CeVOX PC3000 Operators Manual and Product Information Ver 1.1 April 2005

General Information

About this handbook WARNING Read the Operating Instructions carefully before beginning to use the CeVOX equipment! WARNING Important items of information, i.e. activities in the course of which the operating personnel must proceed with extreme caution in order to avoid injury to themselves or the patient. These items of information are always shown in bold print. CAUTION Items of information which must be given careful attention in order to avoid damage to the equipment or the software. These items of information are always shown in bold print.

CeVOX Version 1.1

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General Information

Table of Contents 1

General Information ... 1-1 1.1

Intended Use ... 1-1

1.2

Areas of Application... 1-1

1.3

Contraindications... 1-1

1.4

Warnings ... 1-2

1.5

Cautions ... 1-4

2

Introduction ... 2-1

3

Measurement Principle ... 3-1 3.1

The Parameter of Fiberoptic Oximetry... 3-1

3.2

Normal Value Range ... 3-1

4

Literature... 4-1

5

Description of the System ... 5-1

6

5.1

Front Panel ... 5-1

5.2

Rear Panel... 5-2

Preparation for Use ... 6-1 6.1

Calibration Procedure ... 6-2

6.2

Description of the Menus ... 6-3 6.2.1 Main Menu...6-3 6.2.2 Configuration Screen...6-4 6.2.3 Input Screen ...6-5 6.2.4 Calibration Screen...6-5 6.2.5 ScvO2 Screen...6-6 6.2.5.1

Signal Quality lndicator (SQl) ...6-6

6.2.5.2

Trend Arrow ...6-6

6.2.5.3

Save Function ...6-6

6.3

Contrast Adjustment ... 6-7

6.4

Alarm Signal ... 6-7

6.5

Standby Mode ... 6-7

6.6

Error Messages and Fault Elimination ... 6-8 6.6.1 Fault Messages ...6-8 6.6.2 Alert Messages...6-8 6.6.3 Warning Messages...6-9

6.7

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Cleaning and Disinfecting the Equipment ... 6-10

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General Information

6.8

Maintenance and Service...6-11

6.9

Data Transfer via the RS232 - Interface...6-12 6.9.1 General ... 6-12 6.9.2 Data Transfer ... 6-12

7

Disposables...7-1 7.1

CeVOX fiberoptic probes...7-1

7.2

PULSIOCATH central venous catheter ...7-1

7.3

Compatibility list ...7-2

8

Accessory Items...8-1

9

Technical Data...9-1

10

9.1

Equipment Specifications ...9-1

9.2

EMI Requirements...9-2

Appendix...10-1 10.1 International Symbols...10-1 10.2 Guarantee ...10-1

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General Information

List of Figures Page Figure 1: Oxygen delivery and oxygen consumption... 2-1 Figure 2: Central venous and mixed venous oxygen saturation measurement sites ... 2-2 Figure 3: Correlation between ScvO2 and SvO2 ... 2-2 Figure 4: Clinical use of ScvO2 monitoring... 2-2 Figure 5: Early goal-directed therapy in the treatment of severe sepsis and septic shock (Rivers E et al: N Engl J Med 345 (19), 1368-1377, 2001)... 2-3 Figure 6: The principle of spectrophotometry ... 3-1 Figure 7: Front Panel of the CeVOX ... 5-1 Figure 8: Rear Panel of the CeVOX equipment ... 5-2 Figure 9: Determination of correct CeVOX fiberoptic probe...7-1

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General Information

1

General Information 1.1 Intended Use The CeVOX serves as an auxiliary aid in the diagnosis of the overall condition of the patient and thereby supports the decisions necessary for selecting the direction in which therapy should be carried out. The equipment derives physical values and presents these in appropriate formats, capable of being evaluated. In itself, it exercises no influence upon the patient. The CeVOX technology is based on spectrophotometry. Infrared light signals are transmitted through fiberoptics into the vessel and the reflected light is transmitted back, anaylsed and the determined values are displayed numerically and graphically. For measurement the PULSION CeVOX fiberoptic probes PV2022-xx have to be used exclusively. The CeVOX determines with these probes the following parameter: - Continuous measurement of the oxygen saturation of the blood, usually detected in the central venous area. The CeVOX may be used in hospitals and hospital-type facilities.

1.2 Areas of Application The use of the CeVOX is indicated for those patients for whom continuous monitoring of central venous oxygen saturation is of importance for their treatment, for example: •

All intensive care patients particularly in the case of sepsis, and multi-organ failure

•

Management of early goal directed therapy in severe sepsis In emergency medicine and acute-care for fast track evaluation of the patient´s overall hemodynamic condition

•

For evaluation and optimization of ventilation modes

•

Intra-operative monitoring of high risk surgical patients

1.3 Contraindications Due to the invasiveness of the measurement, it should not be applied in patients where the placement of an indwelling central venous catheter is contraindicated. The CeVOX should only be used in patients where the expected results are reasonable when compared to the risks.

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1.4 Warnings The equipment is intended for use in hospitals and hospital-like facilities by trained and informed personnel. The equipment makes it possible to monitor physiological parameters. The assessment of the clinical significance of changes in parameters is the responsibility of the person who decides upon the course of treatment. For reasons of safety, accuracy of the measurement and to avoid reduced interference resistance, only those disposables and accessory items (e.g. cables, refer to Chapter 8) approved by PULSION Medical Systems may be employed with the CeVOX. The combination and use of CeVOX disposables and accessory items with other devices is not recommended. It may cause an increase of electronic emission and/or a decrease in interference resistance of the devices. When used in association with inflammable anaesthetics there is an explosion risk. Use of the CeVOX equipment in a manner contrary to the Guide Lines supplied in the Operating Instructions can lead to serious equipment faults and possibly, to danger of injury. Every time the equipment is prepared for use, the setting of the alarm limits must be checked. The equipment must not be used for monitoring breathing. The CeVOX equipment may only be regarded as a device providing early warning. If there is an indication of a trend towards de-oxygenation of the patient, blood samples must be taken and tested by a laboratory oximeter in order to draw any conclusions regarding the condition of the patient. If an alarm condition arises while the alarm is suppressed, only the optical warning will be given. The acoustic alarm must not be suppressed or turned down as this could adversely affect the safety of the patient. Never block the loud-speaker. This results in the acoustic alarm being too quiet to hear. Arrange the cable attached to the patient carefully so that there is no risk of entanglement or strangulation of the patient. Position the equipment in such a manner that the patient cannot alter the settings. Position the equipment in such a manner that neither the equipment unit nor other equipment attached to the unit can fall on the patient. Never lift or carry the equipment by the cable attached to the patient or the mains supply cable. Before preparing the unit for use, the Operating Instructions for the CeVOX together with those for the probes must be read carefully. Do not use a damaged probe or patient cable. Do not use probes with exposed optical or electrical components. Incorrect use of the probes can lead to vessel perforation. Check the location of the probes as indicated in the Instructions for Use in order to ensure correct placement. Never place the cables in water or other cleaning solutions. The cables and connections are not watertight. Never sterilize the cables with radiation, steam or gas. Do not use spiky or sharp-edged tools to clean the optical module, as this may damage or destroy optical components. Do not pull on the probes or cables in order to remove these from the equipment. Observe the Instructions for Use for the probes in order to be sure that a technically correct procedure is carried out.

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If the equipment is not standing on a slip-proof surface, hold the unit securely while the function keys are being pressed to prevent displacement occurring Do not use the equipment while an NMR scan is being carried out. An induced voltage can result in potential burns. The equipment can influence the MRI-Screen and the MRI-equipment can affect the accuracy of the CeVOX. Do not place the CeVOX directly beneath of above other devices during operation. When the CeVOX is placed directly beneath or above other devices, the CeVOX should be observed to verify that it is working properly. Dye (e.g. Indocyanine Green) or other substances which contain dyes which usually modify the blood pigmentation, can lead to faulty measurement values of the oxygen saturation. When high-frequency equipment is employed during operative intervention, the Standard for highfrequency Equipment during Operations IEC/TR3 61289-1 and the following must be observed. The patient is protected against injury by electrical burns as a result of additional insulation between the patient and the CeVOX. After use, dispose of all used disposables in accordance with the Guidelines. Further use of the disposable items (e.g. after sterilisation) is not allowed. Do not connect any voltage to the CeVOX if liquid has penetrated the unit. A short circuit could damage the equipment and produce a dangerous situation for the patient and the operator. Removal of the equipotential bonding cable from the rear of the CeVOX equipment invalidates the guarantee. Do not use 2- to 3-pole adaptors to supply mains current to the CeVOX equipment. Do not touch the patient, the bed or the equipment while defibrillation is taking place. Avoid contact between electrically conducting parts of the disposables and the equipment.

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1.5 Cautions Examine the CeVOX carefully for signs of damage. If the CeVOX appears to be damaged, contact PULSION Medical Systems. Do not use the equipment if it appears to be damaged. The equipment can be damaged if insufficient care is taken when it is being unpacked or prepared for use. The user must assure him/herself of the safe and fully functional condition of the equipment before using it. If the System Test identifies an error, no function remains accessible and the message “SERVICE” will be displayed on the screen. Switch the CeVOX off and contact your local PULSION representative. If no direct contact can be made then get in touch with PULSION Medical Systems by e-mail at [email protected] or via the telephone numbers given in Chapter 6.8. Make no attempt to use the CeVOX equipment or repair it. Faulty measurements can result from incorrectly placed or defective probes, faulty connections or by excessive electro-magnetic interference, e.g. from electric blankets and electro-coagulators. Do not forget to remove the CeVOX from the standby mode if patient monitoring activity is continued. The CeVOX is subject to specific precautions concerning EMC and is only allowed to be installed and used according the EMC advices contained in this User´s Manual. Portable and mobile high frequency communication devices may influence the CeVOX. Any additional item or equipment which is connected to the digital interface must satisfy the requirements of the current IEC specification (e.g. IEC 950 for data transfer equipment or IEC 601 for electro-medical units). Furthermore, all configurations must correspond to the System Standard IEC 601-1-1. Any person who attaches additional equipment at the signal input or signal output ports of the CeVOX automatically alters the system configuration and is thereby responsible for observing the requirements of the IEC 601-1-1 Standard. Each unit of the equipment is protected against faulty operations which could be caused by a defibrillator. Defibrillation has no effect on the safety or the function capability of the equipment. After defibrillation the system returns to normal function in less than 10 seconds. Do not expose the CeVOX to a temperature in excess of 40 °C (104 °F) or less than 10 °C (38° F) while in use. Otherwise, the accuracy of the measured values could be adversely affected. Do not place any other item of equipment or containers with liquid upon the CeVOX.

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CeVOX Version 1.1

Introduction

2

Introduction A major goal of managing critically ill patients is to ensure adequate tissue oxygenation. Monitoring of the global hemodynamic situation assists the clinician in meeting that goal and is essential in the treatment of every critically ill patient in intensive care as well as in emergency medicine. Oxygen saturation of the blood in the mixed venous (SvO2) or central venous (ScvO2) area are major components of global hemodynamics. The organism always tries to keep the balance between the amount of oxygen delivered to the body by the circulation (oxygen delivery DO2) and the amount of oxygen consumed by the tissue (oxygen consumption VO2).

Figure 1: Oxygen delivery and oxygen consumption

Oxygen delivery is influenced by oxygen content (haemoglobin, oxygen saturation) and, as a major determinant, by cardiac output. Cardiac output depends on stroke volume, heart rate, preload, afterload and contractility. Oxygen consumption depends on the general body condition and increases in the case of e.g. exercise, fever, seizures, shivering, increased work of breathing. The measurement and continuous monitoring of oxygen saturation of the blood after passage through the body provides information about the balance or imbalance between oxygen delivery and oxygen consumption and serves as an early indicator of the general hemodynamic situation. Generally, this information can be derived either in the vena cava superior (central venous oxygen saturation ScvO2) or in the pulmonary artery (mixed venous oxygen saturation SvO2).

ScvO2 - Oxygen saturation of the hemoglobin of the venous blood in the vena cava superior directly before the right heart

CeVOX Version 1.1

SvO2 -Oxygen saturation of the hemoglobin of the venous blood in the pulmonary artery, behind the right heart

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Introduction

Figure 2: Central venous and mixed venous oxygen saturation measurement sites

Reinhart K et al: Intensive Care Med 30, 1572-1578, 2004 Figure 3: Correlation between ScvO2 and SvO2

When comparing ScvO2 and SvO2 an excellent correlation can be found with systematically slightly higher values for ScvO2. The clinical relevance of both parameters is similar, but there is a big difference when considering the complexity and invasiveness, with an obvious methodological advantage of the central venous oxygen saturation. Central venous oxygen saturation (ScvO2) •

Shows the percentage of hemoglobin saturated with oxygen in the central venous blood, directly before the right atrium

•

Reflects the global balance between oxygen delivery and consumption

•

Normal range: 65-80 %

Typically a decrease in ScvO2 is one of the earliest indicators of the threat to tissue oxygenation. Earlier information enables earlier diagnosis and leads to earlier intervention. Clinical Indications and use of CeVOX: •

