heart rates for various age groups and stress situations.

Heart rate / min Age group

Sleep Rest Stress (e.g. fever)

Newborns 80–160 100–180 max 220 1 week to 3 months 80–200 100–220 max 220 3 months to 2 years 70–120 80–150 max 200

2 to 10 years 60–90 70–110 max 200

10 years and older 50–90 55–90 max 200

8.3 Alarm message priorities in the status line

Fig. 44 Status line on the VitaGuard® display

Physiological alarms have high priority. The text messages of physiological alarms end with three exclamation marks.

Technical alarms have medium priority. The text messages of technical alarms end with two exclamation marks.

!!!

8.4 Physiological and technical alarms

VitaGuard® generates two types of alarms: physiological and technical alarms.

 A physiological alarm is generated when VitaGuard® detects

values that violate one or more of the set alarm limits for longer than the set period.

There are simple alarm limits, e.g. the Lower limit for the Heart rate, and there are alarm limits based on the interaction of several monitor settings, e.g. the deviation alarms.

“Combining apnea alarms with heart rate and SpO plained on page 130.

alarms” is ex-

Alarms, displays, and views during monitoring 71

 A technical alarm is generated when monitoring is no longer

reliable, e.g. when electrodes have become loose.

The reasons for incorrect values can be detached electrodes or other technical defects. When a technical alarm condition occurs, a lifethreatening situation may escape detection.

When, for example, a technical alarm condition relevant to SpO occurred, yet at the same time a physiological alarm condition has been detected by the heart rate and apnea monitor, the physiological alarm condition has priority and the physiological alarm is reported.

When, on the other hand, a technical alarm condition has been detected by the heart rate and apnea monitor and at the same time the SpO physiological alarm condition takes priority.

NOTE An alarm mute time of ten seconds follows a technical alarm triggered by problems with the ECG electrodes or the SpO2 sensor. This delay is to prevent false alarms when the physiological parameters are being recalculated. During the alarm mute time, the bell symbol in the status line is crossed out.

monitor detects a physiological alarm condition, again the

has

8.5 Differentiating physiological and technical alarm signals

The Alarm tone pitch can be set in the System menu so that alarms are heard over the prevailing background noise.

The urgency or priority of an acoustic alarm can be recognized by its characteristics described in the following.

High-priority messages emit two sequences of five tones that are repeated every ten seconds.

72 Alarms, displays, and views during monitoring

The interval between each tone packet is two seconds. Also, there is a slightly longer interval between the third and fourth tone of each sequence.

Fig. 45 Characteristics of the high-priority acoustic alarm signal

Medium-priority messages emit a sequence of three tones which is repeated every 5.2 seconds.

8.6 Acoustic information signals

If wished, the alarm unit next to the display can produce a short acoustic signal to accompany each heartbeat or each breath.

8.6.1 Information signals from the alarm unit next to the display

After the monitor is switched on, an acoustic reminder signal is emitted every twenty seconds until all sensors and electrodes are connected and plausible data have been detected.

8.6.2 Information signals from the sound aperture between the sockets

A pulsating tone is emitted if the external power adapter is disconnected and no batteries are installed.

Alarms, displays, and views during monitoring 73

8.7 The visual alarm signals

 A high-priority alarm, i. e. physiological alarm, causes

the alarm LED to flash red.

 A medium-priority alarm, i. e. technical alarm, causes

the alarm LED to flash yellow.

8.8 Status line displays

During monitoring the status line is displayed in all views.

Fig. 46 The status line displayed in all views

The monitor’s text messages appearing on the left are explained in detail in the section “Alarm messages – meanings and other information” on page 77. On the right of the status line are three symbols.

 Power supply

The power supply symbol indicates whether the NA3000-2 external power adapter or the automobile power supply adapter is connected. When a power adapter is connected, the symbol appears as illustrated on the right. Otherwise the symbol is crossed out.

 Battery voltage indicator

The battery voltage indicator depicts the voltage from the batteries. When the block battery is being recharged this symbol is animated, i. e. a filling animation is displayed.

 Alarm indicator

When you interrupt an acoustic alarm by pressing the <Esc> key, the bell symbol is crossed out. To the left of the bell, the remaining alarm mute time is displayed in seconds. This mute time applies only to the current alarm type.

74 Alarms, displays, and views during monitoring

When a new alarm condition is detected, the acoustic alarm is emitted before the alarm mute time has expired.

Pressing the <Esc> key a second time immediately ends the Alarm mute time.

