Puritan Bennett Renaissance II User Manual
To obtain information about warranty for this product contact
Puritan Bennett Technical Support at:
1-800-255-6774
WARNING
The user should read and understand all product literature, labeling and
warnings prior to operating the Renaissance II Spirometry System
P-495220-00 Rev. D i
Table of Contents
Listing of Warnings, Cautions, and Notes . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Indicators, Symbols, and Icons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Introduction to the Renaissance II Spirometry System. . . . . . . . . . . . . . . 8
Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Basic Spirometry System and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Connecting the AC Adapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Battery Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Connecting the Pressure Tube . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Keypad Functions and Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Main Screen Icon Features. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Initial Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Spirometry Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Introduction to Spirometry Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Obtaining Good Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Pre-Test Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Calibration Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
SSD Calibration Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Cal Check. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Patient Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Entering New Patient Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Pre-Med Testing Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
FVC (Forced Vital Capacity) Test Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
SVC (Slow Vital Capacity) Test Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
FVL (Flow Volume Loop) Test Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
MVV (Maximal Voluntary Ventilation) Test Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
FEV6 (Forced Expiratory Volume in 6 sec.) Test Procedure . . . . . . . . . . . . . . . . . . . . . . . . 33
Post-Med Testing Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Post-Test Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Saving Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Viewing Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
ii P-495220-00 Rev. D
Table of Contents
Printing Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .38
Printing Reports for Multiple Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40
Deleting Patient Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41
Interpretation of the Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Acceptability and Reproducibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42
Grading Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44
Interpretation Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44
Lung Age Interpretation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47
Risk of COPD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47
Graphic Displays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48
Service and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49
Battery Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49
Troubleshooting Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Electromagnetic Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Warranty Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .55
Technical References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Product Specifications Renaissance II Spirometer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .57
Product Specifications Renaissance II Base Station . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .58
The FSII Single-Patient Use Flow Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .59
Predicted Normal Equations and References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60
RS-232 Interface Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .76
Pin Function Descriptions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .76
Using the Renaissance II with a PC and Dataflow™ Software . . . . . . . . . . . . . . . . . . . . .77
System Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Spirometry Options (1). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .78
Device Options (2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .80
Print Options (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .80
Settings (4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83
Display (5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83
Storage (8). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83
Setup and System Configurations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .84
Printing the System Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .86
P-495220-00 Rev. D iii
Table of Contents
Barometric Pressure vs. Altitude . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Glossary of Medical Terminology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Listing of Warnings, Cautions, and Notes
1 P-495220-00 Rev. D
Listing of Warnings, Cautions, and Notes
Throughout this manual there are three indicators to convey information of a
specific nature. These indicators are warnings, cautions and notes. Carefully
read and understand these notices as they relate to adjacent text.
WARNING
Warnings alert the user to potential serious outcomes (death, injury, or
adverse events) to the patient or user.
CAUTION:
Cautions alert the user to exercise care necessary for the safe and
effective use of the Renaissance II Spirometry System.
NOTE: Indicates points of particular emphasis that make operation of the
spirometer more efficient or convenient.
Listing of Warnings, Cautions, and Notes
P-495220-00 Rev. D 2
WARNING
The user should read and understand all product literature,
labeling and warnings prior to operating the Renaissance II
Spirometry System.
Patient Safety Warnings
• This device should be used by trained he al th care professional s an d is
not intended for patient operation.
• Physicians should assess patient’s ability to perform spirometry testing
prior to administering the test.
• Patient fainting or falling due to dizziness may occur as a result of this
test. Advise the patient to sit or stand comforta bly near a chair during
test.
Patient Data Warni ngs
• Predicted values wi ll be extrapolated for patients with age or height
outside the age and/or height limits supported by the selected author’s
normal equations.
• Results from spirometry testing should not be the sole source for
determining a patient's diagnosis and treatment. Other clinic al data,
such as patient symptoms and respiratory history, should always be
considered.
Use Environment Warnings
• The Renaissance II Spirometry System is not intended for use in an
oxygen-enriched atmosphere or in the presence of flammable
anesthetics.
• To avoid risk of electrical shock, this unit should only be used in dry
locations.
Equipment Setup Warnings
• As with all medical equipment, carefully route patient cabling to r educe
the possibility of patient entanglement or stran gulation.
• When connecting the Renaissance II spirometer to any instrument,
verify proper operation. Accessory equipment connected to the data
interface must be certified according to IEC Standard 950 for data
processing equipme nt or IEC Standard 601-1 for electromedical
equipment. All combinations of equipment must be in compliance with
IEC Standard 601-1-1 systems requirements. Anyone who connects
additional equipment to the signal input port or signal output port,
configures a medical system and is therefore responsible that the
system complies with the requirements of IEC Standard 601-1-1 and the
electromagnetic requirements of IEC Standard 601-1-2.
Listing of Warnings, Cautions, and Notes
3 P-495220-00 Rev. D
WARNING
User Warnings
• Chemicals from a broken LCD display panel are toxic when ingested.