Blood sample ScvO2 < 65%, pre-sepsis, sepsis (< 70%) or risk of hemodynamic instability or

•

Signs of reduced tissue perfusion: Clinical inspection, Lactate ↑ or diuresis ↓ or GEDVI ↓ or ICG-PDR ↓

Continuous ScvO2 Monitoring

• Change > ± 5% / 15 min or • < 65% (< 70% in sepsis!) or • > 80%

• Check ventilation/oxygenation/hemoglobin • If ScvO2 persistently abnormal, check: - Hemodynamics/EVLW with PiCCO - Liver perfusion with LiMON

Consider intervention (fluids, inotropes, vasoactive substances…) Normal Range (65-80%)

Continue ScvO2 Monitoring

Figure 4: Clinical use of ScvO2 monitoring

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CeVOX Version 1.1

Introduction

The clinical usefulness of continuous central venous oxygen saturation (ScvO2) monitoring was clearly demonstrated by Rivers et al (N Engl J Med 345 , 2001). The investigators measured and optimized ScvO2 as part of a treatment algorithm of patients fulfilling SIRS (Systemic Inflammatory Response Syndrome) criteria. An aggressive and so called early goal-directed therapy with red blood cells and vasoactive agents was started when ScvO2 fell below the defined threshold value of 70%. Patients treated according to this algorithm showed a significantly lower mortality, shorter hospital stay and lower general treatment costs.

Figure 5: Early goal-directed therapy in the treatment of severe sepsis and septic shock (Rivers E et al: N Engl J Med 345 (19), 1368-1377, 2001)

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Measurement Principle

3

Measurement Principle The CeVOX measures continuous central venous oxygen saturation (ScvO2) by spectrophotometry. Spectrophotometry involves the use of light emitting diodes (LED) that produce light of various wavelengths in the red and infrared spectra. The light is transmitted to the blood through a single fiberoptic in the probe, reflected off the red blood cells, and transmitted back through a separate fiberoptic to an optical module.

Figure 6: The principle of spectrophotometry

The wavelengths are selected so that the absorption characteristics of hemoglobin and oxyhemoglobin are different. Given both the amount of free hemoglobin and the amount of hemoglobin bound to oxygen, the formula shown below can be used to determine the ScvO2.

ScvO2

=

[HbO2] x 100 -----------------[HbO2] + [Hb]

where: ScvO2 = Central venous oxygen saturation [HbO2] = Concentration of oxygenated hemoglobin [Hb] = Concentration of deoxygenated hemoglobin The central venous oxygen saturation (ScvO2) value represents the percent saturation of venous blood as measured in the central venous area.

3.1 The Parameter of Fiberoptic Oximetry The following parameter is calculated and displayed continuously by the CeVOX using spectrophotometry. Central Venous Oxygen Saturation

ScvO2 (%)

3.2 Normal Value Range The Normal Value Range is based upon clinical experience and could vary from patient to patient. The stated value is, therefore offered without guarantee. Central venous oxygen saturation (ScvO2):

CeVOX Version 1.1

65 – 80 %

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Measurement Principle

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Literature

4

Literature (1)

Reinhart K, Kuhn HJ, Hartog C, Bredle DL: Continuous central venous and pulmonary artery oxygen saturation monitoring in the critically ill. Intensive Care Med 30: 1572-1578, 2004

(2)

Muller T, Pfeifer M, Muders F: [Monitoring of the central venous and mixed venous oxygen concentration in intensive care medicine: physiological and technical bases, indications and claims] Das Monitoring der zentralvenösen und gemischtvenösen Sauerstoffsättigung in der Intensivmedizin - Physiologische und technische Grundlagen, Indikationen und Aussagen. Intensivmed 40: 711-719, 2003

(3)

Rivers EP, Ander DS, Powell D: Central venous oxygen saturation monitoring in the critically ill patient. Curr Opin Criti Care 7: 204–211, 2001

(4)

Ladakis C, Myrianthefs P, Karabinis A, Karatzas G, Dosios T, Fildissis G, Gogas J, Baltopoulos G: Central venous and mixed venous oxygen saturation in critically ill patients. Respiration 68: 279-285, 2001

(5)

Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M: Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl H Med 345 (19): 1368-1377, 2001

(6)

Schou H, Perez de Sa V, Larsson A: Central venous and mixed venous blood oxygen correlate well during acute normovolemic hemodilution in anesthetized pigs. Acta Anaesthsiol Scand 42: 172-177, 1998

(7)

