Itamar Medical Watch-PAT200 Sleep Diagnostic Device Operation Manual

Watch-PAT200
Operation Manual
Itamar Medical P/N - OM2196300
!
Caution: Federal (U.S.) law restricts
this device to sale by, or on the order of, a
physician. Not for pediatric use.
Copyright  2002-2009 By Itamar Medical Ltd.
Itamar Medical Ltd.
This manual and the information contained herein are confidential and are the sole property
of Itamar Medical Ltd. Only Itamar Medical Ltd. or its licensees have the right to use this
information. Any unauthorized use, disclosure or reproduction is a direct violation of
Itamar Medical’s proprietary rights.
DISCLAIMER
Itamar Medical Ltd. shall not be held responsible in any manner for any bodily injury
and/or property damage arising from operation or use of this Watch-PAT200 other than that
which adheres strictly to the instructions and safety precautions contained herein and in all
supplements hereto and according to the terms of the warranty provided in the License
Agreement in Appendix A.
Itamar Medical Ltd.
9 Halamish St., P.O. Box 3579
Caesarea 38900, Israel
Tel: International + 972-4-617-7000, US 1-888-7ITAMAR
Fax + 972 4 627 5598
www.itamar-medical.com
0473
ISO 9001:2000 and ISO 13485:2003
See appendix B for contact information of the regulatory authorized representative
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Record of Revisions
Revision
0
1
2
Date
March 2008
June 2008
July 2008
3
Feb 09
Watch-PAT200
Description
Preliminary
Sleep Stages and AHI
ISO logo, list of
standards, Medes
address, pictures
Updating:
Itamar Medical address
List of standards
Labeling
ii
Chapter
All
All
All
Pages
All
All
All
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1.6
1.10.1
i, 47
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Resp.
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Table of Contents
1.
GENERAL INFORMATION ..................................................... 1
1.1.
1.2.
1.3.
1.4.
1.5.
1.6.
1.7.
1.8.
1.9.
1.10.
Intended use / Indications for use ......................................................... 1
Restrictions For Use ............................................................................... 1
Exclusion Criteria ................................................................................... 2
Data Generated by the Watch-PAT200 .................................................. 2
Equipment Classification ....................................................................... 2
Quality Assurance System: ISO 9001 .................................................... 3
CE and CSA Compliance ........................................................................ 3
Conventions Used in this Manual .......................................................... 4
Safety Precautions .................................................................................. 5
Symbols used on the WP200 device labels .......................................... 6
2.
OVERVIEW ............................................................................. 8
2.1.
2.2.
2.3.
System Description................................................................................. 9
WP200 Function .................................................................................... 12
Built-In Self-Diagnostic Procedures .................................................... 12
3.
PREPARATION FOR SLEEP STUDY ...................................18
3.1.
3.2.
3.3.
3.4.
3.5.
3.6.
3.7.
Charging The Battery............................................................................ 18
Preparing The Oximetry Sensor .......................................................... 20
Preparing the Wrist strap ..................................................................... 21
Replacing the PAT Probe ..................................................................... 22
Preparing the WP200 for a New Study ................................................ 23
Testing The WP200 ............................................................................... 23
Packing The Carrying Case .................................................................. 23
4.
DATA DOWNLOAD AND ANALYSIS ....................................24
5.
MAINTENANCE .....................................................................25
5.1.
5.2.
5.3.
5.4.
5.5.
5.6.
5.7.
Cleaning ................................................................................................. 25
Handling ................................................................................................. 26
Replacing The Oximetry Sensor .......................................................... 26
Replacing The PAT Probe Cable.......................................................... 27
Replacing The Battery .......................................................................... 27
Setting The Time and Date of the WP200 ........................................... 28
Storing The WP200 ............................................................................... 28
6.
APPLYING THE WP200 ........................................................29
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6.1.
6.2.
6.3.
6.4.
6.5.
6.6.
6.7.
Preparing for use of the WP200 ........................................................... 29
Applying The WP200 ............................................................................. 30
Applying The Oximetry Sensor ............................................................ 31
Attaching the PAT Probe ...................................................................... 32
Switching On The WP200 ..................................................................... 34
When You Wake Up .............................................................................. 34
Important Notes..................................................................................... 35
7.
PATIENT TRAINING – GUIDELINES ....................................36
7.1.
7.2.
7.3.
7.4.
7.5.
7.6.
7.7.
Walk Through The Process Of Using The WP200 .............................. 36
Product Introduction............................................................................. 36
Applying The WP200 ............................................................................. 36
Switching on the WP200 ...................................................................... 37
Removing The WP200........................................................................... 37
Patient Training ..................................................................................... 37
Review Safety, General And Functional Issues ................................. 38
8.
TROUBLESHOOTING GUIDE ...............................................39
8.1.
8.2
Operator Error Messages ..................................................................... 39
Patient Error Messages ........................................................................ 40
9.
SPECIFICATIONS .................................................................41
APPENDIX A: LICENSE AGREEMENT............................................42
APPENDIX B: REGULATORY REPRESENTATIVE .........................48
APPENDIX D: DESCRIPTION OF THE WATCH-PAT PROBE ........49
APPENDIX E: MANUFACTURING DECLARATION ACCORDING TO
IEC 60601-1-2 ....................................................................................50
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List of Figures
Figure 1 – Packed Device .................................................................................... 9
Figure 2 – Watch-PAT200 Device with all sensors ........................................... 10
Figure 3 – The Buttons and Display ................................................................. 11
Figure 4 – Service Ports and Peripherals.......................................................... 11
Figure 5 – WP200 Wrist with Oximetry module ............................................... 12
Figure 6 – Charging the WP200 ......................................................................... 18
Figure 7 – Oximetry Sensor ............................................................................... 20
Figure 8 – Preparing The Nonin 8000JFW Oximetry Sensor .......................... 20
Figure 9 – Wrist Strap ........................................................................................ 21
Figure 10 – Disconnecting The Probe .............................................................. 22
Figure 11 – Probe disconnected ........................................................................ 22
Figure 12 – WP200 Fully Prepared ..................................................................... 23
Figure 13 – Replacing Oximetry Sensor............................................................ 26
Figure 14 – Replacing the PAT probe ................................................................ 27
Figure 15 – Replacing the Battery..................................................................... 28
Figure 16 – Finger Designation .......................................................................... 29
Figure 17 – Putting On The Wrist strap ............................................................. 30
Figure 18 – Wearing WP200 ............................................................................... 30
Figure 19 – Removing Adhesive Cover ............................................................. 31
Figure 20 – Positioning Oximetry On Ring Finger............................................ 31
Figure 21 – Fold Top Flap and Short Flap ......................................................... 32
Figure 22 – Wrap The Long Flap ........................................................................ 32
Figure 23 – Flexiwrap Line Indication ............................................................... 32
Figure 24 – Placing Finger In PAT Probe .......................................................... 33
Figure 25 – Removing TOP Tab ......................................................................... 33
Figure 26 – Removing BOTTOM Tab ................................................................. 33
Figure 27 – Wearing the WP200 – Ready for Sleep .......................................... 33
List of Tables
Table 1 – Operator Troubleshooting.................................................................. 39
Table 2 – Patient Troubleshooting ..................................................................... 40
Table 3 – WP200 Specifications ......................................................................... 41
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1. GENERAL INFORMATION
This manual is part of the Watch-PAT200 (WP200) system.