The alarm bell outline indicates that all acoustic alarm signals are enabled.

In the event of an alarm, the alarm bell is filled out and flashes.

8.9 SpO2 monitor alarms

After the monitor has been switched on, it can take up to twenty seconds before the first values are displayed.

8.9.1 Physiological SpO2 alarms

The currently set alarm limits are always displayed. When the displayed SpO the period set under Hypoxia alarm delay or exceeds the SpO limit for longer than the period set under Hyperoxia alarm delay, an acoustic alarm signal is emitted and the corresponding message is displayed. The affected alarm limit and the alarm LED flash.

Go immediately to the patient when an alarm occurs and check the patient’s condition.

When the SpO ended automatically. In this case, the affected alarm limit and the

value falls below the SpO2 Lower limit for longer than

Upper

value returns within the permitted range the alarm is

alarm LED continue to flash until the <Esc> key is pressed to indicate that an alarm has occurred.

The SpO

Upper limit is deactivated when it is set to 100% (factory

setting). We recommend setting an upper limit when the patient is undergoing oxygen therapy.

Alarms, displays, and views during monitoring 75

In addition to the alarms based on permanently set limits, deviation alarms can also be activated as explained in the section “Combining apnea alarms with heart rate and SpO

alarms” on page 130.

8.9.2 Technical SpO2 alarms

The section “Table of technical alarm messages” on page 81 can be consulted for the technical alarm signals and the recommended troubleshooting procedures.

The SpO messages. Until the problem has been eliminated, the SpO

monitor displays technical alarms with the corresponding

value and

the pulse rate are replaced by a question mark symbol. Perfusion and signal IQ are set to zero.

8.10 Heart rate and apnea monitoring

After the monitor is switched on, it may take up to twenty seconds before the first values are displayed.

8.10.1 Differentiating between heart and pulse rate

In the menu SpO2, submenu SpO2 Monitor, the doctor can set the source for monitoring the heart rate when activating the SpO

Menu setting SpO2 monitor Source for monitoring heart rate

OFF switched off ECG signal (heart rate)

ON (HR:ECG) switched on ECG signal (heart rate)

ON (PR:Masimo) switched on SpO2 sensor (pulse rate)

 When the ECG signal is set as the source for monitoring the heart

rate, Heart rate appears as the heading in various views. In addi-

module.

tion – when this option has been activated – Views 1 and 2 simultaneously display the current pulse rate determined via the SpO

sensor below the abbreviation PR.

76 Alarms, displays, and views during monitoring

 When the SpO

heart rate, the word Pulse rate appears as the heading in various views. In addition – when this option has been activated – Views 1 and 2 display the current heart rate determined via the ECG electrodes below the abbreviation HR.

We recommend using the Pulse rate for monitoring the heart rate only when the electrodes cannot be used, e.g. owing to allergic reactions.

The heart and pulse rates can differ when irregular heartbeats fail to pump enough blood that can be recognized as a pulse.

sensor is set as the source for monitoring the

8.10.2 Heart and pulse rate alarms

The currently set alarm limits are always displayed. When the displayed Heart or Pulse rate [HR or PR]

 falls below the Lower limit for longer than the set Bradycardia

delay or

 exceeds the Upper limit for longer than the set Tachycardia

delay

 or when the ECG signal is not detected for longer than the set

Asystole delay

VitaGuard® emits an acoustic alarm signal and displays the corresponding message. The violated alarm limit and the alarm LED flash.

Go immediately to the patient when an alarm is reported and check the patient’s condition.

The alarm is ended automatically when the heart rate returns within the permitted limits.

Deviation alarms can also be activated in addition to the alarms based on permanently set limits.

Alarms, displays, and views during monitoring 77

8.10.3 Apnea alarms

An alarm is reported when apnea, i.e. respiratory arrest, is detected for longer than the set Apnea delay. An alarm message then appears on the display, the alarm LED flashes, and an acoustic warning is emitted.

Go immediately to the patient when an alarm occurs and check the patient’s condition. When the patient resumes breathing, the alarm is switched off automatically. Both the delay time and the alarm LED continue to flash to show that apnea has occurred for longer than the set Apnea delay. Pressing the <Esc> key stops the flashing.

8.10.4 Technical heart rate and apnea alarms

The section “Table of technical alarm messages” on page 81 can be consulted for the technical alarm signals and the recommended troubleshooting procedure. The heart rate and apnea monitors display technical alarms with the corresponding messages. Until the problem has been eliminated, the heart and respiration rates are replaced by a question mark symbol.

