MD Diagnostics RP Check User manual
RP Check
Operating Manual
MD Diagnostics Ltd
15 Hollingworth Court
Turkey Mill
Ashford Road
Maidstone
Kent ME14 5PP
UK
Tel: + 44 (0) 1622 682686
Fax: + 44 (0) 1622 681693
Email: [email protected]
www.mdd.org.uk
Revision 1.1 March 2019
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CONTENTS
Package Contents ........................................................................................2
Overview.......................................................................................................3
Intended Use ……………………………………………………………………..3
Contraindications ………………………………………………………………...4
Operation………………………………………………………………………….4
MIP Test .......................................................................................................6
MEP Test......................................................................................................9
SNIP Test ……………………………………………………………………… 11
Indices ........................................................................................................13
Ppeak –Peak maximum Pressure .........................................................13
MEP - Maximal Expiratory Pressure.......................................................13
MIP –Maximal Inspiratory Pressure.......................................................13
MRPD –Maximum Rate of Pressure Development ...............................13
MRR –Maximum Relaxation Rate..........................................................13
PC Installation and Report..........................................................................14
Calibration...................................................................................................18
Battery Life..................................................................................................18
Cleaning......................................................................................................18
Servicing.....................................................................................................19
Spares ........................................................................................................19
Specifications..............................................................................................20
Symbols......................................................................................................21
Environment................................................................................................21
Caution: Federal Law restricts this device to sale by or on the order of a
physician (or licenced practitioner)
0120
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Package Contents
The RPCheck is supplied in a hard-shell carry case containing:
1. RPCheck
2. 2 x Pink Inspiratory Test valves with integral bacterial/viral filter
(Single patient use only)
3. 2 x Blue Expiratory Test valves with integral bacterial/vial filter
(Single patient use only)
4. 4 x Flanged mouthpiece (Single patient use only)
5. PP3 Battery
6. 3 sizes of nasal probe (single patient use)
7. Operating Manual
8. Nasal probe adaptor
9. USB cable
10.USB stick containing RP Check PC software
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Overview
The RP Check is a handheld, portable, battery-operated device used for
rapid assessment of respiratory muscle strength. The unit can measure
mouth pressures - maximum inspiratory (MIP); maximum expiratory (MEP)
pressures and sniff nasal inspiratory pressure (SNIP). The unit measures
the pressures generated in cmH2O, and these are displayed on the backlit
display.
After either the inspiratory or expiratory mouth pressure manoeuvre, the
unit will display the maximum average pressure over one second in
cmH2O. To repeat the test, press the select key and keep it depressed
until the blow icon appears. Additional indices and the pressure/time curve
can be viewed by pressing the select key momentarily.
After a sniff nasal pressure, the unit will display the peak pressure obtained
in cmH2O for the manoeuvre to repeat the test press the select key and
keep it depressed until the sniff icon appears. The pressure/time curve can
be viewed by pressing the select key momentarily.
A Maximum of 10 tests are recorded for reviewing on the display along with
the corresponding pressure time curves. For mouth pressure
measurements (MIP and MEP) the variation from the best test obtained is
also shown and guidance that the ATS/ERS (American Thoracic Society)
reproducibility criteria has been met.
Once the patient has been tested the results may be uploaded to the PC
software using the USB cable provided, alternatively the unit can be
connected to the PC to allow tests to be performed and the results instantly
displayed on the PC screen –please see section on PC connectivity.
The unit does not require any form of calibration and is restricted to use in a
physician’s office or medical healthcare facility.
The device should be used under the guidance of a healthcare
professional.
Intended Use
The RP Check is intended to measure both inspiratory (MIP) and expiratory
(MEP) mouth pressures and Sniff nasal pressures (SNIP) generated by a
patient after being trained in the technique by a qualified healthcare
professional. The RP Check is suitable for both adult and paediatric
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patients from 6 years and older, there is no upper age limit providing the
patient can comply and perform the test as instructed. Interpretation of the
values obtained should only be performed by an appropriate healthcare
professional.
Contraindications
Mouth or nasal pressure testing should be avoided in patients with:
- Aneurisms
- Uncontrolled hypertension
- Urinary incontinence
T. Trooster et al, Eur Respir Mon, 2005, 31, 57–71
Operation
Insert the 9V PP3 battery [6LR61] (supplied) by removing the battery
cover and clipping the battery in place, replace the battery cover. The unit
will switch ON when the battery is connected. The initial displayed screen is
the MD Diagnostics logo along with the version of RP Check.
The display will then change to the below screen requiring the user to select
the test type: MIP, MEP or SNIP.
To select the desired test, press the ENTER key holding it down on the
highlighted test type and the display will change to show the appropriate
manoeuvre. To scroll to a different test type, press the ENTER key to move
the cursor to the next option, once the test has been selected and
highlighted keep the ENTER key depressed to select that option.