1.1. Intended use / Indications for use
The Watch-PAT200 (WP200) device is a non-invasive home care device for use with
patients suspected to have sleep related breathing disorders. The WP200 is a diagnostic aid
for the detection of sleep related breathing disorders and sleep staging (Rapid Eye
Movement (REM) Sleep, Light Sleep, Deep Sleep and Wake). The WP200 generates a
peripheral arterial tonometry ("PAT") respiratory disturbance index ("PRDI"), apneahypopnea index ("PAHI") and PAT sleep staging identification (PSTAGES). The WP200's
PSTAGES provides supplemental information to its PRDI/PAHI. The WP200's PSTAGES
is not intended to be used as the sole or primary basis for diagnosing any sleep related
breathing disorder, prescribing treatment, or determining whether additional diagnostic
assessment is warranted.
The WP200 is not indicated for children less than 17 years old.
1.2. Restrictions For Use
•
The WP200 should be used only in accordance with physician’s instructions.
For exclusion criteria see Section 1.3.
•
Only qualified medical personnel may authorize the use of the WP200.
•
Qualified medical personnel must instruct the patients how to attach and use
the WP200 prior to use.
•
In the event of equipment malfunction all repairs should be executed by
authorized Itamar Medical Ltd. personnel or licensed service agents.
•
The eligibility of a patient for a PAT study is entirely at the discretion of a
physician, and is generally based upon the patient’s medical status.
•
The WP200 system in whole, or in part, may not be modified in any way.
•
The WP200 is used as an aid for diagnostic purposes only, and should not be
used for monitoring.
•
Only suitably trained and qualified personnel should be authorized to prepare
the WP200 equipment prior to use.
•
The WP200 Operation Manual should be carefully studied by the authorized
operators, and kept where it is easily accessible. Periodic review of the
Manual is recommended.
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•
Itamar Medical Ltd. makes no representation whatsoever, that the act of
reading the Manual renders the reader qualified to operate, test or calibrate
the system.
•
The tracings and calculations provided by the WP200 system are intended as
tools for the competent diagnostician. They are explicitly not to be regarded
as a sole incontrovertible basis for clinical diagnosis.
•
In the event that the system does not operate properly, or if it fails to respond
to the controls in the manner described in this Manual, the operator should
refer to the Troubleshooting section. If necessary, contact our service office
to report the incident, and to receive further instructions.
•
The step by step instructions for the patient should be carefully followed
when attaching the unit to the patient.
1.3. Exclusion Criteria
The WP200 should not be used in the following cases:
1.4.
•
Age less than 17 years old.
•
Use of one of the following medications: alpha blockers, short acting nitrates
(less than 3 hours before the study).
•
Permanent pacemaker.
•
Sustained non-sinus cardiac arrhythmias.
Data Generated by the Watch-PAT200
The WP200 generates a PAT respiratory disturbance index (PRDI) and its derivative, the
PAT Apnea-Hypopnea Index (PAHI) and PAT sleep staging identification (PSTAGES).
The PRDI, PAHI and PSTAGES are estimates of conventional RDI and AHI values and
REM, Deep Sleep, Light Sleep and Wake stages identification that are produced by
polysomnography (PSG).
1.5.
Equipment Classification
The WP200 is a Class IIa medical device under MDD 93/42/EEC (1993) Annex IX rule 10.
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1.6. Quality Assurance System: ISO 9001
The Itamar Medical WP200 is compliant to the following standards.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
STANDARD
Medical electrical equipment- general requirements for safety.
Medical electrical equipment electromagnetic compatibility
Medical Device Software- Software Life Cycle Processes
Quality systems – Model for quality assurance in design,
development, production, installation and servicing
Quality systems medical devices
CMDR - Canadian Medical Device Regulations
Risk Analysis for medical devices
Labeling Medical Devices
Medical Device Directive
CSA standard for safety
UL standard for safety
#
IEC 60601-1
IEC 60601-1-2
IEC 62304
ISO 9001
ISO 13485
SOR/98-282
ISO 14971
EN 980
MDD 93/42 EEC
CSA 22.2 No. 601.1
UL 60601-1
1.7. CE and CSA Compliance
The WP200 complies with the CE mark according to
MDD (Medical Device Directive) and related standards.
0473
The unit is marked with the CE logo and a CE conformity
card is included in every shipment.
The WP200 is certified by CSA.
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1.8. Conventions Used in this Manual
!
Warnings are used to identify conditions or actions, which - if the
instructions are ignored - may violate patient safety, or cause
damage/malfunction to the system, resulting in non recoverable loss of
data.
Les avertissements sont utilises pour identifier les conditions ou les
actions qui- si elles sont ignorées- peuvent porter atteinte à la sécurité des
patients ou causer des dommages au système et résulter à une perte
irréversible des données.
Cautions are used to identify conditions or actions, which could cause
interference with data acquisition and/or impair study results.
Les précautions sont utilisées affin d’identifier les conditions ou les
actions qui peuvent interférer avec le ramassage de données et provoquer
des résultats équivoque.
Notes are used to identify an explanation, or to provide additional
information for purposes of clarification.
Les notes sont utilisées pour identifier les explications et pour donner des
informations supplémentaires dans le but de clarifier.
1.8.1. Warnings, Cautions and Notes
The WP200 is internally powered from a 4.2 V battery.
The WP200 is portable with continuous operation.
The WP200 uses BF patient applied parts.
The WP200 uses UL listed power supply.
The power supply is used in a non-patient environment only.
The WP200 should only be transported in its original case.
There are no serviceable parts inside the WP200.
Environmental conditions during transportation & storage:
Temperature: -20ºC ~ 40ºC. Recommended temperature for long term storage <21ºC
Relative humidity: 10% ~ 70%
Atmospheric pressure: 940 hPa ~ 1060 hPa
Environmental conditions during operation:
Temperature: 15ºC ~ 30ºC. Recommended temperature 18ºC ~ 25ºC
Relative humidity: 30% ~ 70%
Atmospheric pressure: 940 hPa ~ 1060 hPa
Sleep professionals (other than patients) using the WP200 should read the Operation
Manual.
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1.9. Safety Precautions
WARNINGS
Use only the USB charger provided (5V DC, 5W maximum capacity power
supply). Only authorized personnel may charge the WP200. Failure to heed this
warning may cause permanent damage to the equipment.
Do not let the unit get wet.
Avoid placing food or water on any part of the system.
In the event of fire use only fire extinguishers approved for use on electrical fires.
Handle unit with care. This unit is sensitive to extreme movements and to falling.
Do not attempt to connect or disconnect any part of the unit.
Do not try to introduce any foreign object into the unit.
The WP200 MUST be charged ONLY after being removed from the patient!
The WP200 MUST be removed from the patient BEFORE connecting it to a PC!
!
The Adult Flex Pulse Oximetry Sensor may cause skin sensitivity to the
patient. Discontinue use of the NONIN double-backed adhesive tape strips or the
Hydrogel tape strips if the patient exhibits allergic reactions to the adhesive
material.
AVERTISSEMENTS
Utiliser seulement un 5V DC, 5W alimentation d'énergie. Seul les techniciens
autorisés peuvent charger la montre PAT. Ignorer cet avertissement peut causer
des dommages irréparables a l’équipement. Ne pas mouiller l’unité. L’unité est
sensible au mouvement extrême est à la chute. L’utiliser avec précaution. Ne pas
essayer de brancher ou débrancher une des parties de l’unité.
Ne pas introduire un objet étranger a l’intérieur de l’unité.
Le système WP200 doit être rechargé uniquement après avoir été retiré de la
main du patient.
Il est impératif de retirer le système WP200 de la main du patient avant de le
relier a l'ordinateur pour faire fonctioner les programmes.
L’Oximetre pur adulte ‘’ Flex Pulse‘’ peut produire des sensibilités
dermatologique aux patients.
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1.10.
!
