Computer-Based Diagnostic Spirometer Standalone Edition: Perator S Anual

Revolutionizing the way the world detects
and treats respiratory diseases
Computer-Based Diagnostic Spirometer

Standalone Edition
OPERATOR'S MANUAL
STANDALONE
Model 313120
(KoKo Sx Pneumotach 313114-SX, KoKo Software and Operation Manual Flash Drive 398086)
www.nspirehealth.com
PN: 762017.B
1 COPYRIGHT AND TRADEMARK NOTICES
 Federal law restricts this device to sale by or on the order of a physician.
 KoKo is a registered trademark of nSpire Health. All other brand and product names mentioned
in this document are trademarks and/or registered trademarks of their respective holders.
 Information in this manual is subject to change without notice and does not represent a
commitment on the part of nSpire Health.
 The software described in this document is furnished under a license agreement and may be
used only in accordance with the terms of the agreement. See Section 4 for more details.
 All rights reserved. Reproduction, adaptation, or translation without prior written permission from
nSpire Health is prohibited, except as allowed under the copyright laws.
Manufactured By: Authorized Representative:

nSpire Health, Inc. nSpire Health, Ltd.
1830 Lefthand Circle Unit 10 Harforde Court
Longmont, CO 80501, USA John Tate Road
+1.303.666.5555 Hertford SG13 7NW, UK
+1.800.574.7374 (US only) +44 (0) 1992 526300
www.nspirehealth.com
KoKo Sx 1000 Standalone Edition Operator’s Manual 2 of 155

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CONTENTS
1 Copyright and Trademark Notices ......................................................................................................... 2
2 Introduction ............................................................................................................................................ 5
2.1 Intended Audience ........................................................................................................................ 5
2.2 Purpose of Manual ........................................................................................................................ 5
3 Conventions, Symbols and Terms ......................................................................................................... 6
4 End User License Agreement ................................................................................................................ 8
5 Intended Use and Indications .............................................................................................................. 12
5.1 General Warnings and Cautions ................................................................................................. 13
5.2 Contraindications: ....................................................................................................................... 13
5.3 Conformance to Standards and Regulations .............................................................................. 14
5.4 Device Description and Specification .......................................................................................... 14
5.5 Environmental Conditions That Affect Use ................................................................................. 15
5.6 Training Requirements ................................................................................................................ 15
6 Product Overview ................................................................................................................................. 17
7 Quick Start Guide................................................................................................................................. 18
7.1 Main Screen ................................................................................................................................ 18
7.2 Task Sequence (FVC, SVV, MVV, or Challenge) ....................................................................... 19
8 Setup and Preparation for Use ............................................................................................................ 20
8.1 Prerequisites ............................................................................................................................... 20
8.2 Unpacking ................................................................................................................................... 20
8.3 InstallingKoKo software ............................................................................................................... 20
8.4 Configuring the system software ................................................................................................. 24
8.5 Registering the KoKo software.................................................................................................... 32
8.6 Checkout ..................................................................................................................................... 33
9 System Administration ......................................................................................................................... 34
9.1 User Administration ..................................................................................................................... 34
9.2 Database Administration ............................................................................................................. 36
9.3 Data management ....................................................................................................................... 38
9.4 Reports ........................................................................................................................................ 41
10 Quality Assurance ................................................................................................................................ 55
10.1 Filter ............................................................................................................................................ 55
10.2 Pneumotach Performance .......................................................................................................... 56
11 Use ....................................................................................................................................................... 60
11.1 Accessing the System ................................................................................................................. 60
11.2 Entering and Managing Patient Information ................................................................................ 60
11.3 Performing Test ........................................................................................................................... 73
11.4 Reviewing Test Data Quality ....................................................................................................... 98
11.5 Interpreting/Analyzing Test Data ............................................................................................... 111
11.6 Distributing Reports ................................................................................................................... 115
12 Maintenance and Care....................................................................................................................... 117
12.1 User Maintenance ..................................................................................................................... 117
12.2 Manufacturer Maintenance ....................................................................................................... 118
13 Troubleshooting ................................................................................................................................. 119
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13.1 Determining why predicted values not shown ........................................................................... 119
13.2 KoKo System will not install ...................................................................................................... 119
13.3 Failure to Complete Printing...................................................................................................... 119
13.4 "Find all matches" Returns Incorrect Results ............................................................................ 120
13.5 Erroneous Results ..................................................................................................................... 121
13.6 Pneumotach Connection Problems .......................................................................................... 121
13.7 Nulling the Pneumotach ............................................................................................................ 121
13.8 Calibration Gain Factor Message.............................................................................................. 122
13.9 Test Could Not Be Completed .................................................................................................. 122
13.10 Date and Time ........................................................................................................................... 123
13.11 Daylight Saving Time ................................................................................................................ 123
14 Frequently Asked Questions .............................................................................................................. 124
14.1 Can I use my digidoser? ........................................................................................................... 124
14.2 Can I use the KoKo Pneumotach handle from my old software? ............................................. 124
15 Glossary of Terms.............................................................................................................................. 125
16 References ......................................................................................................................................... 132
16.1 Predicted Equations .................................................................................................................. 135
16.2 Electromagnetic Compatibility ................................................................................................... 136
16.3 Shortcut Menu ........................................................................................................................... 141
16.4 Report Item: “Patient/Test Series/Protocol Info” Options .......................................................... 144
16.5 Report Item – Numeric Results ................................................................................................. 149
16.6 Report Item – Graphic Results .................................................................................................. 154

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2 INTRODUCTION
KoKo Sx combines proprietary hardware and software with standard Microsoft Windows operating system
software on most Laptops, Desktops, and Tablets to deliver industry leading spirometry performance.
The flow sensor provides ultra-low breathing resistance, is accurate, durable, holds its calibration, and
lasts the life of the spirometer. Standard KoKo Sx software permits Forced Vital Capacity, Slow Vital
Capacity, Maximum Voluntary Ventilation, Challenge, and Pre- and Post-Bronchodilator spirometry
testing. Key features include real-time flow/volume loop and volume/time graphs, multiple incentive
graphic options, fully customizable report templates, predicted normal equations, automated interpretation,
and time series, trend analysis of patient test results.
2.1 INTENDED AUDIENCE

1. This manual is written for physicians or personnel trained in and familiar with lung function testing
under the guidance of a physician. Users should be familiar with standard Windows operating
system software. Consult a Windows® operator’s manual for standard Windows operating system
questions.
2. It is important to read the entire manual before operating this device.
3. No part of this manual may be copied in any form without the express permission of nSpire Health,
Inc.
2.2 PURPOSE OF MANUAL

1. This manual provides step-by-step instructions on how to use the
KoKo® Sx 1000 Spirometer. Additional help is available through the context sensitive Help
menu within the software.
2. Follow the unpacking and assembly instructions included in this
document.
3. After assembling your device and installing the software, please
refer to this manual or the software Help menu for proper operational guidance. Be sure to read
the following sections:
o Software License for which you are assuming liability (Section 4).
o Essential Prescribing Information (Section 5)
o Intended Use and Indications (Section 5)
o Warnings and Cautions(Section 5)

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3 CONVENTIONS, SYMBOLS AND TERMS
This manual uses the following conventions, symbols, and terms:
Warning statements alert operator to the possibility of injury, death, or other serious
adverse reactions with use or misuse of the device. All warning statements should be read
and understood entirely before operating this device. Contact nSpire Health Customer
Support (contact info on page 2) for any questions or concerns.
Caution statements are used to alert the operator of possibilities of problems that could
arise with the use or misuse of this device. Such problems include, but are not limited to:
device malfunction, device failure, damage to the device, or damage to property. Each
caution includes a precaution that should be taken to avoid the potential hazard. All
cautions and precautions should be read and understood entirely before operating this
device. Contact nSpire Health Customer Support (contact info on page 2) for any
questions or concerns.
A HINT describes shortcuts and reminds users of related activities or additional

information.
While reading this manual, keep these in mind to help you navigate:
 References to other manuals or documentation will be bold and italicized.

 References to other sections in this manual will be italicized.
 References to software user interface elements will be bold.
Steps described in procedures must be performed in order.

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Key to Symbols
This symbol indicates that this Class IIA equipment complies with the
European Union Medical Device Directive. 0086 is the Notified Body
number.
Manufacturer
Authorized Representative in the European Community.
Catalog number
Type BF applied part. This equipment provides a degree of protection

against electric shock in regards to Patient Leakage Current and Patient
Auxiliary Current. F-Type (floating from earth ground) applied part.
Dispose of waste electrical products appropriately in conformance with local

regulations.
“Caution: consult accompanying documents.” Read and understand all

instructions and warnings prior to use. Failure to obey the instructions could
lead to patient or operator risk.
Temperature limitation for storage and transport. Limitation is indicated next

to the horizontal lines.
Humidity limitation for storage and transport. Limitation is indicated next to

the horizontal lines.
Atmospheric pressure limitation for storage and transport. Limitation is

indicated next to the horizontal lines.
Prescription only - device restricted to use by or on the order of a physician.

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4 END USER LICENSE AGREEMENT
4.1.1 IMPORTANT – PLEASE READ CAREFULLY THE TERMS OF THIS SOFTWARE LICENSE
AGREEMENT (“AGREEMENT”). BY CLICKING ON THE “I AGREE” BUTTON, (1) YOU
ACKNOWLEDGE THAT YOU HAVE READ, UNDERSTAND, AND AGREE TO BE BOUND BY
THIS AGREEMENT AND (2) YOU REPRESENT THAT YOU HAVE THE AUTHORITY TO
ENTER INTO THIS AGREEMENT PERSONALLY, OR IF YOU HAVE NAMED A COMPANY AS
CUSTOMER, ON BEHALF OF THAT COMPANY (YOU OR ANY SUCH COMPANY, THE
“CUSTOMER”), AND TO BIND THE CUSTOMER TO THE TERMS OF THIS AGREEMENT. IF
YOU DO NOT AGREE TO ALL TERMS AND CONDITIONS OF THIS AGREEMENT, OR IF
YOU DO NOT HAVE SUCH AUTHORITY, YOU SHOULD CLICK ON THE “CANCEL” BUTTON
TO DISCONTINUE THE DOWNLOAD OR USE OF THE LICENSED SOFTWARE.
4.1.2 AGREEMENT. This Agreement is a legal agreement between Customer and nSpire Health
(“Company”) for the accompanying software product, which includes computer software and may
include associated, media, printed materials and “online” or electronic documentation (the
“Licensed Software”). Certain items of independent, third-party code may be included in the
Licensed Software that are subject to the GNU General Public License (“GPL”) or other open
source licenses (“Open Source Software”). Such Open Source Software is licensed under the
terms of the license that accompanies such Open Source Software. Nothing in this Agreement
limits Customer’s rights under, or grants Customer rights that supersede, the terms and
conditions of any applicable end user license for such Open Source Software. In particular,
nothing in this Agreement restricts Customer’s right to copy, modify, and distribute such Open
Source Software that is subject to the terms of the GPL. By accepting this Agreement, you are
also accepting the additional terms and conditions, if any, set forth therein. By downloading the
Licensed Software you agree to be bound by the terms of this Agreement. If you do not agree to
the terms and conditions of this Agreement or do not have the authority warranted above, do not
download or use the Licensed Software.
4.1.3 LICENSE. Subject to the terms and conditions of this Agreement, Company grants to Customer
a nontransferable, nonexclusive, revocable, worldwide license (without the right to sublicense) to
permit those individuals authorized by Customer (“Users”) to install, use, execute and display the
Licensed Software, in executable object code format only, solely for Customer’s own internal
business operations.
4.1.4 RESTRICTIONS. The rights granted to Customer in this Agreement are subject to the following
restrictions: (a) Customer shall not license, sell, rent, lease, transfer, assign, distribute, host,
outsource, disclose or otherwise commercially exploit the Licensed Software or make the
Licensed Software available to any third party other than an authorized User; (b) Customer shall
not modify, make derivative works of, disassemble, reverse compile or reverse engineer any part
of the Licensed Software; (c) Customer shall not access the Licensed Software in order to build a
similar or competitive product or service; (d) except as expressly stated herein, no part of the
Licensed Software may be copied, reproduced, distributed, republished, downloaded, displayed,
posted or transmitted in any form or by any means, including but not limited to electronic,
mechanical, photocopying, recording or other means; and (e) any future release, update, or other
addition to functionality of the Licensed Software shall be subject to the terms of this Agreement,
unless Company expressly states otherwise. Neither Company nor any of its suppliers is
obligated to provide any services, updates or upgrades to the Licensed Software. Customer shall
preserve all copyright and other proprietary rights notices in the Licensed Software and all copies
thereof.

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4.1.5 OWNERSHIP. All right, title, and interest, including all intellectual property rights, in and to the
Licensed Software (including any and all copies thereof) shall be owned and retained by
Company or its suppliers. Any rights not expressly granted by Company in the Agreement are
reserved. Customer acknowledges that it acquires no ownership interest in the Licensed
Software.
4.1.6 DISCLAIMER OF WARRANTIES. THE LICENSED SOFTWARE IS PROVIDED TO

CUSTOMER ON AN “AS-IS” BASIS. COMPANY AND ITS SUPPLIERS DISCLAIM ALL
EXPRESS, IMPLIED OR STATUTORY WARRANTIES RELATING TO THE LICENSED
SOFTWARE, INCLUDING BUT NOT LIMITED TO, MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE, TITLE, AND NON-INFRINGEMENT. COMPANY DOES NOT
WARRANT THAT USE OF THE LICENSED SOFTWARE WILL BE UNINTERRUPTED OR
ERROR-FREE, THAT DEFECTS WILL BE CORRECTED, OR THAT THE LICENSED
SOFTWARE IS FREE OF VIRUSES OR OTHER HARMFUL COMPONENTS. IF APPLICABLE
LAW REQUIRES ANY WARRANTIES WITH RESPECT TO THE LICENSED SOFTWARE, ALL
SUCH WARRANTIES ARE LIMITED IN DURATION TO NINETY (90) DAYS FROM THE DATE
OF DOWNLOAD OR INSTALLATION.
4.1.7 LIMITATION OF REMEDIES AND DAMAGES. TO THE MAXIMUM EXTENT PERMITTED BY

LAW, NEITHER COMPANY NOR ITS SUPPLIERS SHALL BE RESPONSIBLE OR LIABLE
WITH RESPECT TO ANY SUBJECT MATTER OF THIS AGREEMENT OR TERMS OR
CONDITIONS RELATED THERETO UNDER ANY CONTRACT, NEGLIGENCE, STRICT
LIABILITY OR OTHER THEORY (A) FOR LOSS OR INACCURACY OF DATA OR COST OF
PROCUREMENT OF SUBSTITUTE GOODS, SERVICES OR TECHNOLOGY, OR (B) FOR ANY
INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES INCLUDING, BUT NOT LIMITED
TO LOSS OF REVENUES AND LOSS OF PROFITS. TO THE MAXIMUM EXTENT
PERMITTED BY LAW, COMPANY’S AGGREGATE CUMULATIVE LIABILITY HEREUNDER
SHALL NOT EXCEED THE GREATER OF FIFTY DOLLARS ($50.00) OR THE AMOUNT PAID
BY CUSTOMER FOR THE LICENSED SOFTWARE THAT CAUSED SUCH DAMAGE.
CERTAIN STATES AND/OR JURISDICTIONS DO NOT ALLOW THE EXCLUSION OF IMPLIED
WARRANTIES OR LIMITATION OF LIABILITY FOR INCIDENTAL OR CONSEQUENTIAL
DAMAGES, SO THE EXCLUSIONS SET FORTH ABOVE MAY NOT APPLY TO CUSTOMER.
4.1.8 APPLICATION OF LIMITATIONS AND DISCLAIMERS TO CONSUMERS. The limitations or

exclusions of warranties and liability contained in this Agreement do not affect or prejudice the
statutory rights of a consumer, i.e., a person acquiring goods otherwise than in the course of a
business. The limitations or exclusions of warranties and remedies contained in this Agreement
shall apply to Customer only to the extent such limitations or exclusions and remedies are
permitted under the laws of the jurisdiction where Customer is located.
4.1.9 BASIS OF BARGAIN. The warranty disclaimer and limitation of liability set forth above are
fundamental elements of the basis of the agreement between Company and Customer.
Company would not be able to provide the Licensed Software on an economic basis without such
limitations. The warranty disclaimer and limitation of liability inure to the benefit of Company’s
suppliers.

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4.1.10 TERM AND TERMINATION. This Agreement and the licenses granted hereunder are effective
on the date Customer downloads or installs the Licensed Software and shall continue unless and
until this Agreement is terminated by either party pursuant to this section. Company may
terminate this Agreement immediately upon notice to Customer in the event that Customer
materially breaches any of the terms hereof. Customer may terminate this Agreement at any time,
with or without cause. Customer may terminate this Agreement by sending either an email to
nSpireUSTechnicalSupport@nspirehealth.com with Customer’s name and the subject
“TERMINATION OF LICENSE” or a letter by United States mail to: 1830 Lefthand Circle,
Longmont, Colorado, 80501, USA or to such other address as Company may specify in writing by
posting the new address on the Company website. Upon termination, the license granted
hereunder shall terminate and Customer shall immediately destroy any copies of the Licensed
Software in its possession, but the terms of this Agreement which are intended to survive
termination will remain in effect.
4.1.11 MODIFICATIONS. Company reserves the right to change the terms and conditions of this
Agreement or its policies relating to the Licensed Software at any time. We will notify you of any
material changes to this Agreement by sending you an e-mail to the last e-mail address you
provided to us or by prominently posting notice of the changes on our website. Any material
changes to this Agreement will be effective upon the earliest of thirty (30) calendar days following
our dispatch of an e-mail notice to you or thirty (30) calendar days following our posting of notice
of the changes on our website. These changes will be effective immediately for new users of our
Licensed Software. Please note that at all times you are responsible for providing us with your
most current e-mail address. In the event that the last e-mail address that you have provided us
is not valid, or for any reason is not capable of delivering to you the notice described above, our
dispatch of the e-mail containing such notice will nonetheless constitute effective notice of the
changes described in the notice. If you do not agree with the changes to this Agreement, you
must notify us prior to the effective date of the changes that you wish to terminate your license to
the Licensed Software. Continued use of the Licensed Software, following notice of such
changes, shall indicate your acknowledgement of such changes and agreement to be bound by
the terms and conditions of such changes.
4.1.12 EXPORT. The Licensed Software and related technology are subject to U.S. export control laws
and may be subject to export or import regulations in other countries. Customer agrees not to
export, re-export, or transfer, directly or indirectly, any U.S. technical data acquired from
Company, or any products utilizing such data, in violation of the United States export laws or
regulations. Customer will indemnify and hold Company harmless from any and all claims, losses,
liabilities, damages, fines, penalties, costs and expenses (including attorney’s fees) arising from
or relating to any breach by Customer of its obligations under this section. Customer’s
obligations under this section shall survive the expiration or termination of this Agreement.

PN 762017.B
4.1.13 MISCELLANEOUS. Neither the rights nor the obligations arising under this Agreement are
assignable by Customer, and any such attempted assignment or transfer shall be void and
without effect. This Agreement shall be governed by and construed in accordance with the laws
of the State of Colorado and the United States without regard to the conflict of laws’ provisions
therein that would require application of the laws of another jurisdiction. Any action under or
relating to this Agreement shall be brought solely in the state and federal courts located in
Colorado and each party hereby submits to the personal jurisdiction of such courts, except that
Company may seek relief in any court of competent jurisdiction to protect or enforce its
intellectual property and proprietary rights. The United Nations Convention on Contracts for the
International Sale of Goods shall not apply to this Agreement. In the event that any provision of
this Agreement is found to be contrary to law, then such provision shall be construed as nearly as
possible to reflect the intention of the parties, with the other provisions remaining in full force and
effect. Any notice to Customer may be provided by email. This Agreement constitutes the entire
agreement between the parties pertaining to the subject matter hereof, and any and all written or
oral agreements previously existing between the parties are expressly canceled. Except as
otherwise expressly provided in this Agreement, any modifications of this Agreement must be in
writing and agreed to by both parties.
4.1.14 QUESTIONS OR ADDITIONAL INFORMATION. If you have questions regarding this Agreement,
or wish to obtain additional information, please send an e-mail to
nSpireUSTechnicalSupport@nspirehealth.com

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5 INTENDED USE AND INDICATIONS
This device is intended to be used as a pulmonary function diagnostic testing device. It is to be connected
to a customer-supplied personal computer and manufacturer-supplied power supply which is certified to
IEC and/or UL 60950. The device is to connect via the USB port of the computer. During testing it is to
be connected to a KoKo® single patient use, viral/bacterial filter and used by trained medical personnel
under the supervision of a physician in hospitals, clinics and doctor's offices. The operator must maintain
a patient area of 1.5m horizontally and 2.5m vertically, and, at no time, bridge the patient and the
personal computer/printer/specified power supply system. This device is held by the patient, but it does
not in any way interact with or influence the patient when used as specified.
This device is indicated for use in the diagnosis and monitoring of patients with obstructive or restrictive
respiratory disease processes.

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5.1 GENERAL WARNINGS AND CAUTIONS
5.1.1 WARNING: Federal Law restricts this device to sale by or on the order of a physician.
5.1.2 WARNING: Harm can occur during lung function testing as a result of increased thoracic
pressures and their impact on abdominal and thoracic organs/tissues, large swings in
blood pressure causing stresses on tissues in the body, expansion of the chest wall and
lungs, and active communicable diseases. A physician or healthcare expert is required to
judge when it is safe and appropriate to undertake spirometry.
5.1.3 WARNING: During provocation testing, the patient's exposure and response to the
challenge agent may require the suspension of testing. Provocation testing can be
dangerous, and should only be performed with a physician and appropriate emergency
equipment available. Always review the information provided with the challenge agent
very carefully.
5.1.4 WARNING: Verify that the KoKo Filter fits snugly when placed on the KoKo SX.
5.1.5 WARNING: Check the filter for foreign matter prior to patient use.
5.1.6 WARNING: The KoKo® Filter is designed for single patient use only. Do not attempt to
clean or sterilize.
5.1.7 WARNING: Follow good practice on the cleaning and handling of medical devices to
minimize the risk of cross-infection.
5.1.8 WARNING: Connect only to a computer certified to IEC/UL 60950.
5.1.9 WARNING: No modification of this equipment is allowed.
5.1.10 CAUTION: Always follow quality assurance procedures, particularly when testing at
extreme environmental conditions.
5.1.11 CAUTION: Use only nSpire Health authorized filters and accessories.
5.1.12 CAUTION: Do not attempt to autoclave, wash, or submerge the KoKo SX hardware handle
in water or cleaning fluid, as there are electronic components inside the handle that will be
permanently damaged.
5.1.13 CAUTION: Follow the cleaning procedures contained in this manual.
5.1.14 CAUTION: Back up computer before KoKo Sx software installation or update.
5.1.15 CAUTION: Always use KoKo® Filters with the KoKo SX Spirometer; failure to use a KoKo®
filter could affect accuracy of patient test results
5.2 CONTRAINDICATIONS:
Contraindication statements are to alert the operator of the situations in which use of the device
outweighs any possible benefit. Known hazards and not theoretical possibilities are listed.
Patients should not be tested within 1 month of a myocardial infarction.38

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5.3 CONFORMANCE TO STANDARDS AND REGULATIONS
nSpire Health and this device conform to the following:
• Industry Guidelines – ATS/ERS 2005
• Quality System Regulations - FDA QSR, ISO 13485 (CMDCAS, MDD)
• Product Testing Standards – IEC/EN 60601-1, 60601-1-2, 60601-1-6, ISO 26782
• European Directives - MDD 93/42/EEC, RoHS 2011/65/EU
5.4 DEVICE DESCRIPTION AND SPECIFICATION

The KoKo Sx 1000 is manufactured by nSpire Health as a pulmonary function testing device.
 Flow sensor: Brass Fleisch-type Pneumotachometer

Dimensions 19x10x6cm
Weight 0.3kg
Data Sampling Rate 200/sec
Volume Scaling 100mm/L, user variable
Volume Range 0-19.9L
Flow Scaling 5mm/L/sec, user variable
Flow Range ±16L/sec
Accuracy ±2%
Power Source USB port
 Operating Environment:
Temperature -20°C to +35°C
Relative Humidity 0-100%
 Computer Requirements:
o Windows 7, 8, 8.1
o 32- or 64-bit
o minimum 1 GHZ
o minimum 1 GB RAM
o available USB port
 Software:
o KoKo Sx (single user) Ver. 5.0
 Safety:
o Type BF patient applied part
o Ordinary equipment (not protected against harmful ingress of moisture)
o Not suitable for use with flammable anesthetics
o Suitable for continuous operation

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5.5 ENVIRONMENTAL CONDITIONS THAT AFFECT USE
 nSpire Health recommends that the KoKo Sx Spirometer be powered at all times, or that it be
allowed to warm up for 15 minutes after power is applied and before verification of manufacturers’
specification or patient testing is performed.
 The recommended handling, shipping and storage conditions for the KoKo Sx Spirometer are:
Temperature -20°C and +50°C