When VitaGuard® is to be used as a pulse oximeter only, the absence of an ECG patient cable would normally generate a technical alarm. To prevent this technical alarm, the doctor can deactivate the apnea monitor and switch to Pulse rate instead of Heart rate as the source for heart related alarms.

8.11 Alarm messages – meanings and other information

The tables in this section list in alphabetical order all the text messages that can appear on the VitaGuard® display together with more detailed explanations and troubleshooting hints.

78 Alarms, displays, and views during monitoring

8.11.1 Order of equal-priority alarm conditions

The numbers in the No. column on the right indicate the internal priorities that VitaGuard® uses to process the respective messages. This is of importance to the doctor only.

8.11.2 Table of physiological alarm messages

Physiological alarms are reported with high priority.

Message Meaning Information No.

Apnea detected!!!

Apnea and SpO2!!!

ECG amplitude low!!!

A respiration signal has not been detected for longer than the set Apnea delay.

An SpO2 and apnea alarm have occurred simultaneously. The monitor could not detect the ECG signal for longer than the set

When there is no apnea:

- The electrodes are badly placed, i.e. the

signal is too small to be detected.

- Cardiogenic artifacts are superim-

posed on the respiration signal so that it is rejected.

- The monitor, cable, or electrode is

defect.

- The set Apnea delay is too short.

See messages and information for “Apnea detected” and “SpO2 too low”.

When there is no asystole (cardiac arrest or delay):

- The electrodes are badly placed.

Heart rate and apnea!!! Heart rate and SpO2!!!

Asystole delay.

A heart rate alarm and an apnea alarm have occurred simultaneously. A heart rate alarm and an SpO2 alarm have occurred simultaneously.

- The ECG signal is too small to be

detected.

- The monitor, cable, or electrode is

defect. See the messages and information for “Heart rate too high/ too low” and "Apnea detected”. See the messages and information for “Heart rate too high/ too low” and “SpO2 too low”.

Alarms, displays, and views during monitoring 79

Message Meaning Information No.

Heart rate too high!!!

Heart rate

The calculated heart rate exceeds the set Upper limit for longer than the set Tachycardia delay.

The calculated heart rate

When there is no tachycardia:

- T wave peaks are interpreted as R

waves so that the calculated heart rate is too high.

- The electrodes are badly placed.

- Artifacts caused by excessive move-

ment trigger false alarms.

- 50 Hz or other sources of electromag-

netic interference trigger false alarms: suspected interference sources must be removed

- The electrode has become detached.

- The monitor, cable, or electrode is defect.

- The set Upper limit is too low.

When there is no bradycardia:

too low!!!

Heart rate drop detected!!! (when activated)

falls below the set Lower limit for longer than the set Bradycardia delay.

The current heart rate falls below the value based on the set Averag- ing interval by more than the percentage deviation value set under Trend deviation (–).

- Heartbeats are not detected.

- The electrodes are badly positioned.

- Abnormal beats, e.g. extrasystoles, are

not detected.

- The electrode has become detached.

- The monitor, cable, or electrode is

defect.

- The set Lower limit is too high.

When there is no heart rate drop:

- The heart rate and/ or the average

heart rate is incorrectly calculated for the reasons given under “Heart rate too low”

Heart rate rise detected!!! (when activated)

A heart rate rise is detected in the same manner as a heart rate drop, but Trend devia- tion (+) is used instead.

When there is no heart rate rise:

- The heart rate and/ or its average is

incorrectly calculated for the reasons given under “Heart rate too high”.

80 Alarms, displays, and views during monitoring

Message Meaning Information No.

Multiple alarms!!!

Pulse rate and apnea!!! Pulse rate and SpO2!!!

Pulse rate too high!!!

An SpO2 alarm, a heart rate alarm, and an apnea alarm have occurred simultaneously. A pulse rate alarm and an apnea alarm have occurred simultaneously. A pulse rate alarm and an SpO2 alarm have occurred simultaneously. The calculated pulse rate exceeds the set Upper limit for longer than the set Tachycardia delay.

See the messages and information for “Heart rate too high/ too low”, “SpO2 too low”, and “Apnea detected”.

See the messages and the information for “Pulse rate too high/too low” and “Apnea detected”. See the messages and information for “Pulse rate too high/ too low” and “SpO2 too low”. When there is no tachycardia:

- Strong artifacts caused by excessive

movement trigger false alarms.

- The monitor, cable, or sensor is defect.

- The set Upper limit is too low.

Pulse rate too low!!!