Symbols used on the WP200 device labels
Consult operating instructions
Consult accompanying documents
BF Type Applied Parts
The WP200 is certified by CSA
0473
The WP200 complies with the CE EMC Directives and
related standards
Year of manufacture
2008
3.7V DC
Battery Operating Voltage
Do not re-use
40ºC
Temperature limitation
Use by
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1.10.1. WP200 labels
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2. OVERVIEW
Obstructive sleep apnea syndrome (OSAS) is considered a major public health problem.
The prevalence of the syndrome is estimated at 2% to 5% in the adult population. It is
characterized by recurrent events of complete or partial obstruction of the upper airways
during sleep, often leading to hypoxemia, and/or arousals associated with sympathetic
nervous system activation. The diagnosis and assessment of the sleep apnea patient is based
on the Respiratory Disturbance Index (RDI), the number of Apneas, Hypopneas and
Respiratory Effort Related Arousals (RERA) per hour of sleep, along with sleep
architecture. The common consequences of this sleep disruption are daytime sleepiness,
poor daytime performance and increased vulnerability to accidents. Cardiovascular
complications such as systemic/pulmonary hypertension, ischemic heart disease and
arrhythmias are the major sequel of OSAS in the adult population.
The WP200 is worn on the wrist and is utilizing a plethysmographic based finger–mounted
probe, to measure the PAT (Peripheral Arterial Tone) signal. The PAT signal is a
measurement of the pulsatile volume changes in the fingertip arteries which reflects the
relative state of the arterial vasomotor activity, and thus indirectly the level of sympathetic
activation. Peripheral arterial vasoconstriction, which mirrors sympathetic activation, is
shown as attenuation in the PAT signal amplitude. The PAT signal is recorded continuously
and stored on an embedded micro SD card, together with data from a built-in pulseoximetry sensor (mounted on an adjacent finger) and an actigraph (embedded in the
WP200). Following the sleep study, the recordings are automatically downloaded and
analyzed in an offline procedure using the proprietary zzzPAT software.
The zzzPAT algorithms use the four WP200 channels (PAT, oxygen saturation, pulse rate
and actigraphy) for the detection of respiratory events, differentiation between wakefulness
and sleep stages such as Deep, Light and REM sleep. The software issues comprehensive
reports of the study, with statistics and graphic presentation of the results. The whole night
data can be viewed and the automatically detected events can be revised manually.
An optional sensor for Snoring and Body Position provides snoring in decibels during sleep
and 5 body positions (right, left, prone, supine and sit).
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2.1. System Description
The WP200 system is comprised of the following items:
•
WP200 device that includes:
•
o Embedded actigraph
o Embedded pulse oximeter
o Embedded CPU and electrical circuit card
o Embedded micro SD card drive
o Rechargeable Lithium Ion Battery
o LCD display
PAT probe
•
PAT probe connection cable
•
Pulse oximeter sensor – with single use adhesive pads
•
Wrist Strap
•
Snore and Body Position sensor - optional
•
USB battery charger
•
USB cable
•
Step-by-Step Reference Guide
•
Carrying case
Figure 1 – Packed Device
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PAT probe
Oximetry sensor
Optional Snore & Body
Position sensor
Figure 2 – Watch-PAT200 Device with all sensors
An additional item required for the operation of the system is the zzzPAT kit. zzzPAT is a
proprietary PC software for initializing the study, retrieving, analyzing and displaying the
data. For more information, refer to the zzzPAT Operation Manual.
2.1.1. User Interaction with the WP200
Keys
The WP200 has the following keys (see Figure 3):
• Central On/Enter key to power on the WP200 (the only key
visible to the patient)
• Outer ring containing four keys (left, right, up, down) that may
be used by the Operator for entering the diagnostic mode and
navigating through the diagnostic menu. These keys are hidden
from the patient.
LCD display
The display is used for reading status and error messages. The display is divided
to three sections: Title, Info and Status.
• Title: Current operational mode and time
o PATIENT mode while recording night study
o DIAGNOSTIC mode while testing device
o PC HOST while connecting to PC
o CHARGER mode while connecting to USB Charger
• Info: Specific information depending on operational mode
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• Status: Message indicating device status depending on
operational mode
UP
LCD
RIGHT
ON/ENTER
DOWN
LEFT
Figure 3 – The Buttons and Display
PAT probe port
Port for optional Snore
& Body Position
sensor
Oximetry module port
Figure 4 – Service Ports and Peripherals
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USB port for charging
and communication
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Oximetry module
Wrist strap
Oximetry sensor
Oximetry Module connector
Figure 5 – WP200 Wrist with Oximetry module
2.2. WP200 Function
The WP200 records the following channels:
•
PAT Signal
•
Oxygen saturation
•
Actigraphy (movement)
The overnight sleep study data is stored on an embedded micro SD card in the WP200.
After the study is recorded, the data is downloaded from the WP200 through the USB cable
using the zzzPAT software. The zzzPAT software, utilizing automatic algorithms, detects
respiratory and other events that occurred during sleep as well as periods of REM, deep
sleep, light sleep and wakefulness. The pulse rate signal is derived from the PAT signal and
used in the automatic analysis. The software issues comprehensive detailed reports of the
study. The whole night data can be viewed on the PC screen and the automatically detected
events can be revised manually.
2.3. Built-In Self-Diagnostic Procedures
2.3.1. Operator tests
The WP200 contains a comprehensive built-in self-diagnostic procedure. This procedure is
available to the operator and hidden from the patient. The procedure can be accessed it the
UP and DOWN keys (see Figure 3) are pressed simultaneously after the device is powered
ON (during the first 30 seconds only after the device is powered ON). The procedure
performs the following tests:
•
Device Test – tests the WP200 for errors before performing a night study (make
sure all probes are connected before initiating this test)
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•
Oximetry Sensor Test – verifies oximetry sensor is connected and shows average
saturation
The Device test is the default test. Once the device test has passed you should also run the
oximetry sensor test.
Note
In all times, the current time is shown in the upper right hand corner of the
LCD display.
To run the self-diagnostic procedure:
• Press the ENTER button (Center key) for 2 seconds till the Itamar medical logo
appears on he LCD screen
• Immediately press the UP + DOWN keys (see Figure 3) simultaneously for 1
second
The following screen will be displayed:
DIAGNOSTIC
22:40
2.2140
20-Jul-08
*device test (30001)
oxi test
end testing
Select test ↑↓
•
First line displays title and current time
•
Second line displays current embedded S/W version (2.2139) and current date
•
Third line displays option for running device test (serial number of device in
parenthesis)
•
Fourth line displays option for running oximetry sensor test
•
Fifth line indicates option for end testing (turn device off). If no test is selected
within 3 minutes the WP200 device will automatically shut down
•
The Up, Down keys (↑↓) navigate between the lines.
•
An asterisk will indicate current selection. When moving the ↑↓ keys, the asterisk
will move to indicate the current selection. Press the central Enter key to make the
desired selection.
It is recommended that you perform the device and oxi test every time you prepare the
WP200 for a night study.
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2.3.2. Device test
At the completion of the device test, a TEST PASSED indicates that the device is ready
for the night study.
DEVICE TEST
22:50
ID=111-11-1111
sbp=missing
<-Back
TEST PASSED
2:54
At the completion of the device test, a TEST FAILED indicates a problem that should be
taken care of before the device is released for a night study.
DEVICE TEST
22:50
ID=111-11-1111
oxi=mod missing
pat=missing
<-Back
More->
TEST FAILED
2:54
The following are the possible error/warning messages:
•
•
•
•
•
•
•
File error: not loaded, missing – the study file was not loaded or somehow
the file was deleted
Battery error: low – needs charging
Probe error: used, missing, bad – connect an unused probe
Oximetry error: module missing - connect oximetry module
Hardware (H/W) error: error code - contact customer support
SBP (Snore and Body Position sensor) warning: sensor missing – does not
affect PASSED status
RTC (Real Time Clock) warning: faulty – indicates problem with internal
clock but does not affect PASSED status
More-> indicates that there are more error/warning messages and will be displayed if the
Right (->) button is pressed.