Relative Humidity 95%
Barometric Pressure 480mmHg – 800mmHg
 Verification of the Koko Sx system performance to specifications using a 3-Liter syringe as part of
a total quality assurance program prior to testing patients is advisable. The 3-L syringe used for
device quality verification should be validated according to the syringe manufacturer’s
specifications.
 While using a KoKo filter during testing reduces the need for cleaning and disinfection, cleaning
instructions for the KoKo Sx are included in (Section 12).
5.6 TRAINING REQUIREMENTS

Spirometry relies heavily on the patient performing several maximal well performed efforts. This requires
the procedure to be clearly explained and demonstrated to the patient. The technician must actively
coach and motivate the patient to perform maximally. The technician should be familiar with the various
spirometry techniques and comfortable with the software to ensure optimal test results.
An online tutorial program is available to new operators of the system and for those who chose not to
attend a training seminar. Review of the tutorial program will support continued proficiency
5.6.1 Patient Preparation

The patient position can be standing or sitting. To avoid injury related to syncope or dizziness, consider
sitting patients during testing. Chair should not have wheels to ensure stability of patient. If a patient
prefers to stand, place a chair behind them for quick access if they experience symptoms of dizziness or
being light-headed.
The patient should be as relaxed as possible wearing loose clothing. Dentures should be left in place
unless they are loose.
The patient should avoid the listed activities prior to lung function testing:
 Smoking within at least 1 hour of testing

 Consuming alcohol within 4 hours of testing
 Performing vigorous exercise within 30 min of testing
 Wearing clothing that substantially restricts full chest and abdominal expansion
 Eating a large meal within 2 hours of testing

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5.6.2 FVC Procedure
There are three phases to the FVC maneuver: Maximal inspiration, a “blast” of exhalation, and continued
complete exhalation to the end of test. The technician should demonstrate the appropriate technique and
follow ATS/ERS recommendations for “Standardization of Spirometry”.39
Procedures for recording forced vital capacity

Check the spirometer calibration
Explain the test
Prepare the subject
Ask about smoking, recent illness, medication use, etc.
Measure weight and height without shoes
Wash hands
Instruct and demonstrate the test to the subject, to include
Correct posture with head slightly elevated
Inhale rapidly and completely
Position of the mouthpiece (open circuit)
Exhale with maximal force
Perform maneuver (closed circuit method)
Have subject assume the correct posture
Attach nose clip, place mouthpiece in mouth and close lips around the mouthpiece
Inhale completely and rapidly with a pause of <1 s at TLC
Exhale maximally until no more air can be expelled while maintaining an upright posture
Repeat instructions as necessary, coaching vigorously
Repeat for a minimum of three maneuvers, no more than eight are usually required
Check test repeatability and perform more maneuvers as necessary
Perform maneuver (open circuit method)
Have subject assume the correct posture
Attach nose clip
Inhale completely and rapidly with a pause of <1 s at TLC
Place mouthpiece in mouth and close lips around the mouthpiece
Exhale maximally until no more air can be expelled while maintaining an upright posture
Repeat instructions as necessary, coaching vigorously
Repeat for a minimum of three maneuvers, no more than eight are usually required
Check test repeatability and perform more maneuvers as necessary
*Recreated from Table 4 ATS/ERS 2005 Standardization of Spirometry39

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6 PRODUCT OVERVIEW
KoKo Sx 1000 combines proprietary hardware and software with standard Microsoft Windows operating
system software on most Laptops, Desktops, and Tablets to deliver industry leading spirometry
performance. The flow sensor provides ultra-low breathing resistance, is accurate, durable, holds its
calibration, and lasts the life of the spirometer. KoKo Sx software permits Forced Vital Capacity, Slow
Vital Capacity, Maximum Voluntary Ventilation, Challenge, and Pre- and Post-Bronchodilator spirometry
tests. Key features include real-time flow/volume loop and volume/time graphs, multiple incentive graphic
options, fully customizable report templates, predicted normal equations, automated interpretation, and
time series, trend analysis of patient test results.
Optional KoKo Sx® networking software and all other KoKo® products are fully compatible with nSpire
Health’s Iris™ product family. When used with Iris’™ scalable respiratory information system software
KoKo® devices and Iris empower healthcare providers to advance respiratory diagnostic processes and
improve patient outcomes while meeting the demanding clinical objectives of leaders in respiratory care.
An approved KoKo Sx filter is required for all patient testing. The single patient use KoKo filter offers low
resistance, enables accurate spirometry analysis, potentially reduces cleaning and maintenance, and
effectively protects the patient, technician and equipment from contamination. nSpire Health offers a
variety of colors, mouthpiece shapes, and accessories to suit your needs. Contact your nSpire Health
representative or visit www.nspirehealth.com/filters for current options.

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7 QUICK START GUIDE
This “Quick Start Guide” is intended only as an operating checklist for users already familiar with the
KoKo Sx 1000. Do not proceed unless you have read Section 5 “Intended Use and Indications”.
7.1 MAIN SCREEN
11
1 1
2
2
3 108
3 4
7
6 9
4 5
5
8
6
7
1. Select patient and test series, enter/edit patient

7. Print multiple test series
information
2. Perform FVC test 8. Design report format
3. Perform SVC test 9. Verify pneumotach calibration
4. Perform MVV test 10. Log in/Log off
5. Perform Challenge test 11. Help
6. Read/interpret/print results

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7.2 TASK SEQUENCE (FVC, SVV, MVV, OR CHALLENGE)
A. Launch device software (right click desktop icon and select open or double click desktop
icon) (Section 8.2.1).
B. Log in (if KoKo Sx passwords are enabled) (Section 11.1.2).
C. Verify calibration of the pneumotach (section 10.2.1).
D. Enter a new patient, or create a new test series for a returning patient. (Section 11.2).
E. Select the testing module and perform the efforts (Section 11.3).
F. Open a report (Read/Interpret/Print window) (Section 11.5.1.1).
G. Interpret the results (Section 11.5.1.3).
H. Print the results (optional) (Section 11.6).
I. Log off when you are finished (if KoKo Sx passwords are enabled) (Section 8.5).

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8 SETUP AND PREPARATION FOR USE
8.1 PREREQUISITES
The following prerequisites are the bare minimum that the KoKo Sx software needs to function at a
reasonable level. Any system that exceeds these requirements will provide better performance.
Minimum Test Station / Workstation Computer Requirements

Processor: Intel i5 processor 2 GHZ clock (or equivalent)
Operating System: Windows 7 or 8.x, Professional, Ultimate, or Enterprise
RAM: 4 GB RAM
DVD: DVD+/-RW (DVD-Writer)
Hard Drive: 250 GB 7200 RPM
For best results, and improved performance and reliability, nSpire Health strongly recommends a
commercial grade computer that exceeds these minimum requirements.
8.2 UNPACKING
1. Open the nSpire Health KoKo Sx Spirometer box.
2. Remove the KoKo Sx Spirometer handle with the attached USB cable (not included in the KoKo
Sx Testing Software standalone Edition – 398086)
3. Remove the flash drive containing the KoKo Sx 1000 software.
8.3 INSTALLING KOKO SOFTWARE

The below steps only apply for Customers that have opted to provide their own computer. If computer
was purchased with the KoKo Sx from nSpire Health then continue to Configuring the System.
1. Insert the USB installation flash drive on the computer intended for the KoKo Sx Spirometry
System.
a. Minimum Computer Specifications
i. 1 GHz processor
ii. 1GB memory
2. Click Open Folder to View Files

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3. Option A: Double click on KoKo Sx Installation. Exe file.
Or
Option B: to enhance speed of installation, right click on KoKo Sx Installation.exe file and select
Copy.
a. Right click your computer desktop and select Paste
b. The KoKo Sx installation .exe file will display on your desktop
c. Double click the file
4. The Windows notification about trusting the software “Would you like to install this device
software?” displays.
Check “Always trust software from “nSpire Health, Inc.”

5. Click Install
6. The Install Shield Wizard will open and display all required software for KoKo Sx that will be
installed for the system’s operation.
7. Click Install
8. A Windows security message will display. Click Install.
9. When the next InstallShield wizard screen displays, click Next.

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10. Read and accept the software license agreement.
Click Next.
11. The Readme Information screen displays. It contains information about the software as well as
the hardware requirements.
Read and click Next

12. The nSpire Health Software Activation screen displays. Call nSpire Health (contact info on page
2) to register the software (Section 8.4) or click Continue Evaluation, if you chose to activate
during the installation, the installation will continue after you double click on the KoKo Sx icon.
You have 90 days to register the software.
a. Note: After 90 days without registration, the KoKo Sx system will no longer operate.
13. The InstallShield Wizard Completed message appears.

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Click Finish
14. The KoKo Sx software launch icon will display on your desktop.
8.3.1 Starting KoKo Sx

1. With the spirometer handle NOT attached, double click on the desktop icon.
Caution: Attaching the spirometer handle prior to the initial launch of the KoKo Sx
software will prevent proper software installation.
2. If you have not registered your software, click Continue Evaluation or chose to register the
software (Section 8.4).
Note the number days remaining in the 90 day trial before registration is required.
3. A screen may display a message indicating the software cannot find the USB pneumotach
(spirometer) driver. This will occur at initial set up as the KoKo Sx spirometer handle has not yet
been connected.
4. Click Cancel.
5. The KoKo Sx software main screen will display. To enlarge the image, click the maximize button
located at the upper right hand corner of window. If your KoKo Sx software has been registered,
your customer name will display on the main page.

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6. Attach the KoKo Sx spirometer handle to any available USB port on your computer. The KoKo
software will display a message at the bottom right saying the software was installed successfully.
7. Close and re-open the KoKo Sx software while the KoKo Sx spirometer handle is attached via the
USB port on your computer.
It is recommended prior to testing for the first time to configure the system (Section 8.3) and
verify the spirometer is operating within specifications (Section 10.2).
8.4 CONFIGURING THE SYSTEM SOFTWARE

8.4.1 System Date/Time
1. Check the Windows operating system time and date. A 4-digit year date format is recommended.
8.4.2 Preferences Menu
8.4.2.1 Choose Available Predicted Sets

To configure a drop down list of protocols to be available from the testing windows:
1. From the main window, select the System menu, the Preferences menu, and then Predicted.
2. Protocols selected and highlighted in blue will be made available in predicted dropdown menus,
while options that are white will not be.

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You cannot unselect “None.”
8.4.2.1.1 Select Default Predicted Equation Set

To select a default equation set:
1. Scroll to the equation set labeled (default)
2. Click the Move up or Move down button to position (default) label next to the desired equation set.
3. Click OK
When testing a patient the user is able to view and select a different predicted within the testing
window. Details are covered in the testing section.
8.4.2.2 F-Key Menu Accelerators

Checking the “F-key accelerators” option enables the use of F-keys for KoKo Sx function shortcuts.
(section xx – control key menu)

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8.4.2.3 Patient Confirmation
Checking the “Patient Confirmation” option configures the software to always open the “Select patient and
test series” window prior to testing a patient. This ensures the user has accessed the correct patient
record and visit date. To test the patient, the user needs to confirm the highlighted “test series” is the
correct record and click OK.
8.4.2.4 Auto-interpret results Preference

In the main window “System” menu, select the “Preferences” menu and open the “Auto-interpret results”
menu. The options are:
1. Standard
2. ITS
3. McKay
4. Custom
Ensure ITS predicted is selected for patient test series to ensure proper function of this option.
The currently selected computer interpretation will be “checked”. If none of the computer interpretation
options are “checked”, the automatic interpretation process will be disabled.
Automatic computer interpretation occurs when:
 A test is saved .
 Bronchodilator status is changed .
 The predicted equation set is changed .
 Results have changed, and a report window is opened .
 Results have changed, and the testing window is exited .
8.4.2.5 Basic Reports

Configure View of Basic Reports
From the “Read/Interpret/Print Results” window, the user has the option to select a report design by
clicking on the “select report design” button, . The report design options can be viewed and selected
from a single list or can be viewed, organized and selected from a folder.

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 Choose basic report designs from a single list,
 Or organized designs by folders
When organized by folders, the user can access shared reports using a shared folder and/or sort
report design into different categories. (example: Dr. Smith reports)
To configure the system for single list viewing or folder viewing,
1. From the main window select “System” and then select “Preferences”.
2. Check or uncheck “Basic reports”
When “basic reports” item is checked, the single list view is configured.
8.4.2.6 Auto-select Report Design

As part of a report design, you may assign specific designs to test series that contain:
 Pre-Rx tests only
 Pre-Rx with Post-Rx test (s)
 Challenge tests
The assignment of designs to test series allows for automatic report design selection when printing or
displaying reports. (Section 9.4.2 – report design)
Checking the “Auto-select report design” menu option enables the auto selection of a report design.

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8.4.2.7 Entering the Facility Name and Location (Recommended)
Facility name and location will be included on pre-configured standard reports. The Facility name/location
entry fields can be opened from the KoKo Sx main window.
1. Click the Systems menu and then the Preferences menu to find this option.
a. Information in these fields will display in the upper left corner of all pre-configured
reports.
2. Click OK
8.4.2.8 Contact Name

Free text field enables user to label/identify the KoKo software. User can determine naming convention
that best fits the need of the operator. The entered text will appear on the main window of the KoKo Sx
software as illustrated below.
8.4.3 Configuration Menu
8.4.3.1 Pneumotach Enablement

To perform patient testing, the pneumotach must be enabled.
1. From the System menu, select the Configuration menu and click Pneumotach.
The pneumotach is normally enabled by default when KoKo Sx is installed.

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2. Click OK.
8.4.3.2 KoKo Legend data import

The KoKo Legend is a portable spirometer capable of performing Forced Vital Capacity (FVC) tests. It is
designed for standalone operation, where all patient information and test results remain on KoKo Legend.
The specific details of KoKo Legend operation and the importing of data into KoKo Sx are found in KoKo
Legend Guide to Operation. Instructions regarding importing data from a KoKo Legend into the KoKo Sx
1000 can also be found by selecting “help” from the main menu and “help topics” or click the help button
.
1. Select the “search” tab.

2. Type in the word(s) to search for: KoKo Legend and click “List Topics”
3. The selected topics will display. Double click on the topic of choice to access the instructions.
8.4.3.3 Passwords(Optional)
KoKo Sx can be set to require the user to enter a name and password on starting up the software.
 Passwords must be enabled.

 Technicians must log in at startup and before performing any patient-related functions.
 After finishing their tasks, technicians must log off.
 When passwords are enabled, an event log is created.

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Passwords are initially enabled and configured by the person who will be the password
administrator. Once passwords are enabled, general password maintenance can only be performed by
the password administrator.
Entered names will display on the dropdown list of technician names during testing. Passwords
can be removed when the administrator re-accesses the Add Name and Password dialog.
When passwords are enabled, an Event Log is created to show all logins and changes to patient
related data. To view the Event Log refer to the KoKo Sx Service Manual or contact your systems
administrator.
When passwords are enabled the user is required to log in and log off. The “Log in” window will
appear at the KoKo Sx startup or upon selecting any patient-related function. If a password is not
working or is forgotten, contact the system administrator. In the event the system administrator is not
available, contact nSpire Health Customer Service for a temporary password (contact info on page 2).
8.4.3.4 Change _____Password

When passwords are enabled, the “Change _______Password” window is activated to permit the user
logged in to change their password.
1. From the “System” menu, select “Configuration” and click on “Change Password”.
2.
3. Enter current password.
4. Then enter new password and enter again.
5. Click OK.
8.4.3.5 Custom Interpreter

1. From the main window, select “Configuration” and then “Custom interpreter” from the “System”
menu.

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2. You are required to select one of the included computer interpretations to use as the basis for
your customized computer interpretation. Select one of:
a. Standard interpreter
b. ITS interpreter
c. McKay interpreter
3. Click OK.
4. The “Custom Interpreter” window displays.
5. The decision point and phrase entries will depend on the standard computer interpretation
selected.
6. Select a phrase or a decision point entry and click Edit in that section.
7. A new window will open with the default text. Enter the new text. Click OK.
Enter all decision point values as positive numbers, they are converted to negative numbers by the
interpreter where required. Knowledge of the standard interpretation algorithms is essential for editing
the decision points as a clear correlation between decision points and phrases is not provided. Editing
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the phrases will change what appears in the computer interpretation on reports in response to the
decision points.
8.4.3.6 Custom Export Format

Exporting KoKo tests is performed by selecting “File” from the main menu then “Import/Export”. It is
designed to be used as a link between KoKo Sx and an arbitrary external database system. Default
setting is “Use the standard export file formats”. Refer to section 9.3.1 for information regarding
import/export of data.
8.5 REGISTERING THE KOKO SOFTWARE

1. From the “Help” menu select “Activate”.
2. The activation menu displays.
3. Call nSpire Health (contact info on page 2) and provide the following information:
a. The Registration code
b. Customer number
c. The serial number of the KoKo Sx handle
d. Name of facility as it should appear in nSpire Health’s records
The name provided during the registration process will appear on the KoKo Sx main page
when complete.
4. nSpire Health will provide an Activation code. Enter your company name or facility name and the
activation code in the activation menu:
5. The “Activate” button will become functional.

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6. Click “Activate”
a. Software is now registered with nSpire Health.
7. To confirm registration information, from the “Help” menu select “About”. Registration information
will display.
8.6 CHECKOUT
8.6.1 Log Off
Upon completing a series of tasks, and if passwords are enabled, the technician should log off before
leaving the computer.
1. Click on the “Log in, log off” button from the main tool bar.
Or
2. Select “Log off” from the “System” menu
8.6.2 Close KoKo Sx

Before turning the computer power off:
1. Select “Exit” from the “File” menu.
Or
2. Click on the button from the main window.

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9 SYSTEM ADMINISTRATION
9.1 USER ADMINISTRATION

9.1.1 Password Administration
KoKo Sx can be set to require the user to enter a name and password on starting up the software.
 Passwords must be enabled.

 Technicians must log in at startup and before performing any patient-related functions.
 After finishing their tasks, technicians must log off.
 When passwords are enabled, an event log is created.
Passwords are initially enabled and configured by the person who will be the password administrator.
Once passwords are enabled, general password maintenance can only be performed by the password
administrator.
To enable, assign, and edit passwords:
1. From the main window, select the System menu and then the Configuration menu.
2. Select Passwords from the Configuration menu.
The Password Administration dialog will display.
3. Select the Use Passwords checkbox.
4. Select Edit to create an Administrator Password

5. To add additional users click Add.
6. Enter a name and password for the user; click OK.
7. Continue by adding names and passwords for all users of the KoKo Sx software.
8. When you have added all of the names and passwords, click OK.

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Passwords are now in effect. No one is currently logged in, and the first attempt to perform a patient-
related function will cause the “Log in” dialog to appear.
Entered names will display on the dropdown list of technician names during testing. Passwords
can be removed when the administrator re-accesses the Add Name and Password dialog. Highlight the
name and click remove.
9.1.1.1 View the Event Log

When passwords are enabled, an Event Log is created to show all logins and changes to patient related
data.
To view the Event Log:
1. Navigate to the data folder.
2. Double-click on the file name “audit.log”
Note: You may need to associate this file with a text editor. To do this:
1. Right-click on the file
2. Select Open with
3. Select Notepad (or any other text editor desired)
9.1.2 Enter the Facility Name and Location

The facility name and location will be included in all pre-configured standard reports. The entry fields can
be opened from the KoKo Sx main window.
1. From the “Systems” menu select “Preferences” then “Facility name/location..”
a. Information in these fields will display in the upper left corner of all pre-configured reports.
2. Enter the facility name and location associated with the KoKo Sx device.
3. Click OK.

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9.1.3 Pneumotach Calibration Log
9.1.3.1 Review
1. From the main window, select Calibration log menu.
2. A window showing a log of all calibrations will appear.
9.1.3.2 Print
1. Click on the button to print the log just as it appears.
9.1.3.3 Remove Old Entries from the Calibration Log

To delete old items after you've printed them:
1. Highlight the text and press the Del key.
2. Click on the button at the top right corner of the window to exit the calibration log.
3. Answer Yes to the "Do you want to save current changes" prompt.
9.2 DATABASE ADMINISTRATION

9.2.1 Backup Database: Protecting Patient Data From Loss
The system enables the user to back up the database. This will make a “local” copy of all patient and test
data that can be quickly restored in case the database becomes corrupted.
To manually back up database:
In the main window, select “Database” from the File menu, then select Backup database.
Storing the database to external media (e.g. flash drive) will protect against loss of data due to
computer failure.
The Database files that are backed up are:
 KoKoPFT.vot
 KoKoPFT.vs1
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 KoKoPFT.vs2
 KoKoPFT.txn
 KoKoPFT.tsq
The specific backup files are:
 KoKoPFT.bot
 KoKoPFT.bs1
 KoKoPFT.bs2
 KoKoPFT.bsq
 KoKoPFT.bxn
The message that appears describes the path to the backed up files. For optimum safety in the case of
hard drive failure, copy and paste these files to a flash drive.
9.2.2 Restoring the Database
In the unlikely event your hard drive crashes or your database becomes corrupted, contact nSpire Health
Customer Service.
If only the database has become corrupted, select “Restore database” from the “Database” menu located
in the “File” menu. This will restore the database from the local copy on the hard drive.
In the case of a total hard drive failure, the database can be restore if a full system backup was created.
Once the drive is replaced or repaired, restore the backed up information.
Only patient information will be available from the date of the last backup. Any new information
created after a backup is lost.
In the event of a corrupted database with no prompt provided to restore the database (i.e.: an
error message saying "cannot open virtual log manager", in which case the transaction log has become
corrupted), you may need to delete all TxnLog.* files, then start up the system again. Any new information
created after the backup is lost. Call nSpire Health Customer Service for support.

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9.2.3 Compress database
Offices with many patients can accumulate large database files. If you find that the database is taking up
a lot of hard drive space, or program startup is becoming slower, you can compress the database using
File|Database|Compress database from the main window.
Compressing the database can take a long time therefore it is best to run this feature overnight.
Before you start compression you should make a database backup.
9.2.4 Merge database
Merging databases should only be performed under direction of Technical Support. Call nSpire Health
Customer Service for additional support prior to this action.
The fastest way is to simply do a cut and paste of the Database but, you can only do this if NO testing
has been performed on the new computer. This is because when doing a cut and paste, you will overwrite
the existing Database on the new computer, thus overwriting any tests that were done. If tests are
present on the computer that you intend to move old Database into, you have to perform a Merge.
To merge a Database you need a flash drive with the necessary space that the Database will fit on. Two
gigs is most likely sufficient.
1. Move the data from the old computer by going to File> Communication> Write test series and
following the screen prompts, point to the Flash drive or other media you intend to move the data
to.
2. Bring the removable media (Flash Drive) to the new computer, go to File> Communication> Read
test series. This will merge all the data.
Note: Please disable all screen savers and power management before running this process. This will
take some time to merge to the data.
9.2.5 Check database integrity

This function will check for database errors. This may take considerable time and should only be
performed with the system is not needed for testing, reviewing or interpreting tests.
 Select “Check database integrity” from the “Database” menu item from the “File” menu.
 The log file of the database scan will display.
Make note of any test series that displays as containing an error.

 Instructions on correcting problems in the database are included in software help file.
9.3 DATA MANAGEMENT

9.3.1 Import/Export
The Import/Export feature if for moving data to and from the listed 3rd party vendors below only. If there is
a need to moved data between KoKo Spirometry Systems refer to the Database backup/restore and
merge features.
.Please call nSpire Customer Service for data management support (contact info on page 2).
1. From the “File” menu select “Import/export”.

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2. Chose from the following menu items:
3. Import
a. Import MSSX test
b. Import OHM patients
c. Import Rosetta patients
d. Import WinDX patients
e. Import PC-Flow patients
4. Export
a. Export test series
b. Export FVC test to Medgate
c. Export FVC test to Systoc
d. Export FVC test (ATS/ERS 2005)
9.3.2 Communication
To move patients between systems, you may use the read and write to removable media functions. You
first write copies of the selected test series on a removable medium, go to another system, the read the
test series from the removable medium.
9.3.2.1 Read test series
1. To read test series from removable media:

2. Close all testing, report, and/or verification windows.
3. Select “Communication” from the “File” menu located in the main window.
4. Select “Read test series”
If this is the first time selecting this option, and the originally installed KoKo version 4.0 was
installed, a prompt to update the database now will appear (this is necessary to uniquely identify all test
series to other databases). Click on Yes to proceed.
1. Be sure the removable media is already plugged into the computer so the correct drive letter
appears when the Select disk dialog box appears.
9.3.2.2 Write test series

2. To write test series to removable media:
3. Close all testing, report, and/or verification windows.
4. Select “Communication” from the “File” menu located in the main window
5. Select “Write test series”

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If this is the first time selecting this option, and the originally installed KoKo version 4.0
was installed, a prompt to update the database now will appear (this is necessary to uniquely
identify all test series to other databases).
Click on Yes to proceed.
6. Select the test series you want to copy to the removable medium
7. Click on “Write”
8. Insert removable medium as prompted, until done.
Only test series that have a last-modified date earlier than the last-modified date on the
removable medium will be read from the removable medium. This prevents over-writing patient
information or test results that have been changed on the system that is reading the test series
after the test series was written on the removable medium. If this situation occurs, you must
decide by carefully examining the patient information or test results which is the desired version.
Note that this situation will never occur with the networked version. (The last-modified date is
visible as the right-most column in test series selection dialogs).
As test series files are read from the removable medium, they are erased to make room for
writing additional test series, and to simplify determination of which test series could not be read
(due to media errors). Note that removable medium read/write errors will never occur with the
networked version.
The process or writing/reading test series to/from removable media is not an acceptable
substitute for periodic local and off-line backups, since removable media may become unreliable.
The process or writing/reading test series to/from removable media is not intended to be used as
an archive/unarchive function, since the data is not in text (ASCII) format
9.3.3 Delete Test Series

Section 11.2.1.8
9.3.4 Reassign a Test Series

This procedure will remove selected test series from one patient and assign them to another patient.
 Ensure the “assigned to” patient exists before proceeding.