Use caution when handling a Renaissance II spirometer with a broken
display panel.
Flow Sensor Warnings
• Carefully read the flow sensor directions before use, including all
warnings, cautions, and instructions.
• User should visually inspect the FSII sensor for loose particles/foreign
materials prior to patient use.
CAUTION
Federal law restricts this device to sale by, or on the order of, a
physician.
Use Environment Cautions
• Do not use the Renaissance II Spirometry System in areas of high
humidity, dust, or in extreme environments.
• Place the Renaissance II Spirometry System in a secure location, where
it is unlikely to drop or fall. Do not attempt to lift or carry the
spirometer by the pressure tube or power cord.
• The Renaissance II system may be susceptible to radio frequency
interference. Refer to the electromagnetic interference section of this
manual for more information.
Equipment Setup Cautions
• The Renaissance II Spirometry System and base station are designed
for use only with the Puritan Bennett AC adapter (P-4 95208-00). Do not
connect AC Adapter (P-495208-00) to an original Renaissance system
(PB-100/110) or damage will result. Conversely, do not connect a PB100/
PB110 AC adapter (P-062521-00) to the Renaissance II Spirometry
System.
• Prior to verifying calibration, visually verify that there is no foreign
material in the pressure tube and that the tube is not damaged or
kinked.
Listing of Warnings, Cautions, and Notes
P-495220-00 Rev. D 4
CAUTION
Battery Cautions
• The NiCad battery pack or other batteries may discharge over time.
Check batteries at least once pe r month for corrosion and verify
batteries are fully charged. Store spirometer in base station to keep
unit ready for use.
• Remove batteries if sp ir omete r wil l not be used for at least two week s.
• Dispose of batteries properly. Do not incinerate. Puritan Bennett
recommends that customers or technical service personne l follow local
governing ordinances and recycling instructions regarding disposal or
recycling of batteries.
Service Caution
• Do not remove the cover of the Renaissance II Spirometry System or
base. Removal of the cover is permitted only by qualified service
personnel. There are no user-serviceable parts inside.
• Do not spray liquids on the Renaissance II System. Follow the cleaning
instructions outlined in the Service and Maintenance section starting
on page 49 of this manual.
Flow Sensor Cautions
• Use only the FSII flow sensor specifically designed for the Renaissance
II Spirometry System.
• The FSII sensor is for single-patient use only. In the interest of
environmental protection, dispose of all sensors and nose clips
properly.
Notes
Accuracy Notes
• For test accuracy, elevation must be entered.
• V erify that the disp layed barometric pr essure is cor rect. If not corr ect,
there will be an error in the inspired volume (FIVC) during an FVL
maneuver of approximately -1.3% for every 1,000 feet above sea
level. Refer to the System Configuration section starting on page 78
for more information. The barometric pressure displayed is based on
the initial elevation setting of the spirometer. However, the
barometric pressure may be changed and the spirometer will, from
that point on, use the new value en tered.
• If you choose to obtain barometric pressure from an agency, such as
the National Weather Service, verify that the value is NOT corrected
to sea level.
Listing of Warnings, Cautions, and Notes
5 P-495220-00 Rev. D
Calibration Notes
• The date of the last valid calibra tion check will display as part of the
spirometer's initialization sequence if a calibration check has not
been performed in the current calendar day.
• The American Thoracic Society (ATS) recommends performing a threespeed calibration check on a daily basis.
• Puritan Bennett recommends that the 3 liter calibration syringe be
recertified on an annual basis.
• Verify that the temperature of the room is the same as the
temperature noted for the calibration test. For every degree
discrepancy, there will be a corresponding 0.15% error in the test
results.
• Overestimation of the room temperature will cause lung volume to
be underestimated by 5%; conversely, if temperature is
underestimated, lung volume will be overestimated.
Test Method Notes
• The “Val” (best value) method is recommended by the American
Thoracic Society and mandated by NIOSH/ OSHA standards and should
be used for all industrial and disability testing.
• If the patient test will be submitted for Social Security Disability
(SSD) determinations, enter patient information prior to performing
the SSD calibration verification.
• Clinicians performing PFT studies should consider attendi ng NIOSH
training seminars and refresher courses to further their skills in
spirometry testing and to stay current with industry standards.
Spirometer Use Notes
• Demonstrating the test using your FSII sensor is strongly
recommended for patients that have never performed a spirometry
test before.
• Obstructing sensor opening with teeth, lips, or tongue while
performing the test will cause low readings.
Notes
Listing of Warnings, Cautions, and Notes
P-495220-00 Rev. D 6
Battery Notes
• The Renaissance II base station allows interfacing to parallel printers
and computers and provides an alternate means for charging the
custom NiCad battery pack.
• The Renaissance II Spirometry System is designed to recharge only
the custom battery pack supplied with the system, and will not
recharge batteries from other manufacturers.