Pulse rate drop detected!!! (when activated)

Pulse rate rise detected!!!

The calculated pulse rate has fallen below the set Lower limit for longer than the set Bradycardia delay. The current pulse rate has fallen below the value based on the set Averaging interval by more than the percentage deviation value set under Trend deviation (–). A pulse rate rise is detected in the same manner as a pulse rate

When there is no bradycardia:

- No pulse is detected.

- There are abnormal beats.

- The monitor, cable, or sensor is defect.

- The set Lower limit is too high.

When there is no pulse rate drop:

- The pulse rate and/ or the average

pulse rate is incorrectly calculated for

the reasons given under “Pulse rate

too low”.

When there is no pulse rate rise:

- The pulse rate and/or the average

pulse rate is incorrectly calculated for

(when activated)

drop, but Trend devia- tion (+) is used instead.

the reasons given under “Pulse rate

too high”.

Alarms, displays, and views during monitoring 81

Message Meaning Information No.

SpO2 too high!!!

SpO2 too low!!!

The calculated SpO2 exceeds the set Upper limit for longer than the set Hyperoxia alarm delay.

The calculated SpO fallen below the set Lower limit for longer

has

When SpO2 is not too high:

- The sensor is incorrectly attached, e.g.

it is too loose or too tight, the transmitter and receiver are too far apart, or they are not exactly opposite each other.

- The sensor has become detached

- The blood flow is weak or obstructed

e.g. by a pressure cuff.

- Strong artifacts caused by movements

corrupt the signal.

- The monitor, cable, or sensor is defect.

- The set Upper limit is too low.

See “SpO2 too high!!!”. 8

than the set Hypoxia

alarm delay. SpO2 drop detected!!! (when activated)

The currently measured

SpO2 has fallen below the

value based on the set

Averaging interval by

more than the percent-

age deviation value set

under Trend deviation (–).

When there is no SpO2 drop:

- The present SpO

the set averaging interval is incorrect for the reasons given under “SpO high”.

or the value based on

too

8.11.3 Table of technical alarm messages

Message Meaning Cause or elimination No.

Check ECG cable!!

The monitor discovers

that the ECG cable is not

- Check the ECG cable. 22

connected. Check electrodes!!

The monitor discovers that

one or more electrodes

are not connected.

- Check the electrodes: If this message

persists, use new electrodes or replace the ECG cable.

82 Alarms, displays, and views during monitoring

Message Meaning Cause or elimination No.

Check power adapter!!

Conflicting HR limits!!

Conflicting SpO2 limits!! Corrupted ECG signal!!

The measured voltage from the power adapter is less than 8 V or greater than 10 V. The heart rate’s Lower limit has been set higher than the Upper limit. The SpO2 Lower limit has been set higher than the Upper limit. The ECG signal is corrupted too strongly by 50 Hz interference signals from the supply network.

- Check that the stipulated power

adapter is being used.

- Check and, if necessary, replace the

NA3000-2 power adapter.

- Correct the heart rate limits. 19

- Correct the SpO

- Attach the electrodes as symmetrically

as possible.

limits. 20

- Replace the electrodes.

- Select the ”I YE-RD, 3” lead.

- Proceed in accordance with the section

Hardware fault!!

Internal data error!!

No cables connected!!

No power adapter !! Recharge battery!!

The monitor has detected an internal fault.

The internal software monitor has detected a data transfer error. The monitor discovers that both patient cables are not connected. The power adapter has been disconnected. The battery voltage is too low: the monitor can no longer operate reliably

“Electromagnetic interference” on page 26.

- Switch off the monitor, wait for thirty

seconds, and switch it back on: if this message persists, the monitor is defect.

- Switch off the monitor, wait for thirty

seconds, and switch it back on: if this message persists, the monitor is defect.

- Connect the patient cables for SpO

and ECG.

- Reconnect the external power adapter

or press the <Esc> key.

- Operate the monitor with the external

power adapter to recharge the block battery, or insert non-rechargeable

Replace batteries!!

The battery voltage is too low: the monitor can no longer operate reliably.

batteries.

- Insert new batteries or a new block

battery or operate the monitor with the external power adapter.

Alarms, displays, and views during monitoring 83

Message Meaning Cause or elimination No.

SpO2: Check cable!!

SpO2: Defective sensor!! SpO2: Hardware fault!! SpO2: Interference!! SpO2: Pulse search!!

The SpO2 module reports

that the SpO2 cable is not

connected.

The SpO2 module reports

that the SpO2 sensor is

defect.