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 Delete the “removing from” patient using “Delete Test Series” once the test series has been
reassigned.
9.4 REPORTS
This section reviews how to access standard reports and to customize report.
9.4.1 Standard Reports

Greater than 20 standard report designs are provided for use with the KoKo Sx. Current available
standard reports are viewable within the KoKo Sx software.
To review and select reports:
1. From the main window select “Read/interpret/print” from the “Report” menu or click on the
“Read/interpret/print results” button .
2. From the “Read/Interpret/Print Results” window click on “Select design” from the “File” menu or
click on the “Select report design” button .

3. Depending on the “Preference” selection of “Basic reports” (section xx), the reports will be viewed
as a single list or organized in a folder.
4. From the “Open Report Design” window or from the system folder, select a report design to
review.
If the designs are not optimal or do not fit the clinical need, the ability to edit and/or customize a
report is available. The user can edit an existing report or create a new report from a blank design.
9.4.2 Assign Default Reports

Default reports may be assigned for:
 Pretests
 Pre- Post tests
 Challenge tests
The default reports will be used when selecting the following display and print options:
1. “Read/interpret/print results” from the main window; Displays the current patient visit in the
assigned report
2. “Print multiple test series” from main menu (Report menu or print button); prints current patient
visit using the assigned report
3. “Display/interpret/print results” in testing menus (File menu or button); Displays the current patient
visit in the assigned report

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If you are in the main menu, the last visit performed will determine the type of report (Pre, Pre-Post, or
Challenge).
The report assignment feature must be enabled.
To enable:
Open the “Preferences” menu from the “System” menu in the main window. Assure that Auto-
select design has a check mark next to it. Note that this enablement will not take effect until
default reports have been assigned to each report type.
To assign the reports to each test type:
1. Open the report design window (Click on the “Design report format” button in the main
window).
2. Click on the “Open a design” button .

3. Select a report design to use as a default report for one of the categories described.
4. From the “File” menu, Choose“Auto-select” and then “Assign”.
5. Click the check box for either “Pre-Rx only”, “Pre-Rx with Post-Rx”, or “Challenge”.
6. Click “OK”.
7. Repeat for the other two default categories.
To review the current status of report design assignments to test series types, from the “File”
menu, choose “Auto-select” and then “Status”.
All three default report design types must be assigned prior to enabling auto-selection of report designs
as described above.
9.4.3 Printer Setup

The printer settings should be set up in Report Design. Select print setup from the file menu. Select the
appropriate paper size for your printer and printing needs.
Do not make printer settings when printing from other software locations, as these settings will be
overridden by the Report Design setting.

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9.4.4 Customize Reports
Report design tools are available within the KoKo Sx software if the user would like to personalize an
existing design, modify an existing design to add additional spirometry data, or create a new report from a
blank page.
Report customization is not needed to utilize the KoKo Sx as it is intended to be used, “as a pulmonary
diagnostic testing device”. Report customization tools are intended to be used by an individual with mid-
to-advanced level Windows Software operation skills. nSpire Health Customer Service Team supports
customization if resources are unavailable at the customer site (contact info on page 2).
9.4.4.1 Accessing the Report Design Menu

1. From the “Report” menu located on the main window toolbar, select “Design…”
Or
2. Click on the “Design report format” button, .

3. The “Report Design” window is now available.
9.4.4.2 Design a New Report
9.4.4.2.1 New Design

This section describes the first step in creating a new report from a blank page. This function
should be used if modifying an existing design does not meet the needs of the user.
1. Working in the report design window, select “New design” from the “File” menu.
2. From the “File menu”, select “Save design as”. Enter a name for the report design.
3. Utilize report design tools (section xx) to build the new report.
As you add items to the page, it is helpful if the items align themselves automatically and
delete items. Ensure “Select after draw” is checked and enable the “Snap to Grid” feature from
the mode menu. “Coarse” is recommended for text.
9.4.4.2.2 Modify an Existing Design

Modifying an existing report should be done if a supplied report resembles the report style the
user would like. Minor changes or additions, such as adding a facility name and/or location, are
common needs and can easily be accomplished by modifying an existing report. This section
describes the first step in modifying and existing design.
Prior to accessing the report design feature, determine which standard supplied report design the
user would like to modify. To view available standard reports, see section Standard Reports.
1. In the Report Design window, select “Open design” from the “File” menu or use the “Open a
design” button .
a. If “Basic reports” is selected from Main Window ‘s Systems and Preferences menus,
you will get the following reports in the default report folder

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b. If “Basic reports” is not selected from Main Window’s Systems and Preferences
menus, you will get a browser window initially pointing to the default report folder:

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2. Select the report design from the folder or browse a different folder.
3. Click OK or Open.
4. From the “File” menu, select “Save design as” and enter a name for the new report.
Doing this now will prevent accidentally overwriting a standard report design.
5. Utilize report design tools (Section 9.4.4.5) to modify the existing report.
Printing a copy of the report to be edited will provide a reference document during the
editing process.
Custom report designs can be saved for individual physicians or groups. Select “Save
design as” from the file menu and save to a folder designated to the physician or group.
9.4.4.3 Save Your Work
Be sure to save your work periodically by clicking on the “Save design” button .
Report designs are saved into the following path: C:\Users\Public\KoKo PFT Systems. Report
designs in the KoKo PFT Systems folder are the ones accessible to KoKo Sx software when you
select a report in the “Basic reports” option. There are additional reports in the sub-folder
Extended report designs; for easier access, disable “Basic reports”.
Custom report designs can be saved for individual physicians or groups. Select “Save
design as” from the file menu and save to a folder that you create that is designed to be
associated with the physician or group.
9.4.4.4 Preview the report design using patient data

When you have completed the report design:
1. From the main window click on the “Read/interpret/print report” button .
The report name appears at the lower right of the window.

If any report does not display as expected when previewing patient data, modify the report design
accordingly.
9.4.4.5 Design Tools

1. There are two modes associated with editing and/or designing a report, they are “Select” and
“Draw”.
a. When “Select” is checked within the “Mode” menu or the user clicks on the “Select mode”
button , the user is able to select an item to edit. Several different actions associated
with editing the selected text will be available by selecting “Edit” from the menu items or
by right clicking on the text to be edited. Available actions vary depending on the type of
text being edited.

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b. When the “Draw” mode is checked within the “Mode” menu or the user clicks on the
“Draw mode” button , the user is able to insert text , draw a line , add a
border , add a rectangle , add a shadowed text box , add a shadowed
graphic box , or add an image .
2. There are several viewing options available to the designer. To access viewing options, select
“View” from the menu options or utilize the buttons.
Or
Full page Next

page
Reduced Actual Zoom in Previous
size size page
9.4.4.5.1 Select an Item

Ensure the report designer is configured for text selection prior to attempting to edit text. To
ensure this tool is activated:
1. From the “Mode” menu click on “Select” and confirm a check mark is placed in front of
“Select”
Or
Click on the “Selection mode” button before selecting a report item.
From the “Mode” menu confirm a check mark is placed in front of “Select after
draw” to enable the “Select” mode after selecting “Drawing mode” . This will convert
the configuration back to text select mode after each drawing that is made.

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2. To select a report item, click on the item.
Blue selection handles will appear around the selected item.
By right clicking on the item, several menu options become available. Available options
will vary depending on the text selected for editing.
In addition to the menu choices available by right clicking on the selected item, the “Edit”
menu choices are enabled. These include cut, copy, paste and delete, and moving the
item back or to the front. Other options for editing an item include “Color Selection”
and “Line width” . Both “Color” and “Line width” are also available by selecting
“Style” from the menu items.
9.4.4.5.2 Select More Than One Item

To select a group of items:
1. Click on the button to ensure select mode is enabled.

2. Position the mouse cursor away from the group of items to select.
3. Drag over all of the items to move, completely enclosing each one with the red dashed
line that appears. If the cursor does not completely enclose the items, they will not be
selected.
Blue selection handles will be displayed around the group of items.

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As an alternative:
1. In select mode, click on the first item you want to select.
2. Hold the Shift key down, and then click on the remaining item(s) you want to select.
9.4.4.5.3 Select a Hidden Item

If unable to select a report item because a larger item is overlapping it, use Ctrl-click (hold the Ctrl
key down, then click anywhere on the page) to select every visible item on the page. Continue
clicking on the page to scroll through all the items one at a time. The hidden item will eventually
be highlighted.
To zoom in on an area to minimize the number of items to click past, review the “Zoom in”
instructions (section 9.4.4.5.4).
9.4.4.5.4 Zoom in on an Area

To see greater detail in a certain area on the report page:
1. In section mode, click on the (Zoom in) button.

2. Drag the mouse cursor over the area to see in more detail.
3. Work on the report design as usual in this zoomed mode.
4. To return to the normal view, click on the (Actual size view) button (control + A).
9.4.4.5.5 Edit an Item

After an item or items has been selected, right click to see the edit options available for that
selection.
1. For items associated with “PT/Test Series/Protocol Info” a window will appear listing
available items for selection. There are 6 “Category” buttons to choose from:
a. General
b. Patient-related
c. Test series related
d. FVC protocol related
e. SVC protocol related
f. MVV protocol related
Each “Category” will list items to select for inclusion in the report. A list of available
items can be found in Appendix B.
To include the item name/label on the report, ensure the “Show item name” is checked within
the “Format” option.

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Items to consider when inserting “Pt/test series/protocol information””
 Historic test series selection - Select “use the FVC reference effort series” by
checking this selection, or select “use test series” by checking this selection and
enter the number of previous to current tests to include in the report.
 Or
 Leave all selections unchecked.
2. For items associated with “Numeric Results” a window will appear listing available items
for selection. There are 3 “Test type” buttons to choose from:
 FVC
 SVC
 MVV
Each “Test type” will list items to select for inclusion in the report. A list of available
items can be found in Appendix B.
After selecting the numeric result value desired to add to the report, the user will select the
format, effort, appearance and historic test series (optional).
Items to consider when inserting a numeric result:
 Format – includes pre, post, baseline, saline, stage 1-24, and recovery.
 Effort(s) – includes best, 2nd-8th best, best 3, all.
 Appearance – includes show item name, compare to predicted, show absolute
change, show LLN, show CI, show SR (Z-score), compare to reference stage,
compare to previous stage, flag if outside confidence interval, use composite effort.
a. Note: The parameter will display with fields selected in the appearance
options.
 Historic test series selection – includes use FVC reference effort series or use test
series with (insert number) pervious to current.
3. For items associated with “Graphic Results” a window will appear listing available items
for selection. A full list of items can be found in Appendix B.
Items to consider when inserting a graphic result:
 Format – includes pre, post, baseline, saline, stage 1-24, and recovery.
 Effort(s) – includes best, 2nd-8th best, best 3, all.
 Appearance – includes adding predicted normal, FVC reference effort, tidal phase,
and offset effort.
 Historic test series selection - includes use FVC reference effort series or use test
series with (insert number) pervious to current.
9.4.4.5.6 Add an Item

To add an item to a report, select the desired item from the toolbar or select “Add” from the menu.
1. Select one of the following:
a. Pt/test series/Protocol info

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b. Numeric results
c. Graphic results
d. Text
e. Line
f. Border
g. Rectangle
h. Shadowed text box
i. Shadowed graphic box
j. Image
k. New page
Items available for selection within “Pt/test series/protocol info”, “numeric results”, and
“graphic results” are listed in section 16.4.
2. Click on the page where the item is to be placed.
To change the appearance of an item, select the item. Four blue boxes will appear at
the corners surrounding the item. Drag one of the corners upward or downward. When the
mouse button is released, the text will display at the new size.
9.4.4.5.7 Add a Box around text or Graphics

To add a box to the report design:
1. Click on one of these two buttons (Add a shadowed text box or Add a
shadowed graphic box) for the text-box or graphic-box, respectively.
2. Draw the box in the desired location.
3. Enter a title for the box by double-clicking on the box (or right-click, then select “Edit”).
4. Press Enter after entering the title.
5. Add item(s) inside the box (see "Add an Item" in Section 9.4.4.5.6 ). When adding a
graphic item, make sure that the graphic item exactly fills the white area in the box.
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In case the item(s) to be enclosed in the box are already present on the page, draw
the box over the existing items, covering them completely, and adding some extra space
on each side of the existing items for the box borders. With the box still selected, use
“Edit|Move to back” (or press Ctrl/B) to cause the box to move "behind" the report item(s).
You may resize the box like any other report item (see "Resize an Item” Section
9.4.4.5.10). If the box contains a graphic item, you will need to resize the graphic item
after you resize the box.
9.4.4.5.8 Add a Page

To add a new page to the report:
1. Go to the page that will precede the new page, using the buttons.
2. Select New page from the Add menu.
3. A new blank page is inserted after the current page.
9.4.4.5.9 Move to Another Page
To move to another page, click on to move or back forward one page, respectively.
9.4.4.5.10 Move Resize or Delete an Item

To make a change to an item on the report page:
1. Select the item.
2. Click and hold the item with the mouse to drag it to a new location.
3. Drag one of the blue selection handles that appear on the four corners of the selected
item to a new location to resize it.
4. Press the Del key or right click the item and select delete to remove it.
9.4.4.5.11 Move and Item Forward/Backward

Items added last to the page will cover up items added first, in a layered fashion. To move an
item (or multiple items) forward or backward:
1. Right click on the item to ensure blue selection handles appear on the selection.
2. From the “Edit” menu, select to bring forward or move back.

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9.4.4.5.12 Line Up Items (Snap to Grid)
Use the "Snap to grid" option to cause items to "snap" to a new location on an invisible grid as
they are added to the page, making alignment of different items simple.
The invisible grid has two settings:
 coarse (best for text)

 fine (best for graphics)
To enable "Snap to grid":

1. Select Snap to grid from the Mode menu, then Coarse or Fine (check box when
enabled).
To make multiple items already placed on the page "Snap to grid":

2. Enable "Snap to Grid."
3. Select the items to be snapped to the grid.
4. Select Snap selection to grid from the Edit menu.
9.4.4.5.13 Add Historic Results to a Report

In Report Design, you may select a historic visit and display test parameters and graphs for that
visit on the report. To add historical results:
1. In the graph attributes menu, click the check box for Use test series in the Historic
test series selection.
2. For the visit immediately prior to the visit that is being reported, enter the number "1"
in the space provided.
3. Similarly, results for the visit that is any number of visits previous to the visit being
reported, enter that number in the space provided.
For some results, specify what visit type you are interested in (spirometry or challenge),
since that information can't be inferred from the result type.
9.4.4.5.14 Display the FVC Reference Effort

In the graph attributes menu, select the check box for Use FVC reference effort series from the
“Historic test series” selection.
This option is only available for FVC results, not SVC, MVV, or Challenge results.
9.4.4.5.14.1 Display Other Information About the FVC Reference Effort

To display other information about the FVC reference effort (test parameter, visit
time/date, technician, etc.):
1. In “Report Design,” click on “Patient/test series/protocol” button (you must also
select a testing option in the Category section), (numeric), or (graphic)

as appropriate for the type of information you want to display.
2. Select the report item from the dialog that appears.
3. From the “Historic test series” selection group, click on “Use FVC reference effort
series.”
4. Select other options (if applicable).
5. Click on OK.
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6. The report item will take its data from the visit that contains the reference effort,
instead of the current visit.
9.4.4.5.15 Add Trend Graphs to a Report

To add a trend graph:
1. Click on “Add graphic test results” button .

2. Scroll through the graph options on the Select item menu.
3. Select one of the trend graphs.
4. Click on the report page where the graph should appear.
5. Adjust the size of the graph by dragging any of the blue selection handles to a new
position.
9.4.4.5.16 Add Patient Medication/Condition Tracking to a Report

To add a medication/condition tracking graph:
1. The “Add graphic test results” button is used to select all graph types.
2. Two trend graphs are recommended.
a. Spirometry, Pre-Rx trend, %predicted
b. Medication/condition tracking
3. Adjust the size of the graphs to be the same width. The trend and
medication/condition graphs will appear as shown to the right when the report is
displayed or printed:
9.4.4.5.17 Add a Facility Name and Location to Report
Facility name and facility location fields are already included on many standard reports
provided and can be located in the upper left corner of most reports.
1. Click “Pt/test series/Protocol info” from the “Add” menu item or click on the “Add
patient, test series, or protocol info” button, .

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2. Select “General” in the “Category” group to access “Facility name” and “Facility
location”.
3. Click on the desired item.
4. The “Format” option provides the ability to include the “Select item” label on the report
or uncheck the “Show item name” checkbox to remove the label on the report.
or
5. Click “OK”.
6. Select a blank section of the report design.
7. Perform the same process for the facility location.

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10 QUALITY ASSURANCE
10.1 FILTER
An approved KoKo Sx filter is required for all patient testing. The single patient use KoKo filter offers low
resistance, enables accurate spirometry analysis, potentially reduces cleaning and maintenance, and
effectively protects the patient, technician and equipment from contamination. nSpire Health offers a
variety of colors, mouthpiece shapes, and accessories to suit your needs. Contact your nSpire Health
representative or visit www.nspirehealth.com/filters for current options.
10.1.1 Attach the KoKo Sx Filter

Filters have been shown to remove microorganisms from the expiratory air stream and, thus,
prevent their deposition as aerosol nuclei on spirometer surfaces.
1. Place the KoKo Filter on the spirometer. The smaller end of the filter is used for patient
breathing and testing.
2. Make sure that the filter is fitted snugly on to the pneumotach handle.
Inhalation/
Exhalation
Inhalation/Exhalation is in the direction of the arrow marked, “Inhalation/Exhalation”.
Caution: The KoKo Spirometer is designed to be used with the KoKo Filter. Accuracy of
the spirometry system depends on the characteristics of the entire system. System accuracy
testing is performed using nSpire Health KoKo filters. nSpire Health does not guarantee
accuracy of the system if different filters are utilized.
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Caution: If no filter is utilized during testing, accuracy (according to documented
specifications) may be affected due to expectorated matter in the pneumotach.
Caution: The use of in-line filters does not eliminate the need for regular cleaning and
decontamination of lung function equipment.
10.2 PNEUMOTACH PERFORMANCE

10.2.1 Verify Calibration
Verification of pneumotach calibration confirms system accuracy and supports the collection of
high quality data. Calibration verification should be performed with a validated 3-liter syringe.
Assure the pneumotach is connected to the computer via USB prior to verification
1. Click the (Verify pneumotach calibration) button from the main window.
2. Enter the pneumotach environmental conditions.
The numbers that appear are set as default conditions. Adjust the environmental
settings for the current environment. Incorrect numbers can affect pneumotach accuracy.
It is highly recommended that you use in room weather station to enter correct values for
your environmental conditions.
The following table approximates barometric pressure at different altitude. It is highly

recommended that you obtain your barometric pressure from an in-room barometer. If
barometric pressure cannot be obtained, use the following chart to estimate barometric
pressure.
Altitude, feet Barometric pressure, mmHg

Sea level 760
1000 736
2000 712
3000 688
4000 664
5000 640

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3. Click OK.
4. Choose the name of the technician calibrating the pneumotach from the dropdown menu
and click OK.
i. New users can be entered using the button to the right of the drop down.
5. Choose the syringe volume and type from the dialog that appears, and click OK.
If you are using an nSpire Health Multiflow Syringe, check the Multiflow Syringe
box. This option provides a prompt between syringe pushes to set the syringe flow rate
to a new setting.
6. Attach a new KoKo Sx filter with a circular mouthpiece to the calibration syringe, and pull
the syringe handle all the way out.
7. Select “Start verification” from the Tests menu, or click the “Start effort” button.
8. A message asking to verify calibration set up will display. Click OK.
9. The procedure will begin by “nulling” the pneumotach.

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During nulling, assure that there is no air flow through the pneumotach. Do not
push the syringe handle until prompted.
10. During the verification process, perform at least three syringe strokes in each
direction.The software will perform an additional nulling after each outward stroke.
Strokes can be performed at three different flow rates, but this is not necessary to verify
the system.
a. One stroke in each direction that is < 2L/s
b. One stroke in each direction that is > 4L/s and < 6L/s
c. One stroke in each direction that is > 8L/s
If the pneumotach verification was successful, the following message will display:
If the pneumotach was not within tolerance, the following messages may display.
Or

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Refer to “troubleshooting” section for additional information regarding
“Calibration gain factor” message.
11. To print the pneumotach verification reportclick the button.
Caution: The report is not available after exiting calibration. Ensure print occurs
prior to exiting window.
Caution: nSpire Healthrecommends that a syringe that has been dropped or

damaged, or was validated more than a year ago, be revalidated by returning it to nSpire
Health for servicing.

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11 USE
11.1 ACCESSING THE SYSTEM

11.1.1 Launch Device Software
1. Right click desktop icon and select open.

Or
2. Double click the desktop icon .
11.1.2 Log In
When passwords are enabled the user is required to log in and log off.
1. Click on the “Log in, log off” button from the main tool bar.
Or
2. Select “Log in” from the “System” menu.
3. Next, select the correct name from the drop-down list.
4. Enter associated password.
The “Log in” window will appear at the KoKo Sx startup or upon selecting any patient-related function.
If a password is not working or is forgotten, contact the system administrator. In the event the
system administrator is not available, contact nSpire Health Customer Service for a temporary password
(contact info on page 2).
11.2 ENTERING AND MANAGING PATIENT INFORMATION

11.2.1 Select Patient and Test Series, Enter/Edit Patient Information
The “Select patient and test series, enter/edit patient information” window enables the user to search for
an existing patient record, create a new patient record and/or create a new visit for a returning patient.
You can access this window from the main startup screen.
KoKo Sx 1000 Standalone stores patient data utilizing a local system database. When testing a patient
for the first time, you may want to search for an existing patient record within the database. This allows
you to review previous patient test data, review and edit patient information, and ensure new visits for the
patient is associated with any previously entered test data for that patient. If a patient record does not
exist, this will be revealed by your search and you will need to create a patient record and visit.
When searching by date of birth, if the 2-digit year is entered, the current century is substituted for
the un-entered first two digits. After Jan 1, 2000, entering a two-digit year for someone born in the 1900s
may result in a search error. It is best to search using a 4-digit year.

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11.2.1.1 Find Patient Visits and Test Data
Patient test series data (or visit data) is stored in the local database utilizing a unique patient ID. These
unique patient IDs are used as record locators for all of the visits for that patient. The unique patient ID
only needs to be created in the database once with all visits being associated with that ID. (see Section
11.2.1.4.1)
Searching for a previous patient record as a first step is recommended to avoid creating duplicate
patient entries (creating a second ID for the same patient).
1. Click on the (Select patient and test series, enter/edit patient information) button in a window
to find an existing patient visit.
2. Choose a search option (patient last name, patient ID, test series date, test series status, or
group) and corresponding search modifiers. These modifiers vary with the search option selected.
If you know the patient ID, it is the most specific search method.
3. Click on “Show all matches” to perform the search. The matching test series (visits)/patient
records will be shown in the “test series matching” box.
Search method examples:
 Patient last name search: Click on “Starts With” if you want to type in only the first part of
the patient’s last name.
 Click on “equals” if you want to type in the complete last name, ID, test series date or
select status or group.
 Date range search: Click on “between” if you only know a range of dates that a previous
patient visit(s).
If previous visits exist for the patient in your system, multiple visits will be listed for a single
“Patient ID” search.
4. Review the “test series matching” box to locate the desired test record(s) resulting from your
search. Several actions are available from this window:
a. Patient (selection)
i. New: This action would occur if the search did not find a patient record
associated with the patient being tested.

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ii. Edit: Select to edit “patient information” (e.g. patient demographic
information and predicteds)
b. Test Series (selection)
i. New: This action creates a new visit for selected patient.
ii. Edit (section 11.2.1.7)
iii. Delete: Permanently remove test series from database.
c. “Log” creates a list of all “Test series matching” searches that have been performed.
This list can be edited, saved, and/or printed.
i. To delete items from the list, highlight the text and press the Delete key on
your keyboard.
ii. To save the list to a file, click on the “Log to file” button . The “Save
File” window will open.
1. Select a file and file name and then click save.
iii. To print to log, click on the “print” button . The “Print” window will open.
1. Select printer and click “Print”.
The window used to access the “patient information” button will determine which actions are
available (i.e. when reviewing a report, searching for a different patient visit in the “read/interpret/print
results” window will limit actions to viewing a report only).

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11.2.1.2 Create a New Patient Record
If your search has not found a matching patient, you will need to create a new patient in the database.
1. Click “New” under Patient selection.
2. The “Enter Patient Information” dialog box will appear.
a. Enter patient information (Section 11.2.1.4) and click OK to return to the "Select Patient
and Test Series" dialog.
b. The system will automatically create the first test series (i.e. visit) for this patient, and the
test series status is listed as “New.”