• When there is a low battery condition, the Renaissance II spirometer
beeps every 30 seconds and a low battery ic on is displayed.
• Do not mix brands or types of batteries.
• Puritan Bennett recommends replacing the NiCad battery pack at
least once per year.
• If the battery is removed, the unit will operate solely on AC power if
connected to an electrical outlet via the AC adapter.
Spirometer System Notes
• The serial numbers are located on a label affixed to the underside of
the spirometer and base station. The first letter "G" represents the
manufacturer. The next two numbers represent the year of
manufacture. The two digits following the yea r represent either a
base station (08) or a spirometer (07). The last five digits are
sequential numbers assigned during manufacture.
• Materials used to make this Renaissance II Spirometry System and
accessories contain no Latex.
• Replace the pressure tube every year.
• The LCD panel will turn off after 5 minutes (and the unit will power
off after 30 minutes) with no user input. To bring back the display
before the 30-minute limit, press any key.
Notes
Indicators, Symbols, and Icons
7 P-495220-00 Rev. D
Indicators, Symbols, and Icons
WARNING
The Renaissance II Spirometry System is not intended for use in an oxygenenriched atmosphere or in the presence of flammable anesthetics.
CAUTION:
Federal law restricts this device to sale by or on the order of a physician.
Base Station
FSII Sensor
USC
Rx ONLY
Renaissance II Spirometer
SN
Attention, consult accompanying documents
Refers to degree of protection - Drip Proof
Type BF equipment
Agency Certification
Class II equipment
CAUTION: Federal Law (US) restricts
this device to sale by, or on the order of,
a physician
Serial Number
Connection for a printer port
I/O communications port
12 volt DC adapter connection
Attention, consult accompanying documents
Do not reuse - single patient use only
Direction of flow through the flow sensor
Recyclable plastic. The number 6 represents
polystyrene.
Bar coded calibration number
Figure 1: Renaissance II Spirometry System Indicators, Symbols, and Icons
Introduction to the Renaissance II Spirometry System
P-495220-00 Rev. D 8
Introduction to the Renaissance II Spirometry System
The Renaissance II Spirometry System consists of a spirometer, docking base
and optional accessories, as shown in Figure 2. The Renaissance II system
provides long-term data storage capacity, and when connected to a printer
generates printouts of the data. Patient data can also be downloaded to a
computer. The spirometer test results can be compared to any of several adult
or pediatric predicted normal values. The spirometer also performs pre/post
medication comparisons.
Features
• Intuitive graphical user interface.
• Graphic display for real-time viewing of Volume-Time, Flow-Volume and
incentive displays.
• Automatically compares results to predicted values.
• Allows pre/post-medication comparisons.
• Provides clinical interpretations with COPD Risk and Lung Age
calculations.
• Optional software allows data to be downloaded to a computer.
• Memory stores demographic information, graphical data and patient
results for up to 1,000 patients.
• Operates with rechargeable NiCad batteries, alkaline batteries or an AC
adapter.
• Provides printed reports when connected to a parallel printer.
Intended Use
The intended use of the Renaissance II Spirometry System is as a diagnostic
tool to measure the maximal volume and flow of air that can be moved in and
out of a patient’s lungs. The Renaissance II spirometer obtains the spirometric
data by direct measurement of flow via the FSII sensor and pressure tube. The
flow is then electronically integrated to obtain volume. This testing can be used
for the detection, assessment and monitoring of certain lung diseases. The
system is intended for use with pediatric (4 to 17 years) and adult patients (18
to 99) in hospitals, physicians’ offices, laboratories, and occupational health
testing environments.
CAUTION:
• Place the Renaissance I I Spiro metry System in a secure location,
where it is unlikely to drop or fall. Do not attempt to lift or
carry the Renaissance II spi rometer by the pressure tube or
power cord.
• The Renaissance II system may be susceptible to radio
frequency interference. Refer to the Electromagnetic
Interference section on page 54 for more information.
Introduction to the Renaissance II Spirometry System
9 P-495220-00 Rev. D
Basic Spirometry
System and Accessories
The Renaissance II
Spirometry System is
available in a variety of
configurations. The basic
spirometry system consists
of the spirometer, base
station, pressure tube, AC
adapter, FSII flow sensors,
syringe adapter, battery
pack, nose clips and
associated documentation
(See Table 1).
Upon receipt of your
system, verify that all
required parts are present
and undamaged. If any
parts are missing or
damaged, please contact
Puritan Bennett Technical
Support Department at 1800-255-6774.