<-Back we move to previous screen.
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2.3.3. Oximetry test
For the oximetry test make sure the sensor is attached to the finger. At the end of the test
the saturation and/or any error message will be displayed:
OXI TEST
SaO2=98%
22:50
Attach to finger
<-Back
Testing…
OXI TEST
22:50
SaO2=N/A
oxi=mod missing
Attach to finger
<-Back
Testing…
The possible oximetry error messages are:
• Oximetry error: module or sensor missing - connect oximetry module and
sensor.
• SaO2= Not Available (N/A) - attach sensor to finger.
The blood saturation is continuously updated, therefore wait for one minute or so for the
saturation to stabilize when testing.
<-Back we move to previous screen.
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2.3.4. Patient test
When the patient turns on the WP200 by pushing the On/Enter key (center button) for about
2 seconds a self-diagnostic test is automatically performed and the following screen is
displayed:
PATIENT
22:51
Please wait
Testing…
If the WP200 passes this self-diagnostic test, the following screen will be displayed
PATIENT
22:51
GOOD NIGHT!!!
Time elapsed=9:50
Recording…
Note
During recording the LCD display turns off to conserve battery life. Any
key pressed during Recording will turn on the LCD for 30 seconds.
If the WP200 fails this self-diagnostic test, the following screen will be displayed:
PATIENT
22:51
Error=xxxx
Device S/N=xxxxx
Call Help Desk
TEST ABORTED
•
The error message will be displayed for 1 minute then the WP200 will shut off.
The following are the possible error/warning messages:
xxx1 - battery low
xxx2 – Nonin module/sensor disconnected
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xx2x – PAT probe error (used probe)
xx4x – File error (no new file)
xx8x - PAT probe error (bad probe)
x4xx - SBP (Snore and Body Position sensor) missing warning
Note
The "x" stands for 0-F value (Hexadecimal code)
Error codes are additive, i.e. both PAT probe and File errors will produce
error code xx6x.
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3. PREPARATION FOR SLEEP STUDY
3.1. Charging The Battery
Warning
!
For AC charging use only a USB charger having a 5V DC output, with
5W minimum capacity. Using any other charger may cause permanent
damage to the WP200 and may jeopardize the operator.
The battery must be charged every time the WP200 is prepared for use. The battery may be
charged through the USB port of a computer, or with the USB charger provided.
To charge the WP200:
1.
Disconnect the Oximetry module by disconnecting the Oximetry module
connector.
2.
Gently slide the WP200 out of the wrist strap until a click is heard and the
USB port is exposed. Be careful not to damage the oximetry module
connector and cable.
3.
Connect the USB port of the WP200 to the USB port of a computer using the
USB cable provided or to the USB charger provided (see Figure 6).
Figure 6 – Charging the WP200
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4.
The LCD will blink slowly and the following screen will be displayed:
CHARGER
22:51
Bat=3.12 V
Charging…
5.
•
The display will show “CHARGER” if you are charging with the USB
charger or “PC HOST” if you are charging with a computer.
•
The current battery voltage is shown.
•
Charge the battery the first time for approximately three hours.
Thereafter recharging takes approximately 1-1.5 hours.
When charging is complete, the LCD will stop blinking and the following
screen will be displayed:
CHARGER
22:51
Bat=4.2 V
Charging complete
6.
Disconnect the charger or communication cable. The WP200 will switch off
in 30 seconds.
7.
Reseat the WP200 in the wrist strap by gently sliding it back in until a click is
heard.
8.
Check that the oximetry module connector is properly connected to the
WP200.
Should a charging error arise the LCD will blink rapidly and the following screen will be
displayed.
CHARGER
22:51
Bat=4.2 V
Charger fault
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3.2. Preparing The Oximetry Sensor
Use Nonin 8000JFW Flexiwrap pad and Nonin oximeter as supplied.
Figure 7 – Oximetry Sensor
1. If the sensor was previously used, carefully remove the used Flexiwrap
pad from the sensor. Remove any remaining adhesive from the sensor
– if necessary clean the sensor using isopropyl alcohol.
2. Place the new Flexiwrap pad with the printed side facing down on a
flat surface.
3. Partially peel off the paper covering of the pad to expose the adhesive
area around the two cut out sections.
4. Place the sensor on the pad with the back facing the sticky side placing
the sensor’s protrusions into the corresponding cutout sections as
shown in Figure 8.
5. Reapply the paper covering of the pad.
Flexiwrap pad
Oximetry sensor
Figure 8 – Preparing The Nonin 8000JFW Oximetry Sensor
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3.3. Preparing the Wrist strap
The wrist strap requires no special preparation other than ensuring its cleanliness. You may
clean it if needed. Take care not to allow the oximetry module or connector to get wet (see
Figure 5). See section 5.1 for detailed cleaning instructions.
Oximetry module
connector
Oximetry module
Oximetry sensor
Figure 9 – Wrist Strap
3.3.1. Mounting the WP200 on the wrist strap
To mount the WP200 on the wrist strap:
1. Gently slide the WP200 into the wrist strap until a click is heard
indicating that it is properly seated.
2. Connect the oximetry module connector (Figure 9) to the oximetry
module port on the WP200 (Figure 4).
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3.4. Replacing the PAT Probe
Warning
!
The PAT probe connector is very sensitive and therefore should never
be left exposed. Keep the connector connected to the probe at all
times, especially during cleaning. Replace the probe just before
performing the Device test.
Remove a used probe by pressing the blue tab (clip) marked by the arrow in Figure 10, and
then, holding the gray slider, gently slide it away from the probe – do not pull the slider off
by pulling the cord, as it may damage the wiring. Properly dispose of used probes.
Figure 10 – Disconnecting The Probe
Figure 11 – Probe disconnected
Connect a new probe by inserting the gray slider to the probe until the blue tab of the probe
clicks into its place.
Note
Take care when inserting the gray slider to insure proper seating in the
probe.
The WP200 is now ready for performance of a sleep study by the patient. (Figure 12)
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PAT probe
Oximetry sensor
Figure 12 – WP200 Fully Prepared
3.5. Preparing the WP200 for a New Study
Refer to the zzzPAT Software Manual for preparation of the WP200 for a new study.
3.6. Testing The WP200
Run the built-in self-diagnostic facility as described in Section 2.3 above
3.6.1. WP200 self-diagnostic test results and troubleshooting
Should any of the self-diagnostic tests fail or report error messages refer to the troubleshooting guide in Section 8.
3.7. Packing The Carrying Case
The following items must be placed inside the carrying case, in their respective
compartments:
• The WP200 mounted in the Wrist strap with the PAT probe and oximetry sensor
attached.
•
Body Position and Snore sensor (optional)
•
Step-by-Step Reference Guide to the WP200.
Note
Demonstrating the use of the WP200 to the patient is important for
obtaining reliable recordings and improving patient confidence.
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4. DATA DOWNLOAD AND ANALYSIS
Following the sleep study the WP200 is returned to the referring sleep clinic for data
downloading and analysis by the zzzPAT software.
To download and analyze the study data:
1. Connect the USB port of the WP200 to the computer (see Figure 4)
The WP200 will switch off and then switch on in charging mode.
2. Activate the zzzPAT software to download and analyze the study data.
See the zzzPAT Software User Manual for detailed instructions.
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5.
MAINTENANCE
The WP200 has been designed and manufactured to meet all safety requirements applicable
to medical equipment. To ensure maximum safety of operation, the system should be used
and maintained in strict compliance with the safety precautions, warnings and operating
instructions provided in this Manual.