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11.2.1.3 Sorting the Patient Search Results
To sort searchresults by a patient’s name, ID, test series date, status, group, or date modified:
1. Click on one of the column headerson the “test series matching” box.
2. The matching visits will be sorted in ascending order by that column header. To sort in
descending order (i.e. latest test series first), click on that column header again.
Data is assigned a status depending on the task that has been completed for that test series.
Status can be new, tested, reviewed, interpreted, printed, imported and exported. Status is only for
workflow/clerical purposes and does not prevent additional testing regardless of labeled status.
o New: Patient demographic information was manually entered into Koko on this
system

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o Tested: Patient has performed at least one effort in one type of tests (FVC, SVC,
MVV), further efforts/tests may be pending. Tests may have been performed using
either KoKo or Legend.
o Reviewed: Test results have been reviewed.
o Interpreted: Test results have been interpreted by a physician (Automatic
interpretation does not result in this test series status).
o Printed: Test results have been printed.
o Imported: Test results have been imported.
o Exported: Test results have been exported.
11.2.1.4 Enter/Edit Patient Information

The “Enter Patient Information” window, displayed when creating a new patient, and the “Edit Patient
Information” window, available for existing patient records, are accessed from the “Select patient and test
series” window (main and testing windows). The windows are identical and are both used to enter and
edit patient information utilized to create patient visit data.
Required Fields:
 DOB (Date of Birth) Section

 Last name
11.2.1.4.2
 First name  Sex (Birth Gender)
 ID (Identification Number) Section
 Height Section 11.2.1.4.3
11.2.1.4.1
 Predicteds Section 11.2.1.4.4
Optional Fields:
 Smoking History Section

 Weight
11.2.1.4.6
 Ethnic Group (Required for Quanjer
 Diagnosis Section 11.2.1.4.7
GLI and NHANES) Section 11.2.1.4.5
 Group Section 11.2.1.4.8  Comments Section 11.2.1.4.9
 More Section 11.2.1.4.10

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11.2.1.4.1 Patient ID
ID is a unique field and is assigned only once in the KoKo database. Caution should be used
when assigning a new patient ID in the KoKo system to ensure the ID is assigned to only one
unique patient. Duplication of patient IDs is best controlled by performing a search. It is
recommended that the KoKo ID match the patient chart number or patient ID number used by an
electronic medical record system. If the ID number is already in use, the message “The entered
patient ID is already assigned in the local KoKo database: Enter a unique ID” will be displayed.
11.2.1.4.2 Date of Birth

Date of birth is expected to be in the format set in the Windows Control Panel (not KoKo Sx
software). Windows options may vary. The date display options may be under a shortcut called
“Region and Language” or something similar.See Windows help for your system.
Note: If you have selected 2-digit years, the current century is substituted for the un-entered first
two digits, according to standard practice. Therefore, after Jan. 1, 2000, you can't enter the
birthdate of someone born in the 1900s as a two-digit year (example: Patient born on 5/12 in
1961 must be entered as 5/12/1961).
11.2.1.4.3 Enter Patient’s Height and Change Height at Test

Always enter the patient’s current height; measure height and update at each visit if necessary.
The Patient’s predicted values are calculated at the time of the visit from the entered age, gender,
race (ethnic group), and height. Height changes over the patient’s life (along with the predicted
values), so KoKo Sx records “height at test” by saving the patient’s current age and current height
at the time the visit is created as part of the visit data. This ensures that the patient’s predicted
values are correct at the time of testing.
To enter or edit a patient’s height (and height at test):
1. Select Patient Information for the File menu from the main window, or click the
button.
2. Click the New or Edit button under patient selection.
3. The “patient information” window is now available.
4. Enter the correct height and weight.
5. If editing the “height”, KoKo Sx will prompt you to check the “height at test” for all of the
visits for that patient, in case the original height was entered incorrectly, or if the patient's
height was not correctly updated from a previous visit.
6. Ensure to select the correct visit to be updated and any additional visit that should be
updated with the new height (if any).
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7. Click OK.
Previous visits should not be corrected unless a known error has been detected and
identified. This would not be a common occurrence.
Height can also be changed in the “edit test series” window (Section 11.2.1.7) but it is
best to update a returning patient’s height in the “Patient information” window before creating
the new test series for the current visit. This applies primarily to growing children and the
elderly.
Height entered in the “test series” edit window is specific for that visit only and will not
carry forward for subsequent visits.
11.2.1.4.4 Selecting a Predicted Set

Choose a predicted protocol available in the drop down menu.
Predicted protocols, available in the drop down menu, are the available protocols
chosen in the “Select available predicted sets” dialog box. This is accessed from the System
and Preferences menus and would have been selected during the system setup. Changes
can be made by accessing the Preference menu (Section 8.3.2.1).
The predicted protocol can also be changed while in the testing window from the Setup
menu.
If the selected predicted protocol is NHANES based or Quanjer GLI, selecting the
ethnic group is recommended to obtain the correct predicted values. Caucasian, African-
American and Mexican-American selections include “pre-defined” correction factors.
11.2.1.4.5 Adjusting Predicted Values for Races (Ethnic Groups)

1. Open either the Enter or Edit patient information window.
2. Select the patient’s ethnic group.
3. The ethnic correction will be listed as “pre-defined” if race specific predicted protocols
exist in KoKo Sx. These race specific protocols are accessed with certain selected
combinations of “Predicteds” and “Ethnic group” selections.
a) Eigen-Wang-NHANES III includes:
1. Caucasian
2. African-American
3. Mexican-American
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b)Quanjer GLI includes:
1. Caucasian
2. African-American
3. Mexican-American
4. NE Asian
5. SE Asian
6. Mixed
4. If the selected predicted protocol and ethnic group combination is not defined, an entry
field for the “Ethnic correction” will display. A percentage correction can be entered.
 Only the current-entered ethnic group and the currently-entered ethnic correction
percentage for that group are saved (for later use with other patients) when you click
on “OK”.
 Predicted volumes are reduced by the percentage entered. Ratios and flow are not
adjusted.
 In reports, ethnic-corrected predicted values are denoted by an asterisk (*) after the
reported value for the parameter.
11.2.1.4.6 Smoking History

The pack-years value is entered in smoking history. Pack years are defined as the number of
packs per day that the patient smokes times the number of years the patient has smoked.
11.2.1.4.7 Adding, Removing, or Editing a Diagnosis

Each diagnosis you enter for a patient is automatically saved in the list of diagnoses and it is
available for use with other patients.
To add a diagnosis to the list:
1. Click on the menu button next to the diagnosis field and select Add.
2. Enter the new diagnosis or diagnostic code (ICD10).

3. Click on OK.
The entry will now be available on the dropdown menu.

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4. In report design, the diagnosis field is available from the “Add patient, test series, or
protocol information” button.
To remove or edit a diagnosis on the list of diagnoses in the patient information dialog:
1. Select the diagnosis you want to remove.
2. Click on the button.
3. Select Delete or Edit (Delete will remove the entry).

4. If editing, change the text and click OK.
11.2.1.4.8 Adding, Removing or Editing a Group

You may designate a specific patient to a group, allowing patient search by group.
To add a group to the list:
1. Click on the button next to the Group field.

2. Click on Add.
3. Enter the new group.

4. Click on OK.

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To remove or edit a group from the list on the patient information dialog:
1. Select the group you want to edit or remove.
2. Click on the button.
3. Select Delete or Edit.
Delete removes the entry

4. If editing, change the text. Click OK.
11.2.1.4.9 Comments
The field allows for free text to be included on the final reports.
11.2.1.4.10 More (Additional Patient Information)

Click on the “More” button to enter additional information (i.e. patient address, randomization
code, or occupation).
Information in this window can be included in custom reports. To generate a

custom report refer to Section9.4.4.
11.2.1.5 View Existing Visit Data

1. In the “Select patient and test series, enter/edit patient information” window, select a
patient visit and double click it to make it the current visit.

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2. Select a testing module button to access the test data for the visit.
3. Choose “continue with this test series” to view the test efforts for your selected visit.
4. In the testing window, click the reports (Display/interpret/print results) button to view a
report for the visit.
11.2.1.6 Create a “New” Visit for the selected Patient

1. Click “New” in the Test Series area. This will create a new visit in the “test series
matching” list for this patient and the test series status is labeled “New”.
2. Double click on the “New” test series to make it the current visit for testing.
3. From the main window, select a testing module , , , button to begin

testing. You will be prompted to verify your calibration if it is out of date (> 24 hours).
4. Confirm that the patient name, time and date (located on the bottom right of the testing
module window) are correct prior to testing.
11.2.1.7 Edit/Enter “Test Series Information”: Medication/Condition/Environmental Exposure

In the “Select patient and test series, enter/edit patient information” window, select ”Edit” in the “Test
Series” group:

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This information is tracked on a per visit basis. It is possible to track patient exposure(s), exercise,height
and medication(s). Entries can populate fields on a trend report in proximity to the trended numeric and
graphic results.
Height and Weight fields: These fields are pre-populated when creating each new visit for a patient. The
values are derived from the “patient information” window, which should reflect the most up to date patient
information. Changing values in this “Test series information” window should only be to correct an error
and will be specific for the selected visit, and will not modify “patient information” (Section 11.2.1.2).
Ensure changes in height and weight are made in the “Patient information” window.
11.2.1.8 Deleting a Test Series or Patient

To delete a test series or patient:
1. Select “patient information” from the File menu, or click the button.
2. Enter information that will identify the patient and test series (i.e. Patient last name, Section
11.2.1.1).
3. Identify the patient record in the test series matching list and right click on the record to highlight a
test series.
There may be multiple test series for a single patient ID.
4. Click on Show all matches.
5. Highlight the test series you want to erase.
6. Click on Delete

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7. Repeat for any other test series.
Deleting the last test series for a patient will permanently remove the patient from the system
database.
11.3 PERFORMING TEST

This section includes instructions related to operating the KoKo Sx to perform FVC, SVC, MVV, and
Challenge tests. Instructions are limited to operating the system. Performing FVC, SVC, MVV and
Challenge tests should be done by a medical professional trained and skilled in performing spirometry.
 Forced Vital Capacity (FVC) - The maximal amount of air exhaled in a rapid, forced
expiratory maneuver. Multiple parameters collected from the forced expiratory maneuver and the
subsequent Inspiratory maneuver related to flows and volumes.
 Slow Vital Capacity (SVC) – The maximal amount of air exhaled in one slow expiratory (or
Inspiratory; IVC method) maneuver.
 Maximum Voluntary Ventilation (MVV) – Expressed in liters per minute. The volume of air
inspired and expired over a 12 to 15 second period, extrapolated to one minute.
 Challenge Test - Forced Vital Capacity efforts collected in response to provocation. The
provocation may be chemical, exercise, or environmental. Stages are created that capture the
protocol sequence.
The testing module buttons are located on the KoKo Sx main window tool bar.

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11.3.1 Selecting a Test Series
Test series can be accessed from the main window:
1. Be sure to verify the pneumotach calibration each day and that the environmental conditions
have been entered (Section 10.2.1)
2. Click the button ( , , , ) corresponding to the test you wish to perform

Or
Select a testing option from the Tests menu.
The instructions shown exemplify the steps to perform FVC testing. These instructions apply for all
types of testing.
Important:
If the test module button is selected from the main window directly after launching the KoKo Sx
1000 software from the windows desktop, one of the following windows will appear:
If this window appears and you wish to select a different patient or visit:
1. Choose “Selecting a different patient or test series”
2. Click OK
3. The “Select Patient and test series” dialog appears. (Section 11.2.1.1)
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Or
If the software is not closed between patient testing, selecting a visit directly from the main window
will result in the most recent visit viewed being recalled into the testing module.
4. View and confirm the visit and patient information located in the bottom right corner of the
testing module is correct. This will ensure the opened visit is associated with the patient
being tested.

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If the opened visit is not correct (does not match the actual patient):
5. Click the “Select patient and test series” icon to open the search window. (Section
11.2.1.1)
Or
Choose "Select patient and test series” from the File menu.
6. Next, find stored patient visits or test data or create a new patient visit (section 11.2.1.2)
7. On creating or selecting a different visit, you will be prompted to save modifications to the
current visit.
8. The “FVC test” screen is now shown following your response.

9. Confirm test series and patient information located in the bottom right corner of the testing
module are now correct.
11.3.2 Perform Effort
1. Prior to clicking on the Start button to begin spirometry, make sure the spirometer is
held still and the patient is not breathing into it during nulling.
 Nulling is the process of obtaining a baseline reading for zero-flow conditions. This
reading is used as a comparison to measured actual flows during testing; therefore
an accurate null reading is important.
 The KoKo Sx 1000 software detects any flow that occurs near the pneumotach
during the nulling process.
 Avoid errors while nulling the pneumotach by placing the spirometer on a solid
surface away from airflows such as open windows or ventilation ducts.
2. Click on the Start button
3. Follow the prompts for the forced vital capacity effort.

a. Coaching is an essential component of Spirometry testing, it should be enthusiastic
and demanding.
b. When the software prompts a maximal inhalation, the technician will demand a deep
breath in, followed by the phrase “Blast it out”. This phrase encourages the required
maximal forced exhalation.
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c. The technician should then say “Blow, blow, blow” or “Push, push, push” until the
prompt for maximal inhalation is displayed.
d. The final coaching command would then be “Deep breath in” to encourage the final
maximal inhalation to complete the flow volume loop.
4. When the maneuver is complete, a preliminary list of parameters and values will display
along with effort warnings. Read the warnings (if any, they are enclosed by a red outline)
concerning the maneuver quality (Section 11.4.4.2).
(example)
5. Determine if you wish to keep the effort (ask yourself these questions).
a. Is there an absence of cautions?
b. Are the cautions acceptable?
c. Do you think you can obtain a sufficient number of efforts without cautions?
6. After the patient performs an effort, accept the effort by clicking Yes or reject the effort by
clicking No.
Rejecting the effort will permanently eliminate the data. You will not be able to recall or
display the effort after selecting No.
7. Repeat to obtain the required number and quality of efforts. The software will prompt you to
perform more efforts until three acceptable efforts (no cautions) are obtained, two of which
are repeatable for FVC and FEV1.
a. Up to eight maneuvers may be needed to achieve a minimum of three acceptable
FVC results and is generally a practical upper limit for most subjects. For patient
safety, stop testing if there is a cumulative drop exceeding 20% of start value in FEV1
or FVC and/or the patient is unable to continue testing due to fatigue or adverse
symptoms.
8. Click on the save button to save the visit, and the visit status is changed to “Tested” in the
“Select patient and test series” window.

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If you choose to accept the effort and the maximum number of efforts are already
retained, the lowest-ranked effort is dropped before the new effort is added, even if the
current lowest-ranked effort (ex: FVC+FEV1) is ranked greater than the effort being accepted.
You may choose to increase the maximum number of efforts retained (up to 8).
For the FVC test:
 Efforts are ranked by the sum of FVC and FEV1, with the effort labeled "Best" having the
highest sum.
 An effort is repeatable if both the FVC and FEV1 for that effort are within +/- 0.150L of the
FVC and FEV1 (or +/- 0.100L if FVC <= 1.00L) of the best effort.
 ATS requires that the patient perform at least two repeatable efforts.
 You will see a warning if Vext% (extrapolated volume as a percent of FVC) exceeds 5%,
or if Vext (extrapolated volume) exceeds 0.150L.
 You will see a warning if Veot (volume accumulated at the end of the effort) exceeds 25
mL in the last second. An inspiratory phase is required for the Veot calculation, to ensure
that the patient stayed on the mouthpiece for the entire duration of the effort.
 You will see a warning if Texp (expiratory time) is less than 6 seconds (3 sec for age < 10
yrs), from the calculated time zero to the end of measurable expiratory flow.
 See 'Change the way the FVC effort is performed' and 'Change the way efforts are
evaluated' for more information.
For the Challenge test:
 Efforts are ranked within each stage in the challenge dosage protocol (sum of FVC and
FEV1, FVC, or FEV1). FEV1 is the standard ranking result for the Rosenthal protocol.
 Repeatable efforts are ranked ahead of efforts that are not repeatable.
 An effort is consistent with the best effort if the ranking result (ex: FEV1) for that effort is
within +/- 10% of the ranking result of the best effort. The 10% value may be changed in
the challenge dosage protocol dialog box.
For the SVC test:
 Efforts are ranked by SVC value
For the MVV test:
 Efforts are ranked by MVV value
11.3.3 Modify the FVC Effort Protocol

The default setting in the “Effort Protocol” window for FVC in KoKo Sx is “Comply with ATS/ERS
2005 standard”. A check will display in the “check box” when applied. Certain buttons will not be
available with this setting. To change the default setting for “Effort Protocol”, uncheck the “Comply
with ATS/ERS 2005 standard” box.
11.3.3.1 FVC Effort Protocol:

1. From the “FVC test” window, select Effort protocol from the Setup menu.
2. The “Effort Protocol” dialog box appears.

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Start-of-test (Tidal) options:
A) The standard start-of-test selection is Auto, where the patient breathes tidally on the filter for
at least four breaths before performing the FVC maneuver. The prompts then include a
maximal inspiration followed by a maximal exhalation for the FVC maneuver. The technician
does not need to press any keys, since each phase is detected automatically.
B) When you are testing patients with greatly decreased lung function, automatic inspiration
detection is probably not appropriate. The patient may not be able to perform a deep enough
inspiration to be differentiated from normal tidal irregularities. This is where the Manual start
is useful, which requires use of the spacebar to initiate the maneuver.
C) The Skip start does not expect tidal breaths on the filter. The patient takes the maximal
inspiration prior to placing the filter in the mouth. Then the maneuver begins with the
maximal exhalation. This method is often used in screening.
Acceptability Check/ Quality Check Options
A) Start exp: If “Comply with ATS/ERS 2005 standard” is enabled, “Start exp” is checked by default
and cannot be unchecked. This quality check is for extrapolated volume (5% of FVC or 0.15 L,
whichever is higher).
B) Cough: If “Comply with ATS/ERS 2005 standard” is enabled, Cough is checked by default and
cannot be unchecked. This quality check is for cough or abrupt change in flow over the first
second of exhalation.
C) Blast: PEFR/FEF50% > 1.25
D) Exp time: ATS requirement for at least 6 seconds of expiratory time (3 sec if < 10 yrs).
E) End exp: Checked by default. Triggers a caution message if more than 25 ml of flow over the
last second of exhalation.
F) Insp Phase: Checked by default. Triggers a caution message if an Inspiratory phase is absent.

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End-Expiratory
A) ATS 1987: Test is terminated if volume accumulation drops below 0.040L in two seconds.
B) Manual: Allows the user to determine the end of the expiratory phase by pressing the spacebar
which also starts the Inspiratory phase.
a. Consider utilizing with patients having difficulty completing the maximal exhalation for the
FVC maneuver.
C) ATS 1994/2005: Notifies the user that end-of-test criteria (< 25ml) has been met (expiratory
phase complete) and suggests initiation of the Inspiratory phase. Will time out if inspiration is
delayed.
Reproducibility Check/Variability Check

A) FVC: If “Comply with ATS/ERS 2005 standard” is enabled, this is checked by default and cannot
be unchecked. The software will assess efforts other than the “Best” for repeatability of the FVC
parameter.
B) FEV1: If “Comply with ATS/ERS 2005 standard” is enabled, this is checked by default and
cannot be unchecked. The software will assess efforts other than the “Best” for repeatability of
the FEV1 parameter.
C) PEFR (advisory only): If checked, the software will assess efforts other than the “Best” for
repeatability of the peak flow parameter.
Pediatric:
Allow efforts under 1 second and at least 0.25 seconds: If checked, the software will not
automatically discard efforts less than one second.
 If the effort length is less than 0.50 seconds, FEV .5 is reported as the total accumulated volume.
 If the effort length is less than 0.75 seconds, FEV .75 is reported as the total accumulated volume.
 If the effort length is less than 1.0 seconds, FEV1 is reported as the total accumulated volume.
Efforts:
Maximum number of efforts retained: If “Comply with ATS/ERS 2005 standard” is enabled, the
setting will be eight efforts by default and cannot be changed. Otherwise, the default value is
three efforts. Efforts exceeding the set number will be discarded.
Appearance:
Volume/Time graph scale: Configures the time scale for VT graphs. 8 seconds is the default.

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11.3.4 Modify the SVC Effort Protocol
A) Stable tidal breathing/max inspiration/max expiration (EVC): This is checked by default. Referred
to as an expiratory vital capacity. After a baseline is established with tidal breaths, the patient
inhales to total lung capacity followed by complete exhalation to residual volume.
B) Stable tidal breathing/max expiration/max inspiration (IVC): Referred to as an Inspiratory vital

capacity. After a baseline is established with tidal breaths, the patient exhales to residual volume
followed by complete inhalation to total lung capacity.
C) Max inspiration/max expiration, in any order: Only available if “Comply with ATS/ERS 2005
standard” is unchecked.
D) Expiration only, using one-way valve: This method is designed for mouthpieces rather than filters
and only calculates the VC value. Not recommended.
a. IC and ERV can no longer be calculated since there will be no tidal minimum baseline
established.
When “Comply with ATS/ERS 2005 standard” is checked, the option to select maneuver order is reduced
to 3 choices. The default checked is (EVC).
Maximum number of efforts retained: Default is 3.

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11.3.5 Enter a FRC Value
If a value for FRC (Functional Residual Capacity) is available for a specific patient, you may enter
that value, so that RV (residual volume), TLC (total lung capacity), and RV/TLC can be calculated
and reported for that patient visit.
To do this, at the “SVC testing” window:
1. Select Enter FRC value from the Tests menu.
2. Enter the value for FRC
3. Click OK
4. The numeric results pane will show the calculations for RV, TLC, and RV/TLC, if these
values are selected for viewing during testing and an effort has been performed.
Adding the FRC value, obtained from a patient chart or test record, is not considered best
practice and will only result in estimated values rather than true measured values obtained
through formal lung volume testing.
11.3.6 Entering Test Information: Physician, Technician and/or Site Name

Test fields addressed here are included on many standard pre-configured reports.
1. Click on the (Test Information) button or select Test Information from the Setup menu.
2. The button next to the physician, technician, Test Site, and Comments fields provides
options to:
 Add an entry
 Delete an entry
 Edit an entry
 Clear all entries
3. To Add an entry:
 Select Add from the button menu
 Type in the entry for the name, etc. into the Add item field
 Click OK.
 The entry will become available on the dropdown menu and the Delete, Edit, and Clear
list options will become active.

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4. If Delete or Clear list is selected, the action will be immediate.
5. If Edit is selected, you will be able to change the spelling of an entry.
6. Check boxes are selectable for patient position (sitting or standing) and nose clip use during
testing.
7. Click OK.
11.3.7 Change Predicted Set for Individual Patient

If you want to change the predicted set for the current patient only:
1. View the “Predicted Normals”dialog box available for the current patient by clicking on the
buttonor select Predicted from the Setup menu in the testing module window.
2. Navigate the predicted protocol using the arrows; select the new predicted protocol option
and click OK when you are finished.
Alternative:
1. Right click on predicted column in the testing module.

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2. Scroll to and select the preferred predicted equation set. Click OK.
Alternative:
1. Click the (Select patient and test series) button.

2. Select the patient; choose Edit.
3. Select the new predicted equation set from the Predicted menu. Do not forget to enter
any required race selections.
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4. Click OK.
Predicted equations are available upon request from nSpire Health or can be viewed by
utilizing the “Help” menu and searching the desired predicted set.
11.3.8 Incentive Graphics

Incentive graphics are only available for FVC Testing and Challenge Testing. The incentive goal is
automatically determined to be:
 5% greater than the best effort’s FVC (and PEFR, for the wall graphic)
Or
 5% greater than the predicted results, if no effort has been performed.
11.3.8.1 Use an Incentive Graphic
1. From the testing window, click on the button or select Incentive from the Mode menu.
2. The currently-selected incentive graphic will briefly show in the foreground, and then drop to
the background until the effort is performed.
3. To return to standard mode, uncheck Incentive in the Mode menu.
11.3.8.2 Change the Incentive Graphic

1. From the testing window, select Incentive from the Setup menu.
2. Select the graphic you want to use for testing.
3. Click OK.
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11.3.9 Cancel an Effort in Progress
To cancel an effort while it is in progress, either:
 Click on the button.

Or
 Press the Esc key.
If the pneumotach is nulling when you stop the effort, it will take a few seconds for nulling to stop.
11.3.10 Save Efforts

You are automatically prompted to save results before exiting testing, but you may save the results as
often as you like, as testing progresses. To do this:
1. Click on (Save results).

Or
Click Save efforts in the File menu.
2. The test series status will be set to “Tested” the first time efforts are saved for a visit.
11.3.11 Delete Efforts
1. In the testing window, click on the button or select Drop Effort from the Effort menu.
2. A dialog box will ask which effort you want to delete.
3. Select the effort.

4. Click OK.
Alternative 1:
1. Click on the effort graphic itself (in either the F/V panel, the V/T panel).
2. The selected effort will then be displayed as a dashed line to show that it has been selected.