Rady MY, Rivers EP, Nowak RM: Resuscitation of the critically ill in the ED: Responses of blood pressure, heart rate, shock index, central venous oxygen saturation, and lactate. Am J Emerg Med 14: 218-225, 1996

(8)

Nakazawa K, Hikawa Y, Saitoh Y, Tanaka N, Yasuda K, Amaha K: Usefulness of central venous oxygen saturation monitoring during cardiopulmonary resuscitation. Intensive Care Med 20: 450-451, 1994

(9)

Martin C, Auffray JP, Badetti C, Perrin G, Papazian L, Gouin F: Monitoring of central venous oxygen saturation versus mixed venous oxygen saturation in critically ill patients. Intensive Care Med 18: 101-104, 1992

(10)

Rady MY, Rivers EP, Martin GB, Smithline H, Appelton T, Nowak RM: Continuous central venous oximetry and shock index in the emergency department: Use in the evaluation of clinical shock. Am J Emerg Med 10: 538-541, 1992

(11)

Wendt M. Hachenberg T, Albert A, Janzen R: [Mixed venous oxygen saturation versus central venous saturation in intensive care medicine] Gemischtvenöse versus zentralvenöse Sauerstoffsättigung in der Intensivmedizin. Anästh Intensivther Notfallmed 25: 102-106, 1990

(12)

Reinhart K, Rudolph T, Bredle DL, Hannemann L, Cain SM: Comparison of central-venous to mixed-venous oxygen saturation during changes in oxygen supply/demand. Chest 95: 12161221, 1989

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Literature

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Description of the System

5

Description of the System 5.1 Front Panel

Figure 7: Front Panel of the CeVOX

1 2 3

Connection for optical module Function key panel LCD-screen

4 5

Standby indicator Contrast key

Symbol - Description: Patient isolation Contrast adjustment Warning! General source of danger, ensure observance of Operating Instructions Standby indicator

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Description of the System

5.2 Rear Panel

Figure 8: Rear Panel of the CeVOX equipment

8 9 10

Main switch Fuse holder Mains connection socket

11 Equipotential cable socket 12 Serial interface (RS232)

Symbol-Description: Warning! General source of danger, ensure observance of Operating Instructions Equipment Type BF, protected against interference by the defibrillator Socket for equipotential cable Alternating current

Page 5-2

I/O

Mains switch (on/off)

RS 232

Serial interface

CeVOX Version 1.1

Preparation for Use

6

Preparation for Use 1. Before connecting the patient to the equipment, place a conductive connector in position between the equipment and a point on the equipotential facility. To do this, connect the equipotential socket (11) in the rear face of the equipment with the equipotential bus bar in the room by means of the yellow-green equipotential cable supplied with the unit. WARNING Removal of the equipotential cable from the rear of the CeVOX invalidates the guarantee!

2. Use the mains cable supplied with the equipment to connect the mains input socket (10) with a properly installed supply point. WARNING Avoid any contact between the electrically-conducting parts of the optical module/fiberoptic probe and the equipment. 3. Switch on the CeVOX equipment with the mains switch (8) located at the back of the unit. The unit will now carry out a short System Test. CAUTION If the System Test identifies a fault, no function remains accessible and the message “SERVICE” will be displayed on the screen. Switch the CeVOX off and contact your local PULSION representative. If no direct contact can be made please get in touch with PULSION Medical Systems by e-mail at [email protected] or via the telephone numbers given in Chapter 6.8. Make no attempt to use the CeVOX or to repair it. 4. The CeVOX will verify if an old calibration is available and still valid, i.e. not older than 24 hours. This is indicated by the message Check optical module – Please wait... 5. The Patient ID and the message New patient/ probe? will appear. Confirm YES with the Enter key if a new patient should be monitored or a new probe is connected or choose NO with the Plus and Minus keys / and confirm with the Enter key if the monitoring should be continued. • In case of YES: Proceed with 6. • In case of NO: The screen will indicate date and time of the last measurement and calibration as well as the message Use old calibration data? Confirm YES with the Enter key to continue monitoring or choose NO with the Plus and Minus keys / , confirm with the Enter key and proceed to point 6. NOTE When no valid calibration can be detected, the Input Screen will appear and a calibration has to be performed. Please refer to Chapter 6.1. 6. The Input Screen will appear. Confirm the current input parameters with the Enter key or alter the input parameters as described in Chapter 6.2.3. 7. The Calibration screen will appear, indicating Last calibration: **.** **:**. For in-vivo calibration select IN VIVO . See calibration instructions below (Chapter 6.1).

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