The system contains no user-serviceable parts. It should be maintained and serviced only by
qualified service personnel, authorized by Itamar Medical Ltd.
5.1. Cleaning
The various components of the WP200 have different cleaning requirements.
•
The WP200
•
The wrist strap
•
The oximetry sensor
5.1.1. Cleaning the WP200
There is no need to clean the unit during ordinary operation. Should it become necessary to
clean the WP200, proceed as follows:
1.
Wipe parts with a clean, dry, lint-free cloth.
2.
Clean casing with lint free cloth lightly moistened with 70% alcohol.
Warning
!
Clean the WP200 only with the PAT probe attached.
5.1.2. Cleaning the oximetry sensor
The Nonin 8000JFW pulse oximetry sensor has two parts, the single-use
adhesive band and the optical sensor with cable and plug. The sensor/cable
component is reusable, and should be cleaned as described in section 3.2.
5.1.3. Cleaning the Wrist Strap
You may clean the wrist strap with lint free cloth lightly moistened with
70% alcohol.
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5.1.4. The PAT probe
The PAT probe is designed for a single use only. It may not be cleaned and
must be discarded and replaced before each study.
5.2. Handling
Handle with care:
•
Use only the designated case for transportation
•
Store at room temperature, and avoid direct sun light
•
Do not expose the WP200 to extreme temperature or humidity
conditions (such as storing in a car or bathroom)
5.3. Replacing The Oximetry Sensor
Should it become necessary to replace the oximetry sensor, proceed as follows:
1.
Carefully disconnect the oximetry sensor from the oximetry
module on the wrist strap.
2.
Carefully insert the connector of the new oximetry sensor
cable to the oximetry sensor port in the oximetry module on
the wrist strap (see Figure 13) noting proper alignment (3
round protrusions facing up).
Figure 13 – Replacing Oximetry Sensor
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5.4. Replacing The PAT Probe Cable
To replace the PAT probe cable:
1. Carefully disconnect the PAT probe cable from the WP200.
2. Connect a new PAT probe cable by gently inserting the connector
into the WP200, noting proper alignment (3 round protrusions facing
up).
Figure 14 – Replacing the PAT probe
5.5. Replacing The Battery
Warning
!
Replace the battery only with an authorized battery provided by Itamar
Medical Ltd.
In the event of a battery error message during the self-diagnostic tests or after charging, it
may be necessary to replace the battery.
To replace the battery:
1. Open the battery compartment cover with a Phillips screwdriver.
2. Remove the battery.
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3. Gently remove the connector from the connection port.
4. Insert the connector of the new battery into the port. It will slide in easily. Don’t
force the connector into the port. It may properly be inserted in only one
direction.
5. Place the battery and connecting wire into the battery compartment.
6. Close the battery compartment cover and secure with the Phillips screwdriver.
Battery compartment cover
Phillips screw
Battery
Battery Connection port
Connector
Figure 15 – Replacing the Battery
5.6. Setting The Time and Date of the WP200
The WP200's Time and Date can be set through the zzzPAT application. Refer to the
zzzPAT Software Manual for preparation of the WP200 for a new study.
5.7. Storing The WP200
•
The WP200 should be stored in its carrying case at
room temperature and low humidity.
•
In order to preserve battery performance when the
WP200 is not in use, store with the battery fully
discharged. Before storing the WP200 allow it to
deplete the battery charge until it shuts down
automatically.
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6. APPLYING THE WP200
Note
These instructions are designed to help the patient use the WP200 after
seeing a demonstration by trained personnel of how to mount the probes
on his/her fingers and correctly operate the WP200.
The following detailed instructions are summarized in the patient’s step-by-step reference
guide. They are written as if the reader is the patient using the WP200.
6.1. Preparing for use of the WP200
Before using the WP200, review the following notes:
•
Remove all rings, watches and jewelry from your non-dominant hand and
wrist.
•
The probes may be worn on any two fingers of your non-dominant hand.
We recommend that the oximetry sensor and PAT probe be attached to the
ring and index fingers respectively (Figure 16). The following instructions
relate specifically to these fingers. Patients with very large fingers may use
their small finger (pinky) for the PAT Probe.
•
Ensure that fingernails of fingers that will be monitored are well trimmed,
(less than 1mm from nail bed) with no jagged edges. Clip and file nails, if
necessary
•
Remove artificial fingernails or dark nail polish from the monitored fingers
You may need some assistance putting on the WP200. If needed have someone present to
assist you.
Index finger
Ring finger
Small (pinky) finger
Figure 16 – Finger Designation
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6.2. Applying The WP200
To apply the WP200 to your wrist:
1.
Open the carrying case and take out the wrist strap with the
WP200 mounted. All parts should already be connected, as
illustrated in Figure 12.
2.
Ensure that the WP200 is firmly seated in the wrist strap. If not,
gently seat the WP200 in the strap by sliding it into its seating
position. You will hear a click when the WP200 is properly seated
in the strap.
3.
Place the wrist strap with the WP200 on the non-dominant arm
and close it snugly but not tightly. Ensure that the rounded end is
towards the body and the open end towards the fingers. You may
find it convenient to place the wrist strap with the WP200 face
down on the table and then place the back of the wrist over the
wrist strap in order to fasten the straps (Figure 17).
4.
At this point both probes are hanging loose (Figure 18).
.
Figure 17 – Putting On The Wrist strap
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Figure 18 – Wearing WP200
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6.3. Applying The Oximetry Sensor
Now you will attach the oximetry sensor to your ring finger, as was demonstrated to you
and is illustrated in the figures below.
6.3.1
Applying the Nonin 8000JFW Oximetry Sensor
If you are using the Nonin 8000JFW oximetry sensor proceed as follows:
1.
Remove the adhesive strip from the unit (see Figure 19)
2.
Position the oximetry sensor on your ring finger with the wire
on the bottom side of the finger (see Figure 20) – the finger
should reach the centerline marker on the pad
3.
Fold the bottom short flaps around your finger (see Figure 20)
4.
Fold top flap over the finger and fold the short flap around
your finger (see Figure 21)
5.
Complete this procedure by wrapping the long flap around the
short wrapped flaps (see Figure 22).
6.
Ensure that the dotted line of the Flexiwrap pad is properly
located, as indicated by the arrow (see Figure 23), and that the
two square black protrusions are opposite one another.
7.
The oximetry sensor is now attached. When the WP200 is
turned on, the sensor will glow red.
Figure 19 – Removing Adhesive Cover
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Figure 20 – Positioning Oximetry On Ring Finger
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Figure 21 – Fold Top Flap and Short Flap
Figure 22 – Wrap The Long Flap
Figure 23 – Flexiwrap Line Indication
6.4. Attaching the PAT Probe
Proper probe placement is critical for good performance.
Note
The tabs inside the probe should be removed only AFTER the finger is
inserted into the probe.
To attach the PAT probe:
1. Insert your index finger (or other if so instructed) gently into the probe until
it reaches the end (see Figure 24).
2. Make sure that the paper tab marked TOP is above your nail and the tab
marked BOTTOM is below your finger.
3. Detach and pull the tab marked TOP slowly and firmly towards the back of
your hand, until completely removed from the probe (Figure 25).
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4. Detach and pull on the tab marked BOTTOM slowly and firmly towards the
back of your hand, until completely removed (Figure 26). You might feel a
slight suction once the tabs are removed.
The PAT probe is now attached (Figure 27).
Figure 24 – Placing Finger In PAT Probe
Figure 25 – Removing TOP Tab
Figure 26 – Removing BOTTOM Tab
Figure 27 – Wearing the WP200 – Ready for Sleep
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Note
DO NOT remove the PAT probe before the night study is terminated.