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3. Check the status line for confirmation of which effort you've selected.
4. Click on the button or press the Del key.
Alternative 2:
Right-click on the individual effort column (below the header) and select Drop from the pop-up menu.

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If the FVC Results are entered manually (Section 11.3.12) you must click on the
button or select Drop Effort from the Effort menu. Flow/Volume (F/V) and Volume/Time (V/T)
panels do not exist when an effort is entered manually; therefore the alternative methods to delete
the effort are not possible.
11.3.12 Enter Test Results Manually

You may need to enter test results obtained from another system or from historic patient data.
To do this:
1. Create a new visit for the patient.
2. Select Manual result entry from the Test menu (not active if real results exist).
3. The FVC Results Manual Entry dialog will appear.
4. Enter FVC, FEV1, PEFR and FEF25-75%.

 All entries are required.
5. Enter the effort Date and Time, or accept the current values.
a. Effort date and time will be used for trend reports.
b. Use the date and time format currently selected in “Regional Settings” in the
Windows Control Panel.
c. Entering Time is optional.
6. Click on OK.
If this menu item is disabled, it means that test results (either Pre- or Post-) have already
been obtained by actual performance of an effort. Since manual entry results can’t be mixed in
with performed efforts, this option is not available for this test. You may create a new test series,
or delete the performed efforts.
11.3.13 Mark a Test as Post-bronchodilator

After administering a bronchodilator, and when ready to perform post-bronchodilator testing:

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1. From the testing window, click on the (Change bronchodilator status) button.
2. The current (pre-bronchodilator) test will be saved, and you will see the pre-bronchodilator
best effort as a reference:
a. On FVL and VT graphs
b. In place of the predicted column on the datasheet.
3. Numeric results will now be displayed as %Chg from pre-bronchodilator as opposed to

percent predicted.
4. All subsequent efforts will be placed in the post-bronchodilator mode.
11.3.14 Enter Bronchodilator Name
1. In post-bronchodilator mode, click on the (Test information) button or select Test Information
from the Setup menu.

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2. Enter the bronchodilator name. Use the button next to the drop down menu to select Add and
enter bronchodilator options.
3. Click OK.
This option is only available during the post-bronchodilator testing.
11.3.15 Challenge Testing

Challenge testing is used to determine a patient’s response to a bronchial provocation agent. Increasing
dosages of an agent is administered, followed by an FVC effort to document a response at successive
stages.
To access the challenge testing module, select “Challenge test” button or select “Challenge” from
the “Tests” menu. KoKo Sx is shipped with a standard breath unit protocol (Rosenthal) preset as one
protocol selection.
11.3.15.1 Select Challenge Protocol

1. From the “Setup” menu choose “Challenge protocol” and “Select”. The KoKo Sx includes pre-
configured chemical protocols.
2. Select protocol and click OK.
A protocol editor for additional configurations or modifications of existing protocols is available

(Section 11.3.15.4). Newly created protocols are added to the list.
11.3.15.2 Perform a Challenge Test
11.3.15.2.1 (Dosage Protocol)
1. From the main window, click on the button.
2. Click the patient button .

3. Select the patient and test series as for other test types.
4. Verify that a dosage protocol is in effect (the name of the current protocol is shown in
parentheses at the bottom of the window to the right of the center.
5. Perform the Baseline test by clicking on the button, follow the prompts as in FVC testing.

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6. Select the next stage by clicking on the button, and selecting “Saline” as the next stage.
7. DigiDoser operation is disabled, . This feature is no longer available.
8. Perform the Saline test by clicking on the button, follow the prompts as in FVC testing.
9. Repeat the "next stage," "administer," and "test" sequence with the nebulizer set up with the
appropriate concentrations of the challenge agent, until the prescribed drop in FEV1 has been
reached (the FEV1 trend, shown at the right side of the testing window, will drop into the yellow
area).
a. If desired, enter heart rate, blood pressure, and comments into the worksheet.
10. Select the Recovery stage, administer the recovery agent, and perform the recovery test.
Note: The software allows the user to skip stages the patient does not need to perform.To do this,
select “Go to next stage” , then choose the stage you want to perform from the dialog box,
skipping stages by clicking on “Skip this stage” until the stage you want to perform is highlighted. If
you skip performance of the FVC efforts for a stage that you have already administered the dosage
for, the dosage for that stage is still counted into the cumulative dosage.
11.3.15.2.2 (Exercise Protocol)
1. From the main window, click on the “Challenge test” button .

2. Select the patient and visit as for other test types.
3. Verify that an exercise protocol is in effect (the name of the current protocol is shown in
parentheses at the bottom of the window to the right of the center).
4. Perform the pre-exercise Baseline test by clicking on the button; follow the prompts as in
FVC testing.
5. Select Next stage by clicking on the button.

6. Select Stage 1. The "stage timer" prompt will appear:
7. Leave this dialog on the screen until the exercise phase is completed, as a reminder to start the
post-exercise "stage timer".
8. Perform the exercise phase, making sure that the patient reaches the specified target (heart rate,
time, workload, etc.).
9. At the moment the exercise phase is completed, click on “Start timer” in the dialog. (Alternatively,
click on the button to start the timer.)

10. Wait until the timer alarm sounds, then perform the number of efforts required in the protocol.
11. Select Next stage , and then choose the next stage in the sequence.
12. Repeat steps 10 and 11 until the FEV1 decreases to a minimum, and starts to increase again (the
FEV1 trend, shown at the right side of the testing window).
13. If desired, enter heart rate, blood pressure, and comments into the worksheet.

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The software allows the user to skip stages the patient does not need to perform. To do this,
select Next stage , then choose the stage you want to perform from the dialog, skipping stages
by clicking on Skip stage until the stage you want to perform is highlighted.
If you forget to start the stage timer immediately after exercise, you may still start the timer at
the beginning of any stage. The post-exercise timer is set to the post-exercise time specified in the
protocol for that stage.
11.3.15.3 Fill in the Worksheet

As challenge testing using a dosage protocol proceeds through the stages, you may want to enter heart
rate, blood pressure, and comments in the worksheet.
To fill in the worksheet: Click on the worksheet button or select “Edit worksheet” from the “stage”
menu located in the challenge test window.
1. Fill out the fields appropriately.

a. BP, HR, and Comments will be included in the testing data displayed in the testing
module and on the included challenge reports “Per-stage” results.

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2. Reference stage: As stages progress the option to edit the stage becomes available.
3. Nebulizer: Enter output for each stage.
4. Click Close.
You should enter the Dosimeter output in mL/min, if available, to enable calculation of the Cumulative
dosage (mg), PD-20 (mg), and PC-20 (mg) values. If dosimeter output is not available, leave the entry
blank.
11.3.15.4 Edit Challenge Protocols

1. From the “Setup” menu choose “Challenge protocol” and “Edit”.
2. Select the protocol to be edited and click OK.
3. Depending on the selection the “Dosage Protocol” or “Exercise Protocol” window will appear.
 2 dosage protocol templates are available:

o Cockroft, or similar
o Rosenthal, or similar
 1 exercise protocol template is available:
o (treadmill, bicycle ergometer, etc.)
11.3.15.4.1 (Dosage Protocol)

Confirm a dosage protocol to be edited is displayed. This will appear next to “Name”.
There are several fields that can be edited.
 Challenge agent: enter the name of the challenge agent.

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 Decision points:
o (Methacholine, or similar)
 #1 (required) is a percentage drop in FEV1. This % drop will display on the
challenge graph as a horizontal dotted line and will be labeled DP1. This is
intended as an event marker for provocation.
 #2 indicates an additional percentage drop in FEV1. This % drop will display on
the challenge graph as a horizontal dotted line and will be labeled DP2.
o (Manitol, or similar)
 #1 (required) is a percentage drop in FEV1 from reference. This % drop will
display on the challenge graph as a horizontal dotted line and will be labeled DP1.
 #2 (required) is a percentage drop in FEV1 from the previous stage. This % drop
will display on the challenge graph as a horizontal dotted line and will be labeled
DP2.
 Timers: (optional) There are two entries available.
 “admin”: The time in minutes between administering the challenge agent and
performing a FVC maneuver. The timer will chime at the time indicated.
 “Stage”: The time in minutes between stages. This is used to enter in the
number of minutes you would like to wait between FVC staged maneuvers.
 “Dose administration”: Can be utilized as a timer.
 Stages: There are three configurable non-dosage stage types available in the challenge test
protocol. These stages necessitate a selection of “Required”, “Optional” or “Skip”. The default
settings are: Base: Required, Saline: Required, and Recovery: Optional.
 Base: This stage is a pre-drug FVC maneuver.
 Saline: This stage indicates a FVC maneuver associated with inhalation of saline
or other soluent.
 Recovery: This stage represents a FVC maneuver following administration of a
reversing agent (i.e. bronchodilator) or recovery period.
 Recovery: This stage represents a FVC maneuver following administration of a
reversing agent (i.e. bronchodilator) or recovery period.
 Efforts group: There are 3 fields to consider.
o Consistent: Select whether at least one other effort is repeatable with an effort within the
stage. The choice is Required, Optional or Skip.
o Rank on: Select Sum, FEV1, or FVC.
o Consistency criterion (required): Select Liter(L) or % from the dropdown menu. This
value will determine the threshold for repeatability of efforts within a stage. The default
value will vary depending on protocol selected.
 Dosages
 Stage: Breaths, selected for breath-based dosing (dosimeter) or Seconds,
selected for time-based dosing (continuous nebulizer).
 Base: No options; Pre-drug.
 Saline: Choose number of breaths or seconds for the administration of “saline” or
similar soluent.
 Stage 1-24: Choose the number of breaths or seconds for the administration of
agent and enter in the conc (mg/ml) of the agent delivered.
 Stage 1-24: Enter dose in mg.
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 Nebulizer:
 Enter“Nebulizer” output in mL/min (optional), if known in advance of testing. You
may also fill this item in during or after testing by using the worksheet. The
default value is 0.200 ml/min.
Nebulizer output will vary from unit to unit. Refer to the nebulizer user manual if output value is
unknown.

1. Within the challenge testing window, select “Setup” from the menu items.
2. Next select “Edit” from “Challenge protocol” selection.
3. Decide which exercise challenge protocol you wish to edit and click OK.
4. Make the desired changes to the exercise protocol.
There are several fields that can be edited.
 Name: Enter the name of the exercise protocol.

 Exercise device: Enter the name of the exercise device.
 Post-exercise times
o Stage 1-24: Enter time in minutes after exercise is completed when a FVC
maneuver will be performed.
 Decision points:
o #1 (required) is a percentage drop in FEV1. This % drop will display on the
challenge graph as a horizontal dotted line and will be labeled DP1. This is
intended as an event marker for provocation.
o #2 indicates an additional percentage drop in FEV1. This % drop will display
on the challenge graph as a horizontal dotted line and will be labeled DP2.

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 Efforts: There are 3 fields to consider
o Consistent: Select whether at least one other effort is repeatable with an
effort within the stage. Choice is Required, Optional, or Skip.
o Rank on: Select Sum, FEV1 or FVC.
o Consistency criterion (required): Select Liter (L) or % from the dropdown
menu. This value will determine the threshold for repeatability of efforts
within a stage. The default value will vary depending on protocol selected.
5. Click OK.
6. If the current challenge test series is still in the Base stage, the system will ask if you want to
make the changed (or newly-selected) protocol effective immediately for that test series.
Otherwise, the changed (or newly-selected) protocol will be effective for the next challenge
test series.
 In the Decision points group, enter the values for drop in FEV1 (compared to baseline) at which
you would consider ending the test with a positive finding, without waiting for an increase in FEV1
to occur in later stages.
 In the Efforts group: select whether at least one other effort consistent with the first is Required,
Optional, or Skip (the standard is optional). Select how efforts will be ranked within a stage (by
FEV1 is standard). Select how effort consistency is defined (within 10% is standard).
 In the Post-exercise times group: enter the cumulative Time in minutes after the exercise phase is
completed for the performance of each stage defined in the protocol. Use the scroll bar to view
more stages.
11.3.15.5 Create Challenge Protocols
11.3.15.5.1 (Dosage Protocols)

1. From the “Setup” menu choose “Challenge protocol” and “Create”.
2. Select which type of challenge test you wish to perform, and click OK.
3. The“Dosage Protocol” dialog box appears.

4. Make the desired changes or additions to the protocol (edit challenge,Section11.3.15.4), and click
OK.

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1. Within the challenge testing window, select Setup from the menu items
2. Next select “Create” from the “Challenge protocol” selection.
3. The “Challenge Type” dialog box appears.
4. Choose the “Exercise” button, and click OK.

5. The “Exercise Protocol” dialog box appears.
6. Fill in the fields appropriately, and click OK.
7. Click “Yes”when prompted “Do you want to use the protocol named [name] in its revised form as
the protocol for the current test series?” dialog.

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The “Time (minutes)” column contains the time the first effort in each stage was started, after the
exercise phase was completed.
11.4 REVIEWING TEST DATA QUALITY

Tools for evaluating results can be found on the tool bar buttons and View menu within the test modules.
11.4.1 Graph Options
11.4.1.1 Size Scale on Graph

To change the size of graphs:
1. A Scale menu can be accessed from the View menu
Or
2. Use the scale buttons:
The auto-scale button allows KoKo Sx to select the best scale automatically. The smallest
scale that will allow current results, pre-bronchodilator results (Post-Mode), and the reference
effort to fit on the screen will display. Prior to obtaining test efforts, the scale will be determined by
predicted values.
11.4.1.2 Change Time on Volume

FVC and Challenge test windows
1. Select Effort protocol from the Setup menu.

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2. In the Appearance section, select the time for the X axis: 8, 12, or 20 seconds.
Once a new time scale has been selected:
 New visits will use the new setting.

 Existing visits will use the selected time scale for displaying data in the test module and in
report vt graphs, once the data is saved.
 The test module can be revisited to change the time scale for reports.
Caution: This time setting affects Volume vs. Time graphs (Reports). This is a system-
wide setting (as opposed to per-patient or per visit).
11.4.1.3 Zoom In
If you want to see more detail in a particular section of a graph, click (and hold the cursor down)
near the area you want to magnify and drag a box around the area, releasing the button when
done.

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To revert to a normal display size, click on one of the scale buttons: . Saving
results or performing an effort will also restore original magnification.
11.4.2 Change Displayed Results
11.4.2.1 Modify Parameters Displayed

To change the selection of parameters displayed during testing:
1. Select “Numeric results” from the View menu or right click the parameter list on the
datasheet.
2. The numeric result selection dialog box appears.
3. Select the parameters you want to display. Available parameters are listed in (section
16.4)
4. Click on a highlighted parameter to unselect it.
5. Click OK.
These selections do not affect the results shown on reports. The results shown on reports
are determined in report design.
11.4.2.2 SR (Z-score)
To add a column in the datasheet for the standardized residual (Z-score), select SR (Z-score) from the
view menu. If checked, making the selection again un-checks it and removes the column.
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11.4.3 Graph Display Options
11.4.3.1 Display Best Pre-Bronchodilator Effort in Post Mode

Displays the best pre-bronchodilator effort on graphs and in the data results section (instead of the
predicted):
1. Select “Pre-Rx effort” from the View menu. “Pre-Rx effort” is selected as the default
configuration ..
2. If “checked”, click to "uncheck" it.
3. If unchecked, the predicted graph and numeric values are shown, as in pre-
bronchodilator testing.
11.4.3.2 Display the FVC Reference Effort

A reference effort is typically taken from a previous visit. The best of the “best effort”(FVC+FEV1), from
all previous visits for each patient is automatically saved as the "FVC reference effort," and it is available
for display during testing and in reports.
To enable the display of the reference effort on graphs and add a reference effort column to the data
results section:
1. Select Reference effort from the View menu.
i. If this reference effort is already “checked”, reference effort display is already
enabled.
2. Select again to “uncheck” and remove the reference effort.

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You can select a different reference effort than the one automatically selected.
This is done in the File menu in Reports, where the Reference effort option allows
marking or unmarking the reported effort from the current visit as the reference effort.
11.4.3.3 Display a Composite Effort

A composite effort is created and displays the following as a column in the results data section:
 The maximum FVC from any usable effort, and

 The maximum FEV1 from any usable effort, and
 The ratio of maximum FEV1 to the maximum FVC, and
All other results taken from the effort with the maximum FVC + FEV1, the highest-ranked “Best” effort.
The composite effort will be similar to the “Best Effort”, with variation occurring in the FVC, FEV1,
and the ratio.
When ATS/ERS 2005 compliance is selected in the effort protocol, the ability to select a composite effort
to be displayed is available. The selection is not available without selecting ATS/ERS 2005 compliance.
To enable the composite effort:
1. Select Composite effort from the View menu.
2. The image below displays a composite effort column and appears in the data results section.
3. To display in a report, a customized report would need to be created.
a. Use composite effort is an option in the attributes menu for parameters.

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The graphic composite results will not be displayed in the reports.
11.4.3.4 Display the Tidal Loops

If you want to see the tidal loops of all FVC efforts on the flow/volume graph during testing:
1. Select Tidal phase from the View menu.

2. To hide the tidal loops, click again to "uncheck" this option.
If this item is already "checked," tidal graphics are already enabled.
Tidal loop display in reports is determined in Report Design.
11.4.3.5 Offset Efforts

To see the graphic results for individual efforts more clearly, you may display the efforts in staggered
fashion or “offset”. To offset efforts, select “Offset efforts” from the View menu. If Offset efforts is not
checked, the loops will overlay from the same position.
11.4.3.6 Display Best 3 Efforts Only

Select “Best 3 efforts only” from the View menu.

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The selection made here has no effect on the efforts displayed in reports, which are
customized in report design.
An alternative:
1. Right-click a graph and select “View Best 3” or right-click an individual effort column in the
data results section and select “Best 3”.
2. The lower-ranked efforts will be removed from the display.
11.4.3.7 Display All Efforts
1. Select “All efforts” from the View menu.

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2. All effort graphics will be shown on the display.
Alternative:
1. Right-click in the graphic or numeric results area

2. Select View All
11.4.3.8 Effort Display Options
1. Right-click on an effort column in the data result section. The effort option popup menu
appears.
2. Select View and the effort will display on the graph if not already displayed.

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3. To remove the effort from the graph, repeat this operation, un-checking “View”.
4. Selecting or un-selecting Isolate from the effort right click menu toggles a view of only the
selected effort (with the predicted or Pre loop if selected to display).

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11.4.3.9 Report a Different Effort as “Best”
1. Click on an effort other than the “best” and click the (Mark Best Effort) button
Or
Select an effort in the data results section and then select Best Effort from the Effort menu
Or
Right click the effort in the data results section and select “Best”.
If the Effort menu is used, the selected effort will be moved to the “Best” position
(column) and be reported as the best effort.
If the button is used without selecting an effort first, a dialog box will ask which effort
you want to mark as best.
2. Select the effort and click OK.
If an effort is marked as best and selected then “Best effort” will be checked in the
Effort menu and “Best” will be check on the effort right click menu.
3. To revert to automatic reporting of the best effort, right click the best effort and uncheck
“Best”.
Caution: Manually marking an effort as “best” will override subsequent automatic

determination of the best effort.
11.4.4 Evaluate Visit for Effort Quality and Repeatability
11.4.4.1 Visit Grading

When “Comply with ATS/ERS 2005 standard” is checked in the Effort Protocol dialog, visit grading is
enabled. Effort grading can act as a guide as to whether or not to continue testing the patient.
To enable/disable:
1. Select or unselect Grade/summary from the View menu.
2. Below is an example of the grade and summary displays:

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11.4.4.2 Effort Acceptability and Reproducibility (ATS/ERS 2005)
After an effort is performed, you may see some effort acceptability cautions, outlined in red:
If the effort is retained, the acceptability and reproducibility cautions for each effort are shown as
letter codes (outlined in red below), visible in the individual effort column on the data results
section (and available for reports):
Effort quality flags:

Unusable efforts are marked in the individual effort column with a red “X” at the top of the
column. The reasons that an effort can be flagged as unusable can be:
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 Start of expiration (extrapolated volume failure caused by hesitation): Start
 Cough detected: Cough
Unacceptable efforts are marked in the individual effort column with a yellow triangle at
the top of the column. The reasons that an effort can be flagged as unacceptable can be
(only the most-important reason is shown):
 Start of expiration: Start (<5% of the FVC or 0.150L, whichever is greater)

 Cough detected: Cough
 Blast not sufficient:Blast
 Time too short: Time
 End of expiration too sudden: End
The reasons that an effort can be flagged as not repeatable can be:
 FEV1 not repeatable (F); exceeds -0.150L
 FVC not repeatable (V); exceeds -0.150L
 PEFR not repeatable (P); exceeds -15%
11.4.4.3 Evaluate Effort Quality and Variability (ATS 1994)

After an effort is performed, you may see some effort quality cautions, outlined in red:
If the effort is retained, the quality statements for each effort are saved as letter codes (outlined in
red below), visible in the numeric results pane during testing (and available for
reports):
The quality checks performed (and the corresponding codes) are:
If extrapolated volume as a percent of FVC (Vext%) is greater

than 5.0, (or extrapolated volume is greater than 0.150L), there
Start of expiration (code: S)
may be a problem with the patient hesitating at the start of the
expiratory effort.

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Cough (code: C) Triggered by a transient flow greater than 10% of peak flow in
the first second of expiration.
If expiratory time is less than 6 seconds, the patient may not be

Expiratory Time (code: T)
exhaling completely.
If the volume accumulated in the last 2 seconds of expiration is

End of expiration (code: E) greater than 25 ml (per ATS/ERS 2005), or if the expiratory flow
drops from 1.0L/sec to zero in less than 0.2 seconds.
No Inspiration (code: I) Displays if no inspiration is detected.
After the effort is retained, effort variability for efforts other than the best (outlined in red below) is
also shown in numeric results pane:
The variability checks consist of testing whether an effort's FVC, FEV1, or PEFR variation from
the best effort exceeds -0.200L, -0.200L, and -15%, respectively.
11.4.5 Change Test Status To Reviewed

If a study has been reviewed but not interpreted, the option to mark the study as “Reviewed” is available.
This is designed to support workflow and documentation practices.
1. Select “Patient information” from the “File” menu or click on the “Select patient and test series,
enter/edit patient information” button .
2. Search for the test series to be reviewed using “Search options”.
3. Double click on the patient record to be reviewed.
4. From the “Report” menu select “Read/interpret/print” or click on the “read/interpret/print
results” button to access the report.
5. Review report.
6. From the “File” menu select “Mark as reviewed” or click on the “Mark test series as reviewed”
button .
Reviewing test series prior to final interpretation may be part of the implemented workflow.
Caution: Review should not be used to do the test interpretation.
Caution: Generating a report while in the testing module is available. Marking a report as
“reviewed” while in the “testing” mode will yield the following message:

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To avoid this message, close the test module and follow steps 1 through 6 above.
11.5 INTERPRETING/ANALYZING TEST DATA

11.5.1 Accessing Reports
There are several different paths to access reports within the software.
1. From the main window, access reports using the (Read/interpret/print results) button. The
report generated will be from the last patient tested.
2. From the Read/Interpret/Print Results window, click the (Select patient and test series) button
or click on the “Select patient and test series” in the File menu.
a. Search options are the same as when accessing “Select patient and test series” from
other windows. Section 11.2.1.1
3. From testing windows, access reports using the (Display/interpret/print results) button.
a. Accessing a report from the test window is considered a “preview” and any changes
made here will be overwritten when the test series in the other window is saved.
Attempting to interpret results from a testing window will display the following
message:
Note:
 The report design will be populated with data from the selected patient visit. Once the report
is displayed, confirm the patient information on the report matches the patient test series
selected.
 In the “Read/Interpret/Print results” window, you cannot modify any patient or visit information.

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 Test series status, located in the “Test series matching” list, will indicate new, tested,
reviewed, Interpreted, Printed, Imported or Exported.
o New: Patient demographic information was manually entered into Koko on this
system
o Tested: Patient has performed at least one effort in one type of tests (FVC, SVC,
MVV) further efforts/tests may be pending.
o Reviewed: Test results have been reviewed.
o Interpreted: Test results have been interpreted by a physician (Automatic
interpretation does not result in this test series status).
o Printed: Test results have been printed.
o Imported: Test results have been imported.
o Exported: Test results have been exported.