Connecting the AC Adapter
Connect the AC adapter to the 12-volt DC input jack on the side of the
Renaissance II spirometer or on the rear of the base station as shown in
Table 1: Basic Spirometry System and Accessories
1) Renaissance II Spirometer, PB-700 10) Base Station, PB-710
2) FSII Flow Sensor 11) Nose Clip, Plastic
3) AC Adapter, PB-700 Optional Accessories
4) Assy., Pressure Tube FSII 12) 3L Calibration Syringe
5) Syringe Adapter 13) Nose Clip, Plastic (25/pk)
6) User's Manual, PB-700/PB-710 14) Cable, Null Modem, NPB-510/PB-710
7) Warranty Card, PB-700/PB-710 15) DataFlow™ Data Management Software
8) Quick Guide, PB-700/PB-710 16) Cable, Printer
9) NiCad Battery Pack, PB-700 17) Printer, Spirometer Compatible
Spirometry System
User's Manual
Renaissance® II Warranty Registration Form
A
C
/
D
C
A
D
A
P
T
E
R
P
/
N
P
4
9
5
2
0
8
0
0
C
A
U
T
I
O
N
:
F
O
R
U
S
E
W
I
T
H
S
P
I
R
O
M
E
T
E
R
M
O
D
E
L
O
R
B
A
S
E
S
T
A
T
I
O
N
P
B
7
1
0
A
T
T
E
N
T
I
O
N
:
U
T
I
L
I
S
E
R
L
E
S
P
I
R
O
M
È
T
R
E
P
B
7
0
0
,
S
T
A
T
I
O
N
D
E
B
A
S
E
P
B
7
1
0
Basic System Components
Optional Accessories
Guide
Figure 2: Renaissance II Spirometry System
Introduction to the Renaissance II Spirometry System
P-495220-00 Rev. D 10
Figure 3. A green LED indicator will light on the front panel of the
Renaissance II spirometer and on the AC adapter when properly connected to
an electrical outlet.
Battery Operation
The Renaissance II spirometer
includes a pre-installed
rechargeable custom NiCad
battery pack. As an option, the
user can install 4 AA alkaline
batteries or 4 standard AA NiCad
cells. (Refer to Battery Installation
on page 49 for installation
instructions.) If NiCad cells are
used, an external charger is
required.
WARNING
• T o avoid risk of electrical shock, this unit should only be used in
dry locations.
• As with all medical equipment, carefully route patient cabling
to reduce the possibility of patient entanglement or
strangulation.
CAUTION:
The Renaissance II Spirometry System and Base Station are
designed for use only with the Puritan Bennett AC adapter
(P-495208-00). Do not connec t AC Adapter (P-495208-00) to an
original Renaissance system (PB100/PB110) or damage will result.
Conversely, do not connect a PB100/PB110 AC adapter
(P-062521-00) to the Renaissance II Spirometry System.
NOTES:
• The custom battery pack must
be charged at least 24 hours
before portable use.
• The Renaissance II Spirometry
System is designed to recharge
only the custom battery pack
supplied with the system, and
will not recharge batteries
from other manufacturers.
Base Station
A
C
/
D
C
A
D
A
P
T
E
R
AC/DC ADAPTER
P
/
N
P
4
9
5
2
0
8
0
0
P/N P-495208-00
C
A
U
T
I
O
N
:
F
O
R
U
S
E
W
I
T
H
CAUTION: FOR USE WITH
S
P
I
R
O
M
E
T
E
R
M
O
D
E
L
SPIROMETER MODEL
P
B
7
0
0
,
PB700,
O
R
B
A
S
E
S
T
OR BASE ST
AT
I
O
N
P
B
7
1
0
TION PB710
AT
T
E
N
T
I
O
N
:
U
T
I
L
I
S
E
R
A
TTENTION: UTILISER A
V
E
C
VEC
L
E
S
P
I
R
O
M
LE SPIROM
¨T
R
E
M
O
D
TRE MOD
¨L
E
LE
P
B
7
0
0
,
S
T
PB700, ST
AT
IO
N
D
E
B
A
S
E
TION DE BASE
Spirometer
Pressure
Tube
AC Adapter
Figure 3: Setting up the System
Introduction to the Renaissance II Spirometry System
11 P-495220-00 Rev. D
The custom NiCad battery pack has a battery life of 10-12 hours in the ON
position and a battery life of approximately 8 days in the OFF position.
The pre-installed custom NiCad battery pack will continuously charge as long
as power is connected to the spirometer through the AC adapter.
During operation, the Renaissance II spirometer continually checks battery
status. A low battery indicator will appear in the right hand corner of the screen
when fewer than 20 patient tests can be performed. If the battery voltage drops
below a reliable operating level, the unit will shut-off and not power-up until
the batteries are recharged, changed, or the AC adapter is connected.
Connecting the Pressure Tube
The Renaissance II spirometer is shipped
with a pressure tube that connects the FSII
flow sensor to the spirometer. Upon receipt,
inspect the pressure tube for damage. If the
tube is damaged, contact Puritan Bennett
Technical Support at 1-800-255-6774.
Connect the pressure tube to the underside
of the spirometer, as shown in Figure 3.
Connect the other end of the pressure tube
to the FSII flow sensor, as shown in
Figure 4.
NOTE: If the battery is removed, the unit will operate solely on AC power if
connected to an electrical outlet via the AC adapter.
CAUTION:
• The NiCad battery pack or other batteries may discharge over
time. At least once per mo nth, check batteries for corr osion and
verify batteries are fully charged. Store spirometer in base
station to keep unit ready for use.
• Remove batteries if spirometer will not be used for at least two
weeks.
NOTE: Puritan Bennett recommends replacing the NiCad battery pack at least once
per year.
FSII Flow Sensor
Pressure
Tube
Figure 4: Connecting the Pressure tube
to the FS II flow sensor
Introduction to the Renaissance II Spirometry System
P-495220-00 Rev. D 12
After the batteries have been installed and charged and the tube is connected,
the spirometer is ready for use. The pressure tube does not need to be
disconnected from the spirometer between patients.
NOTE: Replace the pressure tube every year.
Warning
• The Renaissance II Spirometry System is not intended for use in
an oxygen-enriched atmosphere or in the pr esence of
flammable anesthetics.
• Carefully read the flow sensor directions before use, including
all warnings, caution s, an d instructio n s.
CAUTION:
Do not spray liquids on the Renaissance II System. Follow the cleaning
instructions outlined in the Service and Maintenance section starting on
page 49 of this manual.
Introduction to the Renaissance II Spirometry System
13 P-495220-00 Rev. D
Keypad Functions and
Controls
The keypad functions and
controls are user friendly and
intuitive. The keypad and Main
screen icons, shown in Figure 5,
represent some of the most
frequently seen icons that will
be displayed. The keypad and
controls are used to access the
various functions of the
Renaissance II spirometer.
Main Screen Icon Features
Allows the user to
enter new patient data
Begins or continues a
spirometry test or
allows SSD calibration
Allows the user to view
the test results
Allows the user to edit
previously entered
patient data
Initiates one-speed
spirometer calibration
Provides a variety of
printed test reports
Locates a patient’s
previously saved test
data
Allows the user to
configure the
spirometer
Figure 5: Keypa d and Main Screen
Soft Keys
Enter
On/Off
Cursor Keys
On/Off is controlled by
the key marked "I/O".
The enter key is used to
select an option or
action in the graphic
display.
Press the up, down, left
or right arrow key to
move the cursor.
1 2 3
4 5 6
7 8
9
0
Green
Power
Indicator
Light
Cursor
Arrow
Keys
ON/OFF
ENTER
Soft
Keys
The four soft keys are used to select the
functions displayed on the screen
immediately above each key.
Initial Configuration
P-495220-00 Rev. D 14
Initial Configuration
The Renaissance II spirometer has a number of user-selectable configuration
options which have been preset at the factory. The first time the spirometer is
powered on after leaving the factory, the user is prompted to select the
configuration options. Refer to System Configuration on page 78 for a
complete listing and description of the system configuration settings.
1. Press the key to power-up the spirometer. The spirometer will display
an introductory screen while a self test is performed. Press the PROCEED
soft key to go to the next screen (Figure 6).
2. In the “INITIAL SETUP” screen the user is prompted to select certain con-
figurable options. This screen will be displayed each time the spirometer is
powered-up until the user sets the displayed options (Figure 7).
3. Using the cursor key, highlight each option and enter the desired settings
using the keypad. Press the DONE soft key to go to the “MAIN” screen
(Figure 5).
4. From the “MAIN” screen, adjust the display appearance by pressing the
LIGHTER, DARKER, and BACKLIT soft keys to the desired settings.
Warning
The Renaissance II Spirometry System is not intended for use in an
oxygen-enriched atmosphere or in the presence of flammable
anesthetics.
NOTE: The date of the last valid calibration check will display as part of the
spirometer's power-up sequence if a calibration check has not been performed in
the current calendar day.
NOTE: For test accuracy, elevation must be entered.
Figure 6: Ready for Use
Figure 7: Initial Setup
Spirometry Testing
15 P-495220-00 Rev. D
Spirometry Testing
Introduction to Spirometry Testing
The purpose of a spirometry test is to assess and monitor a patient’s lung
condition. The most common spirometry test is the Forced Vital Capacity
(FVC) test. This test requires the subject to take a deep breath and then exhale
into the spirometer as forcefully, rapidly and completely as possible. The FVC
test results report how fast the air was exhaled (flow rate) and how much air
was exhaled (volume). These parameters are compared to values derived
from ‘Predicted Normal Equations” based on the patient's age, height, gender
and race. These equations are listed starting on page 60. Depending on the
results, the healthcare professional will be able to determine whether the patient
is normal, or has an obstructive or a restrictive lung pattern.
Obstructive diseases are characterized by an increased resistance to air flow.
This resistance makes it more difficult to move air into and out of the lungs
rapidly. An obstructive pattern is characterized by a reduction in the volume
that can be exhaled in the first second of the FVC test (FEV1) and by a low
FEV1/FVC ratio. The most common obstructive diseases are asthma, chronic
bronchitis and emphysema. Asthma constricts the bronchial tubes but can be
controlled by drug therapy. Bronchitis also constricts the bronchial tubes but
may not respond to drug therapy. Emphysema is the slow, irreversible
destruction of the alveoli, leading to collapsed airways.
Restrictive diseases impair the movement of the lungs or the volume of air that
can be expelled by the lungs. They are characterized by a reduction in the total
volume of air that can be exhaled. The FEV1/FVC ratio remains normal or
increases. Gross obesity, lung fibrosis, neuromuscular diseases or paralysis can
cause restrictive diseases. Several occupational related diseases such as “black
lung” and “cotton dust lung” also result in a restrictive pattern.
In addition to the FVC test, the Renaissance II spirometer can perform FlowVolume Loop (FVL), Slow Vital Capacity (SVC), Maximal Voluntary
Ventilation (MVV), and FEV6 tests. These additional tests will sometimes
provide more information that is helpful in the diagnosis of a patient's lung
disorder.
Spirometry Testing
P-495220-00 Rev. D 16
Obtaining Good Test Results
Unlike many other medical tests in which the patient is passive, spirometry
requires active cooperation and strenuous effort by the patient. Obtaining the
subject's full understanding and cooperation is essential.
The 10 steps to good spirometry results are listed below:
• Patient should refrain from taking bronchodilators 6-8 hours prior to
testing, unless instructed by a physician.
• Loosen any restrictive clothing. Remove loose dentures, candy, gum, etc.
• Ensure accurate input of ID#, height, weight, gender, birth date, and race.
• Patient may sit or stand, but be consistent and record position.
• The use of nose clips is optional but recommended.
• Explain procedure carefully and demonstrate how it is done.
• Coaching is critical. Remind patient to "BLAST" out the air - don't just
blow! Keep going as long, as hard, and as completely as possible (at least 6
seconds).
• Watch the patient inhale maximally and exhale forcefully and completely
with mouth and teeth firmly sealed around the mouthpiece. Watch and
listen for the incentive display.
• If the test is unacceptable, identify the reason(s) and explain how to correct
the technique.
• Obtain at least three acceptable and two reproducible tests. See pp. 1122 1123 of Reference 11 (page 91) for ATS acceptability and reproducibility
criteria. If tests are below normal, consider administering a bronchodilator
according to office protocol, then retest in 10 to 15 minutes, or as
suggested by the physician.
As the test is performed, coaching messages or incentive messages, e.g.,“Start
Test, Keep Going” appear on the display to encourage the patient. Depending
on the user's preferences, a graph of the data or an animated incentive will be
displayed during the test. These messages and graphics should be used to coach
the subject to perform the test maximally.
Warning
Patient fainting or falling due to dizziness may occur as a result of this
test. Advise the patient to sit or stand comfortably near a chair during
test.
Warning
This device should be used by trained healthcare professionals and is not
intended for patient operation.
Pre-Test Procedures
17 P-495220-00 Rev. D
Pre-Test Procedures
Calibration Verification
The American Thoracic Society (ATS) recommends that a three-speed
calibration verification, using a calibrated syringe with a minimum volume of 3
liters, be performed on a daily basis to verify the accuracy of the system prior to
testing patients. Puritan Bennett recommends using the 3-liter calibrated syringe
specified in Table 1: Basic Spirometry System and Accessories, optional
accessory item 12 (see page 9) for verifying the calibration of the Renaissance
II. The syringe should be recertified for volume accuracy and leaks per
manufacturer recommended intervals.
The Renaissance II can perform two types of calibration verifications: SSD and
Cal Check.
The SSD calibration verification satisfies both ATS and Social Security
Disability requirements for verification at three flow rates.
The Cal Check is performed at one flow rate and can be accessed immediately
after the power-on self test, or from the Cal Check menu item (5) on the Main
screen. When running a Cal Check, calibration syringes ranging in size from 1liter to 8-liters may be used, and the Renaissance II will automatically
determine the size of the syringe. A Cal Check may be desirable in addition to
the daily three-speed (SSD) calibration to verify volume accuracy at multiple
points during studies involving a large number of maneuvers.
SSD Calibration Verification
The Renaissance II’s SSD calibration verification feature can be used to perform
either the ATS recommended daily three-speed verification, or a verification
suitable for Social Security Disability claims submissions. In both cases, the
verifications are performed using a 3-L syringe at three flow rates: 3 L/sec, 1 L/
sec, and 0.5L/sec.
To perform an ATS calibration verification, obtain a flow sensor and 3-L
calibrated syringe, and follow the instructions starting on page 19. There is no
need to enter any patient information prior to performing this verification. The
date and time of the calibration verification will be retained in memory until the
next time a calibration verification is performed.
Social Security Disability Testing requires that the calibration error at the tested
flow rates is within ± 1% of the calibrating volume. In order for the spirometer
to meet the ±1% requirement, a correction factor must be obtained to correct
the measured volume. This correction factor is then applied to the
measurements obtained during the patient tests. For this reason the sensor used
to verify the spirometer’s calibration for an SSD claims submission must also be
used for the actual patient test.
Pre-Test Procedures
P-495220-00 Rev. D 18
NOTE: If the patient test will be submitted for Social Security Disability (SSD)
determinations, enter patient information prior to performing the SSD calibration
verification.
CAUTION:
Prior to verifying calibration, visually verify that there is no foreign
material in the pressure tube and the tube is not damaged or kinked.
Pre-Test Procedures
19 P-495220-00 Rev. D
1. From the “MAIN” screen, press 2 on
the keypad or scroll to TEST using
the cursor key and press ENTER
(Figure 8).
2. From the “PRE MED TEST” screen,
press 3 on the keypad, or use the cursor key to scroll to SSD CAL and
press ENTER (Figure 9).
3. On the “SSD CAL” screen, verify
that the temperature and barometric
pressure are correct. If not, scroll to
the corresponding field and type the
correct information using the
numeric keypad before swiping the
sensor. (Figure 10.)
4. Use the cursor key to scroll to the
sensor code field and swipe the sensor (Figure 11) or enter the numeric
code and press the DONE soft key.
5. Continue to follow the screen’s
directions when prompted.
6. Push the 3-Liter syringe plunger in
smoothly over a period of approximately one-second for the 3 L/sec
verification.
7. The dotted lines appearing on the
display represent the upper and
lower limits for the flow rate. While
pushing the plunger in, the graph
will develop on the display. Try to
keep the graph within the dotted
lines. The “SSD CAL” screen will
prompt faster/slower if necessary,
(Figure 12). Repeat until you are
prompted to proceed.
8. Press the YES soft key to proceed
with the 1 L/sec verification, and follow the same procedures as before
(steps 6 through 7) when prompted on the screen for the next calibration
maneuver. Push the 3-Liter syringe plunger in over a period of approximately 3 seconds for the 1 L/sec verification.
9. Press the YES soft key to proceed with the 0.5L/sec verification.
Figure 8: Select TEST from MAIN screen
Figure 10: Enter room temperature and
barometric pressure
Figure 9: Select SSD CAL from PRE-MED
TEST screen
Pre-Test Procedures
P-495220-00 Rev. D 20
10. Follow the directions on the screen
and push the 3-Liter syringe plunger
in over a period of approximately
6 seconds for the last SSD verification.
11. The final “SSD CAL” screen (Figure
13) will display the volume of the
calibration syringe, the corrected
measured volume and associated
percentage error for each of the three
flow rates indicated on the illustration.
12. Press DONE to save the calibration
results, DISCARD to delete, or
PRINT to print out a record of the
results. See Printing Results on page
38 for more information on printing.
NOTE: When performing either the
CAL check or SSD CAL maneuver, if
the measured flow or volume is not
within allowable range, the screen
will indicate "Unsuccessful CAL Try
Again?" Refer to the Calibration Error
section of the Troubleshooting Guide
on page 52 to resolve the problem.
Figure 11: Swipe the sensor
Figure 12: SSD CAL
Figure 13: SSD CAL Complete
Pre-Test Procedures
21 P-495220-00 Rev. D
Cal Check
1. Connect the pressure tube to the
spirometer and to the FSII sensor.
(Shown previously in Figures 3 and
4.)
2. Following the power-up and initial
setup screens, the “CAL NOW?”
screen will appear on the display.
3. Press the YES soft key to perform the
calibration check or NO to proceed
with a test. When prompted, swipe
the sensor or enter the numeric code
printed on the sensor (Figure 14).
NOTE: Verify that the temperature of the room is the same as the temperature
noted for the calibration test. For every degree discrepancy, there will be a
corresponding 0.15% error in the test results.
NOTE: Verify that the displayed barometric pressure is correct. If not correct, there
will be an error in the inspired volume (FIVC) during an FVL maneuver of
approximately -1.3% for every 1,000 feet above sea level. Refer to the System
Configuration section starting on page 78 for more information. The barometric
pressure displayed is based on the initial elevation setting of the spirometer.
However, the barometric pressure may be changed and the spirometer will, from
that point on, use the new value entered.
CAUTION:
Prior to verifying calibration, visually verify that there is no foreign
material in the pressure tube and the tube is not damaged or kinked.
NOTE: You may also perform a Cal Check by pressing 5 on the keypad at the
“MAIN” screen or scrolling to CAL CHECK with the cursor key and pressing ENTER.