Once the probe is removed it cannot be re-attached.
6.5. Switching On The WP200
You are now ready to switch on the WP200.
Just before you lie down to go to sleep, firmly press the ON/Enter center button (Figure 3)
until the LCD display lights up. After a short delay the LCD will display “Good Night!
Recording…”
PATIENT
22:51
GOOD NIGHT!!!
Time elapsed=9:50
Recording…
Note
To conserve the battery the LCD display will switch off after a few
seconds. Pressing any button will restore the display for about 30
seconds.
6.6. When You Wake Up
When you awake, remove the WP200 from your arm as follows:
1.
Remove both probes from your fingers.
2.
Take off the wrist strap.
3.
Place all parts in the carrying case.
Note
Pressing the center button does not switch off the WP200. The oximetry
sensor red light will remain lit. Approximately ten hours after the WP200
is turned on, it will switch off. This is normal.
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6.7. Important Notes
Wearing the WP200 should not cause any discomfort or pain. If you experience wrist or
arm discomfort, loosen up the wrist strap. If the discomfort is not alleviated immediately,
call the service number.
•
Do not attempt to connect or disconnect any part of the unit.
•
Do not try to introduce any foreign object into the unit.
•
Do not try to connect the unit to an electrical supply or any other unit,
machine or computer.
•
If any part appears disconnected or does not resemble the illustrations, call
the service number for assistance.
•
Do not, under any circumstances, attempt to fix the problem yourself.
If you have any questions about using the machine, before, during or after your at-home
recording session, call the service number.
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7. PATIENT TRAINING – GUIDELINES
7.1. Walk Through The Process Of Using The WP200
•
Product introduction – WP200, wrist strap, PAT probe, oximetry sensor
•
WP200 and wrist strap attachment
•
Probe and sensor attachment
•
Switch on
•
Ending the study
7.2. Product Introduction
•
Open the Demo-case and introduce the ‘Quick guide step-by-step’
instruction manual.
•
Introduce each component by its name and identify it as in the figures in the
manual.
7.3. Applying The WP200
Use the Demo Kit.
•
Demonstrate how to apply the WP200 on your wrist while following the
‘step by step’ guidelines and referring to the relevant figures.
•
Demonstrate the following:
1. Hand Preparation
• Remove rings, watches and jewelry from hand
• Remove fingernail polish and artificial nails
• Make sure finger nails are closely trimmed
2. Wearing the Wrist Strap
• Should be comfortable, not too tight
3. Attaching the WP200
•
Make sure the WP200 is properly mounted on the wrist
strap. If it is loose, gently slide it in until you hear a click.
4. Attaching the oximetry sensor
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•
Before PAT probe attachment
•
If using the Nonin 8000FJW sensor, demonstrate proper
placement of the finger on the Flexiwrap pad – note the
position of the fold line, and that the two black square
protrusions are opposite each other.
•
Folding the flaps of the Flexiwrap pad to secure sensor
properly.
•
Make sure it is not too tight
5. Attaching the PAT probe
•
Insert finger all of the way into the probe
•
Remove the Tabs one by one by pulling slowly and
gradually
•
Both tabs must be fully removed
•
The probe is limited to a SINGLE USE. Do not remove
probe during the night.
7.4. Switching on the WP200
Demonstrate switching on the WP200 by pressing the round center button
•
Push button firmly until the LCD display lights up
•
The oximetry sensor light will glow red during the entire test
7.5. Removing The WP200
•
Demonstrate how to remove the WP200 and place it back in the carrying
case.
•
The oximetry sensor light will keep glowing red.
•
The WP200 doesn’t switch off – once turned on it will record until the
battery is exhausted.
7.6. Patient Training
Following your demonstration have the patient attach the demo device by himself.
Verify that the attachment is properly done. Especially monitor carefully attachment of the
oximetry sensor.
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7.7. Review Safety, General And Functional Issues
•
Avoid exposing the WP200 to extreme conditions (high temperature, high
humidity)
•
Provide a telephone number to call in case of questions or problems.
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8. TROUBLESHOOTING GUIDE
8.1.
Operator Error Messages
If an error message is displayed while performing the self-diagnostic tests, take the actions
specified below. If the problem persists contact Itamar or an authorized representative.
Table 1 – Operator Troubleshooting
Error
File error
Loaded
Unloaded
Battery error % full
Possible Reason
Action
File not loaded
Battery defective or
uncharged
Load file
Charge battery or replace
Probe error
Used
Probe previously used
Missing
Probe absent
Oximetry sensor error
No sensor
Sensor absent
Disconnected
Sensor disconnected
No communication Module not connected
Hardware status error code WP200 defective
SBP discon
WP200 defective
RTC faulty
WP200 defective
Short recording time
Patient removed the WP200 or
probe from hand prematurely
Insufficient battery charge
caused early termination of
recording
Damaged WP200
Watch-PAT200
39
Replace probe
Attach probe
Replace sensor
Connect sensor cable to port
Check cable connection
Consult Itamar or authorized representative
Consult Itamar or authorized representative
Consult Itamar or authorized representative
Explain proper use to patient
Recharge battery and try again
Contact your authorized sales representative
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Itamar Medical Ltd.
8.2
Patient Error Messages
If an error message is displayed when the patient powers on the WP200, the patient should
take the actions specified below. If the problem persists the patient may contact Itamar or an
authorized representative directly.
Table 2 – Patient Troubleshooting
Error
Oximetry sensor light
turns off while WP200 is
on.
Possible Reason
Oximetry sensor plug not
fully inserted
Faulty oximetry sensor
Action
Verify that oximetry sensor plug is fully
inserted into the WP200
Check the oximetry sensor probe for damage
and replace if necessary
Oximetry sensor
disconnected
WP200 doesn’t switch on
Sensor not properly
connected or faulty
ON button not activated
Probe disconnected
PAT probe not connected
Probe may not be connected,
or may be a used probe
Hardware code
WP200 failure
Check connection. If problem persists replace
sensor
Press the ON button firmly for at least 3
seconds
Ensure probe is connected and try again
Check connection of probe to cable and cable to
the WP200; check if probe has been previously
used and replace with new probe if necessary
Contact Itamar or authorized representative
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9. SPECIFICATIONS
Table 3 – WP200 Specifications
Properties
Description
PAT Probe
Itamar’s proprietary probe only
Recording Time
10 hours (minimum)
Oximetry Probe
Custom Nonin 8000J Flex Sensor
Channels
Measuring 4 signals: PAT, Pulse rate, Oximetry,
Actigraphy
Sample Resolution
PAT and Actigraph – 12 bit; oximetry – 1%
User Interface
Pulse rate
Amplitude
Oximetry
LCD display
30-150 ± 1 bpm
0-1V 1%
70-100% ± 1%
Fixed Gain
600
Fixed Offset
1.5 Volts
Bandwidth
0.1-10 Hz
Media
Micro SD card
Capacity
64 MB (minimum)
Format type
Formatted to FAT 32
Battery
Proprietary, rechargeable Lithium Ion Battery
Capacity
> 500-700 mAh
Cell Type
Lithium Ion cell type
Internal Charger
Proprietary Lithium Ion battery charger
External Power Supply
5V DC, 5W with USB connector
Accuracy
PAT Channel
Data Storage
Power Supply
Operating Voltage
Temperature
3.3 V
Operation
Room temperature
Storage
0 – 50 0C
Humidity
Operating & Storage
10% – 60% (non-condensing)
Dimensions
LxWxH
80 x 50 x 20 mm
Weight
0.13 kg
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APPENDIX A: LICENSE AGREEMENT
License To Operator From Itamar
IMPORTANT – PLEASE READ THIS LICENSE AGREEMENT CAREFULLY BEFORE
INSTALLING OR OTHERWISE USING THE LICENSED SOFTWARE (AS DEFINED
BELOW) OR THE PRODUCT WITH WHICH YOU RECEIVED THIS LICENSE
AGREEMENT. THIS LICENSE AGREEMENT APPLIES TO (a) ALL LICENSED
SOFTWARE, (b) ALL LICENSED PRODUCTS (AS DEFINED BELOW), AND (c) ALL
THIRD PARTY PRODUCTS INTO WHICH A LICENSED PRODUCT OR LICENSED
SOFTWARE IS INCORPORATED.
SHOULD YOU HAVE ANY QUESTIONS
CONCERNING THIS LICENSE AGREEMENT, PLEASE CONTACT THE VENDOR
FROM WHICH YOU PURCHASED THE LICENSED SOFTWARE, LICENSED
PRODUCT, OR PRODUCT INTO WHICH A LICENSED PRODUCT OR LICENSED
SOFTWARE IS INCORPORATED. YOU MAY ALSO CONTACT ITAMAR AT THE
ADDRESS PROVIDED AT THE END OF THIS LICENSE AGREEMENT.
This License Agreement is a legal agreement between you (as an individual, company,
organization or other entity) and Itamar Medical Ltd. (“Itamar”). By installing, copying, or
otherwise using the Licensed Software, and/or by using the Licensed Product or third party
product into which a Licensed Product or Licensed Software is incorporated (“Third Party
Product”), you agree to be bound by the terms of this License Agreement with respect to the
Licensed Software and Licensed Products. If you do not agree to the terms of this License
Agreement, including, without limitation, the Restrictions on Use as provided in Section 2
do not install, use or copy the Licensed Software or use the Licensed Product or the Third
Party Product.
The Licensed Software and the Licensed Products are protected by US patent laws, trade
secret laws, copyright laws, and international treaty provisions as well as other intellectual
property laws and treaties. Therefore, you must treat the Licensed Software and the
Licensed Products like any other copyrighted and protected material or product. All title to
the Licensed Software and all intellectual property rights in and to the Licensed Software
and the Licensed Products shall remain with Itamar.
1
DEFINITIONS
1.1.
“Licensed Product(s)” means the Watch_PAT200 (Watch-PAT200), the
Site_PAT200, the PAT Probe and the corresponding components of any
Third Party Product with which this License Agreement was received.
Some Licensed Products are stand-alone products and some Licensed
Products are incorporated as components within Third Party Products, in
each case sold or otherwise made available, by Itamar and/or third
parties. If you have received this License Agreement with a Third Party
Product, this License Agreement applies only to the Licensed Product
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incorporated as a component within such Third Party Product.
1.2.
2
“Licensed Software” means the zzzPAT software, the associated media
and accompanying materials provided to you with such zzzPAT software.
Some Licensed Software is a stand-alone product and some Licensed
Software is incorporated as a component within a Licensed Product, in
each case sold or otherwise made available, by Itamar and/or third
parties. If you have received this License Agreement with a Licensed
Product which incorporates the Licensed Software as a component within
such Licensed Product, this License Agreement applies to the Licensed
Software.
GRANT OF LICENSE AND RESTRICTIONS ON USE
2.1 Itamar hereby grants you a non-exclusive right to use the Licensed Software , solely for
its intended use in sleep medicine (with the term "sleep medicine" including CheyneStokes respiration as well as research in sleep medicine and Cheyne-Stokes respiration) (i)
with the Licensed Product(s) and (ii) in accordance with the provisions of this License
Agreement and the instructions provided in the documentation accompanying the Licensed
Software and the Licensed Product You may make one copy of the Licensed Software
solely for backup or archival purposes, or transfer the Licensed Software to a single hard
disk, provided you keep the original solely for backup or archival purposes. However, you
may not cause any Licensed Software which is not designed for use on a server, to execute
or be loaded into the active memory or media of more than one computer at any one time.
2.2 Any use of the Licensed Software and/or Licensed Product other than as set forth in
Section 2.1 above is strictly forbidden. Without derogating from the generality of the above,
you may not:
• distribute, reproduce, copy, assign, rent, lease, or otherwise transfer the rights
granted to you under this License Agreement to any third party except explicitly as
set forth in this License Agreement;
• reverse engineer, decompile, or disassemble, as applicable, the Licensed Software or
the Licensed Product, except as expressly permitted by applicable law; or
• modify in any manner the Licensed Software and/or the Licensed Product unless
obtaining the prior written consent of Itamar.
3
TRADEMARKS
Cardio-PAT™, Sleep-PAT™ and all trademarks and logos, which appear on or in
connection with the Licensed Software and/or the Licensed Products, as may be amended
from time to time, are, unless stated otherwise, trademarks of Itamar. No right, license, or
interest to such trademarks are generated or granted hereunder other than the limited right
to use provided herein, and you agree that no such right, license, or interest shall be asserted
by you with respect to such trademarks. You may not remove or destroy any copyright,
trademark, logo or other proprietary marking or legend placed on or contained in the
Licensed Software or a Licensed Product.
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4
LIMITED WARRANTIES AND DISCLAIMERS
a. Against Infringement. Itamar hereby warrants to you that it has the right to grant you the
license to use the Licensed Software and/or the Licensed Product and to enter into this
License Agreement and that neither the Licensed Software nor the Licensed Product(s)
infringes the intellectual property rights of any third party.
b. As to Licensed Product. Itamar warrants that the Licensed Product with which this
License Agreement was delivered, will be free from defects in design, materials and
workmanship for a period of one year from the date of delivery of the Licensed Product to
you. If the Licensed Product contains a defect in design, materials or workmanship and
such Licensed Product is returned to Itamar within one (1) year of delivery of the Licensed
Product to you, Itamar will repair or replace the Licensed Product, or issue a credit for the
purchase price of the Licensed Product, with the choice to repair, replace or credit being
within the sole discretion of Itamar. The foregoing repair, replacement or credit remedy
will be your sole remedy for breach of the warranty set forth in this Section 4(b).
c. As to Licensed Software. Itamar warrants that for a period of ninety (90) days from the
date of delivery of the Licensed Software to you, the Licensed Software will, under normal
use, be free from defects in materials and workmanship and will perform substantially as it
is intended to perform. If during such ninety (90) day period, the Licensed Software has a
defect in materials or workmanship or does not perform substantially as it is intended to
perform, Itamar shall (a) attempt to correct or assist you around errors with efforts which
Itamar believes suitable to the problem, (b) replace the Licensed Software with a
functionally equivalent software, or (c) issue a credit for the purchase price of the Licensed
Software, with the choice to correct or assist, replace or credit being within the sole
discretion of Itamar. The foregoing correct or assist, replacement or credit remedy will be
your sole remedy for breach of the warranty set forth in this Section 4(c).
d. Limitation of Warranties. The warranties contained in Sections 4(b) and 4(c) above do
not cover damage to the Licensed Products or the Licensed Software caused by accident,
misuse, abuse, negligence, failure to install in accordance with Itamar’s installation
instructions, failure to operate under conditions of normal use and in accordance with the
terms of the documentation accompanying the Licensed Product and/or the Licensed
Software, failure to maintain in accordance with applicable documentation accompanying
the Licensed Product and/or the Licensed Software, alteration or any defects not related to
materials or workmanship, or in the case of Licensed Products, design, materials or
workmanship. This warranty does not cover damage which may occur in shipment. This
warranty does not apply to Licensed Products and/or Licensed Software not purchased new.
This warranty does not apply to any Licensed Product or any individual parts of a Licensed
Product which have been repaired or altered by anyone other than Itamar or a person or
entity authorized by Itamar to repair Licensed Products.