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11.5.1.1 Select Report Design
1. From “File” menu click “Select design”.
2. Choose the report from a folder or single list dropdown menu. (Section 8.3.2.5)
11.5.1.2 Add an Interpretation
1. Click the (Interpret results) button or select “Interpret” from the File menu.
The “Spirometry interpretation” window will display.
2. There are several options for entering an interpretation:

a. Typing in free text.
b. Inserting “Standard phrases”.
i. The button next to the “Standard phrases” field is used to Add text for
insertion.
ii. Options on the button menu include Add, Delete, Edit, and Clear list.
iii. Prior to the first entry, only the Add button is active.
iv. Added entries display on the “Standard phrases” dropdown menu.
v. Once a phrase is selected, place the cursor in the interpretation field where
you want to enter the text and click the “Insert selected phrase into
interpretation” button.
c. Select or change a computer generated interpretation by clicking on a “Perform
automatic interpretation” button:
i. Standard
ii. ITS
1. Ensure the ITS predicted equation set is selected for this custom
interpretation to function properly.
iii. McKay
iv. Custom (section 8.3.3.5)

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If the system is configured for “Auto-interpret results”, the default computer
generated interpretation will appear in the “Spirometry interpretation” text box after saving
the patient visit after testing and prior to clinician interpretation. To determine which
“automatic interpretation” has been selected refer to Section 8.3.2.4.
A custom interpretation allows the user to modify an automatic interpretation by

either changing the values used at any decision point or by changing the phrases the
interpreter uses. To create a custom interpretation, refer to Section 8.3.3.5.
3. The clinician interpreting the results has the option to add their name to the record:
a. Click the button next to the “By” field.
b. button options are Add, Delete, Edit, and Clear list.
Clinicians can enter their name on this list and they will populate the drop down menu for
the “By” field.
This field is valuable when printing multiple reports for a single clinician (Section 11.6.1.3).
This field can be added to report designs by accessing “Design report format” from the
main window (Section 9.4.4.2)
4. There is a “Mark as final” check box to indicate that the visit is complete. By checking, “Mark
as final”, the automatic interpretation process will not over-write an existing interpretation if
additional testing is performed.
5. Click on OK to finish.
Upon completion of an interpretation, the test series “status” for the test should now be
listed as “Interpreted” in the “test series matching” list.
11.5.1.3 Override the FVC Reference Effort Selection

Select a different FVC reference effort from the one automatically selected by the system. To do this:
1. In the report window, open the test series that contains the FVC effort you want to make the
reference effort.
2. From the “File” menu, select “Reference effort|Mark”.
3. If there is more than one FVC test in the series (i.e.: pre- and post-bronchodilator have both
been performed), you will be asked to choose which of these tests contains the reference
effort.
To revert to automatic selection of the FVC reference effort (based on all-time best FVC+FEV1),
select “Reference effort Unmark”.

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11.6 DISTRIBUTING REPORTS
11.6.1 Print
Printing the Current Visit from the “Read\Interpret\Print results” window:
1. Click on the (Print the current test series) button.

2. Select the printer from the available options.
3. The currently selected report will be printed (or faxed if using a fax printing option).
4. In the “Select patient and test series” window, the status will be set to “Printed.”
11.6.1.1 Print to a PDF File

1. In the “Read\Interpret\Print result” window, click the "Print to PDF file" button .
2. A PDF file of the report will be created in the path: C:\Users\Public\KoKo PFT System\PDF.
3. The file name is created automatically: It will use the patient's last name, first name, ID
number, and visit date, which are separated by underscores.
11.6.1.2 Print Multiple Visits
1. In the main window, click the “Print multiple test series” button.
2. The “Print Multiple Test series” patient selection window displays.
3. In the search options area select a search option and click “show all matches”:
4. Left click on one or more test series to be printed or click “Select all matching test series” to
select all searched visits for printing.
5. Click “Print”
Click on any “Test series matching” column header to sort the matched visits. Sorting by
column header may support printing multiple test series by date, physn, status and or group.

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11.6.1.3 Print a Report with Verification of System Performance
When printing a report, select the report named “Disability,” which includes verification of calibration
numeric and graphic results.
If you need to change the size of the verification graphic result to meet reporting requirements:
1. From the main window, select Report|Design.
2. Select File|Open Design.
3. Select Disability.
4. Click on View|Next page, so that the calibration graphic is visible.
5. Click on the graphic, then drag one of the blue sizing "handles" on the graphic to change its
size.
6. Click on File|Save to save the modified report design.
11.6.1.4 Adjust Print Capabilities

Certain printers can't print rotated text or dashed lines. To accommodate these printers:
1. In the “Display/Interpret/Print report” window, select Printer mode from the File menu or
select the “Printer Mode” button in the “Print multiple test series” window.
2. The “Printer Mode” window will appear.
You have the option to accommodate certain printers by disabling rotating text or
dashed lines.
You also have the option to save ink.
Printing in monochrome mode is most appropriate for “Fax” printing options.
3. Check the print mode modification boxes to be enabled. Click OK.

PN 762017.B 155
12 MAINTENANCE AND CARE
12.1 USER MAINTENANCE

12.1.1 Disposable Filter
A KoKo single patient use disposable filter should be used during testing. Failure to use filters may result
in expectorated material depositing on the pneumotach, causing measurement inaccuracy. If the
pneumotach core becomes contaminated with phlegm or foreign objects, or if the cleanliness of the core
is suspected as the cause of performance degradation, discontinue use of the KoKo SX 1000 and refer to
the core assembly cleaning instructions. If the core appears damaged, please contact nSpire Health for
repair or replacement.
12.1.2 Dust Removal

Use a moisture free dust remover spray, or moisture free compressed air, to remove dust from the
surface of the pneumotach core.
12.1.3 Cleaning the Handle

Use a mild non-abrasive cleanser with very little moisture on a clean soft cloth to clean the outside of the
KoKo SX spirometer. Low moisture Accelerated Hydrogen Peroxide wipes such as Oxivir TB wipes or
other disinfecting wipes may also be used.
12.1.4 Cleaning the Core Assembly

If it becomes necessary to use a cleaning solution on the core, the core assembly must be removed from
the spirometer handle. This is the only part of the KoKo Sx Spirometer that can be submerged in liquid.
See below for the recommended cleaning agents.
1. Remove the O-ring from the side of the pneumotach to which the arrows point.
2. Push the core assembly out of its holder taking care not to put pressure on the brass core.
3. After removing the core assembly from the pneumotach handle, submerge or spray saturate the core
assembly only according to the solution manufacturer’s directions. Rinse thoroughly in distilled water
and air dry.
4. Slide the core assembly back into the handle, making sure that the tab matches with the slot provided
for it in the handle.
5. Replace the O-ring.

PN 762017.B 155
After cleaning the core assembly, re-calibrate the KoKo Sx Spirometer prior to patient testing.
Always calibrate with a filter in place.
Caution: Do not attempt to wash or submerge the KoKo Sx Spirometer handle in water or
cleaning fluid. There are electronic components inside the handle that will be permanently damaged.
12.1.5 Recommended Cleaning Agent

The core of the pneumotach is made from a brass alloy. Care should be taken to ensure that the
disinfectant solution used does not damage the core. nSpire Health, Inc. recommends
Diisobutylphenoxyethoxyethyl dimethyl benzyl ammonium chloride, Accelerated Hydrogen Peroxide (.5%)
such as Oxivir TB, or any equivalent non-corrosive solution.
12.2 MANUFACTURER MAINTENANCE
Before performing any maintenance procedures, make sure the power to the computer is off or that the
KoKo Sx-1000 is disconnected from the computer. The KoKo Sx-1000 has no user internal serviceable
parts. Therefore, for issues not covered in Maintenance, or if you are having problems with your system,
contact your local distributor or, nSpire Health Service personnel (contact info on page 2).
If the pneumotach core appears damaged, please contact nSpire Health for repair or replacement.
nSpire Healthrecommends that a calibration syringe that has been dropped or damaged, or was
validated more than a year ago, be revalidated by returning it to nSpire Health for servicing.

PN 762017.B 155
13 TROUBLESHOOTING
13.1 DETERMINING WHY PREDICTED VALUES NOT SHOWN

Any time a predicted value can't be calculated, a substitute symbol will be shown instead. These symbols
are:
Symbol Meaning
--- Predicted equation not selected, or value not defined in
selected equation set.
*** Patient’s age, height, weight, ethnic group, etc. out of
the range specified by the source document for the
predicted equation set.
Refer to Section 11.2.1.4 and review data entered to ensure patient information and values are correct.
13.2 KOKO SYSTEM WILL NOT INSTALL

See Check System Requirements (section 5.4) for information on requirements for computer systems that
are intended to run KoKo Sx.
It is not recommended that you attempt to run this software if your computer system does not meet or
exceed these requirements. Running the software while not meeting these requirements will likely result
in the loss of synchronization with the pneumotach which will halt the operation in progress.
13.3 FAILURE TO COMPLETE PRINTING

Under certain circumstances, “Print Multiple Test Series” will fail to complete with an "Unable to complete
printing" message. The reasons and solutions for this include:
1. A transaction for the patient(s) for the unprinted test series is pending in another process and
could not be resolved.
2. If a database transaction for a patient and a specific test is in conflict with another transaction
in a different process during printing (i.e.: after multiple test series have been selected and
printing actually starts), the test series can't be printed.
Solution:
Allow the other task(s) to complete. If you then simply select 'Print Multiple Test
Series' again, the unprinted (and/or not updated) test series will still be highlighted
and ready for you to re-attempt printing.
3. Test series in use in another window. If the specific test series being printed is opened in
another window during printing (i.e.: after multiple test series have been selected and printing
starts), the test series can't be printed. The reason is that the report function needs access to
the test series in order to update the "printed" status, but can't because changes are pending
to that test series in another window.
Solution:
Close the window for that test series. If you then simply select “Print Multiple Test
Series” again, the unprinted test series will still be highlighted and ready for you to re-
attempt printing.

PN 762017.B 155
4. Printer error(s)
The printer may have caused an error during printing, such as printer off-line, paper
out, power off, disconnected from system, etc.
Solution:
Make sure the printer is now "on-line." If you then simply select 'Print Multiple Test
Series' again, the unprinted test series will still be highlighted and ready for you to re-
attempt printing.
5. Database keys corrupted
In the unlikely event that the database has become corrupted due to an abnormal
termination of your workstation, or an abnormal termination of the server/network due
to power failure, etc., the database may be left in an inconsistent state in which the
"printed" status cannot be updated.
Solution:
You should rebuild the database as described in the next section
13.4 "FIND ALL MATCHES" RETURNS INCORRECT RESULTS

In the event that the database has become corrupted, the database may be left in an inconsistent state in
which the "Find all matches" does not return any (or incorrect) test series.
You may use the "Reset KoKo Database" function to create a new empty database. Before doing
this:
1) Assure that all patient information has previously been transmitted to the Iris central
database.
2) From the Start menu, select nSpireHealth.
3) Select Reset KoKo Database.
Caution: All patient data stored in the current user's local database will be deleted!
If you don't know if all patient information has previously been transmitted to the Iris central
database, contact nSpire Health, Inc.
To correct the incorrect "Find all matches" results problem, you should rebuild the database keys.
The database keys can be automatically rebuilt at next startup by making an addition to the
KoKoPFT configuration file.
To automatically rebuild the database keys:
1. Exit KoKo Sx.
2. Find the “KoKoPFT configuration file” (located in the data folder) using Windows Explorer.
3. Double-click the “KoKoPFT configuration file” to start the Notepad editor.
4. Find the section titled [Database].
5. Add a new line under that section:
6. AutoRebuild=True.

PN 762017.B 155
7. Close Notepad.
8. Restart KoKo Sx.
13.5 ERRONEOUS RESULTS

If you think you are receiving erroneous results from KoKo Sx you should check the following items:
 Is the filter attached to the correct end of the pneumotach?

 Has pneumotach verification of calibration been performed recently?
 Is the pneumotach screen free of debris?
 Are there any restrictions being placed on the air flow though the pneumotach, such as the
patient placing his/her hand over the pneumotach outlet port, rather than holding the bottom of
the handle?
If you are still receiving erroneous results after checking the above items, contact nSpire Health Customer
Service for further assistance (see page 2 for contact information).
13.6 PNEUMOTACH CONNECTION PROBLEMS

 If you see a message saying the "pneumotach driver has not been installed yet":
1. Exit the KoKo program.
2. Re-install the KoKo program from the original installation media to restore any missing driver
files.
 The pneumotach is not enabled.
a. Refer to (section 8.3.3.1) to enable the pneumotach.

 Ensure the correct pneumotach handle is connected to the software. KoKo Sx 1000 (ver.
5.0) is not compatible with prior pneumotach handles.
13.7 NULLING THE PNEUMOTACH

Nulling the pneumotach occurs immediately prior to testing the patient. After clicking the “Start effort”
button, the message “Assure zero flow through the mouthpiece” and “Maintain zero flow through the
mouthpiece” will display.
If the KoKo software detects flow prior to testing, (while nulling the pneumotach), due to starting breathing
at the wrong time, or moving the pneumotach, a problem message will display.

PN 762017.B 155
Click OK and try again.
To avoid errors while nulling the pneumotach, you should place the KoKo Spirometer on some surface,
away from airflows such as open windows or ventilation ducts.
If the pneumotach cannot be zeroed and the problem message continues to display, utilize a different
pneumotach handle and/or call nSpire Health Customer Service for support(contact info on page 2).
13.8 CALIBRATION GAIN FACTOR MESSAGE

To verify the pneumotach is functioning within specifications, verification of calibration is recommended
using a 3-L calibration syringe. If the user encounters the message “Calibration gain factor has
increased…Check for leaks in the syringe circuit”, it is recommended you test the syringe. Wear and tear
can affect the accuracy of the 3-L calibration syringe over time. Reference “3 Liter Calibration Syringe
Instructions for Use” for additional detail and instruction.
1. Fully draw back the syringe piston rod.

2. Place a hand over the outlet of the syringe.
3. Depress the syringe piston rod gently.
Note: With your ear close to the piston rod end plate, listen for a hissing sound indicating a
leak. No air should escape the syringe.
4. Visually verify the displacement stop position has not been loosened or moved.
5. Next, (with the outlet open) empty the syringe by depressing the piston rod.
6. Place hand over the outlet of the syringe.
7. Pull gently on the syringe piston rod.
Note: With your ear close to the piston rod end plate, listen for a hissing sound indicating a
leak. No air should escape the syringe.
If the syringe appears to have a leak, utilize a different 3-L calibration syringe if available.
Call nSpire Health Customer Service for servicing of the leaky syringe(contact info on page 2)
If the syringe does not appear to have a leak, repeat verification of calibration. If a “calibration gain
factor” message continues to appear, call nSpire Health Customer Service for support(contact info on
page 2).
13.9 TEST COULD NOT BE COMPLETED

If you receive a message that the test could not be completed, there may be another process executing
on your computer that uses an excessive amount of processor time, disrupting data communications with
the pneumotach.
 One cause of problems has been found to be the use of certain USB expansion hubs. The
problem may persist even when the pneumotach is connected directly to one the system's built-in

PN 762017.B 155
USB ports, but the expansion hub is still connected to one of the system's built-in USB ports for
the use of other USB devices. To correct this condition, discontinue use of the USB expansion
hub.
 See IncentiveSound=True in the KoKoPFT configuration file settings.
 Check the Pneumotach connection (section 8.3.3.5) for further suggestions.
13.10DATE AND TIME

If you change the date and time formats from the Windows Control Panel, all programs are notified, and
their displays are adjusted accordingly.
To change the date and time format:
1. Click the “Control Panel” (either from the "My Computer" icon on the desktop or from the Start
menu "Settings" item).
2. Double-click on the "Regional Settings" icon.
3. Make adjustments to the date and/or time formats using the tabs of the same name.
4. The PFT System will respond by updating open report windows when you close this dialog
box.
13.11DAYLIGHT SAVING TIME

You must enable the automatic daylight savings adjustment in Windows, so that the date/time of tests will
be displayed properly in reports.

PN 762017.B 155
14 FREQUENTLY ASKED QUESTIONS
14.1 CAN I USE MY DIGIDOSER?

The Digidoser is not supported by this KoKo Sx software version.
14.2 CAN I USE THE KOKO PNEUMOTACH HANDLE FROM MY OLD SOFTWARE?
Only KoKo Sx pneumotach handles are supported. If you are using a pneumotach from previous KoKo
products you will receive a message stating the pneumotach handle is not supported. Contact nSpire
Health for further information (contact info on page 2).

PN 762017.B 155
15 GLOSSARY OF TERMS
3-L calibration syringe
Used for calibration checks and linearity testing to establish the relationship between sensor-determined
values of flow or volume and the actual flow or volume.
ATPS
Ambient temperature, pressure, and saturation (water vapor)
ATS
Abbreviation for the American Thoracic Society. The most recent set of ATS standards were published in
2005.
Back Extrapolation
It is recommended by ATS/ERSthat "time-zero" be adjusted when performing Forced Vital Capacity tests.
This adjustment is known as back extrapolation. If a hesitant or slow start of the FVC test occurs, this can
lead to an extrapolated volume in excess of what is recommended by the ATS/ERS.The allowed
extrapolated volume is 5% of the FVC volume (or 150 ml, whichever is greater). Extrapolated volume
introduces inaccuracy into the measurement of all timed forced expiratory volumes and flows.
BTPS
Body temperature, pressure and saturated. Symbol indicating that a gas volume has been expressed as
if it were saturated with water vapor at body temperature and at the ambient barometric pressure.
Body temperature (37°C), Pressure (760mmHg), Saturated with H2O vapor at 47mmHg or 43.8mEq/L at
37C. Environmental conditions enter during calibration are used to correct spirometry measurements for
BTPS.
Calibration
To adjust or mark so that it can be used in an accurate and exact way. The accuracy of electronic
components used in all instruments naturally drifts over time. Therefore, it is important to calibrate
instruments at regular intervals if accuracy is valued. Calibration quantifies and improves the
measurement performance of an instrument. Benefits of maintaining properly calibrated equipment
include reduced measurement errors, consistency between measurements, and the assurance of
accurate measurement.
Challenge
Tests bronchoreactivity in response to provocation. With chemical challenge testing the provocative drug
(e.g. methacholine) is introduced in a stepwise fashion. With exercise challenge testing, the patient is
exercised for a specified time period (8 min for Adults) and testing is performed at time intervals
subsequent to the exercise. The decrease in FEV-1 at each level is measured to determine if
brochoreactivity is present.
Cockcroft Protocol
A method of delivering methacholine to the airway where only a nebulizer is used; normal relaxed
breathing is used as the patient inhales aerosol. It is operated while continuously calibrated to an output
of 0.13 mL/min ±10%. The protocol is based on the “Two-minute tidal breathing dosing protocol”
recommended by the American Thoracic Society and detailed in the 1999 publication “Guideline for
Methacholine and Exercise Challenge Testing”.
Drift
Refers to a parameter that changes slowly. In electronics, to vary or deviate from a set adjustment;
variation in the output of an instrument. When verifying calibration of the system, the current and
previous results are compared. The difference between the measurements is termed drift.

PN 762017.B 155
Dsg
Dose
Du
Breath Units
ERV(L)
Expiratory reserve volume expressed in liters.
Exp time (s)

The amount of time reported in seconds an expiratory blow was recorded.
FEFmax
See PEFR
FEF-25%
Forced Expiratory Flow at a point in time at which 25% of the FVC has been expired, expressed in liters
per second.
FEF-50%
per second.
FEF-75%
per second.
FEF 25-75%
The averaged expiratory flow rate between 25% and 75% of the FVC, expressed in liters per second.
Also known as MMEF (Mid-Maximal Expiratory Flow), MEF (Mid-Expiratory Flow) or Midflow. The FEF
25-75% is considered an indication of early onset small airways obstruction.
FEF 75-85%
The averaged expiratory flow rate between 75% and 85% of the FVC, expressed in liters per second.
FEF .2-1.2(L/s)
The averaged Forced Expiratory Flow between .2 and 1.2 liters of the FVC, expressed as liters per
second.
FEVT
The forced expiratory volume expired over a given time interval (T) from the beginning of the FVC
maneuver.
FEV.5(L)
The volume of air exhaled in the first half second of a forced expiration from a position of full inspiration (L
at BTPS). Useful with Pediatric patients.
FEV.75(L)
The volume of air exhaled in the first ¾ of a second of forced expiration from a position of full inspiration
(L at BTPS). In pediatric patients, if the effort length is less than 0.75 seconds, FEV.75 is reported as the
total accumulated volume.
FEV1(L)
The volume of air exhaled in the first second of a forced expiration from a position of full inspiration (L at
BTPS). Used for determining severity of Pulmonary disease.
PN 762017.B 155
FEV3(L)
The volume of air exhaled in the first three seconds of a forced expiration from a position of full inspiration
(L at BTPS).
FEV6(L)
The volume of air exhaled in the first six seconds of a forced expiration from a position of full inspiration (L
at BTPS).
FEV75%
The ratio of FEV.75 to FVC expressed as a percentage, where .75 is the interval from the start of the FVC.
FEV-1/FVC %
The ratio of FEV-1 to FVC, expressed as a percentage.
FIF 25%(L/s)
Forced Inspiratory Flow at 25% of the FIVC, expressed as liters per second.
FIF 50%(L/s)
FIF 75%(L/s)
FIF25-75%(L/s)
The averaged inspiratory flow ratebetween 25% and 75% of the FIVC, expressed in liters per second.
FIF.2-1.2(L/s)
Forced Inspiratory Flow between 200ml and 1200ml, expressed in liters per second.
FIF50/FEF 50 %
The ratio, expressed as a percentage of FIF 50% to FEF 50%, useful in determining the location of a
large airway obstruction.
FIVC(L)
Forced Inspiratory Vital Capacity-volume calculated following completion of the Inspiratory portion of the
flow volume loop.
FIV.5(L)
The volume of air inhaled in the first half second of a full inspiration from a position of full expiration(L at
BTPS).
FIV1(L)
The volume of air inhaled in the first second of a full inspiration from a position of full expiration (L at
BTPS).
FIV3(L)
The volume of air inhaled in the first three seconds of a full inspiration from a position of full expiration (L
at BTPS).
FIVC/FVC %
The ratio of FIVC to FVC, expressed as a percentage.
Five-breath dosimeter method

Variations on this protocol exist in the clinical domain. The KoKo Sx “Rosenthal Protocol” follows the

PN 762017.B 155
“Guidelines for Methacholine and Exercise Challenge Testing – 1999” for the 5-breath dosimeter method,
published by the American Thoracic Society. It is a quantitative challenge test activated during inspiration
to deliver a consistent volume of drug, either automatically (by flow sensor) or manually for an optimum
output of 0.009ml for each 0.6-second actuation of the dosimeter.
FRC(L)
Functional residual capacity expressed in liters.
FVC(L)
Forced Vital Capacity – the maximal volume of air exhaled in a forced expiratory maneuver from a
position of maximal inspiration.
IC(L)
Inspiratory capacity expressed in liters.
Insp Time (s)

The amount of time reported in seconds an inspiratory effort was recorded.
Linearity
The ability to produce a proportional output for a given input across a fixed range.
MET(s)
Mid-expiratory time is the time elapsed between the 25% of FVC point and the 75% of FVC point.
MIT(s)
Mid-inspiratory time is the time elapsed between the 25% of FIVC point and the 75% of the FIVC point.
MVV(L)
Maximum Voluntary Ventilation – expressed in liters per minute. The volume of air inspired and expired
over a 12 to 15 second period, extrapolated to one minute.
Nulling
Nulling is the process of obtaining a baseline reading for zero-flow conditions. This reading is used as a
comparison to measured actual flows during testing; therefore an accurate null reading is important.
Patient Demographics
Information about a patient which includes height, age, sex, race, etc. Required for calculation of the
predicted values.
PC20
Provocative concentration causing a 20% fall in FEV1
PD20
Provocative dose causing a 20% fall in FEV1
PEFR(L/s) and PEFR(L/m)

Peak Expiratory Flow Rate – the highest flow measured during the forced expiratory maneuver.
PIFR (L/s)
Peak Inspiratory Flow Rate – the highest flow measured during a full inspiratory maneuver.
Predicted Set
Reference values for pulmonary function tests derived by statistical analysis of a population of healthy
subjects. Choice of spirometric reference values should be derived from a population similar to the
individual subject using the same kind of instrument and testing procedure. In the USA, ethnically