The SpO2 module is not

supplying data.

The SpO2 module detects

electromagnetic interfer-

ence.

When switched on, at

first, the SpO2 module

reports that it is search-

- Connect the SpO

- Replace the SpO

persists.

- Replace the SpO

cable.

cable, if this message

sensor. 27

- Switch off the monitor, wait for thirty

seconds, and switch it back on: if this message persists, the monitor is defect.

- Locate any interference sources in the

direct vicinity and, if necessary, remove them.

- When this message is displayed during

monitoring, check whether the sensors are secured and positioned properly.

SpO2: Sensor off!!

SpO2: Too much light!! SpO2: Unrecognized sensor!!

ing for the pulse.

The SpO2 sensor is defect

or not connected.

The SpO2 module reports

that there is too much

light.

The SpO2 module reports

that an unrecognized

sensor is connected.

- Check whether the SpO

correctly connected to the cable; if necessary replace the sensor.

- Protect the SpO

sources, e.g. by covering it.

- Replace the SpO

(use only the sensors from Masimo Inc.).

sensor from light

sensor

sensor is

84 Alarms, displays, and views during monitoring

8.12 Table of information messages

Message Cause Meaning No.

Calculating heart rate

Heart and pulse rates diverge!!

Internal battery too low

SpO2: Low perfusion

The current heart rate cannot be displayed while it is being calculated. The heart rate determined via the ECG electrodes differs from the pulse rate by more than ±40%.

The internal battery for alarms during a power failure is depleted. The SpO2 module reports that the blood

The current heart rate is displayed after it has been calculated.

- Check the ECG electrodes and the

SpO2 sensor.

- See also the messages for “Heart

rate too high”, “Heart rate too low”, “Pulse rate too high”, “Pulse rate too low”.

- The monitor is defect i. e. the

internal battery needs to be replaced by a technician.

- Either use a different attachment

site, or set Sensitivity to maximum

SpO2: Low signal IQ

flow is too weak. The SpO2 module reports that the signal quality is low.

in the SpO2 menu.

- Use a different attachment site, or

check for the presence of light or electromagnetic interference sources in the vicinity.

- Whenever possible, prevent vigorous

movements by the patient.

Status: ok No messages 40

Alarm and monitor settings 85

9 Alarm and monitor settings

The functions described in this section can be accessed only when the doctor has set Settings protection to Limited in the System menu. This setting requires a code.

The function Admit new patient in the System menu overwrites all earlier settings.

The set alarm limits and other monitor parameters are stored and retained when the monitor is switched back on after a battery change.

9.1 Safety instructions for the alarm settings

It is important that the doctor responsible sets new alarm limits and monitor parameters for each patient and for each new medical situation. Never change alarm limits without consulting the treating doctor.

Never set the alarm limits to extreme values that render the monitoring system useless.

When you have been given a code for changing alarm limits, it is important that you treat this code as confidential. Life is in danger when alarm limits are not adapted specifically to each and every patient.

86 Alarm and monitor settings

9.2 Summary of views and menus

The views presented here are intended to provide extensive information on the monitoring situation. When Settings protection is set to Limited, they can be accessed with the direction keys Y and Z.

The keys U and V let you access more detailed information and enter menus for changing monitor settings.

 The U or V key takes you from the System view to the System

menu. The first setting is highlighted.

 The U or V key leafs through pages on the Info display.  The U or V key takes you from View 1, 2, or 3 to the menu

“Manual data storage or Transmit data”. This is explained in the corresponding section on page 116.

 The SpO

menu for adjusting the respective settings and can be accessed with the U or V key. The first setting is highlighted.

, Heart rate, and Respiration displays each feature a

 The U or V key takes you from the Events or Trends views to

detailed views, Waveforms, and Trends.

9.3 Additional views

When the doctor has configured VitaGuard® so that also the caregivers can change settings, i.e. Settings protection is set to Limited, Views 2 and 3 are also activated in addition to View 1. View 1 is explained in the section “The display” on page 46.

Alarm and monitor settings 87

9.3.1 View 2 – Large data presentation and waveforms

View 2 displays in large digits the current values for the monitored vital functions and, on the right in smaller digits, the set alarm limits.

Also, each section on the left presents a waveform of the monitored vital function.

Fig. 47 View 2

9.3.2 View 3 – Smaller data presentation and waveforms

The top half of View 3 displays the current measured values and the alarm limits.

The bottom half of View 3 displays the waveforms over a longer interval than View 2.