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While every reasonable effort has been made to ensure that you will receive Licensed
Software that you can use, Itamar does not warrant that the functions of the Licensed
Software will meet your requirements or that the operation of the Licensed Software will be
uninterrupted or error free. Itamar is not responsible for problems caused by changes in the
operating characteristics of the hardware or operating system software you are using, nor for
any problems in the interaction of the Licensed Software with non-Itamar software.
ITAMAR HEREBY DISCLAIMS, WITH RESPECT TO THE LICENSED PRODUCTS
AND THE LICENSED SOFTWARE, ALL OTHER WARRANTIES AND CONDITIONS,
WHETHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY
WARRANTIES OR CONDITIONS OF OR RELATED TO MERCHANTABILITY,
FITNESS FOR A PARTICULAR PURPOSE, ACCURACY OR COMPLETENESS OF
INFORMATION, LACK OF NEGLIGENCE AND CORRESPONDENCE TO
DESCRIPTION.
5
LIMITATION OF LIABILITY
(A)
TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, EXCEPT
FOR DAMAGES ARISING UNDER SECTION 4(A) ABOVE, IN NO EVENT SHALL
ITAMAR BE LIABLE TO YOU FOR DAMAGES IN EXCESS OF THE PURCHASE
PRICE YOU PAID FOR THE LICENSED SOFTWARE, THE LICENSED PRODUCT
OR THE APPLICABLE THIRD PARTY PRODUCT. THE FOREGOING LIMITATION
SHALL BE APPLICABLE REGARDLESS OF WHETHER THE ACTION GIVING RISE
TO SUCH DAMAGES IS IN TORT, CONTRACT, STRICT PRODUCTS LIABILITY,
OR OTHERWISE.
(B)
IN NO EVENT SHALL ITAMAR BE LIABLE FOR ANY SPECIAL,
INCIDENTAL, INDIRECT OR CONSEQUENTIAL DAMAGES WHATSOEVER
ARISING OUT OF OR IN ANY WAY RELATED TO THE USE OF OR INABILITY TO
USE THE LICENSED SOFTWARE AND/OR THE LICENSED PRODUCT AND/OR
THE THIRD PARTY PRODUCT, OR THE PROVISION OF OR FAILURE TO
PROVIDE SUPPORT SERVICES BY ITAMAR, EVEN IF ITAMAR HAS BEEN
ADVISED OF THE POSSIBILITY OF SUCH CONSEQUENTIAL DAMAGES. THE
FOREGOING DISCLAIMER OF CONSEQUENTIAL DAMAGES SHALL BE
APPLICABLE REGARDLESS OF WHETHER THE ACTION GIVING RISE TO SUCH
DAMAGES IS IN TORT, CONTRACT, STRICT PRODUCTS LIABILITY, OR
OTHERWISE.
(C)
IN ORDER TO BE ENTITLED TO INDEMNIFICATION HEREUNDER IN
CONNECTION WITH AN INFRINGEMENT CLAIM, YOU MUST (i) NOTIFY
ITAMAR IN WRITING PROMPTLY UPON BECOMING AWARE OF AN
INFRINGEMENT CLAIM OR THE POSSIBILITY THEREOF, (ii) GRANT ITAMAR
SOLE CONTROL OF THE SETTLEMENT, COMPROMISE, NEGOTIATION AND
DEFENSE OF ANY SUCH ACTION, AND (iii) PROVIDE ITAMAR WITH ALL
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INFORMATION RELATED TO THE ACTION THAT IS REASONABLY REQUESTED
BY ITAMAR. NOTWITHSTANDING THE FOREGOING, ITAMAR SHALL HAVE NO
INDEMNIFICATION OBLIGATIONS WITH RESPECT TO ANY INFRINGEMENT
CLAIM TO THE EXTENT ARISING FROM YOUR USE OF THE LICENSED
PRODUCT AND/OR LICENSED SOFTWARE IN CONJUNCTION WITH OTHER
HARDWARE OR SOFTWARE WHERE USE WITH SUCH OTHER HARDWARE OR
SOFTWARE GAVE RISE TO THE INFRINGEMENT CLAIM.
6
TERMINATION
Without prejudice to any other rights or remedies, Itamar may terminate this License
Agreement immediately if you fail to comply with any of its terms and conditions. In the
event of such termination, you must, within ten (10) business days of receiving notice of
termination from Itamar, cease all use of the Licensed Software and destroy all copies
thereof, and cease all use of the Licensed Product (including Licensed Product incorporated
within Third Party Product).
7
TRANSFERABILITY
You may only transfer or assign the rights and obligations hereunder together with the
Licensed Software and/or the Licensed Product or Third Party Product as a whole, without
retaining any rights or, subject to Sections 2 and 3 above, any obligations arising after the
date of such transfer or assignment, or retaining any installed or uninstalled copy of the
Licensed Software, the Licensed Product or the Third Party Product. Any attempt by you to
rent, lease, sublicense, assign or transfer any of the rights, duties or obligations hereunder in
any other way is forbidden and shall be null and void.
8
SEVERABILITY
Should any term or provision of this License Agreement be declared void or unenforceable
by any court of competent jurisdiction in any country or countries, such declaration shall
have no effect on the remainder of this License Agreement in such country or countries, or
on this License Agreement in other countries.
9
NO WAIVER
The failure of either party to enforce any rights granted to it hereunder or to take action
against the other party in the event of any breach hereunder shall not be deemed a waiver by
that party as to subsequent enforcement actions in the event of future breaches.
10 GOVERNING LAW AND JURISDICTION
This License Agreement is governed by the laws of the State of New York, excluding its
conflict of laws principles. The United Nations Convention on Contracts for the
International Sale of Goods shall not apply to any of the transactions contemplated by this
License Agreement.
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11 ENTIRE UNDERSTANDING
This License Agreement represents the complete and exclusive understanding between you
and Itamar concerning the license by Itamar to you of Licensed Software and Licensed
Products and supersedes all prior agreements and representations between the parties with
respect to the subject matter hereof, unless specifically stated otherwise in a writing signed
by Itamar and you. This License Agreement may not be amended other than by a written
agreement specifically intended for this purpose and signed by Itamar and you.
Note: Should you have any questions concerning this License Agreement, or if you desire to
contact Itamar for any reason, please write to: Itamar Medical Ltd., 9 Halamish St.,
Caesarea, 38900, Israel, Facsimile: +972-4-627 5598, or visit Itamar’s web site at
www.itamar-medical.com.
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APPENDIX B: REGULATORY REPRESENTATIVE
Itamar Medical’s authorized regulatory representative is:
MEDES LIMITED
5 Beaumont Gate, Shenley Hill,
Radlett, Herts WD7 7AR
England
Tel: +423-663-169205
Tel / Fax: + 44 1923859810
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APPENDIX D: DESCRIPTION OF THE WATCH-PAT PROBE
The Watch-PAT probe is an opto-pneumatic finger-mounted probe.
Its role is to continuously measure the relative state of the vasomotor activity in the distal
part of the finger based on a plethysmographic method. The Watch-PAT probe is designed
to cover the distal part of the finger with a uniform pressure field extending to the tip of the
finger. This design prevents venous blood pooling, engorgement and stasis, which inhibits
retrograde venous shock wave propagation, and allows partial unloading of arterial wall
tension that significantly improves the dynamic range of the measured signal. The optic
component of the probe measures the optical density related changes of the arterial blood
volume in the digital arteries, associated with each heartbeat. Peripheral arterial
constrictions, when present, are shown by attenuation in the PAT signal amplitude, a
marker of sympathetic activation.
The Watch-PAT probe is an integral part of the Watch-PAT device.
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APPENDIX E: MANUFACTURING DECLARATION ACCORDING TO
IEC 60601-1-2
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