PN 762017.B 155
appropriate National Health and Nutrition Examination Survey (NHANES) III reference equations are
recommended for those age 8-80 yrs. For children aged <8 yrs, the equations of Wang, et al are
recommended. Predicted equations are available upon request. A list of the available predicted sets are
listed:
Crapo 1981 – Forced expiratory volumes and flows measured in 251 healthy nonsmoking men
and women using techniques and equipment that meet ATS recommendations. Note: Predicted
values for FVC and FEV1 were almost identical to predicted by Morris JF 1971. Morris study was
performed at sea level in rural subjects, whereas Crapo performed at an altitude of 1,400m (4593
ft) in urban subjects. Equations for Crapo are for age ≥ 18 years.
Polgar – Regression equation for pediatric and adolescent subjects generated using a set of
predicted values for age, height and sex using published prediction equations. Available for age
<18 years.
ITS (Intermountain Thoracic Society) 1984 – Predicteds available for age 6 – 78 years of age,
extrapolated for those < 6 years of age and > 78 years of age. Precludes African-American and
Mexican American equations.
Knudson 1976 – 746 symptom free white adults from Tucson, Az. Predicted equations available
for males <25 years of age and ≥ 25 years of age, and for females < 20 years of age and ≥ 20
years of age.
Knudson 1983 - 697 nonsmoking healthy subjects’ representative of the white non-Mexican-
American population of Tucson, Az. Expanded predicted equations for additional parameters.
ECCS (European Community for Coal and Steel)1983 and 1993 – Equations apply to
Caucasian men and women of European descent, aged 18-70 yrs. Derived from studies carried
out on subjects who were nonsmokers without disease. Reference values for the appropriate
ethnic group can be consulted or a correction factor can be applied to the corresponding
reference value for white people. Extrapolated for those > 70 years of age.
Hankinson (NHANES III) – Spirometric reference values for Caucasians, African-Americans, and
Mexican Americans 8 to 80 years of age from 81 counties across the United States. Developed
from 7,429 asymptomatic, lifelong nonsmoking participants in the third National Health and
Nutrition Examination Survey (NHANES III). Extrapolated predicted available for those <8 and
>80.
Toronto 1991 – Toronto Hospital 1991 predicted equations age 5 to 99 years of age.
Extrapolated values available for age < 5 years.
Morris JF 1971 – A sample of 988 healthy nonsmoking men and women age 20 to 84 years of
age from the Mormon and Seventh-Day Adventist church from western Oregon. Men and women
6 to 78 of age. Extrapolated predicted available for those< 6 and > 78 years of age.
Morris JF 1988 – 199 of the 988 original sample population from Morris JF 1971. Men and
women 6 to 78 years of age. Extrapolated predicted available for those < 6 and > 78 years.
Gore 1995(Australia) – Asymptomatic Caucasian adults in the Australian population. 1,302
(614 female and 621 male) subjects age 18-78 years from the metropolitan Adelaide, South
Australia. Sample data was reduced to 249 female and 165 male when only lifetime nonsmokers
with no adverse bronchial symptoms were selected. Extrapolated predicted values <18 years of
age and > 78 years of age.
Pereira 1996 (Brazil) – Predicted values available for age 6 to 78 year old males and age 6 to 76
year old females. Extrapolated values available for those < 6 years of age and >76.
Pereira 2008 (Brazil) – Predicted values available for age 6 to 86 years both male and female.
Extrapolated values available for those < 6 years of age and > age 86.
Thai 1996 – A normal group of 2299 women and 1655 men age 10 years and over from the
whole country of Thailand. Results reported FVC and FEV1 from this study to be close to the
Chinese but are 8-20 per cent lower than the Caucasians. Predicted equations available for
males age 10 to 87 and female age 10 to 92. Extrapolated values available for some values.
Miller 1986 – Predicted equations were modelled for 396 normal non-obese adult lifetime
nonsmokers and continuing smokers. Subjects came from a random cross-section of the white
population of Michigan, a large industrial state. Predicted equations available for males age 18 to
85 years and females age 18 to 82 years. Utilizes Polgar for age <18 years.
Eigen (pediatric) – 214 healthy children aged 3-6 yr for this study group. Of those, 114 where

PN 762017.B 155
boys and 100 where girls of which 184 white, 14 black, 7 Asian, and 9 other living in the
Indianapolis, IN area. Predicted equations available for males and females age 3 to 6 years of
age. Extrapolated values available for those less than 3 years of age.
Viljanen/KLNW– Finnish reference values and equations for male and female age 4 to 98 years
of age.
Hedenstrom/Solymar – Swedish reference values; Hedenstrom for adults included 146 smokers
and 124 never-smokers. and Solymar for children included 218 healthy children aged 2 to 18
years studied using a modification of the forced oscillation technique.
Gulsvik – A group of 488 subjects between the age of 18-73 from south-western coastal Norway.
Forche – Austrian patient population 1986 ages 5 to 90 years
SEPAR – (Spanish Society of Pneumology and Thoracic Surgery)Wang 1993 – 11,630 white
children and 989 black children aged 6-18. Includes race, sex and age-specific regression
equations based on height are provided, which permit the evaluation of growth during
adolescence with improved accuracy, and, more importantly, in comparison with previous
observations for the same child. Equations available for male and female age 6 to age 70 years.
Hibbert (pediatric) – A cohort of 543 healthy Caucasian children and adolescents ages 8 to 19
years from 62 government and private schools in the Melbourne, Australia, metropolitan region.
Predicted equations available for age 8 to 19 years.
Shands (mixed) – hospital system reference set; no publication. Predicted equations available
for all ages.
Wang (Peds) – The sample cohort included 12,305 white children, 1,074 black children, and 358
of other racial groups. The analysis was limited to non-smoking and nonasthmatic white and
black children resulting in 11,630 white children from Watertown, MA, Kingston and Harriman, TN,
Steubenville and Mingo Junction, OH, St. Louis, MO, Portage, Pardeeville, Rio and Wyocena, WI,
and Topeka, KS and 989 black children from Steubenville, OH and Topeka, KS. Measurements
include FVC, FEV1, FEF25-75% and FEV1/FVC. Predicted equations available for male and
female age 6 to age 18 years.
Gutierrez 2004 (Canada) – Canadian Caucasian reference set of 327 women and 300 men.
Obtained through a multicenter, cross-sectional study in six centers across Canada to establish a
national standard for pulmonary function tests using healthy, lifetime nonsmokers, with each
center aiming to test 10 men and 10 women from each decade from 20 to 80 years of age.
Predicted equations available for all ages.
Hsu 1979 – A study was undertaken to establish the normal values of peak expiratory flow rate
using the Wright peak flow meter. Testing of 1,805 healthy students 7 to 20 years of age in the
Houston public schools. Significant differences were noted among the three races and between
boys and girls. Predicted equations and regression lines were developed from this study.
Predicted equations available for age ≤20 with extrapolation for children less than 7 years of age.
Quanjer GLI – Over 160,000 data points from 72 centers in 33 countries resulted in 97,759
records from healthy nonsmokers (55.3% female) age 2.5-95 years. Reference equations were
derived from healthy individuals aged 3-95 years for Caucasians (57,395), African-Americans
(3,545), and North (4,992) and South East Asians (8,255).
Reference Effort
The effort with the all-time best FVC+FEV1 (by default) for each patient. This is automatically saved as
the “FVC reference effort” and can come from historical FVC tests. It is available for display during
testing and in reports. The automatic selection of the FVC reference effort may be manually overwritten.
Relinearization
The process of determining the non-linear flow characteristics of the pneumotach, then applying the
changes to raw flow data to obtain an actual flow.
Rosenthal Protocol
Historical reference for the five-breath dosimeterprotocol. Variations on this protocol exist in the clinical
domain. The KoKo Sx “Rosenthal Protocol” follows the “Guidelines for Methacholine and Exercise
Challenge Testing – 1999, published by the American Thoracic Society. It is a quantitative challenge test

PN 762017.B 155
activated during inspiration to deliver a consistent volume of drug, either automatically (by flow sensor) or
manually for an optimum output of 0.009ml for each 0.6-second actuation of the dosimeter.
RR (b/m)
Respiratory rate expressed in breaths per minute.
RV(L)
Residual Volume – The amount of air remaining in the lungs after a maximal slow exhalation.
SR (Standardized Residual)
This is the ration of the difference betweenthe observed count and the expected count to the standard
deviation of the expected count. SR= observed count – expected count/√expected count.
SVC(L)
Slow Vital Capacity – The maximal amount of air that can be exhaled or inhaled in one slow maneuver.
TLC(L)
Total Lung Capacity – the amount of air in the lungs after a maximal inhalation.
Tpeak(ms)
The time of the peak flow expressed in milliseconds measured from the start of expiration.
Two minute tidal breathing method

A method of delivering methacholine to the airway where only a nebulizer is used; normal relaxed
breathing is used as the patient inhales aerosol. It is operated while continuously calibrated to an output
of 0.13 mL/min ±10%. The protocol is based on the “Two-minute tidal breathing dosing protocol”
recommended by the American Thoracic Society and detailed in the 1999 publication “Guideline for
Methacholine and Exercise Challenge Testing.” The 2-minute tidal breathing method is labeled “Cockroft”
in the KoKo software.
Veot(L)
Volume accumulated at the end of the effort. If the volume at the end of a test exceeds 25mL in the last
two seconds, you will see a warning for Veot. An inspiratory phase is required for the Veot calculation.
Vext(%)
The extrapolated volume as a percent of FVC. You will see a warning if Vext% exceeds 5%.
Vext(L)
The extrapolated volume as a percent of FVC. You will see a warning if Vext(L) exceeds 0.150L.
(Z-Score)
Describes how many standard deviations above or below a size or age specific population mean a given
measurement lies. It is a way to compare results from a test to a “normal” population.
where x is the observed measurement, μ is the expected measurement, and σ is the standard deviation of
the population.

PN 762017.B 155
16 REFERENCES
1. Aldas JS, et al. Espirometria forzada. J. Roca Torrent 1985

2. American Thoracic Society: Guidelines for Methacholine and Exercise Challenge Testing – 1999. Am.
J. Respir. Crit. Care Med. Vol. 161 2000. pp 309-329.
3. American Thoracic Society. “Lung Function Testing: Selection of Reference Values and Interpretative
Strategies” Am Rev Respir Dis 1991; 144:1202-1218.
4. Bass, Harry-. The Flow Volume Loop: Normal Standards. Chest. 1973;63:171.
5. Bates, D., et al. Respiratory Function and Disease (Second Edition). 1971 W.B. Saunders,
Philadelphia.
6. Boren, H., et al. The Veterans Administration-Army Cooperative Study of Pulmonary Function.
American Journal of Medicine 1966;41:96-113.
7. Bucci, G., et al. Studies of Respiratory Physiology in Children. Pediatrics. 1961;58:820.
8. Bull. Standardization of Lung Function Tests. Europ. Physiopath Resp. 1983;19 Suppl. 5.
9. Burrows, B. et al. Clinical Usefulness of the Single-Breath Pulmonary Diffusing Capacity Test. The
American Review of Respiratory Diseases 1961;84:789-806.
10. Cherniack, R. and Raber, M. Normal Standards for Ventilatory Function Using an Automated Wedge
Spirometer. American Review of Respiratory Disease 1972;106:38-46.
11. Cockcroft DW, et al.. Bronchial reactivity to inhaled histamine: a method and clinical survey. Clin
Allergy. 1977;7(3):235-243.
12. Cockcroft, DW. Direct Challenge Tests Airway Hyperresponsiveness in Asthma: Its Measurement
and Clinical Significance. Chest 2010; 138(2)(Suppl):18S-24S
13. Cole, M. The Hospital for Sick Children, Toronto, Ontario, Canada. Hospital Clinical Guidelines 1991;
3:12-18.
14. Crapo RO et al. Reference spirometric values using techniques and equipment that meet ATS
recommendations. Am Rev Respir Dis. 1981 Jun; 123(6):659-64.
15. Crapo, R., et al. Lung Volumes in Healthy Nonsmoking Adults, Clinical Respiratory Physiology
1982;18:419-25.
16. Crapo, R., and Morris, A. Standardized Single Breath Normal Values for Carbon Monoxide Diffusing
Capacity. American Review of Respiratory Disease 1981;123:185-89.
17. Dejsomritrutai W, et al. Reference spirometric values for healthy lifetime nonsmokers in Thailand. J
Med Assoc Thai 2000 May;83(5):457-66.
18. DeMuth, G, et al. Forced Flow Rates. Pediatrics. 1965;35:200.
19. Dickman, M. et al. 1971. Spirometric Standards for Normal Children and Adolescents. American
Review of Respiratory Disease 1971; 104:680-87.
20. Duarte AA, et al. Validation of new Brazilian predicted values for forced spirometry in Caucasians
and comparison with predicted values obtained using other reference equations. J Bras Pneumol.
2007;33(5):527-535.

PN 762017.B 155
21. Eigen H., et al. Spirometric Pulmonary Function in Healthy Preschool Children. Am J Respir Crit
Care Med. Vol 163. Pp 619-623.
22. Gaensler, E., and Wright, A. Evaluation of Respiratory Impairment. Archives of Environmental Health.
1966;12:146-189.
23. Goldman, H. and Becklake, M. Normal Values at Median Altitudes and the Prediction of Normal
Results. American Review of Tuberculosis and Pulmonary Disease 1959;79:457-67.
24. Gore CJ, et al. Spirometric standards for healthy adult lifetime nonsmokers in Australia. Eur. Respir J.
1995: 8: 773-782.
25. Grimby, G. and Soderholm, B. Spirometric Studies in Normal Subjects. Acta Medica Scandinavica
1963;173:199-206.
26. Gulsvik A, et al. Spirometric Standards in Norway. 2001 Clinical Physiology 22, 1-13.
27. Gutierrez C et al, Reference Values of Pulmonary Function Tests for Canadian Caucasians. Can
Respir J 2004; 11(6):414-424.
28. Hankinson JL, et al. Spirometric Reference Values from a Sample of the General US Population.
Am J Respir Crit Care Med 1999;159:179-187.
29. Hedenstrom H, et al. Reference values for lung function tests in men: regression equations with
smoking variables. Ups J Med Sci. 1986;91(3):299-310. Hibbert ME, et al. Lung function values from a
longitudinal study of healthy children and adolescents. Pediatric Pulmonology 7:101-109(1989)
30. Hsu, K. et al. Ventilatory Functions of Normal Children and Young Adults - Mexican, American White
and Black. Journal of Pediatrics. 1979;95:14,192.
31. Knudson, R. et al. The Single-Breath Carbon Monoxide Diffusing Capacity. American Review of
Respiratory Disease. 1987;135:805-811.
32. Knudson RJ, et al. The maximal expiratory flow-volume curve. Normal standards, variability, and
effects of age. Am Rev Respir Dis. 1976 May; 113(5):587-600.
33. Knudson RJ, et al. Changes in the normal maximal expiratory flow-volume curve with growth and
aging. Am Rev Respir Dis. 1983 Jun; 127(6):725-34.
34. Kory, R., et al. The Veterans Administration-Army Cooperative Study of Pulmonary Function, I,
Clinical Spirometry in Normal Men. American Journal of Medicine. 1961;30:243-58.
35. Leuallen, E. and Fowler, W. Maximum Mid-expiratory Flow. American Review of Tuberculosis.
1955;72:783-800.
36. Lindal, A., et al. A Re-evaluation of Normal Pulmonary Function Measurements in the Adult Female,
American Review of Respiratory Disease 1967;95:1061-64.
37. Miller, W., et al. Relationships Between Fast Vital Capacity and Various Timed Expiratory Capacities.
Journal of Applied Physiology 1959;14:157-63.
38. Miller MR, et al. Series “ATS/ERS Task Force: Standardization of Lung Function Testing”; General
considerations for Lung Volume testing. Eur Respir J. 2005; 26: 153-161
39. Miller MR, et al. Series “ATS/ERS Task Force: Standardization of Lung Function Testing”;
Standardization of spirometry. Eur Respir J. 2005; 26: 319-338
40. Miller, A., et al. Single Breath Diffusing Capacity in a Representative Sample of the Population of
Michigan, a Large Industrial State. American Review of Respiratory Disease. 1983;127:270-277.

PN 762017.B 155
41. Miller A, et al. Mean and instantaneous expiratory flows, FVC and FEV1:prediction equations from a
probability sample of Michigan, a large industrial state. Bull Eur Physiopathol Respir. 1986 Nov-
Dec;22(6):589-97.
42. Morris JF, et al. Spirometric standards for healthy nonsmoking adults. Am Rev Respir Dis 1971: 103:
57 - 67.
43. Morris JF, et al. Fifteen-year Interval Spirometric Evaluation of the Oregon Predictive Equations.
Chest 1988; 92(1):123-27.
44. Pellegrino R, et al. Series “ATS/ERS Task Force: Standardization of Lung Function Testing”;
Interpretative strategies for lung function tests. Eur Respir J. 2005; 26: 948-968.
45. Pereira, CA, et al. New reference values for forced spirometry in white adults in Brazil. J Bras
Pneumol. 2007;33(4):397-406.
46. Pereira, C.A. I Consenso Brasileiro sobre Espirometria. Jornal de Pneumologia
May/June 1996 Vol. 22 No.3: 130-136.
47. Polgar G, et al. Pulmonary function testing in children: techniques and standards. Philadelphia,
Saunders, 1971.
48. Quanjer PhH et al. Lung Volumes and Forced Ventilatory Flows: Report Working Party
Standardization of Lung Function tests European Community for Steel and Coal. Eur Respir J 1993, 6,
Suppl. 16, 5-40.
49. Quanjer, PhH, et al. The ERS Global Lung Function Initiative. Multi-ethnic reference values for
spirometry for the 3-95-yr age range ; the global lung function 2012 equations. European Respiratory
Journal. Dec. 1, 2012 Vol. 40. No. 6 p.1324-1343.
50. Schmidt, C. et al, Spirometric Standards for Healthy Men and Women. American Review of
Respiratory Disease. 1973; 108:933-39.
51. Solymar L, et al. Respiratory resistance and impedance magnitude in healthy children aged 2-18
years. Pediatr Pulmonol. 1985 May-Jun;1(3):134-40.
52. Van Ganse, Wet al. Cigarette Smoking and Pulmonary Diffusing Capacity (Transfer Factor).
American Review of Respiratory Disease 1972;105:30-41
53. Viljanen AA, et al. Spirometric studies in non-smoking, healthy adults. Scand J Clin Lab Invest
Suppl. 1982;159:5-20.
54. Wang X, et al. Pulmonary function between 6 and 18 years of age. Pediatric Pulmonology 15:75-
88(1993).
55. Wanger, J., et al. Series “ATS/ERS Task Force: Standardization of Lung Function Testing”;
Standardization of the measurement of Lung Volumes. Eur Respir J. 2005; 26: 511-522.
56. Zapletal, A., et al. Maximum Expiratory Flow-Volume Curves and Airway Conductance in Children
and Adolescents. Journal of Applied Physiology 1969;26:308-16.
57. Web page for ATS Pulmonary Function Testing Articles:
http://www.thoracic.org/statements/pulmonary-function.php

PN 762017.B 155
16.1 PREDICTED EQUATIONS
This section explains the normal (predicted) equation sets used by the system.
The following abbreviations are used:
A is age in years
H is height in centimeters
Hin is height in inches
Hm is height in meters
W is weight in kilograms
Wlb is weight in pounds
BSA is body surface area in square meters:
BSA=(W^.425)*(H^.725)*71.84/(10^4)
Any time a predicted value cannot be calculated due to height or age outside of the range
specified by the source document for the selected equation set, the predicted value will be shown as "***"
instead of the usual "---".
The * symbol means "times".
The ^ symbol means "exponent".
16.1.1 Access Equations

From the main toolbar:
1. Click on the “Help” button .

2. From the “Contents” menu, select “Reference”.
3. Click on the “Normal equations” selection.
A list of all available equations will display. To view an equation set, left click on the desired equation.
16.1.2 Access Sample Values

From the main toolbar:
1. Click on the “Help” button .

2. From the “Contents” menu, select “Reference”.
3. Click on the “Sample values” selection.
A list of all available equations with sample values will display. To view an equations sample values, left
click on the desired equation.

PN 762017.B 155
16.2 ELECTROMAGNETIC COMPATIBILITY
Although this equipment conforms to the intent of the 2004/108/EC EMC Directive, all medical equipment
may produce electromagnetic interference or be susceptible to electromagnetic interference.The following
are guidance and manufacturer’s declarations regarding EMC for the nSpire Koko SX 1000.
 The nSpire Koko SX 1000 needs special precautions regarding EMC and needs to be installed
and put into service according to the EMC information provided in the following pages.
 Warning: This equipment is intended for use by healthcare professionals only. As with all
electrical medical equipment, this equipment may cause radio interference or may disrupt the
operation of nearby equipment. It may be necessary to take mitigation measures such as re-
orienting or relocating the nSpire Koko SX 1000 unit or shielding the location.
 Portable and Mobile RF communications equipment can affect the performance of the nSpire
Koko SX 1000. Please use the guidelines and recommendations specified in Tables 6-01 and 6-
02.
 Other Medical Equipment or Systems can produce electromagnetic emissions and therefore can
interfere with the functionality of the nSpire Koko SX 1000. Care should be used when operating
the nSpire Koko SX 1000 adjacent to or stacked with other equipment. If adjacent or stacked use
is necessary, the nSpire Koko SX 1000 should initially be observed to verify normal operation in
the configuration in which it will be used.
 The electrical cables, external power supplies and accessories listed or referenced in this manual
have been shown to comply with the test requirements listed in the following tables. Care should
be taken to use only manufacturer-recommended cables, power supplies and electrical
accessories with the nSpire Koko SX 1000. If a third-party supplier offers cables, external power
supplies and electrical accessories for use with the nSpire Koko SX 1000 and they are not listed
or referenced in this manual, it is the responsibility of that third-party supplier to determine
compliance with the standards and tests in the following tables.
 The use of electrical cables and accessories other than those specified in this manual or
referenced documents may result in increased electromagnetic emissions from the nSpire Koko
SX 1000 or decreased electromagnetic immunity of the nSpire Koko SX 1000.

PN 762017.B 155
Table 6-01
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

The nSpire Koko SX1000 is intended for use in the electromagnetic environment specified below. The
customer or the end user of the nSpire Koko SX1000 should assure that it is used in such an
environment.
Emissions test Compliance Electromagnetic environment - guidance

The nSpire Koko SX 1000uses RF energy only for its
RF Emissions - CISPR 11 internal function. Therefore, its RF emissions are very
Group 1
(Radiated & Conducted) low and are not likely to cause any interference in
nearby electronic equipment.
RF Emissions - CISPR 11
Class A
(Radiated & Conducted)
The nSpire Koko SX 1000is suitable for usein all
Harmonic Emissions Not establishments other than domestic and thosedirectly
Applicable connected to the public low-voltage powersupply
EN/IEC 61000-3-2
network that supplies buildings used for domestic
Voltage fluctuations/ purposes.
Flicker Emissions Not
Applicable
EN/IEC 61000-3-3
Table 6-02
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The nSpire Koko SX 1000is intended for use in the electromagnetic environment specified below. The
customer or the end user of the nSpire Koko SX 1000unit should assure it is used only in such an
environment.
EN/IEC 60601 Intended Electromagnetic

Immunity Test Compliance Level
Test Level Environment
Electromagnetic ± 6kV contact ± 6kV contact Floors should be wood, concrete
Discharge (ESD) or ceramic tile. If floors are
covered with synthetic material,
± 8kV air ± 8kV air the relative humidity should be at
EN/IEC 61000-4-2 least 30%.
Electrical fast ± 2kV for power ± 2kV for power

transient/burst supply lines supply lines Mains power quality should be
that of a typical commercial or
hospital environment.
EN/IEC 61000-4-4 ± 1kV for input/output ± 1kV for input/output

PN 762017.B 155
lines lines
Surge ± 1kV differential

mode (line-line) Mains power quality should be
Not Applicable that of a typical commercial or
± 2kV common mode hospital environment.
EN/IEC 61000-4-5 (line-earth)
Voltage dips, short <5% UT (>95% dip in

interruptions and UT) for 0.5 cycle
voltage variations
on power supply Mains power quality should be
input lines that of a typical commercial or
40% UT (60% dip in hospital environment. If the user
UT) for 5 cycles of the nSpire KoKo SX 1000
requires continued operation
EN/IEC 61000-4- Not Applicable
during power mains interruptions,
11 70% UT (30% dip in it is recommended that the nSpire
UT) for 25 cycles KoKo SX 1000 be powered from
an uninterruptible power supply or
a battery.
<5% UT (>95% dip in
UT) for 5 seconds
Power frequency
(50/60Hz) Power frequency magnetic fields
magnetic field should be at levels characteristic
3A/m 3A/m of a typical location in a typical
commercial or hospital
environment.
EN/IEC 61000-4-8
Note: UT is the a.c. mains voltage prior to application of the test level.

PN 762017.B 155
Table 6-03
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The nSpire KoKo SX 1000is intended for use in the electromagnetic environment specified below. The
customer or the end user of the nSpire KoKo SX 1000 unit should assure it is used in such an
environment.
EN/IEC 60601 Compliance

Immunity Test Intended Electromagnetic Environment
Test Level Level
Portable and mobile RF communications
equipment should be used no closer to any
part of the nSpire KoKo SX 1000, including
cables, than the recommended separation
distance calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance

d = 1.2√P
Conducted RF 3Vrms 3Vrms
d = 1.2√P 80MHz to 800 MHz
EN/IEC 61000- 150kHz to 150kHz to
4-6 80MHz 80MHz d = 2.3√P 800MHz to 2.5GHz
where P is the maximum output power

rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended minimum
separation distance in meters (m).
Radiated RF 3V/m 3V/m
Field strengths from fixed RF transmitters,
EN/IEC 61000- 80MHz to 80MHz to as determined by an electromagnetic site
4-3 2.5GHz 2.5GHz surveya, should be less than the compliance
level in each frequency range.b
Interference may occur in the vicinity of

equipment marked with the following
symbol:
NOTE 1: At 80MHz and 800MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from objects, structures and people.

PN 762017.B 155
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in
the location in which the nSpire KoKo SX 1000 is used exceeds the applicable RF compliance level
above, the nSpire KoKo SX 1000 should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or relocating
the nSpire KoKo SX 1000.
b Over the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m.
Table 6-04
Recommended separation distances between portable and mobile RF communications equipment and
the nSpire KoKo SX 1000.
The nSpire KoKo SX 1000 unit is intended for use in an electromagnetic environment in which radiated
RF disturbances are controlled. The customer or the user of the nSpire KoKo SX 1000 can help prevent
electromagnetic interference by maintaining a minimum distance between the portable and mobile RF
communications equipment (transmitters) and the nSpire KoKo SX 1000 as recommended below,
according to the maximum output power of the communications equipment.
Rated maximum output Separation distance according to frequency of transmitter in meters (m)
power of transmitter in
watts (W) 150kHz to 80MHz 80MHz to 800MHz 800MHz to 2.5GHz
d = 1.2√P d = 1.2√P d = 2.3√P
0.01 .12 .12 .23
0.1 .38 .38 .73
1.0 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

PN 762017.B 155
16.3 SHORTCUT MENU
Control Key and F-Key selections provide shortcut access to KoKo Sx functions for advanced users.
Control Key functions are available at all times. To activate the F-Key functions, from the “System” menu
select “Preferences” and check “F-key menu accelerators”
16.3.1 CONTROL KEY MENU
16.3.1.1 Main window shortcuts:

Ctrl Key Combination Command F-Key Equivalent
Ctrl+T Select Patient and test series menu F2
Alt+F4 Exit Software
Ctrl+F Open FVC Test window F3
Ctrl+V Open SVC Test window F11
Ctrl+M Open MVV Test window F12
Ctrl+C Open Challenge Test window -
Ctrl+R Open Reports (Read/Interpret/Print) -
Open the Print multiple Test Series

Ctrl+P -
menu
Ctrl+D Open Report Design menu -
Ctrl+A Open Calibration menu -
Ctrl+L Open Calibration log -

PN 762017.B 155
16.3.1.2 Testing window shortcuts:
Ctrl+T Open Select patient and test

F2
series menu
Ctrl+S Saves current efforts F5
Ctrl+P Opens Reports
F6
(Read/interpret/print results)
Alt+F4 Exits Testing Window F9
Ctrl+E Starts an effort in selected test

F4
window
Ctrl+F Switches to FVC Test Window
F3
from other test windows
Ctrl+V Switches to SVC Test Windows
F11
Ctrl+M Switches to MVV Test Window
F12
Ctrl+G In the Challenge Test window,

Opens the Go to Next stage
-
dialog with the default next stage
for the protocol pre-selected
Ctrl+W Opens a summary page of
Challenge efforts performed -
(Challenge Test worksheet)
Ctrl+B Toggles select effort to Best effort

-
position
Del Deletes selected effort after
-
confirmation
Ctrl+R Switches test mode:

Pre to Post or Post to Pre F7
Ctrl+O Opens temperature, barometric

pressure and humidity settings -
(Pneumotach Environment)
Ctrl+N Opens Test Information dialog F8

PN 762017.B 155
16.3.1.3 Report Window shortcuts
(File:)
Ctrl+T Opens the Select patient and test
-
series dialog
Ctrl+D Opens the dialog for selecting
-
reports (Select design)
Ctrl+I Opens the Spirometry
-
Interpretation dialog
Ctrl+R Mark as reviewed -
Ctrl+P Opens the Print menu F6
Ctrl+E Reduces the size of the report

-
page
Ctrl+A Returnes the report page to
-
original viewing size
16.3.1.4 Report Design window shortcuts
Ctrl Key Combination Command

(File:)
Ctrl+O Lauches Open Report Design dialog
Ctrl+S Saves changes made to the current report design
Ctrl+X Cuts selected item

Ctrl+C Copies selected item
Ctrl+V Pastes selected item
Del Deletes selected item
Ctrl+L Selects entire report
Ctrl+F Bring to front
Ctrl - Move backward
Ctrl+M Turns of drawing tool

Ctrl+D Initiates line Drawing tool
(View:)
Ctrl+W Shows full page of report design
Ctrl+E Reduces report design size
Ctrl+A Returns report design to original size
Ctrl+Z Opens magnifier;select area to be magnified
PgDn Next page
PgUp Previous page
Ctrl+P Opens a dialog for adding features to the report

design (Pt/Series/Protocol info)
Ctrl+G Opens the dialog for adding graphical features

PN 762017.B 155
16.4 REPORT ITEM: “PATIENT/TEST SERIES/PROTOCOL INFO” OPTIONS
16.4.1 General
Select item:
Facility location Facility Name
Report printed Software version
Format
Show item name Report item will have a heading before the
measured or entered value.
16.4.2 Patient-related
Select item
Address Ethnic predicted correction (%) Randomization
Age Group Referring physician
Birthdate Height (cm) Sex
City Height (in) Smoking history (pk-yrs)
Comments ID State/Province
Country Name Weight (kg)
Diagnosis Occupation Weight (Lb)
Ethnic-correction predicted Predicted set Zip/Postal code
Ethnic group Predicted value extrapolation
allowed
Format
Show item name Report item will have a heading before the measured or entered
value.

PN 762017.B 155
16.4.3 Test series-related
Select item:
Age at test FEF25-75/SVC (post-Rx) Nebulizer output (ml/min)
Area under curve FEF25-75/SVC (Pre-Rx) Order #
Best post-Rx FEV1, effort FEV1/SVC (Post-Rx) PC-20 (mg)
sequence
Best post-Rx FVC, effort FEV1/SVC (Pre-Rx) PC-20 (mg/ml)
sequence
Best pre-Rx FEV1, effort Final interpretation PD-20 (du)
sequence
Best pre-Rx FVC, effort Height at test (cm) PD-20 (mg)
sequence
Challenge protocol Height at test (in) Reference stage
Decision point 1(%) Interpretation Reference test series mark
Decision point 2(%) Interpretation predicted set Shift
Dosimeter inhalation onset (L) Interpreted by Stage of maximum change in
FEV1
Dosimeter inhalation rate (L/s) Iris test series ID Status
Dosimeter inhalation time (s) Load type SVC/FVC
Estimated Lung Age Maximum post-exercise change Test series date/time
in FEV1(%)
Exercise level Medication #1 Time of maximum change in
FEV1 (minutes, post-exercise)
Exercise phase completion Medication #2 Weight at test (kg)
date/time
Exposure #1 Medication #3 Weight at test (lb)
Exposure #2 MVVest
Format
Show item name Report item will have a heading before the measured or entered
value.
Historic test series selection
Use FVC reference effort series Check box to display the visit that contains the FVC reference
effort, as a comparison for the reported data from the current visit.
Use Check box and select spirometry test series or challenge test series
and enter the number of visits “previous to current” to display the
value or graph from that defined visit.

PN 762017.B 155
16.4.4 FVC protocol-related
Select item:
Advisory code (best 3 Effort #2 variability
Effort #6 quality code Heart Rate
efforts) code
Effort #3 acceptability
Effort #6 reproducibility
Agent caution (ATS/ERF KoKoMate QC Code
code (ATS/ERF 2005)
2005)
ATS recommendations
Effort #3 consistency Effort #6 sequence Load
met
Effort #6 usability
Barometric pressure
Effort #3 date/time caution (ATS/ERS Medication status
(mm Hg)
2005)
Effort #3 FEV1 Effort #6 variability
Blood pressure Nose Clip
variation from best (%) code
Effort #3 FEV1 Number of effort
Comments caution (ATS/ERF
variation from best (L) performed
2005)
Cumulative dosage Effort #3 FVC variation
Effort #7 date/time Physician
(du) from best (%)
Cumulative dosage Effort #3 variation from Pneumotach calibration
Effort #7 quality code
(mg) best (L) date/time
Effort #7 reproducibility Pneumotach calibration
Dosage breaths Effort #3 quality code
code (ATS/ERF 2005) expected volume (L)
Dosage concentration Effort #3 reproducibility
Effort #7 sequence Pneumotach ID
(mg/ml) code (ATS/ERS 2005)
Effort #7 usability
Pneumotach ID
Dosage date/time Effort #3 sequence caution (ATS/ERS
(w/auth)
2005)
Effort #3 usability
Effort #7 variability Pneumotach part
Dosage duration (m) caution (ATS/ERS
code number
2005)
Effort #1 acceptability Effort #8 acceptability
Effort #3 variability Pneumotach serial
caution (ATS/ERS caution (ATS/ERF
code number
2005) 2005)
Effort #4 acceptability Pneumotach
Effort #1 date/time caution (ATS/ERF Effort #8 date/time temperature, calibration
2005) (deg C)
Pneumotach
Effort #1 quality code Effort #4 date/time Effort #8 quality code temperature, test (deg
C)
Pneumotach
Effort #1 reproducibility Effort #8 reproducibility
Effort #4 quality code verification actual
code (ATS/ERS 2005) code (ATS/ERF 2005)
volume (L)
Effort #4 reproducibility
Effort #1 sequence Effort #8 sequence Pneumotach verified by
code (ATS/ERF 2005)
Effort #1 usability Effort #8 usability
caution (ATS/ERS Effort #4 sequence caution (ATS/ERS Position
2005) 2005)
Effort #2 acceptability Effort #4 usability
Effort #8 variability Quality code (best 3
caution (ATS/ERF caution (ATS/ERS
code efforts)
2005) 2005)

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Effort #4 variability
Effort #2 consistency Effort protocol Relative humidity (%)
code
Room temperature
Effort #2 date/time caution (ATS/ERF Effort summary
(deg C)
2005)
FEV1 variation, highest
Effort #2 FEV1
Effort #5 date/time to 2nd-highest result Site
variation from best (%)
(%)
Effort #2 FEV1 FEV1 variation, highest
Effort #5 quality code Syringe serial number
variation from best (L) to 2nd-highest result (L)
FEV1 variation, highest
Effort #2 FVC variation Effort #5 reproducibility
to 3rd -highest result Technician
from best (%) code (ATS/ERF 2005)
(%)
Effort #2 FVC variation FEV1 variation, highest
Effort #5 sequence Test date/time
from best (L) to 3rd highest result (L)
Effort #5 usability FVC variation, highest
Effort #2 quality code caution (ATS/ERS to 2nd-highest result Test grade
2005) (%)
Effort #2 reproducibility Effort #5 variability FVC variation, highest Texp, from FVC best
code (ATS/ERF 2005) code to 2nd-highest result (L) result(s)
Effort #6 acceptability FVC variation, highest
Time, post-exercise
Effort #2 sequence caution (ATS/ERF to 3rd -highest result
(min)
2005) (%)
Effort #2 usability Variability code (best 3
FVC variation, highest
caution (ATS/ERS Effort #6 date/time efforts)
to 3rd highest result (L)
2005)
Format
Pre (only) Displays pre-bronchodilator efforts as selected
Post (only) Displays post-bronchodilator efforts as selected
Base, Saline, Stage (x), Displays the Challenge stage as defined
and Recovery
Pre vs. Post (Numeric Displays both the reported pre-bronchodilator, the reported post-
Results) bronchodilator efforts, and the percent change
Pre vs. Reference Displays the reported pre-bronchodilator effort and the FVC reference effort.
(Numeric Results)
Pre and Post (Graphs) Displays pre-bronchodilator efforts and post-bronchodilator efforts as
configured in the attributes menu
Base to Recovery Displays and overlays all challenge test stages (can choose to offset
(Graphs) overlays)
Use FVC reference Check box to display the visit that contains the FVC reference effort, as a
effort series comparison for the reported data from the current visit.
Use Check box and enter the number of visits “previous to current” to display the

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16.4.5 SVC protocol-related
Select item:
Agent Effort #2 acceptability caution Medication status
(ATS/ERS 2005)
ATS recommendations met Effort #2 date/time Number of efforts performed
Comments Effort #2 reproducibility code Physician
(ATS/ERS 2005)
Effort #1 acceptability caution Effort #3 date/time Position
(ATS/ERS 2005)
Effort #1 date/time Effort #3 reproducibility code Site
(ATS/ERS 2005)
Effort #1 reproducibility code Effort protocol Technician
(ATS/ERS 2005)
Effort #2 acceptability caution Effort summary Test date/time
(ATS/ERS 2005)
Format
effort, as a comparison for the reported data from the current visit.
Use Check box and enter the number of visits “previous to current” to
display the value or graph from that defined visit.
16.4.6 MVV protocol-related

Select item:
Agent Effort protocol Position
Comments Medication status Site
Effort #1 date/time Nose clip Technician
Effort #2 date/time Number of efforts performed Test date/time
Effort #3 date/time Physician
Format
effort, as a comparison for the reported data from the current
visit.
Use Check box and enter the number of visits “previous to current” to
display the value or graph from that defined visit.

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16.5 REPORT ITEM – NUMERIC RESULTS
16.5.1 Test Type FVC

Select item:
 FVC (L)  FEV75% (L)  Veot (L)  FIV3 (L)
 FEV.5 (L)  PEFR (L/s)  MET (s)  FIV3/FIVC
 FEV.5/FVC  PEFR (L/m)  Exp time (s)  PIFR (L/s)
 FEV.75 (L)  FEF25% (L/s)  Vext (%)  FIF25% (L/s)
 FEV1 (L)  FEF50% (L)  Vext (L)  FIF50% (L/s)
 FEV1/FVC  FEF75% (L/s)  Tpeak (ms)  FIF75% (L/s)
 FEV1/FEV6  FEF25-75% (L/s)  FIVC (L)  FIF25-75% (L/s)
 FEV3(L)  FEF75-85% (L/s)  FIV.5 (L)  FIF50/FEF50
 FEV3/FVC  FEF.2-1.2 (L/s)  FIV.5/FIVC  FIF.2-1.2 (L/s)
 FEV6 (L)  FEF25-75/FVC  FIV1 (L)  MIT(s)
 FEV6/FVC  FEF50/FIF50  FIV1/FIVC  Insp time (s)

Format
Base, Saline, Stage (x), Displays the Challenge stage as defined

and Recovery
Pre vs. Post (Numeric Displays both the reported pre-bronchodilator, the reported post-bronchodilator
Results) efforts, and the percent change
Pre vs. Reference Displays the reported pre-bronchodilator effort and the FVC reference effort.
(Numeric Results)
Effort(s)
Best effort Displays the reported (best) effort (Highest sum of FVC + FEV1 from
acceptable efforts)
Best 3 efforts Displays the three best efforts
All efforts (FVC only) Display all efforts performed, up to the preset maximum number. (Note that
selecting this option may cause numeric results to be wider than the page.)

PN 762017.B 155
Appearance
Show item name Report item will have a heading before the measured or entered value.
Compare to predicted Displays predicted (mean) value and percent of predicted mean for each effort
shown. If the predicted value is out of range (age or height not within the
ranges specified in the predicted set source document), three asterisks (***)
will be shown. If the predicted value has been manually adjusted for ethnic
group, the predicted value will be displayed with a leading asterisk (*).
Show LLN Displays the Lower Limit of Normal (LLN predicted value for the parameter)
one column after the mean predicted value. A "¤" character will be shown next
to the reported result when it is less than the LLN (see below).
Show CI Causes results that are above or below the confidence interval defined for that
result to be displayed with a leading "¤" character and shown in red (when
using predicteds with confidence interval information, as ITS 1984, or
Hankinson).
Show SR (Z-score) Standardized Residual (SR) displayed for each effort after the %Pred value.
Note: SR information is only available for the ECCS predicted equation set.
Flag if outside causes results that are above or below the confidence interval defined for that
confidence interval result to be displayed with a leading "¤" character and shown in red (when
using predicteds with confidence interval information, as ITS 1984, or
Hankinson).
Use composite effort Displays the created composite effort as the reported effort. Composite efforts
are marked on the report with two asterisks (**) appearing after the parameter
name.
Use FVC reference Check box to display the visit that contains the FVC reference effort, as a
effort series comparison for the reported data from the current visit.
Use Check box and enter the number of visits “previous to current” to display the
16.5.2 Test Type SVC
Select item:
SVC (L) TLC (L)
IC (L) RV/TLC
ERV (L) MV (L)
RV (L) Vt (L)
FRC (L) RR (b/m)
Format
Pre vs. Post (Numeric Results) Displays both the reported pre-bronchodilator, the
reported post-bronchodilator efforts, and the percent
change

PN 762017.B 155
Effort(s)
Best effort Displays the reported (best) effort (Highest sum of FVC
+ FEV1 from acceptable efforts)
All efforts (FVC only) Display all efforts performed, up to the preset maximum
number. (Note that selecting this option may cause
numeric results to be wider than the page.)
Appearance
Show item name Report item will have a heading before the measured or
entered value.
Compare to predicted Displays predicted (mean) value and percent of predicted
mean for each effort shown. If the predicted value is out
of range (age or height not within the ranges specified in
the predicted set source document), three asterisks (***)
will be shown. If the predicted value has been manually
adjusted for ethnic group, the predicted value will be
displayed with a leading asterisk (*).
Show LLN Displays the Lower Limit of Normal (LLN predicted value
for the parameter) one column after the mean predicted
value. A "¤" character will be shown next to the reported
result when it is less than the LLN (see below).
Show CI Causes results that are above or below the confidence
interval defined for that result to be displayed with a
leading "¤" character and shown in red (when using
predicteds with confidence interval information, as ITS
1984, or Hankinson).
Show SR (Z-score) Standardized Residual (SR) displayed for each effort
after the %Pred value. Note: SR information is only
available for the ECCS predicted equation set.
Flag if outside confidence interval causes results that are above or below the confidence
Use FVC reference effort series Check box to display the visit that contains the FVC
reference effort, as a comparison for the reported data
from the current visit.
Use Check box and enter the number of visits “previous to
current” to display the value or graph from that defined
visit.

PN 762017.B 155
16.5.3 Test Type MVV
Select item:
MVV (L/m) Vt (L)
MVV (L/s) RR (b/m)
Test time (s)
Format
Pre vs. Post (Numeric Results) Displays both the reported pre-bronchodilator, the
reported post-bronchodilator efforts, and the percent
change
Effort(s)
Best effort Displays the reported (best) effort (Highest sum of FVC
All efforts (FVC only) Display all efforts performed, up to the preset maximum
number. (Note that selecting this option may cause
Appearance
Show item name Report item will have a heading before the measured or
entered value.
Compare to predicted Displays predicted (mean) value and percent of predicted

mean for each effort shown. If the predicted value is out
of range (age or height not within the ranges specified in
the predicted set source document), three asterisks (***)
will be shown. If the predicted value has been manually
adjusted for ethnic group, the predicted value will be
displayed with a leading asterisk (*).
Show LLN Displays the Lower Limit of Normal (LLN predicted value
Show CI Causes results that are above or below the confidence

Show SR (Z-score) Standardized Residual (SR) displayed for each effort

after the %Pred value. Note: SR information is only
available for the ECCS predicted equation set.

PN 762017.B 155
Flag if outside confidence interval causes results that are above or below the confidence
Use FVC reference effort series Check box to display the visit that contains the FVC
reference effort, as a comparison for the reported data
from the current visit.
Use Check box and enter the number of visits “previous to
current” to display the value or graph from that defined
visit.
Format Options
Pre and Post (Graphs) Displays pre-bronchodilator efforts and post-
bronchodilator efforts as configured in the attributes
menu
Base to Recovery (Graphs) Displays and overlays all challenge test stages (can
choose to offset overlays)
Effort(s) Options
Displays the reported (best) effort (Highest sum of FVC
Best effort
Display all efforts performed, up to the preset maximum
All efforts (FVC only) number. (Note that selecting this option may cause
Appearance Options
Displays the Lower Limit of Normal (LLN predicted value
Show LLN (Numeric Results)
Overlays (offset option available) the predicted graphic
 Add predicted normals (Graphs)
values along with the other displayed efforts.
Overlays the defined FVC reference effort along with the
 Add FVC reference effort (Graphs)
other displayed efforts.
Staggers individual efforts on the graph rather than
 Offset efforts (Graphs) overlaying them from the same initial position on the
graph.
 Add tidal phase (FVC Graphs) Displays tidal breaths on the graph

PN 762017.B 155
Historic Test Series Options
Select the use FVC reference effort series check box to display the visit that contains the FVC
reference effort, as a comparison for the reported data from the current visit.
Select the Use test series check box and enter the number of visits “previous to current” to display the
16.6 REPORT ITEM – GRAPHIC RESULTS

Select item:
FVC: Flow vs. volume Spirometry: Stacked-bar graph
FVC: Volume vs. time Spirometry: Separate-bar graph
FVC: Flow vs. time Spirometry: Pre-Rx trend, %predicted
SVC: Volume vs. Time Spirometry: Pre-Rx trend, %reference test
MVV: Volume vs. time Spirometry: Post-Rx trend, %change
Challenge: Dosage trend (du, cumulative) Spirometry: Pre-Rx trend, Std Residuals
Challenge: Concentration trend Spirometry: Post-Rx trend, Std Residuals
Challenge: Dosage trend (mg, per-stage) Medication/condition tracking
Challenge: Concentration trend Calibration: Flow vs. Volume
Challenge: Dosage trend (mg, per-stage) Calibration: Volume vs. time
Format Options
Base, Saline, Stage (x), and Recovery Displays the Challenge stage as defined
Displays pre-bronchodilator efforts and post-

Pre and Post (Graphs) bronchodilator efforts as configured in the attributes
menu
Displays and overlays all challenge test stages (can

Base to Recovery (Graphs)
choose to offset overlays)
Effort(s) Options
Displays the reported (best) effort (Highest sum of
Best effort
FVC + FEV1 from acceptable efforts)
Display all efforts performed, up to the preset
All efforts (FVC only) maximum number. (Note that selecting this option may
cause numeric results to be wider than the page.)

PN 762017.B 155
Appearance Options
Overlays (offset option available) the predicted graphic
Add predicted normals (Graphs)
values along with the other displayed efforts.
Overlays the defined FVC reference effort along with

Add FVC reference effort (Graphs)
the other displayed efforts.
Staggers individual efforts on the graph rather than

Offset efforts (Graphs) overlaying them from the same initial position on the
graph.
Add tidal phase (FVC Graphs) Displays tidal breaths on the graph
Historic Test Series Options

Select the use FVC reference effort series check box to display the visit that contains the FVC
reference effort, as a comparison for the reported data from the current visit.
Select the Use test series check box and enter the number of visits “previous to current” to display the

PN 762017.B 155

Computer-Based Diagnostic Spirometer Standalone Edition: Perator S Anual

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Revolutionizing the way the world detects

and treats respiratory diseases

Computer-Based Diagnostic Spirometer

Manufactured By: Authorized Representative:

KoKo Sx 1000 Standalone Edition Operator’s Manual 2 of 155

KoKo Sx 1000 Standalone Edition Operator’s Manual 4 of 155

2.1 INTENDED AUDIENCE

2.2 PURPOSE OF MANUAL

KoKo Sx 1000 Standalone Edition Operator’s Manual 5 of 155

A HINT describes shortcuts and reminds users of related activities or additional

 References to other manuals or documentation will be bold and italicized.

Steps described in procedures must be performed in order.

KoKo Sx 1000 Standalone Edition Operator’s Manual 6 of 155

Authorized Representative in the European Community.

Type BF applied part. This equipment provides a degree of protection

Dispose of waste electrical products appropriately in conformance with local

“Caution: consult accompanying documents.” Read and understand all

Temperature limitation for storage and transport. Limitation is indicated next

Humidity limitation for storage and transport. Limitation is indicated next to

Atmospheric pressure limitation for storage and transport. Limitation is

Prescription only - device restricted to use by or on the order of a physician.

KoKo Sx 1000 Standalone Edition Operator’s Manual 7 of 155

KoKo Sx 1000 Standalone Edition Operator’s Manual 8 of 155

4.1.6 DISCLAIMER OF WARRANTIES. THE LICENSED SOFTWARE IS PROVIDED TO

4.1.7 LIMITATION OF REMEDIES AND DAMAGES. TO THE MAXIMUM EXTENT PERMITTED BY

4.1.8 APPLICATION OF LIMITATIONS AND DISCLAIMERS TO CONSUMERS. The limitations or

KoKo Sx 1000 Standalone Edition Operator’s Manual 9 of 155

KoKo Sx 1000 Standalone Edition Operator’s Manual 10 of 155

KoKo Sx 1000 Standalone Edition Operator’s Manual 11 of 155

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5.1.8 WARNING: Connect only to a computer certified to IEC/UL 60950.

5.1.9 WARNING: No modification of this equipment is allowed.

5.1.13 CAUTION: Follow the cleaning procedures contained in this manual.

5.1.14 CAUTION: Back up computer before KoKo Sx software installation or update.

KoKo Sx 1000 Standalone Edition Operator’s Manual 13 of 155

5.4 DEVICE DESCRIPTION AND SPECIFICATION

 Flow sensor: Brass Fleisch-type Pneumotachometer

KoKo Sx 1000 Standalone Edition Operator’s Manual 14 of 155

Temperature -20°C and +50°C

5.6 TRAINING REQUIREMENTS

5.6.1 Patient Preparation

 Smoking within at least 1 hour of testing

KoKo Sx 1000 Standalone Edition Operator’s Manual 15 of 155

Procedures for recording forced vital capacity

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7.1 MAIN SCREEN

1. Select patient and test series, enter/edit patient

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B. Log in (if KoKo Sx passwords are enabled) (Section 11.1.2).

C. Verify calibration of the pneumotach (section 10.2.1).

F. Open a report (Read/Interpret/Print window) (Section 11.5.1.1).

G. Interpret the results (Section 11.5.1.3).

H. Print the results (optional) (Section 11.6).

KoKo Sx 1000 Standalone Edition Operator’s Manual 19 of 155

Minimum Test Station / Workstation Computer Requirements

8.3 INSTALLING KOKO SOFTWARE

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Check “Always trust software from “nSpire Health, Inc.”

KoKo Sx 1000 Standalone Edition Operator’s Manual 21 of 155

Read and click Next

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8.3.1 Starting KoKo Sx