Fig. 48 View 3

9.4 Changing the settings

Use the direction keys to highlight a menu option or an entry in this option. Once you have highlighted the option you want, press the <Enter> key to change it. When you do not want to keep your changes, press the <Esc> key.

88 Alarm and monitor settings

The U key takes you to the menus. The first entry in the list is highlighted. Use the V key to high- light the setting LCD brightness (“Changing multiple-component settings” is explained on page 109 for the doctor and qualified medical staff).

Fig. 49 Menu system, “LCD brightness: 80%” highlighted

Press the <Enter> key. A window appears where you can change the old value.

Use the U and V keys to change the highlighted value.

Fig. 50 System, “LCD brightness” highlighted in the change window

Pressing the <Enter> key after changing a value causes a prompt to appear with Accept: No highlighted. Press the Y key to highlight Accept: Yes.

Fig. 51 System, accept change to LCD brightness highlighted

Confirming the prompt Accept: Yes with the <Enter> key displays the changed value in the list. To exit the menu press the <Esc> key.

Alarm and monitor settings 89

9.5 System menu – general settings

NOTE You can familiarize yourself with the menus without changing values. Simply press the <Esc> key to exit each menu and submenu without saving changes.

Fig. 52 System menu – general settings

9.5.1 System\ Screen saver (Off/ On)

When Screen saver is set to On, an animation appears on the display when no key has been pressed for five minutes.

When you press a key or an alarm is triggered, the previous mask is displayed again.

9.5.2 System\ LCD brightness

You can set the LCD brightness from 0% to 100% in steps of 5%. When 0%, the display’s backlight illumination is switched off. The factory setting is 95%.

9.5.3 System\ LCD contrast

You can set the display’s contrast from 0% to 100% in steps of 5%. The factory setting is 70%.

90 Alarm and monitor settings

9.5.4 System\ Signal beep tone

You can configure the monitor to emit a brief signal tone with every detected respiration (Respiration) or with every detected heartbeat (Heart/ pulse beat).

When this tone disturbs the patient or caregivers, choose the setting Off.

The factory setting is Off.

Fig. 53 System\ submenu “Signal beep tone”

9.5.5 System\ Alarm tone pitch

You can set the pitch of the acoustic alarm signals to Low, Medium, or High so that they can be heard over the expected background noise. The DIN settings (DIN) match the alarm tone characteristics as described from page 71 on in the section “Differentiating physiological and technical alarm signals”. As an alternative, you can set the alarm tone characteristic (gtm) as familiar from other getemed devices.

The factory setting is Medium.

Fig. 54 System\ submenu “Alarm tone pitch”

9.5.6 System\ RS232 format

This submenu lets you assign the format for online data output from the AUX serial port.

Fig. 55 System\ RS232 format

Alarm and monitor settings 91

9.5.7 System\ Settings protection On, Limited, Off

The codes that protect the alarm defaults from unauthorized changes must be given by the doctor to those persons only whom the doctor judges to be adequately informed about monitoring and their responsibility for the patient. The doctor should point out that the code must be treated as confidential, that settings should be changed at the doctor’s request only, and that all changes must be confirmed by the doctor.

VitaGuard® provides the following three settings for Settings protection.

 Settings protection ON deactivates all options to change moni-

tor settings. The display presents only View 1, the Info display, and the System menu.

 Settings protection Limited enables access to all views and

menus. Of all the monitor settings, however, only the alarm limits can be changed.

 Settings protection Off enables all views and menus and allows

changes to all monitor settings.

The factory setting is Settings protection Limited.

After highlighting the function Settings protection, press the <En- ter> key to open a submenu.

 This submenu always displays Settings protection as “00” irre-

spectively of the current setting. Pressing the <Enter> key activates Settings protection.

 When you enter a code Settings protection appears as Limited.  When you enter a different code, Settings protection appears as

Off.

When the wrong code has been entered three times Settings protection cannot be so easily deactivated. In this case, consult your

authorized dealer.

92 Alarm and monitor settings

9.6 SpO2 display and menu

The Z key takes you from View 1, 2, or 3 to the SpO2 display. Here you can open the menu with the U or V key. Having highlighted a row, press the <Enter> key to change its contents.

9.6.1 SpO2 view

The top half of the display presents: 1 the status line 2 the current value with the

set alarm limits

1 2

3 the current three-minute

trend views that update the last value every two seconds

Fig. 56 SpO2 view, plethysmogram, perfusion index, and signal IQ

The SpO2 trend displays the SpO2 values between 70 and 100% over the last three minutes.

