biopac nibp100b noninvasive blood pressure system with vital signs

Transcription

BIOPAC NIBP100B
NONINVASIVE BLOOD
PRESSURE SYSTEM
WITH VITAL SIGNS OPTIONS
OPERATOR'S MANUAL
Notice: All users of the Fusion™ System should read and understand
this Operator's Manual in its entirety prior to use.
Federal (U.S.A.) law restricts this device to sale
by or on the order of a physician
US Patents:
5,241,964, 5,649,542, 5,450,852, 5,797,850, 5,832,924, 5,640,964, 5,720,292, 5,738,103, 5,722,414,
5,941,828, 5,642,733, 5,938,618, 5,993,394, 6,017,314, 6,099,477, 6,132,382, 6,159,157, 6,241,679,
6,340,349, 6,245,022, 6,471,646, 6,986,741. Other US and Foreign Patents Pending.
© 2006 Medwave, Inc.
Document #797-0076 Rev. B
02/2007
Page 1 of 66
Medwave®, Inc.
4382 Round Lake Road West
St. Paul, MN 55112-3923
USA
651-639-1227
Medwave, Inc.
800-894-7601
E-mail: [email protected]
Clinical Service Support Line: 866-273-1486
TABLE OF CONTENTS
Revision History..................................................................................................................................................................... 7
Section 1 Safety Considerations ............................................................................................................................................. 8
1.1 Warnings, General....................................................................................................................................................... 8
1.1.1 Warnings, Parameter Specific, Blood Pressure ................................................................................................... 8
1.1.2 Warnings, Parameter Specific, Temperature Option ........................................................................................... 8
1.1.3 Warnings, Parameter Specific, Oximetry (SpO2) Option.................................................................................... 9
1.2 Precautions and Limitations, General.......................................................................................................................... 9
1.2.1 Precautions and Limitations, Parameters Specific, Blood Pressure..................................................................... 9
1.2.2 Precautions and Limitations, Parameter Specific, Temperature .......................................................................... 9
1.2.3 Precautions and Limitations, Parameter Specific, Oximetry (SpO2) ................................................................... 10
Section 2: Introduction ........................................................................................................................................................... 11
2.1 Intended Use................................................................................................................................................................ 11
2.2 General Description..................................................................................................................................................... 11
Section 3: Displays, Keys and Connectors ............................................................................................................................. 13
3.1 Front Panel – Blood Pressure, Temperature and Oximetry ......................................................................................... 13
3.1.1 Front Panel – Blood Pressure and Oximetry........................................................................................................ 14
3.1.2 Front Panel – Blood Pressure Only ..................................................................................................................... 15
3.2 Rear Panel ................................................................................................................................................................... 16
3.3 Side Panel Left ............................................................................................................................................................ 17
3.3.1 Side Panel Right .................................................................................................................................................. 17
3.4 Patient Cable for Blood Pressure................................................................................................................................. 18
3.5 SpO2 Cable .................................................................................................................................................................. 18
3.6 Description of Rotary Selector .................................................................................................................................... 19
3.6.1 System Maintenance............................................................................................................................................ 20
3.6.2 Communications.................................................................................................................................................. 20
3.6.3 Blood Pressure Setting......................................................................................................................................... 21
3.6.4 SpO2 Setting ........................................................................................................................................................ 21
3.6.5 Temperature Setting ............................................................................................................................................ 22
3.7 Description of Dedicated Keys.................................................................................................................................... 23
3.8 Description of Soft Keys ............................................................................................................................................. 25
3.9 Description of Audible Indicators ............................................................................................................................... 25
Section 4: Set-Up and Usage .................................................................................................................................................. 26
4.1 Initial Set-Up ............................................................................................................................................................... 26
4.2 Blood Pressure Monitoring Process............................................................................................................................. 28
4.3 Display Screens ........................................................................................................................................................... 31
4.3.1 Waveform Trend Display Screen ........................................................................................................................ 32
4.3.2 Trend Table Display Screen ................................................................................................................................ 33
4.3.3 Real Time Display Screen ................................................................................................................................... 33
4.3.4 Graphical Reading Display Screen ...................................................................................................................... 34
4.4 Set-Up Screens for Blood Pressure Monitoring .......................................................................................................... 35
4.4.1 Cycle Time Screen............................................................................................................................................... 35
4.4.2 Sensor Height Screen........................................................................................................................................... 36
4.4.3 Alarm Set-Up Screen........................................................................................................................................... 37
4.4.4 Set Clock Screen.................................................................................................................................................. 38
4.5 Communications Screen .............................................................................................................................................. 38
4.5.1 V-Line Interface Screen....................................................................................................................................... 39
4.5.2 Serial Communications........................................................................................................................................ 41
02/2007
Page 2 of 66
4.5.3 Printer Feature (Optional).................................................................................................................................... 43
4.6 Alarms ......................................................................................................................................................................... 43
4.6.1 Patient Alarms ..................................................................................................................................................... 44
4.7 Tympanic Temperature Measurement (Optional) ....................................................................................................... 45
4.7.1 Displays, Buttons and Panels............................................................................................................................... 45
4.7.2 Taking a Temperature Reading ........................................................................................................................... 45
4.7.3 Tips on Technique ............................................................................................................................................... 47
4.7.4 Operating Controls .............................................................................................................................................. 48
4.7.5 Special Features................................................................................................................................................... 48
4.7.6 Important Precautions.......................................................................................................................................... 49
4.7.7 Fusion™ Temperature Display............................................................................................................................ 50
4.8 Oximetry SpO2 (Optional)........................................................................................................................................... 51
4.8.1 Indications/Contraindications .............................................................................................................................. 51
4.8.2 Monitoring SpO2.................................................................................................................................................. 51
4.8.3 How to Apply the DS-100A Finger Sensor ......................................................................................................... 52
4.8.4 Cleaning Procedures ............................................................................................................................................ 53
4.8.5 Important Precautions.......................................................................................................................................... 53
4.8.6 Oximetry Table Trend Display............................................................................................................................ 54
Section 5: System Features and Specifications ...................................................................................................................... 55
5.1 System Features........................................................................................................................................................... 55
5.2 Technical Specifications.............................................................................................................................................. 55
5.3 Performance Specifications ......................................................................................................................................... 57
Section 6: Troubleshooting..................................................................................................................................................... 58
6.1 Troubleshooting Guide ................................................................................................................................................ 58
6.2 Alarms and Warning Messages ................................................................................................................................... 59
6.2.1 Non-Recoverable Alarms .................................................................................................................................... 59
6.2.2 Recoverable Alarms ............................................................................................................................................ 60
Section 7: Maintenance and Care ........................................................................................................................................... 60
7.1 Service Policy.............................................................................................................................................................. 60
7.2 Cleaning Procedures .................................................................................................................................................... 60
7.3 Precautions for Handling Valve Regulated Lead-Acid Batteries ................................................................................ 61
Section 8: Warranty................................................................................................................................................................ 61
8.1 One Year Limited Warranty for the Fusion™ Equipment........................................................................................... 61
8.2 Contact Information..................................................................................................................................................... 62
8.3 EU Authorized Representative .................................................................................................................................... 62
Section 9: Accessories and Supply Information ..................................................................................................................... 63
Appendix A: Fusion™ System Wrist Strap Replacement ...................................................................................................... 64
Appendix B: Fusion™ System Key and Icon List ................................................................................................................. 65
02/2007
Page 3 of 66
Thank you for purchasing the Medwave Fusion System. The Fusion System is a
sensor based vital signs monitor with available options that uses non-invasive sensors to
measure blood pressure, pulse rate, temperature and Sp02.
02/2007
Page 4 of 66
Index of Figures
Figure 1: Fusion™ System Front Panel - Blood Pressure, Temperature and Oximetry
Figure 2: Fusion™ System Front Panel Blood Pressure Plus Oximetry
Figure 3: Fusion™ System Front Panel - Blood Pressure Only
Figure 4: Fusion™ System Rear Panel
Figure 5: Fusion System Left Side With Printer Option
Figure 6: Fusion System Left Side Without Printer Option
Figure 7: Fusion System Right Side With Temperature Option
Figure 8: Fusion System Right Side Without Temperature Option
Figure 9: Patient Cable End Side View
Figure 10: Patient Cable End Front View
Figure 11: SpO2 Extension Cable
Figure 12: Durasensor
Figure 13: Fusion System Blood Pressure Plus Temperature And SpO2 Label
Figure 14: Fusion System Blood Pressure Plus SpO2 Label
Figure 15: Fusion System Blood Pressure Only Label
Figure 16: System and Maintenance Dial Selection
Figure 17: Communications Dial Selection
Figure 18: Blood Pressure Dial Selection
Figure 19: Set Up Key, Display Key
Figure 20: SpO2 Dial Setting
Figure 21: Fusion System SpO2 Display
Figure 22: Temperature Dial Selection
Figure 23: View Of Dedicated Keys
Figure 24: Soft Keys
Figure 25: Power Cord Receptacle, Back Panel
Figure 26: BP Cable Panel Connection
Figure 27: SpO2 Panel Connector
Figure 28: Thermometer Side Panel View
Figure 29: Probe Cover Side Panel View
Figure 30: Thermal Printer Paper Cover Open
Figure 31: Thermal Printer Paper Cover Closed
Figure 32: On/Standby Key, Front Panel
Figure 33: Zero Sensor Screen
Figure 34: Wrist Piece Of Patient Cable
Figure 35: Wrist Circumference
Figure 36: Placement Guide Label
Figure 37: Placement Guide, Wrist Piece
Figure 38: Placement Guide Installed
Figure 39: Palpate To Find Distal Edge of Radius Bone
Figure 40: Place Sensor At This Point
Figure 41: Secure Strap
Figure 42: Rotary Selector Switch BP
Figure 43: Verify Your Placement
Figure 44: BP Rotary Selector Switch, Start/Stop Key
Figure 45: Waveform Trend Display Screen
02/2007
Page 5 of 66
13
14
15
16
17
17
17
17
18
18
18
18
19
19
19
20
20
21
21
21
21
22
23
25
26
26
26
27
27
27
27
28
28
28
29
29
29
29
30
30
30
28
30
30
32
Figure 46: Table Trend Display Screen
Figure 47: Real Time Display Screen
Figure 48: Graphical Reading Display Screen
Figure 49: Cycle Time Screen
Figure 50: Sensor Height Screen
Figure 51: Waveform Trend Screen With Sensor Height Icon
Figure 52: Alarm Set-Up Screen (Default Settings)
Figure 53: Set Clock Screen
Figure 54: Rotary Function Selector – Communication
Figure 55: V-Line Interface Port
Figure 56: V-Line Interface Communication Screen
Figure 57: Printer Mode Screen
Figure 58: Thermal Printer Screen
Figure 59: Mute Key
Figure 60: Right Panel with Tympanic Thermometer
Figure 61: Mode Selection Button
Figure 62: Battery Panel
Figure 63: Removing Probe From It’s Cradle
Figure 64: Placing Disposable Cover On Probe Tip
Figure 65: Place Probe In Ear Canal
Figure 66: Reading Temperature
Figure 67: Discarding Probe Cover
Figure 68: Fusion Displaying Temperature
Figure 69: Fusion Data Transmission
Figure 70: Battery Removal
Figure 71: Rotary Function Indicator Temperature Position
Figure 72: Temperature Table Trend Display Screen
Figure 73: Finger Sensor
Figure 74: Finger Sensor
Figure 75: Fusion SpO2 Cable Connector Slot
Figure 76: Oximetry Table Trend Display Screen
Figure 79: Position Wrist Strap
Figure 80: Pressing Velcro End In Place
Figure 81: Measure Your Patient’s Wrist Circumference
02/2007
Page 6 of 66
33
33
34
35
36
36
37
38
38
39
39
41
43
43
45
45
45
45
45
46
46
46
47
47
49
50
51
52
52
52
54
64
64
64
Revision History
Rev
ECO
Date
A
60269
10/24/2006
B
70012
02/12/07
02/2007
Page 7 of 66
SECTION 1: SAFETY CONSIDERATIONS
1.1 Warnings, General
Carefully read all of the instructions and precautions described in operator’s manual
prior to clinical use of the Fusion™ Non-Invasive Blood Pressure Patient Monitor
System With Vital Signs Options (The Fusion System).
1.
The Fusion™ System should be placed on a firm flat surface or mounted on a pole or rolling
stand utilizing its integrated pole mount, assuring that the vents on the side and bottom
panels are free of obstructions.
2.
Fusion™ System sensors are not sterile devices and should not be sterilized. ETO or
autoclaving will damage sensors.
3.
Using the Fusion™ System in the presence of flammable anesthetics represents an explosion
hazard.
4.
The Fusion™ System is to be used only by trained medical personnel.
5.
Plug the power cord into an appropriate outlet. To ensure reliable grounding, use only
receptacles marked “HOSPITAL ONLY” or “HOSPITAL GRADE.”
6.
The battery is normally discharged. Allow 8 to 10 hours to completely charge before using
the Fusion™ System in battery backup mode.
1.1.1 Warnings, Parameter Specific, Blood Pressure
1. Proper functioning of the Fusion™ System requires pulsatile radial artery blood flow. The
Fusion™ System cannot be used during cardiopulmonary bypass or cardiopulmonary
resuscitation when radial artery blood flow is absent. Fusion™ may not operate effectively
on patients experiencing tremors, arrhythmias or excessive movement.
2.
The sensor placement and associated extremity should be checked at least every four hours
for circulatory status and skin integrity when Fusion™ System is used over a prolonged
period of time, or if Fusion™ is used on patients with known peripheral vascular disease.
3.
Since the Fusion™ System blood pressure measurement intermittently compresses the radial
artery, it should be used with caution in patients with absent ulnar artery collateral
circulation. If an Allen’s test suggests that this is the case, the Fusion™ System NonInvasive Blood Pressure (NIBP) measurement should not be used in continual mode. If the
opposite arm has better ulnar collateral circulation, this arm should be used instead.
1.1.2 Warnings, Parameter Specific, Temperature Option
1. In the TYMPANIC mode, failing to seal the ear canal opening may result in lower
temperatures. If it is not possible to seal the opening, use the other ear or select an alternative
device and measurement site to obtain the temperature.
02/2007
Page 8 of 66
1.1.3 Warnings, Parameter Specific, Oximetry (SpO2) Option
1. When using the Nellcor® Durasensor® option, always change the sensor location every four
hours (or more often if indicated by circulatory status or skin integrity).
2. The Nellcor® Durasensor™ is for use on patients larger than 40 Kg.
1.2 Precautions and Limitations, General
1. The Fusion™ System may not operate effectively on patients experiencing tremors,
arrhythmias or excessive movement.
2.
•
•
•
•
•
If a Fusion™ System reading does not appear to correspond with other physiological
parameters:
Verify the patient’s physiological state visually and through the use of other monitoring
devices.
Check the patient’s body position to account for hydrostatic pressure differences (specific to
blood pressure).
Observe for motion or noise artifact.
Refer to the Operator’s Manual for the specific parameter in question.
Contact a Medwave® service representative.
1.2.1 Precautions and Limitations, Parameter Specific, Blood Pressure
1. When monitoring blood pressure the Fusion™ System is not intended for use on patients
during cardiopulmonary bypass.
2.
To reference central blood pressure the Fusion™ System blood pressure sensor must be at
heart level or the system must be adjusted (see section 4.4.2, Fig. 50 Sensor Height Screen)
to compensate for the height difference due to the effect that hydrostatic pressure creates.
The approximate rule is for every inch the blood pressure sensor is above heart level, 1.9
mmHg should be added to the reading. For every inch the blood pressure sensor is below
heart level, 1.9 mmHg should be subtracted from the reading.
1.2.2 Precautions and Limitations, Parameter Specific, Temperature
1. Although the Genius™ is ruggedly constructed, it is an optical instrument. For trouble-free
operation, handle carefully and do not drop.
2. Visually inspect the probe cover prior to taking a temperature. The probe cover membrane
should be smoothly stretched across the membrane rim with no holes or wrinkles.
3. In the TYMPANIC mode, failing to seal the ear canal opening may result in lower
temperatures. If it is not possible to seal the opening, use the other ear, or select an
alternative device and measurement site to obtain the temperature.
4. Accuracy is dependent on careful and proper use. Right-handed operators achieve better
accuracy in the patient’s right ear; left-handed operators in the patient’s left ear.
5. Ear-to-ear differences are not an indication of unit inaccuracy. Discrepancies are attributed
to placement “handedness,” asymmetry of ear structures, and blood flow. The incidence of
ear-to-ear discrepancies declines with operator experience. Always wait at least 2 minutes
before taking another temperature reading in the same ear.
6. Should the lens or black window on the tip of the probe become soiled, gently clean using a
lens wipe or lint-free swab. Lens should appear shiny and free of fingerprints and debris.
02/2007
Page 9 of 66
Precautions and Limitations, Parameter Specific, Temperature (continued)
7.
8.
9.
10.
11.
12.
13.
14.
15.
Always use a new probe cover. Soiled covers affect accuracy. Use only FirstTemp Genius™
probe covers. The Genius is only calibrated for use with Genius probe covers. The Genius
probe cover reorder number is 480-0002.
When not in use, Genius should be protected by snapping it into the base unit on the
Fusion™ System for storage.
Genius should not be used on patients with ear drainage, blood, tears, saliva, cerebrospinal
fluid, vernix, ear wax plugs or other foreign body in the ear canal.
Mist tents can leave a wet film inside a patient’s ear, causing evaporative cooling. Unless
ears are covered, the Genius should not be used with patients in mist tents.
Patients with removable hearing aids should remove the device 10 minutes prior to ear
temperature assessment. Implanted hearing aids generally do not affect the ear temperature.
Pressure equalization (PE) or tympanostomy tubes will not compromise the measurement
accuracy. However, to assure patient comfort, one week should be allowed post-operatively
before using the Genius.
Patients assessed immediately after coming in from cold weather may exhibit lower ear
temperatures. A 10-minute wait is recommended for re-warming.
Excessive scarring of the eardrum can cause lowered temperature readings.
Earwax normally does not affect accuracy. However, cerumen plugs or impactions contain
debris, such as dirt and dead skin cells that can lower ear temperature measurements by
several tenths of a degree.
1.2.3 Precautions and Limitations, Parameter Specific, Oximetry (SpO2)
1. Do not sterilize by irradiation, steam, or ethylene oxide. Such sterilization could damage the
sensor.
2. Failure to apply the DS-100A properly may cause incorrect measurements.
3. Using the DS-100A in the presence of bright lights may result in inaccurate measurements.
In such cases, cover the sensor site with an opaque material.
4. Reusable sensors must be moved to a new site at least every 4 hours. Because individual skin
condition affects the ability of the skin to tolerate sensor placement, it may be necessary to
change the sensor site more frequently with some patients. If skin integrity changes, move
the sensor to another site.
5. Intravascular dyes or externally applied coloring such as nail polish, dye, or pigmented
cream, may lead to inaccurate measurements.
6. The performance of the DS-100A is compromised by motion.
7. Do not apply tape to secure the sensor in place or to tape it shut; venous pulsations may lead
to inaccurate saturation measurements.
8. As with all medical equipment, carefully route cables to reduce the possibility of patient
entanglement or strangulation.
9. Do not use the DS-100A or other oximetry sensors during Magnetic Resonance Imaging
(MRI) scanning. Conducted current may cause burns. Also, the DS-100A may affect the
MRI image, and the MRI unit may affect the accuracy of oximetry measurements.
10. Do not alter or modify the DS-100A. Alterations or modifications may affect performance or
accuracy.
02/2007
Page 10 of 66
SECTION 2: INTRODUCTION
2.1 Intended Use
The Fusion™ Non-Invasive Blood Pressure Monitor is intended to be used on patients with wrist
circumference of 11cm – 22cm by trained medical personnel to continually monitor systolic, diastolic and
mean blood pressure and pulse rate.
The Fusion™ System module option of SpO2 is indicated for the continuous non-invasive monitoring of a
patient’s functional oxygen saturation of arterial hemoglobin (SpO2) by trained medical personnel.
The Fusion™ System module option of Genius™ Thermometry is indicated for the measuring of a
patient’s body temperature.
The Fusion™ System is a sensor based vital signs monitor that uses non-invasive sensors to measure blood
pressure, pulse rate, temperature and SpO2. This device is intended for use on patients by trained medical
personnel to continually monitor systolic, diastolic and mean blood pressure as well as pulse rate with SpO2
and temperature as optional parameters. The information from this device is intended to guide clinicians in
the therapeutic management of their patients by providing accurate and frequently updated vital signs
information in a safe, non-invasive, easily obtained, and comfortable manner.
It should be recognized that this device is intended for use by competent, trained, healthcare providers who
will determine a diagnosis based on many factors, of which the Fusion™ System is one component.
Incorrect readings due to such things as motion artifact are expected to be disregarded by the practitioner.
The sensor locations for SpO2 and blood pressure and the associated extremity should be checked every
four hours for circulation and skin integrity when the Fusion™ System is used over a prolonged period of
time.
2.2 General Description
The basic Fusion™ System is a non-invasive blood pressure monitor that uses a pressure sensor placed
directly on top of the radial artery. This sensor is non-invasive and eliminates the need for an occlusive
inflatable blood pressure cuff. This device is intended for use on patients by trained medical personnel to
continually monitor systolic, diastolic and mean blood pressure as well as pulse rate. The Fusion™ System
has a built in battery backup feature that provides uninterrupted operation for approximately three hours
while in the continual mode. The system has the capability to have expanded monitoring with temperature
and or SpO2 parameters optional.
The Fusion™ System uses a patented “sweep technique” for blood pressure monitoring that applies a
varying force on the radial artery. The counter-pressure in the artery produces a signal that is digitized and
used to calculate blood pressure parameters.
The sensor measures the pulse at the point of maximum energy transfer. Medwave’s proprietary algorithms
analyze the wave shapes. Parameters are extracted from the waveforms and a set of coefficients is applied
to them yielding systolic, diastolic and mean blood pressures approximately every 15 heart beats. These
algorithms have been tested and validated in clinical studies by synchronized comparisons to arterial line
blood pressure waveforms and values.
Patient blood pressures can be monitored by viewing the screen and entering limits into the Fusion™
System alarm menu. Patient measurements above or below the limits will be automatically brought to the
attention of the caregiver through visual and audible alarms. An NIBP START/STOP key provides the
operator with an option to cancel operation at anytime.
The Fusion™ System is delivered with the built in “V-Line Interface” that enables the blood pressure
parameters and arterial waveforms to be displayed on a larger systems based “host” patient monitor. It is
02/2007
Page 11 of 66
compatible with any patient monitor that has an invasive arterial line blood pressure channel that provides a
transducer excitation (supply) voltage in the range of 4 to 8 volts DC.
General Description (continued)
The Fusion™ System V-Line Interface generates an analog signal that is interpreted by the Invasive Blood
Pressure (IBP) channel in the “host” patient monitor as if it were an arterial line pressure transducer signal
in the patient’s artery.
Your unit may also come equipped with the Nellcor® Oximetry and Durasensor® Adult Oxygen Sensor,
Model DS-100A. It is indicated for use when continuous non-invasive arterial oxygen saturation and
monitoring is required for patients weighing greater than 40 Kg.
Additionally your Fusion™ System may come equipped with the Kendall Genius tympanic thermometry
option. This allows the caregiver to take the patient’s temperature in the ear canal. Based on clinical studies
it has the ability to compensate for the average differences between its reading and those found when
measuring temperature orally, rectally or with a Swan-Ganz catheter. The Genius will adjust its reading to a
user selected equivalence based on statistical differences.
The Fusion™ System can come equipped with a built-in thermal printer. The printer can print data tables
for data retention and patient charting.
02/2007
Page 12 of 66
SECTION 3: DISPLAYS, KEYS AND CONNECTORS
3.1 Front Panel - Blood Pressure, Temperature and Oximetry
This shows the front views of the Fusion System and identifies displays, controls, indicators,
and connectors.
19
1
18
17
16
2
3
15
14
13
4
5
12
Figure 1 Front Panel-Blood Pressure,
Temperature and Oximetry
1
2
3
4
5
6
7
8
9
10
6
7
8 9 10 11
Temperature Display*
Oximetry Display*
AC Power Indicator
On/Standby Key
Fusion System Patient Cable Connector
Rotary Function Selector
System Soft Keys
Set-Up Screen Key
Display Screen Key
Mute Key
11
12
13
14
15
16
17
18
19
NIBP Start/Stop Key
SpO2Cable Connector*
Main Display
DC Power Indicator
Low Battery Indicator
Mean Display
Diastolic Display
Systolic Display
Degree C or F Indicator*
*Optional Equipment
02/2007
Page 13 of 66
3.1.1 Front Panel-Blood Pressure and Oximetry
17
16
1
15
2
14
13
12
3
11
4
Figure 2 Front Panel-Blood Pressure
and Oximetry
1
2
3
4
5
6
7
8
9
5
6
7 8 9 10
Oximetry Display*
AC Power Indicator
On/Standby Key
System Soft Keys
Set-Up Screen Key
Display Screen Key
Mute Key
10
11
12
13
14
15
16
17
NIBP Start/Stop Key
SpO2 Cable Connector*
Main Display
DC Power Indicator
Mean Display
Diastolic Display
Systolic Display
*Optional Equipment
02/2007
Page 14 of 66
3.1.2 Front Panel –Blood Pressure Only
15
14
1
13
12
11
10
2
3
4
5
6 7 8 9
AC Power Indicator
9
On/Standby Key
10
11
12
System Soft Keys
13
Set-Up Screen Key
14
Display Screen Key
15
Mute Key
Figure 3 Front Panel –Blood Pressure Only
1
2
3
4
5
6
7
8
02/2007
Page 15 of 66
NIBP Start/Stop Key
Main Display
DC Power Indicator
Mean Display
Diastolic Display
Systolic Display
3.2 Rear Panel
Figure 4 Rear Panel
1
2
3
4
02/2007
Page 16 of 66
Power Cord Connection
RS232 Serial Communication Port
V-Line Interface Port
Pole Mount Knob and Clamp
3.3 Side Panel Left
Figure 5 Fusion System Left Side
With Printer Option
Figure 6 Fusion System Left Side
Without Printer Option
3.3.1 Side Panel Right
Figure 7 Fusion System Right Side
With Temperature Option
02/2007
Page 17 of 66
Figure 8 Fusion System Right Side
Without Temperature Option
3.4 Patient Cable for Blood Pressure
Figure 9 Patient Cable End Side View
1
2
3
4
Bale Cord
Bale
Wrist Guide
Wrist Strap
Figure 10 Patient Cable End Front View
5 Sensor
6 Cable Strain Relief
7 Cable
3.5 SpO2 Cable
Figure 12 Durasensor
Figure 11 SpO2 Extension Cable
02/2007
Page 18 of 66
3.6 Description of Rotary Selector
Depending on the configuration of your Fusion™ System you will have one of the three labels shown
below associated with the rotary selector.
Please note that the Fusion™ System must pass the zero sensor process prior to use or Fusion™ System
will not allow access to other screens. If equipped with either temperature or SpO2 option, Fusion™ System
will still show temperature and SpO2 on their respective digital displays but will not allow access to the
memory until the zero sensor process is complete.
Figure 13 Fusion™ System Blood Pressure Plus Temperature and SpO2 Label.
Figure 14 Fusion™ System Blood Pressure Plus SpO2 Label.
Figure 15 Fusion™ System Blood Pressure Only Label.
02/2007
Page 19 of 66
Set-Up Key
Figure 16 System and Maintenance Dial Selection
3.6.1
System and Maintenance
Allows the user to set the proper time on the Fusion™ System. For more information on setting the time
refer to section 4.4.4 SET CLOCK SCREEN.
Set-Up Key
Figure 17 Communications Dial Selection
3.6.2
Communications
When communications is selected, the first screen available in this setting allows the user to test the
interface connection to the invasive pressure channel of a cardiac monitor. For more information on
interfacing Fusion™ System with another monitor see section 4.5 COMMUNICATION SCREENS.
By pressing the Set-Up key once, the user is brought to the general serial device (GSD) screen. It allows the
user to download blood pressure or SpO2 or temperature readings or SpO2 from the memory if the Fusion™
System is equipped with these functions. For more information on the computer interface refer to section
4.5.2 SERIAL COMMUNICATION.
By pressing the Set-Up key a second time, the user is brought to the thermal printer (TP) screen. If the
Fusion™ System is equipped with the optional thermal printer, this allows the user to print blood pressure
readings and if configured, SpO2 and temperature. For more information on the print function refer to
section 4.5.3 PRINTER FEATURE.
02/2007
Page 20 of 66
Set-Up Key
Display Key
Figure 18 BP Dial Selection
3.6.3
Figure 19 Set-Up, Display
Blood Pressure Setting
With the selector in the BP setting, the initial screen will be the waveform trend screen. This is the main
monitoring screen for blood pressure. If the display screen key or Set-Up key is pressed the display will
have various functions that are described in detail in section 3.7 DESCRIPTION OF DEDICATED KEYS.
SpO2
Figure 20 SpO2 Dial Selection
Figure 21 SpO2 Display
3.6.4 SpO2 Setting
If your Fusion™ System is configured for SpO2 monitoring, with the rotary selector set in SpO2 it
allows the user to view the SpO2 Memory table. If configured with the SpO2 option, the selector
does not have to be in the SpO2 setting to view real time readings. These are displayed on the
SpO2 digital display regardless of the rotary selector setting as long as the SpO2 sensor is properly
connected to a patient. For more information on the SpO2 memory table refer to section 4.8.6
OXIMETRY TABLE TREND DISPLAY.
02/2007
Page 21 of 66
Figure 22 Temperature Dial Selection
3.6.5
Temperature Setting
If your Fusion™ System is configured for temperature monitoring, with the rotary selector set in
temperature it allows the user to view the temperature table. The most recent measurement is displayed on
the temperature digital display (once the probe is docked on the side of Fusion™ System) regardless of the
rotary selector setting, and on the temperature probe’s independent display. For more information on the
temperature table refer to section 4.7 TYMPANIC TEMPERATURE MEASUREMENT.
02/2007
Page 22 of 66
Figure 23 View of Dedicated Keys
3.7 Description of Dedicated Keys
The On/Standby key, which is a momentary hold down button, powers the Fusion™
System on or off.
With the rotary selector set to BP, the Set-Up key, when depressed, allows the user to access
four different screens.
Press once: Fusion™ System switches to the cycle time screen, allowing the user to select the
time interval between blood pressure readings. For detailed instructions see Fig. 49, section
4.4.1 CYCLE TIME SCREEN.
Press twice: Fusion™ System switches to the Sensor Height Screen, allowing the user to
compensate for the height difference between the wrist sensor and heart level. For detailed
instructions see Fig. 50, section 4.4.2 SENSOR HEIGHT SCREEN.
Press three times: Fusion™ System switches to the alarm setting screen allowing the user to
set high and low alarm limits for systolic, diastolic and mean blood pressure as well as pulse
rate. For detailed instructions see Fig. 52, section 4.4.3 ALARM SET-UP SCREEN.
Press four times: Fusion™ System returns to the cycle time screen. With the rotary selector
set to the communication symbol, the display defaults to the V-Line set up screen. For
detailed instructions see section 4.5.1 V-LINE INTERFACE SCREEN.
With the rotary selector set to the communications setting, the Set-Up key when depressed
allows the user to access two different screens.
Pressing the Set-Up key once: Fusion™ System switches to the general serial device (GSD)
screen allowing the user to download blood pressure readings from memory to a computer.
For detailed instructions see Fig. 57, section 4.5.2 SERIAL COMMUNICATION.
Pressing the Set-Up key twice: Fusion™ System switches to the thermal printer screen
allowing the user to print blood pressure readings, SPO2 and temperature from memory if the
printer option is installed. For detailed instructions see Fig. 58 section 4.5.3 PRINTER
FEATURE.
02/2007
Page 23 of 66
Description of Dedicated Keys (continued)
With the rotary selector set to BP, the Display Screen key is used to switch between four
screens.
Waveform Trend Display: This is the default screen when the rotary selector is initially set
to BP. This is considered the main monitoring screen for blood pressure. For a detailed
explanation of the Waveform Trend Display, refer to Fig. 50, section 4.4.2
SENSOR HEIGHT SCREEN.
Press the Display Key once: Fusion™ System switches to the table trend display screen
allowing the user to scroll forward and backward to view blood pressure readings stored in
memory. For detailed instructions see Fig. 46 section 4.3.2 TABLE TREND DISPLAY
SCREEN.
Press the Display Key twice: Fusion™ System switches to the graphical trend screen
allowing the user to view the blood pressure readings in memory in a line graph format to
easily spot rising or falling trends. For detailed instructions see Fig. 48 section 4.3.4
GRAPHICAL READING DISPLAY SCREEN.
Press the Display Key three times: Fusion™ System switches to the real time screen
allowing the user to view the pressure sensor waveform as it is being swept against the
patient’s wrist. For detailed instructions see Fig. 47 section 4.3.3 REAL TIME DISPLAY
SCREEN.
Press the Display Key four times: Fusion™ System reverts back to the waveform trend or
main blood pressure monitoring screen.
The display key is only functional in the BP setting of the rotary switch.
Mute: Pressing the Mute key once silences the audible alarms for recoverable errors. For
detailed instructions see sections 4.6 and 6.2.2.
NIBP Start/Stop: Starts or stops a blood pressure monitoring session.
02/2007
Page 24 of 66
3.8 Description of Soft Keys
(Located below the Display Screen)
Soft Keys
Soft Keys
Figure 24 Soft Keys
Soft Keys perform different functions with different screens. The screen label above the key
indicates its function. Note: Fusion™ System is not a touch screen device.
3.9 Description of Audible Indicators
A one-second beep is heard when the Fusion™ System is powered on. Two one-second beeps are
sounded when the blood pressure sensor is successfully zeroed.
If the Fusion™ System is equipped with the Kendall Genius temperature option, the temperature
probe generates three beeps when a temperature reading is complete.
For a description of audible alarms refer to section 4.6 ALARMS.
02/2007
Page 25 of 66
SECTION 4: SET-UP AND USAGE
4.1 Initial Set-Up
The Fusion™ System is always equipped with Medwave’s blood pressure monitor, a blood pressure patient
cable, with a Fusion permanent sensor, a pole mount clamp, and internal battery and power cord plus RJ11
Cable. Options for Fusion™ System are: SpO2, tympanic thermometry and printer.
1.
Unpack the Fusion™ System. Verify that all your components are included. Place the base
of the unit on a firm flat surface or mount it to a pole or rolling stand using the installed pole
mount. The vents at the side and bottom must be free of obstructions.
2.
Connect the power cord to the receptacle on the back panel of the
Fusion™ System. Plug the power cord into an appropriate outlet. To
ensure reliable grounding, use only wall receptacles marked
“HOSPITAL ONLY” or “HOSPITAL GRADE.” The battery may not
be fully charged upon receipt. You should leave the Fusion plugged
in for 24 hours to insure that the battery is fully charged.
Figure 25 Power Cord Receptacle, Back Panel
3.
Connect the blood pressure patient cable to the BP cable connector
labeled with this icon located in the lower left corner of the front panel.
BP Cable Connection
Figure 26 BP Cable Panel Connector
4.
If you have the SpO2 option, connect the sensor to the cable and then attach
the cable to the connector on the lower right side.
SpO2 Connector
Figure 27 SpO2 Panel Connector
02/2007
Page 26 of 66
Set-Up and Usage(continued)
5.
If you have the temperature option, place the probe cover cartridges in the probe cover cartridge holder
on the right side of the Fusion™ System and place the temperature probe in the Fusion™ System
temperature probe cradle.
Probe
Probe Covers
Figure 28 Thermometer Side Panel View
Figure 29 Probe Cover Side Panel View
6. If you have the thermal printer option, install paper included for the printer.
1 Press the paper cover open-button to open the paper cover.
Handle the paper cutter carefully so as not to cut your hand.
2 Set a paper roll (size 58mm width by 28mm diameter) as shown in the illustration below.
3 Close the paper cover by pressing both ends of the cover so the tip end of the paper emerges from
the printer.
Figure 30 Thermal Printer Paper Cover Open
02/2007
Page 27 of 66
Figure 31 Thermal Printer Paper Cover Closed
Initial Set-Up (continued)
7.
As in Fig. 42, set the rotary selector switch to BP. Turn the system on by pressing
and momentarily holding the ON/STANDBY key. Refer to Fig. 32.
Figure 32 On/Standby Key, Front Panel
Figure 42 Rotary Selector Switch BP
The Fusion System automatically performs a Self-Test before displaying the “Zero Sensor” screen. You
are ready to begin the BP Monitoring Process.
4.2 Blood Pressure Monitoring Process
4.2.1
ZERO Sensor Process
As demonstrated in Fig. 34, hold the wrist piece of
the blood pressure Patient Cable vertical.
Press the soft key
below the word
zero on the
screen as shown
in Fig. 33.
Figure 33 Zero Sensor Screen
Figure 34 Wrist Piece of Patient Cable
Note: Each time the unit is powered on, the ZERO SENSOR process must be performed.
Once the Zero Sensor process has been completed, the monitor will beep twice indicating the Zero Sensor process is
complete. You can now begin monitoring your patient.
02/2007
Page 28 of 66
4.2.2 Select The Correct Placement Guide and Wrist Strap.
Measure your patient’s wrist circumference. Select the appropriate
placement guide and wrist strap for your monitoring session. You must use
a placement guide when monitoring your patient.
Adult Normal
Black Guide\Label
Black Wrist Strap
Wrist Sizes:
15 – 18 cm
Figure 35 Wrist Circumference
Large Adult
Gray Label
Black Wrist Strap
Wrist Sizes:
18 – 22 cm
Pediatric
Blue Label
Navy Blue Wrist Strap
Wrist Sizes:
11 – 15 cm
Figure 36 Placement Guide Label
4.2.3
Installing The Placement Guide
The placement guide has two keyhole locators for placing and positioning. One end of
the keyhole has a larger hole than the other end of the keyhole.
Holding the wrist piece in one hand and the placement guide with your thumb and
forefinger of the other hand, align both of the larger holes over each of the guide posts.
Press the placement guide to the wrist piece and slide the placement guide forward –
locking the guide posts into the smaller holes of the keyhole. The guide should snap into
the correct position.
Figure 37 Placement Guide,
The placement guide edge should line up flush to the
Wrist Piece
sensor holder edge. You must use a placement guide
when monitoring your patient.
4.2.4
Removing the Placement Guide
The placement guide has two keyhole locators for placing and positioning. One end of
the keyhole has a larger hole than the other end of the keyhole.
Figure 38 Placement
Guide Installed
Holding the wrist piece in one hand and the placement guide with your thumb and
forefinger of the other hand, press the placement guide to the wrist piece and slide the
placement guide backward – moving the guide posts from the smaller holes of the
keyhole to the larger hole of the keyholes. Pull the guide upward, away from wrist
piece.
Install your new placement guide as described in 4.23 Installing The Placement Guide.
Note: Beneath the placement guide you will see a label stating:
If you see this label - Do not place the sensor on a patient.
You must install a placement guide before proceeding.
02/2007
Page 29 of 66
4.2.5 Placing The Sensor On Your Patient
To locate the proper sensor position, with your finger palpate to
find the distal edge of the radius bone. See Fig. 39..
Figure 39 Palpate To Find Distal Edge Of Radius Bone
Place the sensor directly over the distal edge of the radius
bone as indicated in Fig. 40.
Figure 40 Place Sensor at This Point
Secure the strap snugly
as in Fig.41
.
Figure 41 Secure Strap
Place a finger through the
access hole of the placement
guide and feel the distal edge
of the radius bone. Verify
your nylon Velcro® strap is
secure
Figure 43 Verify Your Placement
Prior to starting your blood pressure monitoring session, you may
want to review the operator’s manual sections scale adjustment
(section 4.3.1), cycle time (section 4.4.1) sensor height (section
4.4.2), and alarms (section 4.4.3) to make additional settings.
Check that your rotary selector switch is set to BP as in Fig. 44.
NIBP START/STOP key to begin monitoring.
Press
Always conclude the monitoring session by pressing the NIBP
START/STOP key prior to removing sensor from patient.
02/2007
Page 30 of 66
B
Figure 44 BP Rotary Selector Switch, Start/Stop Key
Placing the sensor (continued)
If the Fusion™ System is not providing a reading, the strap tension may need to be adjusted or the sensor
repositioned. (Refer to steps A-C of this section). Patient movement or motion artifact may also cause
missed readings; this will be noticeable on the elapsed time clock on the Waveform Trend Screen.
Note: The system requires the initial strap tension to be snug before it allows monitoring to begin.
The first reading may take up to 30 seconds. During this time it is especially important that the patient’s
wrist remain still.
When set in the CONTINUAL cycle mode, the Fusion™ System is designed to obtain and update accurate
blood pressure readings every 12-15 heart beats. Once the Fusion™ System begins displaying blood
pressure readings, you should see updated readings every 12-15 seconds. If the elapsed time display is
greater than 12-15 seconds you may need to check your sensor placement.
NOTE: Accurate and repeatable operation of the Fusion™ System is dependent upon the proper
preparation and placement of the sensor. It will tolerate some flexibility in placement. However, for the
best signal, placement needs to be over a hard surface, not where tissue is soft. Optimum sensor position
occurs when the sensor signal strength bar, which is located on the right hand side of the LCD display, is
at its maximum height, the readings are updating approximately every 15 seconds. Additionally, the
operator should observe the arterial waveform for consistency. If sensor placement is in question, these
parameters (arterial waveform consistency, sensor signal strength, elapsed time between readings, and
arterial waveform consistency) may be used as indications of sensor placement.
4.3 Display Screens
Note: When the Rotary Function Selector Indicator is in BP position.
Display modes: Repeatedly pressing the DISPLAY
key scrolls through four different screens:
• Waveform Trend Display Screen (See section 4.3.1)
• Table Trend Display Screen (See section 4.3.2)
• Graphical Reading Display Screen (See section 4.3.4)
• Real Time Display Screen (See section 4.3.3)
02/2007
Page 31 of 66
4.3.1 Waveform Trend Display Screen
This screen is the main monitoring screen for blood pressure. It shows the arterial waveform, elapsed time
from the previous reading, the current time, the cycle time setting, as well as pulse rate. Additionally this
display shows the sensor signal strength and sensor pressure and whether the blood pressure alarm is active
or muted.
Figure 45 Waveform Trend Display Screen
(00:08 Elapsed time since last displayed reading)
Scale Adjustment
For optimal viewing of the arterial waveform, the scale of the waveform trend screen may need adjustment.
This involves the use of two soft keys. Using the example in Fig. 45, pressing the soft key under “scale”
will increase the scale as indicated by the word up and the up arrow↑ If it is desired to decrease the scale,
you would press the soft key under the up arrow, it will change to down↓ and now pressing the scale soft
key will decrease the scale. Proper scaling for optimal viewing of the waveform can also be achieved
automatically. This is achieved by pressing the up↑/down↓ soft key until the display changes to Auto.
Up↑ allows you to move upward through the preset graduations for each press of the scale soft key.
Down↓ allows you to move downward through the preset graduations of 40 - 100 mmHg, 30 - 150 mmHg,
20 - 200 mmHg, and 0 - 300 mmHg for each press of the soft key.
Auto automatically scales the preset graduations upward when the arterial waveforms’ peak value exceeds
10% of the current scale graduation or downward when the arterial waveform’s peak value is 30% less than
the current scale.
02/2007
Page 32 of 66
4.3.2 Table Trend Display Screen
The Table Trend Display Screen displays the patient’s systolic, diastolic, mean, and pulse rate in tabular
form. This screen is selected by toggling the display key.
SCAN FWD
Figure 46 Table Trend Display Screen
Allows the user to scroll forward in time.
SCAN BACK Allows the user to scroll back in time to view previous readings.
CLEAR
Erases all of the trend data, including waveform and graphical trend data. When
this option is selected, a confirmation notice is displayed with YES and NO
options. If YES, is chosen, the data is erased; if NO is chosen, you are taken back
to the trend screen.
The Fusion™ System will store up to 900 time-stamped blood pressure readings 100 SpO2 readings and 25
temperature readings if configured with these options. This allows the user to view readings that occurred
at any time in the patient’s treatment cycle. If more than 900 readings occur for a given patient, the oldest
data is replaced. The user also has the ability to print these readings if the optional thermal printer is
installed, or export the readings to a computer. (See sections 4.5.2, SERIAL COMMUNICATION AND
4.5.3, PRINTER FEATURE) This provides the caregiver flexibility in recording the blood pressure
readings into the patient chart.
Note: The Table Trend Display Screen contains no patient identification information so care should be
taken to clear the trend data between patients to eliminate the possibility of confusing the data.
4.3.3 Real Time Display Screen
The Real Time Display Screen displays the pressure signal as produced by the sweeping motor activity.
This signal is NOT the patient’s blood pressure waveform in mmHg. The pressure graphically
displayed is the amount of pressure being applied against the patient’s wrist.
Figure 47 Real Time Display Screen
02/2007
Page 33 of 66
Real-Time Display Screen (continued)
The Fusion™ System uses a patented “sweep technique” for blood pressure monitoring that applies a
varying force on the radial artery. The counter-pressure in the artery produces a signal that is digitized and
used to calculate blood pressure parameters. The sensor measures the pulse at the point of maximum energy
transfer; Medwave’s proprietary algorithms analyze the wave shapes. Parameters are extracted from the
waveforms and a set of coefficients is applied to them yielding systolic, diastolic and mean pressures
approximately every 15 heart beats. These algorithms have been tested and validated in clinical studies by
synchronized comparisons to arterial line pressure waveforms.
4.3.4 Graphical Reading Display Screen
The Graphical Reading Display Screen displays the patient’s systolic, diastolic, mean, and pulse rate in
graphical forms over a selected period of time.
Figure 48 Graphical Reading Display Screen
MEAN
SYS/DIA
PULSE
TIME
User is able to view graphical display of mean pressure readings.
User is able to view graphical display of systolic and diastolic readings.
User is able to view graphical display of pulse readings.
Changes the increments that are displayed on the graph. Toggles through display
increments of 15, 30 minutes; 1, 2, 4, 8 hour.
These screens give the clinician a quick overview of the patient’s pressure readings over time.
They illustrate clearly the trend of the patient’s pressures and pulse rate, allowing a rapid
assessment of the improvement or degradation of the patient over the course of monitoring.
Note: Clearing the table trend information also clears the graphical readings.
02/2007
Page 34 of 66
4.4 Set-Up Screens for Blood Pressure Monitoring
Set-up modes:
key while the rotary selector is set to BP scrolls through
Repeatedly pressing the SET-UP
three different screens:
• Cycle Time Screen (See section 4.4.1)
• Sensor Height Screen (See section 4.4.2)
• Alarms Set-up Screen (See section 4.4.3)
With Rotary Function selector in System and Maintenance:
Set Clock Screen (See section 4.4.4)
4.4.1 Cycle Time Screen
The Cycle Time Screen allows the user to select the length of time between pressure
measurements. You can make an immediate (STAT) measurement during all cycle times with the
exception of Continual.
Figure 49 Cycle Time Screen
CYCLE
Adjusts the time between pressure measurements. Cycle Time is Continual, 1 minute,
3 minutes, 5 minutes, or 15 minutes. The default is continual.
STAT
Takes continual readings for one minute then reverts to previously set cycle time.
---
These three dashes will appear on the waveform trend screen over the fourth soft key
when STAT key is inactive. If other than continual is selected, you must begin
monitoring for the word STAT to appear over the fourth soft key.
02/2007
Page 35 of 66
4.4.2 Sensor Height Screen
The Sensor Height Screen allows the user to enter the height difference between the wrist sensor and the
heart level. The range is 12 inches (30 cm) above the heart to 24 inches (62 cm) below the heart.
Figure 50 Sensor Height Screen
SENSOR↓
Decreases the height difference between the sensor housing and the heart level in
one-inch increments. Range is 1 through 24 inches.
SENSOR↑
Increases the height difference between the sensor housing and the heart level in
one-inch increments. Range is 1 through 12 inches.
INCH CM
Selects inches or centimeters as the height units.
OFF ON
Turns feature off or on. Default is OFF, height difference is set to zero.
Note: When the Sensor Height option is selected and in use, the Sensor Height
icon will appear on the left side of the waveform trend screen indicating that it is
active and displaying the sensor height setting.
Figure 51
Waveform Trend Screen with Sensor Height Icon
To reference central blood pressure the Fusion™ blood pressure sensor must be at heart level or the system
must be adjusted to compensate for the height difference due to the effect that hydrostatic pressure creates.
The approximate rule is for every inch the blood pressure sensor is above heart level, 1.9 mmHg should be
added to the reading. For every inch the blood pressure sensor is below heart level, 1.9 mmHg should be
subtracted from the reading. Adjusting the sensor height compensation correctly ensures accurate blood
pressure readings.
02/2007
Page 36 of 66
4.4.3 Alarm Set-Up Screen
ALARM SET-UP screen allows for customizing alarm values for systolic, diastolic, and mean blood
pressures and pulse rate.
Figure 52
Alarm Set-Up Screen (Default Settings)
SELECT
Selects the desired parameter. A solid, vertical bar will indicate the selected
parameter.
HI LMT
Moves the high limit up for the selected parameter in increments of 5 mmHg,
until the maximum value allowed for that parameter is reached. The limit then
“rolls over” to the minimum value allowed for that parameter.
LO LMT
Moves the low limit down for the selected parameter in increments of 5 mmHg,
until the minimum value allowed for that parameter is reached. The limit then
“rolls over” to the maximum value allowed for that parameter.
DEFAULT
Returns to default settings as shown in Fig. 52.
Alarm Parameter Ranges
High Limits
High Limit Default
Systolic
75 - 250
240
40 - 150
40
Mean
60 - 200
140
30 - 130
30
Diastolic
40 - 180
130
20 - 120
20
Pulse Rate
60 - 200
200
40 - 120
40
02/2007
Page 37 of 66
Low Limits
Low Limit Default
4.4.4 Set Clock Screen
The SET CLOCK screen controls setting of time and can be viewed when the rotary function selector is in
the System and Maintenance position.
Figure 53 Set Clock Screen
SELECT
Moves cursor to the hours or minutes.
INCREASE
Increases the numerical values of the selected parameter.
DECREASE
Decreases the numerical values of the selected parameter.
ACCEPT
Sets the clock to the time and date on the screen.
NOTE
The time is displayed in 24-hour format and is factory set. To exit this screen
without changing time, you must rotate the Rotary Function Selector off from
System and Maintenance.
4.5 Communication Screens
Note: The Rotary Function Selector has to be in the Communications Indicator Position.
Figure 54 Rotary Function Selector Communication
02/2007
Page 38 of 66
4.5.1 V-Line Interface Screen
V-Line interface port in the back side
of the unit is labeled with this symbol.
Figure 55 V-Line Interface Port
Set-Up
Note: The Fusion™ V-Line interface needs a host patient monitor with an available invasive blood
pressure channel which operates in a range of 4 - 8V DC. Check your Invasive Blood Pressure (IBP)
manufacturer’s manual for the channel’s excitation voltage range.
1.
You will need a host patient monitor with invasive blood pressure channel, an extension transducer
cable that is compatible to your host patient monitor’s IBP channel and the Fusion™ RJ11 cable
(included). These are typically unshielded extension transducer cables provided by your host IBP
patient monitoring company.
2.
Locate the pressure extension transducer cable that is compatible to your host patient monitor’s IBP
channel. You should confirm that the available end of that cable has a four-conductor (RJ11) phone
jack connector to connect to Fusion™ RJ11 cable (included). If you do not currently have this style
cable, contact your host patient monitoring company to purchase or contact Medwave.
3.
Connect the host monitor’s IBP exension transducer cable to the V-Line port via the RJ11 cable on the
rear of the Fusion™ monitor and insure it is connected properly to the host monitor. The Rotary
Function Selector needs to be in the Communication position. The screen below will be shown:
Figure 56
V-Line Interface Communication Screen
02/2007
Page 39 of 66
V-Line Interface Screen (continued)
Numeric scaling must be verified and the host monitor requires zeroing before utilizing the V-Line feature.
Each of the keys has a value (0, 50, 100, and 150) and once the key is pressed the corresponding value will
be sent to the host monitor.
4.
Press the soft key for 0 mmHg and zero the host monitor. The host monitor should show 0 mmHg in its
Invasive Blood Pressure (IBP) display, with accuracy being +/- 2.5 mmHg.
5.
Press the soft key for 50 mmHg and the host monitor should show 50 in its IBP display, with accuracy
being +/-the 2.5 mmHg.
6.
Press the soft key for 100 mmHg and the host monitor should show 100 in its IBP display, with
accuracy being +/-the 2.5 mmHg.
7.
Press the soft key for 150 mmHg and the host monitor should show 150 in its IBP display, with
accuracy being +/-the 2.5 mmHg.
This process ensures proper communication between Fusion™ System and the Host monitor.
Note: Fusion™ System sends the arterial waveform to the host monitor and the host monitor calculates
blood pressure from the waveform. You may observe a slight discrepancy between the Fusion™ blood
pressure readings and those calculated by the host monitor due to differences in algorithms.
Important
The arterial waveform sent to the host by Fusion™ System will appear to be continuous. It is not.
The waveform is replicated to ensure it does not cause nuisance alarms on the host monitor. The waveform
will not change until the next reading in approximately 15 seconds. However, if the signal is lost it will
immediately reflect on the host monitor.
Safety Considerations
Do not use the Fusion™ System V-Line interface Package if it has failed to scale from 0
mmHg to 150 mmHg during the initial set up. If the values displayed by the host monitor do
not correspond to the values being sent by the Fusion™ System V-Line Interface, readings may
be inaccurate and may affect the quality of monitoring.
To avoid risk of damage to the Fusion™ System V-Line interface RJ11 cable and/or to your IBP pressure
transducer cable, pull by RJ11 phone jack end rather than the cord when disconnecting it from the IBP
extension transducer cable.
Make sure the Fusion™ System RJ11 Cable, connected to your pressure transducer extension cable is
located so that it will not be stepped on, tripped over, or otherwise subjected to damage or stress.
Do not operate the Fusion™ System V-Line Interface with a damaged cord, jack, and/or plug, or if it has
received a sharp blow, been dropped, or has been damaged. Contact Medwave Customer Service at 800894-7601 or e-mail at [email protected] for any further questions.
02/2007
Page 40 of 66
4.5.2 Serial Communication
The Data communication port in the back side of the unit is labeled with this symbol.
With the rotary function selector set to the Communication Indicator, press the set-up key once. The Serial
Communication screen is used to download tabular data to a user supplied general purpose computer (such
as a personal computer) with an RS232 port. Blood pressure readings are directed to the data port from the
trend history table when the PRINT NOW key is pressed. Pressing the mode soft key allows download of
optional parameters for SpO2 or temperature if equipped.
Serial Communication Screen
Figure 57 Printer Mode Screen
Hardware Requirements
The data port is an EIA-232 serial port (commonly referred to as RS232). A standard RS232 cable is
normally used, 9 pins at one end for the Fusion™ System, and whatever your computer needs at the other
end. A Null modem connector is usually not required when connecting to a personal computer such as an
IBM-PC.
Fusion™ Data Port Pin Connections
Function
Pin
Description
Direction
2
TX
Transmit Data
output
3
RX
Receive Data
input
5
GND
Signal ground
na
Port Settings
19200 baud, 8 data bits, no parity and 1 stop bit.
The data is transmitted at 19200 baud, but with one character sent every 128th of a second. This is slow
enough that handshaking is generally not required by the external computer.
Warning: As shipped from the factory, the data port is not electrically isolated. Any leakage
current sourced by the external computer will be accessible on the Fusion™ System mounting
screws.
02/2007
Page 41 of 66
Software Requirements
Data sent via the data port are standard ASCII characters in a simple format, as follows:
For blood pressure data each line is terminated by a carriage return (0x0D) and a line feed
(0x0A).The fields have exactly the number of digits as shown above, with leading zeros used if
necessary.
Example Data Output For BP
yy-mm-dd hh:mm:ss sys dia map hr
05-14-05 09:14:00 121 065 087 064
05-14-05 09:14:45 115 062 081 065
05-14-05 09:14:59 121 065 085 063
05-14-05 09:15:13 128 069 091 072
05-14-05 09:15:28 125 064 092 072
For oximetry data each line is terminated by a carriage return (0x0D) and a line feed (0x0A).
Example Data Output for SpO2
yy-mm-dd hh:mm:ss sat
07-02-01 12:13:19 100
07-02-01 12:13:33 96
07-02-01 12:13:43 96
07-02-01 12:13:53 96
07-02-01 12:14:03 96
07-02-01 12:14:13 96
07-02-01 12:14:20 95
07-02-01 12:14:30 95
07-02-01 12:14:40 95
07-02-01 12:14:50 95
For temperature data each line is terminated by a carriage return (0x0D) and a line feed (0x0A).
Example Data Output for Temp
yy-mm-dd hh:mm:ss temp u/m
07-01-30 16:16:06
07-01-30 16:16:47
07-02-01 12:13:29
07-02-01 12:14:03
07-02-01 12:14:11
07-02-01 12:14:17
07-02-01 12:14:27
100.0
24.8
24.4
76.3
74.8
76.4
75.3
C
C
C
F
F
F
F
Medwave does not presently provide any software for the computer. You can run a terminal
emulation program to view and/or store the data on a personal computer. For example, with
Windows® run HyperTerminal and configure for a direct connection to a port such as COM1 or
02/2007
Page 42 of 66
COM2. Configure the port settings for 19200 baud, 8 data bits, no parity and 1 stop bit. You may
use the capture text option to record data to a file. Data transfer is initiated on the Fusion™ System by
using the serial communication screen (use PRINT NOW key to initiate the data transfer).
4.5.3 Printer Feature (Optional)
The Fusion™ System can come equipped with a built-in thermal printer. With the Rotary Function Selector
set to the Communication Indicator and the Set-Up Key pressed twice, the printer can print patient data
tables for data retention and patient information. The Print screen is shown below. Pressing the mode soft
key allows printing of optional parameters for SpO2 or temperature if equipped.
Thermal Printer Screen
Figure 58 Thermal Printer Screen
4.6 Alarms
The Fusion™ System has both audible and visual alarms. An audible alarm can be silenced by pressing the
MUTE key at any time (except in the case of non-recoverable system errors). When the MUTE key is
pressed, the bell symbol in the upper right corner of the display will appear with an “X” through it. In the
case of patient alarms, the pressure value that has triggered an alarm will continue to flash until the
condition has been resolved, even if the MUTE key has been pressed.
Mute Key
Figure 59 Mute Key
02/2007
Page 43 of 66
4.6.1 Patient Alarms
Defined as those alarms activated when the patient’s blood pressure or pulse rate goes above or below the
predetermined limits.
Alarm Parameter Ranges
High Limits
High Limit Default
Low Limits
Low Limit Default
Systolic
75 – 250
240
40 – 150
40
Mean
60 – 200
140
30 – 130
30
Diastolic
40 – 180
130
20 – 120
20
Pulse Rate
60 – 200
200
40 – 120
40
02/2007
Page 44 of 66
4.7 Tympanic Temperature Measurement (Optional)
4.7.1 Display, Buttons, and Panels
Figure 61 Mode Selection Button
Figure 60 Right Panel with Tympanic Thermometer
Figure 62 Battery Panel
4.7.2 Taking a Temperature Reading
1. Remove probe from its cradle on the right side
panel on the Fusion™ System by lifting firmly
near RELEASE button.
Figure 63 Removing Probe from its Cradle
2. The equivalence setting is preset to oral.
3. Select TYMPANIC by pressing MODE button
(if TYMPANIC not already displayed).
4. Place disposable cover (located on the right
side on the Fusion™ System) on probe tip.
5. Insert probe tip into a disposable cover until cover
is completely on probe tip.
Figure 64 Placing Disposable Cover On Probe Tip
02/2007
Page 45 of 66
Tympanic Temperature Measurement (Optional) (continued)
6. Place probe in ear canal and seal opening. In
infants, seal outer opening of ear canal.
Figure 65 Place Probe in Ear Canal
7. Press and release SCAN button.
8. Remove probe from ear as soon as triple beep is heard and display flashes DONE.
9. Read temperature in display window.
Figure 66 Reading Temperature
10. Press blue RELEASE button to discard probe cover.
Figure 67 Discarding Probe Cover
02/2007
Page 46 of 66
Tympanic Temperature Measurement (Optional) (continued)
Return probe to the cradle on the right side panel on the Fusion™ System for data transmission and LED
temperature display on front panel of the Fusion™ System.
Temperature
Figure 68 Displaying the Temperature
Figure 69 Fusion Data Transmission
NOTE: If the Genius probe is removed from its base, a probe cover is installed and then it is left
unused for more than 30 seconds (approximately), it enters a power-saving sleep mode. The
display will read “USE NEW COVER” even though one is installed. Press release button and
reinstall unused probe cover to take next temperature.
4.7.3 Tips on Technique
Although the technique for using the Genius is not as critical as with oral or rectal thermometry, the
following guidelines will improve the consistency and accuracy of measurement:
1.
If necessary, gently restrain the patient’s head movements while taking temperature.
2.
Insert probe tip into ear canal just far enough to seal opening. No additional pressure or tugging on
the ear is required.
3.
In infants, where the probe tip cannot enter the outer ear canal, seal outer opening with probe tip,
then gently press scan button.
4.
Remove probe as soon as triple beep is heard and display blinks DONE. Removal of the
thermometer from the ear before DONE is displayed may result in a low temperature reading.
02/2007
Page 47 of 66
4.7.4 Operating Controls
Mode Button
This is located on the underside of the probe and is used to select the TYMPANIC and TIMER modes.
Pressing and releasing the MODE button after installing a probe cover sequences the thermometer among
the modes. Pressing and holding MODE button allows for °C/°F conversion.
NOTE: If the MODE button does not respond, Genius is in its power-saving SLEEP mode. Press the
Release button and reinstall a probe cover, then press the MODE button.
Tympanic Mode – This is the primary mode of the Genius and is used to measure a temperature.
Timer Mode – Pressing the SCAN button when in timer mode starts a 15-second timer which may be used
in taking pulse rates. Simply press the SCAN button and simultaneously count heartbeats until a triple beep
is heard. Multiply by 4 to get heartbeats per minute. The timer may be interrupted by pressing the MODE
button. The Screen will return to tympanic mode upon completion of the timer cycle.
°C / °F Conversion – Pressing and holding the MODE button for 6-7 seconds will cause the displayed
temperature to convert from °C reading to °F reading or vice versa.
4.7.5 Special Features
Genius has a number of smart features to make clinical temperature taking easier and more accurate than
ever before. With its unique In-Service Menu System, Genius practically “in-services” itself using the
following operator prompt on the LCD display on the thermometer:
USE NEW COVER
Place a new disposable probe cover onto the probe. The SCAN button will not operate until this is done.
PRESS SCAN
Genius is ready to take a temperature. Press the SCAN button upon sealing the ear canal.
DONE
The temperature measurement is completed.
PRESS RELEASE
Press the RELEASE button to eject the probe cover. This must be done before you install a new probe
cover and take another temperature.
LOW ERROR
Indicates that temperature is below Genius’ range limit (60°F / 15.6°C).
HI ERROR
Indicates that temperature is above Genius’ range limit (110°F / 43.3°C).
ERROR
Genius’ internal self-test has detected a problem. Consult your biomedical engineer or contact Medwave®
Inc.
02/2007
Page 48 of 66
LOW BATTERY
The Genius will take approximately 5000 readings with a new fully charged battery installed. Genius has a
2-level low battery detection feature. At the first level, the LOW BATTERY is lit and approximately 100
more temperatures may be taken. Replace the battery as soon as it is practical to do so. At the second level,
the ERROR indicator is also lit and the Genius will not operate until the battery is replaced.
WAIT
The WAIT indicator will appear if you attempt to take successive temperatures in too short of a time
period. Wait briefly until the WAIT indicator disappears before taking another temperature.
The “down arrow” arrow is a warning indicating that the room temperature is below the ambient
temperature operating range low limit.
The “up arrow” is a warning indicating that the room temperature is above the ambient
temperature operating range high limit.
BATTERY REMOVAL
Located on the lower portion of the Genius probe are two philips screws. Loosen
philips screws, take great care when taking the cover off and replace the battery with a 9-volt battery. To
install cover and philips screws reverse process.
Figure 70 Battery Removal
4.7.6 Important Precautions
1. Although the Genius is ruggedly constructed, it is an optical instrument. For trouble-free
operation, handle carefully and do not drop.
2. Visually inspect the probe cover prior to taking a temperature. The probe cover membrane
should be smoothly stretched across the membrane rim with no holes or wrinkles.
3. Failing to seal the ear canal opening may result in lower temperatures. If it is not possible to
seal the opening, use the other ear, or select an alternative device and measurement site to
obtain the temperature.
4. Accuracy is dependent on careful and proper use. Right-handed operators achieve better
accuracy in the patient’s right ear; left-handed operators in the patient’s left ear.
5. Ear-to-ear differences are not an indication of unit inaccuracy. Discrepancies are attributed
to placement, “handedness,” asymmetry of ear structures, and blood flow. The incidence of
ear-to-ear discrepancies declines with operator experience. Always wait at least 2 minutes
before taking another temperature reading in the same ear.
02/2007
Page 49 of 66
Battery Removal (continued)
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
Should the lens or black window on the tip of the probe become soiled, gently clean using a
lens wipe or lint-free swab. Lens should appear shiny and free of fingerprints and debris.
Always use a new probe cover. Soiled covers affect accuracy. Use only FirstTemp Genius
probe covers. The Genius is only calibrated for use with Genius probe covers. The Genius
probe cover reorder number is 480-0002.
When not in use, Genius should be protected by snapping it into the base unit on the
Fusion™ for storage.
Genius should not be used on patients with ear drainage, blood, tears, saliva, cerebrospinal
fluid, vernix, ear wax plugs or other foreign body in the ear canal.
Mist tents can leave a wet film inside a patient’s ear, causing evaporative cooling. Unless
ears are covered, the Genius should not be used with patients in mist tents.
Patients with removable hearing aids should remove the device 10 minutes prior to ear
temperature assessment. Implanted hearing aids generally do not affect the ear temperature.
Pressure equalization (PE) or tympanostomy tubes will not compromise the measurement
accuracy. However, to assure patient comfort, one week should be allowed post-operatively
before using the Genius.
Patients assessed immediately after coming in from cold weather may exhibit lower ear
temperatures. A 10-minute wait is recommended for rewarming.
Excessive scarring of the eardrum can cause lowered temperature readings.
Earwax normally does not affect accuracy. However, cerumen plugs or impactions contain
debris, such as dirt and dead skin cells that can lower ear temperature measurements by
several tenths of a degree.
4.7.7
Fusion Temperature Display
The user can scroll through all the temperature
measurements while the rotary function indicator
is in the temperature position.
Figure 71 Rotary Function Indicator Temperature Position
Temperature readings are displayed in tabular form similar to the blood pressure reading table as shown
below, in addition to the 7 segment LED’s on the front panel:
02/2007
Page 50 of 66
Fusion Temperature Display (continued)
Figure 72 Temperature Table Trend Display Screen
SCAN FWD
Allows the user to scroll forward in time
SCAN BACK
Allows the user to scroll back in time to view previous readings.
CLEAR
Erases all temperature readings. When this option is selected, a confirmation notice
is displayed with YES and NO options. If YES, is chosen, the data is erased; if NO
is chosen, the display returns to the trend screen.
4.8 Oximetry SpO2 (Optional)
4.8.1 Indications/Contraindications
The Nellcor® Durasensor® adult oxygen sensor, Model DS-100A, is indicated for use when continuous
noninvasive arterial oxygen saturation monitoring is required for patients weighing greater than 40 Kg.
The DS-100A is contraindicated for use on active patients or for prolonged use. It is not designed for longterm monitoring. It must be moved every 4 hours (or more often, if indicated by circulatory status and/or
skin integrity) and reapplied to a different site. If long-term monitoring is required, use an OXIMAX
oxygen sensor (MAX-A, MAX-AL, or MAX-N) or an Oxisensor II® sensor (D-25, D-25L, or N-25),
depending on patient age and size, and instrument compatibility.
4.8.2 Monitoring SpO2
Use this sensor only with Nellcor instruments and instruments containing Nellcor oximetry, or with
instruments licensed to use Nellcor sensors (Nellcor-compatible instruments). This sensor integrates
Nellcor OXIMAX® technology into its design. When connected to an OXIMAX-enabled instrument, this
sensor uses OXIMAX technology to provide additional advanced sensor performance features. Consult
Medwave® for compatibility of particular sensor models.
Reusable sensors may be used on the same site for a maximum of 4 hours, provided the site is inspected
routinely to ensure skin integrity and correct positioning. Because individual skin condition affects the
ability of the skin to tolerate sensor placement, it may be necessary to change the sensor site more
frequently with some patients.
02/2007
Page 51 of 66
4.8.3 How to apply the DS-100A Finger Sensor
1. Place an index finger over the sensor window of the
DS-100A with the finger tip against the stop.
Figure 73 Finger Sensor
2.
If the fingernail is long, the nail tip will extend over the finger stop.
3.
Spread open the rear tabs of the sensor to provide even force over the length of the pads.
Check the position of the sensor. If an index finger cannot be positioned correctly, or is not
available, a smaller finger can be used, or use an OXIMAX or an Oxisensor II oxygen
sensor. Do not use the DS-100A on a thumb or toe or across a child’s hand or foot.
Note: When selecting a sensor site, priority should be given to an extremity free of an arterial catheter,
blood pressure cuff, or intravascular infusion line.
4.
Plug the Durasensor into the SpO2 Extension Cable.
The sensor should be oriented in such a way that
connector cable is positioned along the top of
the hand.
Figure 74 Finger Sensor
5.
Plug the SpO2 Extension Cable into the Fusion™
System SpO2 Cable Connector.
Figure 75 Fusion SpO2 Cable Connector
Note: If the sensor does not track the SpO2 reliably, it may be incorrectly positioned-or the sensor site may
be too thick, thin, or deeply pigmented, or otherwise deeply colored (for example, as a result of externally
applied coloring such as nail polish, dye, or pigmented cream) to permit appropriate light transmission. If
any of these situations occurs, reposition the sensor or choose an alternate Nellcor sensor for use on a
different site.
02/2007
Page 52 of 66
4.8.4 Cleaning Procedures
The DS-100A may be surface-cleaned by wiping it with a solution such as 70% isopropyl alcohol. If lowlevel disinfection is required, use a 1:10 bleach solution. Do not use undiluted bleach (5%~5.25% sodium
hypochlorite) or any cleaning solution other than those recommended here because permanent damage to
the sensor could occur.
CAUTION: Do not expose connector pins to cleaning solution as this may damage the sensor.
To clean or disinfect the sensor:
1.
Saturate a clean, dry gauze pad with the cleaning solution. Wipe all surfaces of the sensor and cable
with this gauze pad.
2.
Saturate another clean, dry gauze pad with sterile or distilled water. Wipe all surfaces of the sensor
and cable with this gauze pad.
3.
Dry the sensor and cable by wiping all surfaces with a clean, dry gauze pad.
4.8.5 Important Precautions
1. Do not sterilize by irradiation, steam, or ethylene oxide. Such sterilization could damage the sensor.
2.
Failure to apply the DS-100A properly may cause incorrect measurements.
3.
Using the DS-100A in the presence of bright lights may result in inaccurate measurements. In such
cases, cover the sensor site with an opaque material.
4.
Reusable sensors must be moved to a new site at least every 4 hours. Because individual skin
condition affects the ability of the skin to tolerate sensor placement, it may be necessary to change the
sensor site more frequently with some patients. If skin integrity changes, move the sensor to another
site.
5.
Intravascular dyes or externally applied coloring such as nail polish, dye, or pigmented cream, may
lead to inaccurate measurements.
6.
The performance of the DS-100A is compromised by motion.
7.
Do not apply tape to secure the sensor in place or to tape it shut; venous pulsations may lead to
inaccurate saturation measurements.
8.
As with all medical equipment, carefully route cables to reduce the possibility of patient entanglement
or strangulation.
9.
Do not use the DS-100A or other oximetry sensors during MRI scanning. Conducted current may
cause burns. Also, the DS-100A may affect the MRI image, and the MRI unit may affect the
accuracy of oximetry measurements.
10. Do not alter or modify the DS-100A. Alterations or modifications may affect performance or
accuracy.
02/2007
Page 53 of 66
4.8.6 Oximetry Table Trend Display
The user can scroll through all the oximetry measurements while the rotary function selector is on the SpO2
setting.
Oximetry readings are displayed in tabular form similar to the blood pressure reading table as shown below
in addition to the 7 segment LED’s on the front panel:
Figure 76 Oximetry Table Trend Display Screen
SCAN FWD
Allows the user to scroll forward in time.
SCAN BACK
Allows the user to scroll back in time to view previous readings.
CLEAR
Erases all oximetry readings. When this option is selected, a confirmation notice is
displayed with YES and NO options. If YES, is chosen, the data is erased; if NO is
chosen, the display returns to the trend screen.
02/2007
Page 54 of 66
SECTION 5: SYSTEM FEATURES AND SPECIFICATIONS
5.1 System Features
Non-invasive
Eliminates those risks associated with invasive monitoring to the patient and caregiver.
Microprocessor based design
Provides reliable, high speed, digital signal processing.
Artifact rejection
Advanced programming allows the system to identify and eliminate some noise and motion artifact.
Audible & visual alarms
Audible and visual alarms for systolic, diastolic and mean pressures and pulse rate can be set to individual
parameters or preset default values. Additional alarms will alert the caregiver of any abnormal condition or
failure with the system.
LCD and LED displays
LCD display provides the caregiver with selective viewing of the pressure waveforms, trending, and alarm
settings. LED displays provide clear, continuous readout of patient blood pressure values.
5.2 Technical Specifications
Product Description
Medwave Fusion™ Non-Invasive Blood Pressure Patient Monitor System With Vital Signs Options
Physical Description
Case: Plastic
Size: 14” (h) x 9.5” (w) x 9.5” (l) [35.5cm x 24cm x 24cm]
Weight: 14lbs. [6.4Kg] with power cord and patient cable (approximate)
Displays
Liquid crystal (LCD) with Cold Cathode Fluorescent (CCF) back light
Size: 2.5” (h) x 4.5” (w) [6.4 cm x 11.4 cm]
3-5 (depending on configuration) seven segment Light Emitting Diode (LED) arrays
Size: .75” (h) x 1.5” (w) [1.9 cm x 3.8 cm]
Safety Classification
The Fusion™ System is classified to U.S. and Canadian safety standards by Underwriters
Laboratories Inc. with respect to electric shock, fire and mechanical hazards only in
accordance with UL 60601-1, IEC 60601-1, and with CAN/CSA C22.2 No 601.1 Control
Number : 39RM
Classification: Class I equipment.
Type: BF, defibrillation proof.
Fluid protection: Ordinary equipment (monitor and printer).
Drip proof (IPx1) for patient cable housing only.
Equipment is designed for continuous usage, as programmed by the user.
Equipment is not suitable for use in the presence of a flammable anesthetic mixture.
See warnings section.
The monitor has line voltage present inside the case. Refer servicing to a qualified
technician.
02/2007
Page 55 of 66
Safety Classification (continued)
Electrical
Input
Fusing
series 217P
Batteries
100-240 VAC, 50-60 Hz, 0.4 - 0.8 Amp.
Two 5x20mm, 2 Amp, fast acting, 250 volt. Recommended replacements: Littelfuse
12V Panasonic valve-regulated lead acid battery LC-R123R4P approximately 3 hours run
time with 4-6 hours charge time. Where the integrity of external protective earth
conductor arrangement is in doubt, Fusion™ System shall be operated from
internal battery.
9V DC alkaline battery is used in the Genius probe.
Electromagnetic Compatibility
Complies with the requirements of European Standard EN 60601-1-2:2001 for electromagnetic emissions
and immunity.
Environmental - Operating
Temperature:
Humidity:
10°C to 40°C (50°F to 104°F)
10% to 90% RH, non-condensing
Environmental - Storage & Transport
Temperature:
-20°( C to 70°C (-4°F to 158°F)
Humidity:
10% to 90% RH, non-condensing
Calibration Requirements
Fusion™ NIBP System and SpO2 has been calibrated at the factory at the time of manufacturing and
requires no further calibration.
Calibration Verification
The Genius® Tympanic Thermometer verification of temperature readings needs to be performed every 6
months or when temperature measurements are in question.
Specification Limits for Genius® Tympanic Thermometer
In range 36°C to 39°C (96.8 to 102.2°F), ± 0.2°C (± 0.4°F); and in the ranges less then 36°C (98.6°F) or
greater then 39°C (102.2°F), ± 0.3°C (± 0.5°F.)
If the readings are out of the range listed above, contact Medwave Customer Service at 800-894-7601,
within the St. Paul/Minneapolis metropolitan area (651) 639-1227, or e-mail: [email protected].
02/2007
Page 56 of 66
5.3 Performance Specifications
Blood pressure measurements determined with this device are equivalent to those obtained by an intraarterial blood pressure measurement device, within the limits prescribed by the American National
Standard, Electronic or automated sphygmomanometers. The proposed ANSI/AAMI SP10-2002 Standards
are: For systolic and diastolic pressures, treated separately, the mean difference of the paired measurements
of the test system and the comparison system shall be + or - 5 mmHg or less with a standard deviation of
8mmHg or less.
At minimum cycle time setting:
Determination Time*
Systolic
~ every 15 seconds
Range Min/Max
40 mmHg - 240 mmHg
Accuracy
(mean difference)**
±5 mmHg / SD 8 mmHg
Mean
~ every 15 seconds
30 mmHg - 200 mmHg
Diastolic
~ every 15 seconds
20 mmHg - 180 mmHg
Pulse Rate
~ every 15 seconds
40 bpm - 200 bpm
Trend
Updates following
each BP reading
± 5 bpm or 10%
Approximately 900
readings in tabular mode
*
Determination time will vary depending on the pulse rate. The minimum cycle (occurs at high pulse
rates) is 10 seconds. The minimum or “continual” cycle is 14 beats plus the time to retract the sensor,
plus the time to step from fully retracted to 50% of the previous valid mean pressure. In recovery
sweep mode (after power ON or a recoverable error) there is no step up and the default motor speed is
slow. Recovery sweeps, therefore, take somewhat longer (20 to 25 seconds generally). The cycle time
may be set by the user to be greater than the minimum. Refer to section 4.4.1, CYCLE TIME
SCREEN.
**
Pressure accuracy specifications are based on clinical data. The pressure range of this clinical data
was less than the range min/max specification.
02/2007
Page 57 of 66
SECTION 6: TROUBLESHOOTING
6.1 Troubleshooting Guide
If the Fusion™ System is unable to take pressure readings, the pressure and heart rate numeric displays will
all flash in unison. In the case of certain errors, the Fusion™ System will automatically discontinue
monitoring. In either of these two cases the user should make an assessment of the system to look for one
or more of the following possible causes:
Cause
Possible Solution
Artifact caused by patient movement
Immobilize the patient’s arm
Improper strap tension
Adjust Velcro strap as directed by screen instructions.
Verify patient’s wrist size is in range of Placement Guide
Improper sensor placement
Check the placement of the sensor on the patient (refer
to Section 4.3 DISPLAY SCREEN).
Check that the sensor is not compressed by any force other than the
strap.
Restriction of sensor movement
Fusion™ System component failure
No display
No signal display
Fusion™ System resets and
Runs Self-Test
Fusion™ System V-line interface not working
properly
E01 indicated in SpO2 LED Display
Check the sensor for leaks. If found power OFF, replace the Patient
Cable and repeat the Set-Up and Usage steps.
Check power cords, plug, and power connection.
Check sensor placement.
Check Patient Cable connections.
Check Sensor and Patient Cable for breaks.
Check Sensor placement.
Check Power Cords, Plug, and power connection.
Check Patient Cable Connections.
Check Patient Cable for breaks.
Check voltage compatibility to host monitor.
Check all connections from Fusion™ V-Line Interface to host monitor.
Repeat IBP zero and check that numeric scaling was done properly and
the 0 mmHg-150 mmHg scale range is verified.
Check that all connections are connected from the SpO2 probe to the
Fusion™ System.
Check to make sure SpO2 probe is installed on patient properly.
Check for patient motion.
Check for excessive patient motion.
02/2007
Page 58 of 66
6.2 Alarms and Warning Messages
Error messages will appear on the LCD display to alert the user of system errors. There are several system
alarms to alert the operator to abnormal conditions within the internal system or with a particular reading.
System alarms fall in one of two categories: 1) Recoverable and 2) Non-Recoverable errors.
6.2.1 Non-Recoverable Alarms
All non-recoverable errors will halt system operation and will require intervention by either the user or a
service technician to repair or adjust the unit to eliminate the malfunction. A screen error message will be
displayed giving specific details of the error.
An alternating ON-OFF alarm will sound in case of severe system hardware problems, until the unit’s
power is switched OFF.
Certain non-recoverable errors will cause the system to discontinue monitoring. In these cases, the user
may be able to remedy the cause of the error and then restart the monitoring process by pressing the NIBP
START/STOP key. Note that the system will automatically retract the sensor when monitoring is
discontinued, and as always during retraction, the keys are disabled. An audio alarm is emitted for these
types of errors.
Alarm Message
Cause
Remedy
“Adjust strap, then press start”
The pressure on the patient’s wrist is
measured by the sensor and is not in
the acceptable starting pressure
range.
Loosen or tighten the strap on the patient’s
wrist.
Verify presence of sensor in wrist piece.
MISSING OR DAMAGED SENSOR
OR PATIENT CABLE.
TURN OFF POWER, ATTACH SENSOR OR
PATIENT CABLE, THEN TURN POWER ON.
Sensor and/or Patient Cable is not
connected to the Fusion Monitor.
Verify that the patient cable is connected to the
Fusion monitor.
Verify the patient cable is completely inserted into the
patient cable connector on front panel.
Once you have corrected, power off the Fusion.
Power on the Fusion. Resume monitoring.
Check and adjust your patient’s wrist strap.
CHECK YOUR PATIENT’S WRIST.
ADJUST TENSION OF THE
WRIST STRAP.
PRESS THE START/STOP KEY
TO RESUME MONITORING.
CHECK YOUR PATIENT’S WRIST
SENSOR IS COMPRESSED BY A
FORCE OTHER THAN THE STRAP.
PRESS THE START/STOP KEY
TO RESUME MONITORING.
02/2007
Page 59 of 66
The pressure on your patient’s wrist is
not sufficient to continue monitoring.
The pressure on your patient’s wrist has
increased to a value greater than
acceptable. This increased pressure has
been caused by something other than the
wrist strap tension.
Verify that your patient’s sensor end of patient cable
is free from obstructions and not pressed against a
firm surface
.
Verify your patient’s wrist has not changed positions.
6.2.2 Recoverable Alarms
These errors will not halt system operation but will prevent any new pressure values from being displayed
until the cause of the error is remedied. If consecutive recoverable errors last longer than 70 seconds (at the
minimum cycle time setting), a message on the LCD will indicate the time when the last valid reading
occurred, and the LED’s will flash until the error has recovered.
The LCD display is the error message area. The message displayed will be the highest priority message
which occurred since power on in the case of non-recoverable errors, or since the previous sweep in case of
recoverable errors.
SECTION 7: MAINTENANCE
7.1 Service Policy
The monitor portion of the Fusion™ System does not require any routine maintenance.
Should service be required, it should be performed by a qualified technician. All
maintenance and repair procedures should be directed to the nearest Medwave Service
Center.
To obtain information on or order repair parts call Medwave Customer Service at 800-894-7601, within St.
Paul/Minneapolis metropolitan area (651) 639-1227, or e-mail: [email protected].
For authorization and instructions for repair service, contact your local Field Service Representative.
Provide the following information:
Your Name
Hospital Name
Address
Telephone Number
Facsimile Number
Monitor S/N
Sensor Lot Number
Describe the Problem
E-mail Address
You will be advised of the corrective action to take.
7.2 Cleaning Procedures
Monitor, Patient Cable & Sensor Housing Cleaning Procedures
The monitor, sensor, placement guide and patient cable may be cleaned on an as-needed basis. To clean the
monitor, sensor, placement guide or patient cable, dampen a cloth with a commercial, nonabrasive cleaner
and wipe the surfaces lightly. Always apply the solution to the cloth, not directly to the monitor, placement
guide, sensor and/or patient cable.
Should the sensor be punctured and/or leak fluid, the sensor will need to be replaced. The fluid is non-toxic
and should be washed from skin or other surfaces with soap and water.
Warning
Do not sterilize the monitor, sensor, patient cable or sensor housing by autoclaving (steaming),
irradiation or ethylene oxide (ETO). Do not soak sensor or any part of the Fusion™ System in any
solution or water.
02/2007
Page 60 of 66
7.3 Precautions for Handling Valve-Regulated Lead-Acid Batteries
The Fusion™ System is equipped with a valve-regulated lead-acid battery LC-R123R4P.
Recommendation
The battery and /or equipment should be installed by skilled personal (specialists) such as personal
qualified for maintaining battery equipment. Handling of the battery by unskilled personal may lead to
dangerous errors.
WARNING
Do not throw the battery in fire nor heat the battery. The battery may burst or generate a toxic gas if
placed in contact with fire.
Do not attempt to disassemble, remodel, or destroy the battery, as it may cause battery leakage, fire,
or burst and could also create sulfuric acid spills from the battery resulting in possible burns to
persons and damage to the immediate environment.
Disposal of batteries
This battery is fully recyclable and should be accepted at any location that accepts common automotive
starter batteries. Examples of places that accept theses batteries are: County or municipal recycling drop off
centers, scrap metal dealers and retailers who sell automotive replacement lead acid starter batteries. In
North America, non-consumers can call 1-800-SAV-LEAD for assistance in recycling.
SECTION 8: WARRANTY
8.1 One Year Limited Warranty For The Fusion™ Equipment
The Fusion™ System consists of 1) monitor, 2) patient cable, and 3) power cord, with the addition of the
available optional equipment for SpO2 and temperature, 4) RJ11 cable, 5) patient placement guide kit
and/or 6) printer. Here after referred to as the “System”.
WARNING
Medwave, Inc. makes no representation or warranty as to the effectiveness of the System as a
treatment.
LIMITATIONS
The System is sold in an “as is” condition. The entire risk as to the quality and performance of the System
is with the buyer, except to the extent set forth in the “LIMITED WARRANTY”. This Limited Warranty is
expressed or implied, including any implied warranty of merchantability or fitness for a particular purpose,
whether arising from statute, common law, custom or otherwise. The remedies set forth in this Limited
Warranty shall be the exclusive remedy available to any person. No person has any authority to bind
Medwave, Inc. to any representation, condition, or warranty except this Limited Warranty.
Some states do not allow limitations on how long an implied warranty lasts, so the above limitation may
not apply to you.
DISCLAIMER
LIMITED WARRANTY ON MONITOR
Medwave, Inc. warrants the monitor to be free from defects in material and workmanship for one (1) year
following the delivery of the monitor to the original purchaser. Medwave, Inc. shall repair or replace any
part or parts of the monitor upon which Medwave, Inc.’s examination shall disclose to have become
defective within the warranty period: or at Medwave, Inc.’s discretion, it may elect to supply a substantially
similar new or equivalent replacement monitor or refund the price (as of the date of the System sale) in lieu
of repairing or replacing any defective part or parts in such monitor. To qualify for such repair,
02/2007
Page 61 of 66
replacement, or refund, the defective monitor must be returned within thirty (30) days after discovery of the
defect. Such repair, replacement, or refund obligation does not apply to any monitor which has been
repaired or altered outside of Medwave, Inc. facility in any way so as, in the judgment of Medwave, Inc., to
affect its stability and reliability, or which has been subjected to misuse, negligence, or accident.
LIMITED WARRANTY ON SENSORS
Medwave, Inc. warrants the sensor to be free from defects in material and workmanship for thirty (30 days)
following the delivery of the sensor to the original purchaser. Medwave, Inc. shall repair or replace any part
or parts of the sensor upon which Medwave, Inc.’s examination shall disclose to have become defective
within the warranty period: or at Medwave, Inc.’s discretion, it may elect to supply a substantially similar
new or equivalent replacement sensor or refund the price (as of the date of system sale) in lieu of repairing
or replacing any defective part or parts in such sensor.
To qualify for such repair, replacement, or refund, the defective sensor must be returned within fifteen (15)
days after discovery of the defect. Such repair, replacement, or refund obligation does not apply to any
sensor which has been repaired or altered outside of Medwave, Inc.’s facility in anyway so as, in the
judgment of Medwave, Inc. to affect its stability and reliability, or which has been subjected to misuse,
negligence, or accident, including but not limited to membrane damage from sharp objects or submersion
of sensor into any kind of fluid.
MISCELLANEOUS
A. Medwave, Inc. shall not be liable for any medical expenses or any damages resulting from or
caused by any defect, failure, or malfunction of the System, whether a claim for such
damages is based upon warranty, contract, tort or otherwise. However, some states do not
allow the exclusion of incidental or consequential damages, so the above limitations may not
apply to you.
B.
This Warranty gives you specific legal rights and you may have other rights which vary from
state to state.
8.2 Contact Information
Manufacturer:
Address:
Telephone:
24 Hour Clinical Support Paging Service:
Facsimile:
e-mail:
Printed in USA
8.3 EU Authorized Representative
MDSS
Burckhardtstrasse 1
30163 Hannover, Germany
02/2007
Page 62 of 66
Medwave, Inc.
4382 Round Lake Road West
St. Paul, MN 55112
651-639-1227
800-894-7601
866-273-1486
651-639-1338
[email protected]
SECTION 9: ACCESSORY AND SUPPLY INFORMATION
Standard Accessories
Item
Part Number
Power Cord
131-0011
Fusion™ System Patient Cable
000-9122
*Nellcor® Durasensor® Adult Oxygen Sensor Model DS- 100A
000-9114
*Nellcor® OxiMax™ OEM-10 Pulse Oximetry Cable
000-9115
*Genius™ Tympanic Thermometer
480-0001
RJ11 Cable
401-0060
Placement Guide Kit
000-5043
*Optional Equipment
Replacement Parts
Item
Part Number
Wrist Strap, Navy Blue - Pediatric Wrist Size 11 – 15 cm – Pack of 5
000-5010
Fusion™ Placement Guide Kit, consists of:
One Adult Large Size Wrist Size 18 – 22 cm, One Pediatric Wrist Size 11 – 15 cm,
One Pediatric Strap Wrist Size 11-15 cm.
000-5043
Fusion™ Placement Guide Pediatric Wrist Size 11 – 15 cm
000-5044
Fusion™ Placement Guide Adult Normal Size Wrist Size 15 – 18 cm
000-5046
Fusion™ Placement Guide Adult Large Size Wrist Size 18 – 22 cm
000-5058
Wrist Strap, Black - Adult Normal Size Wrist Size 15 – 22 cm – Pack of 5
000-9001
*Genius™ Tympanic Thermometer Probe Covers
480-0002
Fusion™ Systems Operator’s Manual
797-0076
02/2007
Page 63 of 66
Appendix A: Fusion™ System Wrist Strap Replacement
The Fusion™ wrist strap is manufactured from durable nylon webbing. One side of the strap has Velcro®
hook and loop pieces attached; the other side has a single one-inch Velcro hook piece attached.
To install a new wrist strap,
position the hook and loop piece
side upwards. Thread the single
one-inch Velcro loop end piece
through the strap loop guide. Pull
just to the end of the strap loop
guide, align the Velcro loop end
to the hook piece, and press into
position.
Figure 79 Position Wrist Strap
Figure 80 Pressing Velcro End In Place
Figure 81 Measure Your Patient’s Wrist Circumference
Medwave Recommended Placement Guide and Strap According to Wrist Circumference
Wrist Circumference
Corresponding Wrist Strap Color
15 – 18 cm
Black
18 – 22 cm
Black
11 – 15 cm
Navy Blue
02/2007
Page 64 of 66
APPENDIX B: FUSION™ SYSTEM KEY AND ICON LIST
System and Maintenance Position Indicator
Communications Position Indicator
NIBP Monitoring Position Indicator
Temperature Position Indicator*
Oximetry Position Indicator*
NIPB Connector Location for the Fusion™ System Patient Cable
SpO2 Connector Location for the SpO2 Cable*
V-Line Interface Connector Port
Data Communication Connector Port (RS232)
ON/STANDBY key
*Optional Equipment
02/2007
Page 65 of 66
Fusion™ System Key and Icon List (Copy)
NIBP START/STOP key
DISPLAY Screen key
SETUP Screen key
MUTE Key
AC Power Indicator
DC Power Indicator
02/2007
Page 66 of 66

biopac nibp100b noninvasive blood pressure system with vital signs

Transcription

Similar documents

Flyer FuseNet Association

Two forces working with the weather…

rbtec.com [email protected]

AlcoMate Prestige (Model AL-6000)

The idea with modifying stock down pipes is to gut the pre

your seventh sense - L

SAFEDRIVE. Drive Safe. Save Lives.

CARDELL Quick Reference Guide