A maximum of 10 of each test type can be performed.
SELECT
TEST TYPE
MIP
MEP
SNIP
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If a patient has previously been tested, then the results are stored on the
device along with the corresponding mouth or nasal pressure graphs. The
options available will then be displayed:
The three options available are:
YES –to Upload the current test records to the PC software, to perform this
please see section on PC Report.
NO –selecting this will change the screen to the test type option.
NOTE: If NO is selected, the previous patients’ tests will be over written,
the device only keeps the last test results in the memory.
CONTINUE TESTING –the display will change the display back to the test
screen with the last graph displayed, pressing the ENTER key will change
back to the test icon and allow tests to be performed.
NOTE: The continue testing option allows the previous test type to
continue, there is not an option to change the test type –for example if the
patient was performing MIP tests and needed a rest and the device turned
OFF due to timing out or was turned OFF, the results and graphs are saved
on the device and MIP testing will be resumed if the Continue Testing
option is chosen.
NOTE: Once a test type has been selected the unit will continue giving an
audible beep to advise the operator that no flow is currently detected
through the unit. Once the patient begins the manoeuvre the audible beep
will be longer, to signify the start of the test.
UPLOAD LAST TEST
TO COMPUTER?
YES
NO
CONTINUE TESTING
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A total of 10 tests can be performed and stored on the RP Check, as tests
are performed the storage bar in the top left of the display will slowly
become shaded to signify that tests are being stored.
For mouth pressures MIP and MEP tests, if the reproducibility criteria have
been met –(3 tests performed and the highest 2 tests are within 20% of
each other), a flag will be displayed in the top bar of the display between the
test storage icon and the battery icon.
Switch OFF the unit by pressing the power button and keeping it
depressed for 3 seconds, the display will show the symbol and switch
off.
NOTE: If the RP Check has been left without being used for 5 minutes then
then it will turn itself OFF to save the battery power.
MIP Test
Insert the pink inspiratory disposable T piece valve. Connect the flanged
mouthpiece to the valve.
The valves are colour coded and are single patient use and should be
disposed of after each patient in accordance with your local infection control
policies. The inspiratory T piece valve have a proven bacterial and viral
efficacy >99% and offer protection to both patient and device. The flanged
mouthpiece is also a single patient use accessory. Failure to dispose of the
inspiratory T piece valve and flanged mouthpiece after each patient may
lead to cross infection between patients.
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Switch the unit ON and select the MIP test, wait for an exhale icon to
appear.
Request the subject to insert the mouthpiece into their mouth, ensuring the
flange is positioned over the gums and inside the lips, whilst the ‘bite
blocks’ are between the teeth. The subject should exhale as much air as
possible to empty their lungs, to residual volume (RV) and then inhale with
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as much effort and for as long as possible (minimum 1.5 seconds). If no
inhalation has occurred the alarm will constantly make an audible beep
indicating it is waiting for a test to be performed, when inhalation starts a
longer audible beep will be heard.
The display will show maximum average inspiratory pressure sustained
over a one second period of the test - MIP. If the manoeuvre was less than
1.5 seconds, the unit will beep and a stopwatch with an exclamation mark
will be displayed indicating that the expiration needs to be longer. When 2
seconds exhalation has occurred, an audible noise will be made indicating
the acceptable time period has been met. After each manoeuvre has been
performed pressing the select key momentarily will allow the operator to
view the Pressure time trace and the additional indices PMax, PAv, MRPD,
and MRR.
Pressing the select key and keeping it held down will change the display
back to the MIP blow icon.
It is recommended to perform three good tests and use the best result as
the maximum achievable MIP, MEP or SNIP. The ATS recommends for
reproducibility that the three tests performed should be within 20% of the
highest MIP pressure obtained. As tests are performed the highest value
acceptable test (over 1.5 seconds) will be displayed along with a cup to
indicate the best test, if subsequent tests are within 20% they will be shown
with a smiley face and if not within the 20% reproducibility a sad face will be
displayed, indicating further testing should be performed.
NOTE: Once three acceptable tests have been performed a flag will be
shown at the top of the display to indicate the reproducibility criteria has
been met.
The maximum reading the RPCheck can measure is equivalent to
300 cmH2O. Any reading above that will be displayed as ---
(overflow).
NOTE: If the patient does not inhale for the minimum period of 1.5 seconds
the display will show the stopwatch icon pressing the select key will
display the test icon so testing can be repeated
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MEP Test
Insert the blue expiratory disposable T piece valve. Connect the flanged
mouthpiece to the valve.
The valves are colour coded and are single patient use and should be
disposed of after each patient in accordance with your local infection control
policies. The expiratory T piece valves have a proven bacterial and viral
efficacy >99% and offer protection to both patient and device. The flanged
mouthpiece is also a single patient use accessory. Failure to dispose of the
expiratory T piece valve and flanged mouthpiece after each patient may
lead to cross infection between patients.
Switch the unit ON the unit and select the MEP test, wait for the exhale icon
to appear.
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Request the subject to insert the mouthpiece into their mouth, ensuring the
flange is positioned over the gums and inside the lips, whilst the ‘bite
blocks’ are between the teeth. The subject should inhale as much air as
possible until the lungs are fully (Total Lung Capacity –TLC) and then
exhale with as much effort and for as long as possible (minimum 1.5
seconds). If no exhalation has occurred the alarm will constantly make an
audible beep indicating it is waiting for a test to be performed, when
exhalation starts a longer audible beep will be heard.
The display will show maximum average expiratory pressure sustained over
a one second period of the test - MEP. If the manoeuvre was less than 1.5
seconds, the unit will beep and a stopwatch with an exclamation mark will
be displayed indicating that the expiration needs to be longer. When 2
seconds exhalation has occurred, an audible noise will be made indicating
the acceptable time period has been met. After each manoeuvre has been
performed pressing the select key will allow the operator to view the
Pressure time trace and the additional indices PMax, PAv, MRPD, and
MRR.
Pressing the select key and keeping it held down will change the display
back to the MEP blow icon.
It is recommended to perform three good tests and the best result as the
maximum achievable MIP, MEP or SNIP. The ATS recommends for
reproducibility that the three tests performed should be within 20% of the
highest MIP pressure obtained. As tests are performed the highest value
acceptable test (over 1.5 seconds) will be displayed along with a cup to
indicate the best test, if subsequent tests are within 20%, they will be shown
with a smiley face and if not within the 20% reproducibility a sad face will be
displayed, indicating further testing should be performed.
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NOTE: Once three acceptable tests have been performed a flag will be
shown at the top of the display to indicate the reproducibility criteria has
been met.
NOTE: If the patient does not exhale for the minimum period of 1.5
seconds the display will show the stopwatch icon pressing the select
key will display the test icon so testing can be repeated.
The maximum reading the RPCheck can measure is equivalent to
300 cmH2O. Any reading above that will be displayed as ---
(overflow).
SNIP Test
Insert the nasal probe adaptor to the front of the RP check, select the
appropriate sized nasal probe for the patient to be tested and connect to
the nasal probe adaptor ensuring it is twisted into place.
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Switch the unit ON and select the SNIP test, wait for the SNIP icon to
appear.
Ask the patient to insert the nasal probe into their nostril so it fits snugly and
will not fall out during testing. The patient should take a maximum sniff
through the occluded nostril. The manoeuvre is a hard-short sharp sniff and
the measurement taken is the maximum peak pressure as a result of the
sniff manoeuvre.
It is recommended to take a maximum of between 5 and 10 SNIP tests and
take the highest test achieved.
NOTE: The contralateral nostril should not be occluded during the sniff
manoeuvre.
The nasal probes are single patient use and should be disposed of
after testing in accordance with local disposal policy. Failure to use a new
nasal probe for individual testing may result in patient cross contamination
and infection.
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Indices
Ppeak –Maximum Peak Pressure
Ppeak is the maximum pressure achieved during the test.
MEP - Maximal Expiratory Pressure
MEP is the highest average expiratory pressure achieved over one second.
MIP –Maximal Inspiratory Pressure
MIP is the highest average inspiratory pressure achieved over one second.
MRPD –Maximum Rate of Pressure Development
MRPD is the highest rate of change of pressure on the upward stroke
(before the one second average is achieved) of either a MIP or MEP test.
MRR –Maximum Relaxation Rate
MRR is the maximum rate of change of pressure on the downward stroke
(after the one second average) of either a MIP or MEP test, divided by the
one second sustainable pressure value (the MIP or MEP value
respectively)
SNIP - Sniff nasal inspiratory pressure
SNIP is the peak pressure obtained from a maximum sniff nasal
manoeuvre
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PC Software installation and report
Installation
Attach the memory device supplied, to your PC USB port. When prompted,
open the folder and execute the setup.exe file. This will guide you through
the installation process. This will load the required software and drivers to
communicate with the device. It will also add an icon on your desktop.
Modes of operation when connected to the PC
The RP Check can be used in two modes:
1. USB connection to the PC to upload the last patients tests that have
been stored on the unit
2. “Live tests” performed on the RP Check and the results will be
displayed on the PC software as well as on the unit.
For both of the above modes of operation, turn the RP Check ON and
connect the USB cable to the side of the unit and to a free USB port on the
PC.
Note: When the RP Check is connected to the PC via the USB cable it will
gain power from the USB port and will not use the battery. To turn the unit
OFF disconnect the USB and press the ON/OFF button of the keypad until
the unit turns OFF.
Uploading a patient’s tests to the RP Check software from the unit:
a)Connect the USB cable to a free port of the PC and to the USB port
of the PC
b)Turn the RP Check unit ON using the keypad
c) Double click on the RP Check desktop icon
d)Click on the Connect button of the RP Check software and the
patient demographics fields will be displayed
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e) Enter the patient’s details and also the physician/healthcare
professionals name and the Hospital or organisations name –
these will appear on the PDF report that is created for the patient.
Note: ALL fields must be completed.
f) Once complete click on the button “Confirm Patient details”
g)The software will then offer the options to Upload Existing tests (from
the RP Check unit) or “Start New Test” using the PC software.
h)Select Upload Existing Tests and the individual tests will be uploaded
for viewing.
“Live tests” performed on the RP Check and displayed on the PC whilst
connected to the PC.
Follow the same procedure as if Uploading from the RP Check but select
Start new Test.
Note: It is important that you tell the PC software which test you are
performing MIP, MEP or SNIP, using the drop-down menu on the PC
software.
PC software Functionality
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Select Save Directory - this will allow you to select the directory as the
default directory where you wish to save the PDF reports created by the RP
Check Software
Export PDF –this will create and export the PDF report document to the
selected folder –the format for saving PDF’s is the patients ID followed by
the date and time the PDF was created.
Show Patient details –this will show the patient details that have been
completed for the aptient , along with the healthcare professionals name
and the organizations name. These details can be changed at any time
prior to exportimg the tests to a PDF format.
Select Test type –this is required when the RP Check is connected to the
PC for performing “live” tests, the PC software needs to be told which test
is being performed, select MIP, MEP or SNIP form the drop down. The
corresponding predicted value should also be chosen from the drop down
choice.
The + symbol will show a list of numbers in circles and these will
correspond to the individual tests. The circles encasing the numbers are
colour coded as follows:
Gold/yellow is the Best test
Green shows the test is within 20% of the best test –as per the ATS/ERS
Guidelines
Blue shows the test is technically acceptable and lasted for the required 1.5
seconds but falls outside of the 20% reporducibility criteria. Selectng the
individual circle will display the corresponfing test.
Once a test has been selected and reviewed and it is deeemed
unacceptable by the healthcare professional then selecting the Delete
current Test, will delete the test from the list .
NOTE: the numbering will stay the same but the numbered circle will now
appear grey.
Selecting Show ALL Tests will display all the tests performed overlaid on
top of each other.
Selecting Export to PDF will export the PDF to the chosen directory and will
show the patients details, a table of results, the Best pressure trace graph
and All pressure trace graphs
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Calibration
The unit contains a pre-calibrated temperature compensated pressure
sensor which requires no calibration during its lifetime.
Battery Life
The 9V PP3 battery should provide at least 20 hours of continuous use.
When the battery is low, the battery low icon will show only one segment.
The device can still be used, but it is advisable to replace the battery.
.
Please dispose of the battery for recycling according to your local
procedures.
Please remove the battery when the RP Check is not in use.
The battery should be changed when the low battery icon appears
on the display.
Power Saving
During the normal operation the unit will automatically switch OFF five
minutes after the last operation.
Cleaning
The RP Check unit requires no routine maintenance and is protected from
contamination by the Bacterial Filter. The inspiratory and expiratory valves
with integral filter have a bacterial/viral efficacy of >99% and are single
patient use. The flanged mouthpiece and nasal probes are also designed
as a single patient accessory. After patient testing, the valves and flanged
mouthpiece should be disposed of in accordance with local policy.
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External surfaces of the device may be wiped with a disinfection wipe,
acceptable wipes include but are not limited to Clinell Universal wipes, and
SaniCloth AF3 wipes. Wiping the screen should be avoided.
Servicing
Please only use accessories supplied by MD Diagnostics to ensure
the device performs as intended.
Please return the device to MD Diagnostics or its authorised
distributor for recycling at the end of its useful life.
If your unit requires servicing, then please contact your authorised
distributor or MD Diagnostics Ltd directly.
On request, MD Diagnostics Ltd will provide circuit diagrams, component
part lists, descriptions, calibration instructions to assist to service personnel
in parts repair.
Tel: + 44 (0) 1622 682686
Spares
Catalogue
Number
Description
MEP50
50 Single patient use Expiratory Valve with bacterial filter
and flanged mouthpiece
MIP50
50 Single patient use Inspiratory Valve with bacterial filter
and flanged mouthpiece
PP3B
Alkaline PP3 Battery
NPR01
Small nasal probes (pack of 10)
NPR02
Medium nasal probes (pack of 10)
NPR03
Large nasal probes (pack of 10)
ANPA01
Nasal probe adaptor
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