The first row under the trend view is the Signal IQ as vertical bars, the second the Plethysmogramme. At the bottom perfusion index [PI] and pulse rate [PR] are displayed.

When the monitor is switched on, it can take up to twenty seconds before the first values are displayed.

Bear in mind that the plethysmogram is NOT proportional to the pulse volume. A regular plethysmogram, for example, indicates that the SpO2 sensor is correctly secured.

Every time the SpO2 monitor detects a pulse beat a vertical bar appears in the Signal IQ row. The higher this bar, the better the signal from the SpO

sensor. A high Signal IQ indicates that:

Alarm and monitor settings 93

 the sensor is correctly attached,  an adequately strong signal is detected for the arterial blood flow,  the patient does not move or is not moved too vigorously.

The calculated percentage value for Perfusion (PI) can vary between 0 and 20%. When this value is very low, SpO no longer monitored. When the Sensitivity in the SpO

and the pulse rate are

menu is set to

Maximum, the cut-off limit is 0.02%; when set to Standard, this limit ranges from 0.5 to 0.02%, depending on the signal quality.

The principal of operation for this calculation can be found in the section “Measuring principle for the SpO

monitor” on page 135.

9.6.2 SpO2 menu – alarm settings (Settings protection

Limited)

The SpO2 menu lets you view and change the current SpO settings.

alarm

Changes are permitted only when Settings protection is set to Limited in the System menu.

Factory settings are shown in bold type.

Fig. 57 SpO2 menu for viewing and setting alarm limits

Lower limit ............................ 50, 51 ... 88 ... 99, 100 %

Lower alarm limit for the measured arterial oxygen saturation; an alarm is reported when the measured value falls below this limit for longer than the set Hypoxia alarm delay

94 Alarm and monitor settings

Upper limit .............................. 50, 51 ... 88 ... 99, 100 %

Upper alarm limit for the measured arterial oxygen saturation; an alarm is reported when the measured value exceeds this limit for longer than the set

Hyperoxia alarm delay

SpO

monitor ........................ Off/

On (HR: ECG) /

On (PR: Masimo) Here you can view or set the following: whether the SpO

monitor is deacti-

vated or, when it is activated, whether the heart rate derived from the ECG electrode signals or the pulse rate derived from the SpO

sensor is used as

the alarm criterion.

9.7 Heart rate display and menu

Depending on the setting in the SpO the heart rate derived from the ECG electrode signals or the pulse

menu, you can decide whether

rate derived from the SpO2 sensor is used as the alarm criterion.

The Z key takes you from View 1, 2, or 3 to the heart rate display. From here you can open the menu with the U or V key. When a row is highlighted, press <Enter> to change the corresponding value.

Alarm and monitor settings 95

9.7.1 Heart rate display

The top half of the display presents:

1 2

1 the status line 2 the current values with

the set alarm limits

3 the current three-minute

trends that update the last value every two seconds

Fig. 58 Heart rate display

The heart rate trend display presents the heart rate over the last three minutes. This display varies with the set age group:

0 to 2 years 2 to 6 years > 6 years

Heart rate

between 230 and 50 between 180 and 50 between 150 and 45

trend display

[per min]

The bottom half of the display presents the ECG. A small vertical bar above the ECG indicates every detected heartbeat. Under the ECG you can see the evaluated amplitude of the ECG signal known from View 1.

9.7.2 Heart rate menu – alarm settings (Settings

protection Limited)

The Heart rate menu lets you view and, if necessary, change the current heart rate settings. You may have to adapt the default age group alarm limits to the current patient. These settings can be changed only when Settings protection has been set to Limited in the System menu.

Different heart rate alarm limits can be set as the default values for each age group:

96 Alarm and monitor settings

Default 0 to 2 years 2 to 6 years > 6 years

Lower heart rate limit [/min] 80 60 55

Upper heart rate limit [/min] 220 150 140

In the event of persistent false alarms, a different lead can be set in the Heart rate menu as explained in the section “Changing the ECG lead for signal optimization” on page 127.

The heart rate’s Lower limit can be set from 30 to 180 beats and the heart rate’s Upper limit from 100 to 255, each in steps of five beats per minute.

Factory settings are shown in bold type.