Figure 14: Enter code or swipe sensor
Pre-Test Procedures
P-495220-00 Rev. D 22
4. Continue to follow the screen's
directions when prompted (Figure
15).
5. When the display prompts, push the
plunger in smoothly and completely over approximately one
to two seconds.
6. Press the DONE soft key if com-
plete, or pull the plunger out to
complete an INSPIRATORY CAL
check. (Figure 16.)
7. If the calibration check was suc-
cessful, the syringe volume,
measured volume and error percentage will be displayed on the
final screen. (Figure 17.)
8. To assure accurate patient testing,
the calibration check volume
error is required to be ±3% or
less. If the error is greater than
±3%, refer to the Calibration Error
section of the Troubleshooting
Guide on page 52 of this User’s
Manual.
9. Press DONE to save the Cal Check,
DISCARD to delete, or PRINT to
print out a record of the Cal Check
results. See Printing Results on page
38 for more information on printing.
NOTES:
• The ATS does not require an Inspiratory
Calibration.
• The Renaissance II’s Inspiratory
Calibration function has been validated
only for elevations below 4000 feet.
Figure 15: Attaching syringe
Figure 16: Calibratio n chec k
Figure 17: Cal Check complete
Pre-Test Procedures
23 P-495220-00 Rev. D
Patient Preparation
Coaching the patient will result in more accurate results. There are several
possible reasons why accurate results are not obtained the first time.
• Not taking a maximal inhalation at the beginning of the maneuver.
• Not blasting the air out quickly or starting slow.
• Not blowing out completely.
Verify that the opening of the sensor is not blocked.
Instruct the patient to:
•Relax
• Loosen tight clothing, such as neckties or tight collars
• Remove dentures, candy, gum, etc.
• Elevate chin and extend the neck slightly
• Avoid leaning forward
• Use a nose clip if available (strongly recommended)
• Blast out air forcefully, completely, and as long as possible
WARNING
• Physicians should assess patient’s ability to perform spirometry
testing prior to administering the test.
• Patient fainting or falling due to dizziness may occur as a result
of this test. Advise the patient to sit or stand comfortably near a
chair during test.
• User should visually inspect the FSII sensor for loose particles/
foreign material prior to patient use.
NOTES:
• Demonstrating the test using your own FSII sensor is strongly recommended for
patients who have never performed a spirometry test before.
• The American Thoracic Society (ATS) recommends performing a three-speed
calibration check on a daily basis.
• Materials used to make this Renaissance II Spirometry System and accessories
contain no Latex.
Pre-Test Procedures
P-495220-00 Rev. D 24
WARNING
• Results from spirometry testing should not be the sole source
for determining a patient's diagnosis and treatment. Other
clinical data, such as pa tient symptoms an d re spiratory hi story,
should always be considered.
• Predicted values will be extrapolated for patients with age or
height outside the age and/or height lim its supporte d by the
selected author’s normal equations.
NOTES:
• Verify that the temperature of the room is the same as the temperature noted
for the calibration test. For every degree discrepancy, there will be a
corresponding 0.15% error in the test results.
• Verify that the displayed barometric pressure is correct. If not correct, there will
be an error in the inspired volume (FIVC) during an FVL maneuver of
approximately -1.3% for every 1,000 feet above sea level. Refer to the System
Configuration section starting on page 78 for more information. The barometric
pressure displayed is based on the initial elevation setting of the spirometer.
However, the barometric pressure may be changed and the spirometer will, from
that point on, use the new value entered.
Entering New Patient Data
25 P-495220-00 Rev. D
Entering New Patient Data
1. From the “MAIN” screen press 1 on the keypad or use the cursor key to
scroll to the NEW option and press ENTER.
2. When prompted to start a new patient, press the YES soft key. Pressing NO
will return you to the “MAIN” screen.
3. Enter data on the “NEW PATIENT” screen by using alpha or numeric
characters when appropriate. Press ENTER after each field is completed.
Numbers may be entered directly using the numeric keys with the spirometer in numeric mode. Alpha characters can only be entered with the spirometer in alpha mode.
Alpha character entry is modeled after
cell phones. For example, the first key
press displays the first letter, the second
press displays the second letter, and so
on until the last key press displays the
numeral. A pause in pressing the key
causes the entry point to move to the
next character.
4. When the desired character is highlighted, pause or press the cursor
key to move to the next character
space.
5. When the current field is complete,
press the ENTER key to move to
the next field and repeat the process. You must enter the patient’s
height, birth date, and gender or no
interpretation or predicted values
will be displayed.
6. Enter the patient’s race, by pressing
the corresponding number on the
keypad and then pressing ENTER.
NOTE: When in numeric mode (Figure 18), only numbers may be typed on the key
pad. Pressing the ABC... soft key puts the key pad into alpha character mode (Figure
19) allowing both letters and numbers to be entered from the key pad.
Figure 18: New Patient (Numeric)
Figure 19: New Patient (Alpha)
Loading...