Fig. 59 Heart rate menu for viewing and setting alarm limits

Lower limit (heart rate) ...... 30, 35 ... 80 ... 175, 180/min

Lower limit for the heart rate; an alarm is reported when the heart rate falls below this limit for longer than the set

Bradycardia delay

Upper limit (heart rate) ....... 100, 105 ... 220 ... 250, 255/min

Upper limit for the heart rate; an alarm is triggered when the heart rate exceeds this limit for longer than the set

Tachycardia delay

9.8 Respiration display and menu

The Z key takes you from View 1, 2, or 3 to the Respiration display. From here you can open the menu with the U or V key. Having highlighted a row, press <Enter> to change the corresponding value.

Alarm and monitor settings 97

9.8.1 Respiration display

The top half of the display presents: 1 the status line 2 the current values with

the set alarm limits

3 the current three-minute

trends that update the last value every two seconds

Fig. 60 Respiration display, respiration graph

The Respiration trend display presents the respiration rate over the last three minutes. This display varies with the set age group:

0 to 2 years 2 to 6 years > 6 years

Respiration rate trend

between 0 and 60 between 0 and 60 between 0 and 30

1 2

display [per min]

The bottom half of the Respiration display presents the respiration waveform. A small vertical bar above the respiration waveform indicates every detected respiration signal. Under the respiration curve you can see the respiration signal’s Basal impedance in ohms, as in View 1.

The displayed respiration rate is not used in the alarm assessment and is calculated and displayed only when the respiration signal exhibits an adequate amplitude and is relatively free of movement artefacts. Otherwise a question mark is displayed. This has no negative effects on either the alarm function or the detection of central apneas.

98 Alarm and monitor settings

9.8.2 Respiration menu – alarm settings (Settings protection Limited)

These settings can be changed only when Settings protection is set to Limited in the System menu.

Factory settings are shown in bold type.

Fig. 61 Respiration menu for viewing and setting alarm limits

Apnea delay ............................ 8, 10 ... 20 ... 32, 34 seconds

VitaGuard® interprets apnea and triggers an alarm when a respiration signal or movement is not detected and Apnea delay is exceeded. The doctor must have set Apnea alarms to Always.

Apnea alarms ........................ Off/Always/Combined

CAUTION A deactivated apnea monitor can no longer detect apnea!

Off and Always switches off and on

the apnea monitor. In both cases the respiration waveform is displayed and stored. When Apnea alarms is set to Combined, an apnea alarm is triggered only when at the same time an apnea is detected shortly before a change in Heart rate and/or SpO

(see Section

10.14).

Information for the doctor and qualified medical staff 99

10 Information for the doctor and

qualified medical staff

The treating doctor is responsible for monitoring with VitaGuard®. This also applies to ambulatory monitoring.

This section contains all safety and settings information that only the treating doctor can make decisions on. Remember that all the information and instructions in the sections “Intended use” on page 14 and “Safety” on page 22 must also be observed.

Only getemed AG personnel or authorized dealers certified by getemed AG as medical product advisers in accordance with § 31 MPG (German Medical Products Act) may instruct the doctor and the qualified medical staff on how to handle and use VitaGuard®. This certification is awarded only to those persons that have received adequate training from getemed AG for its products.

10.1 Safety instructions

The safety instructions in this section address special technical and medical issues that are of particular importance to the doctor and qualified medical staff.

10.1.1 Preparing for a new patient

When more than one VitaGuard® monitor with differing settings are used in the same environment, there is a risk of mixing monitors and a particular patient may be monitored with unsuitable settings. For this reason check the currently set alarm limits every time the monitor is switched on.

100 Information for the doctor and qualified medical staff

It is important that VitaGuard® is configured so that false alarms are avoided to the greatest possible extent. Frequent false alarms can prove detrimental to the alertness of caregivers.

When VitaGuard® is to be used for a new patient, the doctor or the qualified medical staff are obliged to take the following important precautionary measures.

 Place used consumables such as electrodes or sensors in a plastic

bag before disposing of them in household or medical waste.

 Clean the device and disinfect all cables (e.g. as described in the

guidelines from the Robert Koch Institute).

 Insert new batteries or a fully charged block battery.  Select the age group in System\ Admit new patient as explained

under “System\ Admit new patient – restoring factory settings” on page 110.

 Check that the monitor settings are suitable for the patient and, if

necessary, adapt them.

 Consider that the monitor settings may need to be changed at a

future date and, as appropriate, arrange appointments to change these settings.

 Check that the acoustic alarm signal is loud enough to be heard

over the prevailing or expected noise levels in the monitor’s environment.

 When necessary, set Settings protection to Limited.  When necessary, train caregivers in the necessary resuscitation

measures.

GeTeMed VG 3100 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual