SimCPR PRO User manual

SimCPR® Pro
User Manual
Read carefully before first use!
1 Intended use and contraindications
SimCPR® Pro support first responders in performing effective
chest compressions in accordance with scientific CPR
guidelines
Indication of use:
SimCPR® Pro supports first responders performing CPR on
patients of 12 years of age and older who are suspected of
having a cardiac arrest.
SimCPR® Pro feedback provides extra support for the
rescuers doing CPR based on their training and experience.
Contraindications:
SimCPR® Pro may not be used in the following situations:
• The patient is younger than 12 years old.
• The patient reacts when spoken to.
• The patient breathes normally.
• CPR during transport.
• CPR on a soft surface.
2 Description
SimCPR® Pro is a medical device that provides real-time
feedback to the rescuer who is performing CPR on a patient in
cardiac arrest.
The device is worn as a wristband.
SimCPR® Pro registers the up and down movements of the
rescuer's wrist during chest compressions (amplitude).
The built-in accelerometer analyses these movements and
accurately calculates the traveled distance (depth) and tempo.
Through a red and green LED-light the first responder gets
feedback if chest compression depth and tempo are correct.
SimCPR® Pro is set according to the scientific CPR-guidelines
for patients older than 12 years: chest compressions with a
minimum depth of 2 inches (5 cm) and a rate between 100-120
per minute.
SimCPR® Pro can be used multiple times on different patients.
3 Warning
SimCPR® Pro calculates the depth based on the traveled
distance during compression/decompression.
When the rescuer compresses the chest for e.g. 2.4 inches (6
cm) but keeps leaning 0.8 inches (2 cm), the measured
distance will be only 1.6 inches (4 cm). In this case the red
LED-light will keep on flashing.
The moment the rescuer stops leaning, with full chest recoil,
the traveled distance will be 2.4 inches (6 cm) and the green
LED-light will be activated.
If the rescuer does not keep contact with the patient chest after
recoil, the device will measure a larger distance traveled.
In this case the green LED-light can be activated while chest
compressions are not deep enough.
SimCPR® Pro is only intended to be used on patients over 12
years of age. The medical device is not suitable for children
under 12 years of age. This age group requires a different
compression depth than older children and adults.
4 Complications and safety information
Several medical studies have shown that different types of
injuries can be caused by performing chest compressions on
patients in cardiac arrest.
In general these injuries are not fatal and the chance of death
is more likely without chest compressions.
For users/patients within the European Union (Medical device
regulation EU 2017/745), the following applies:
In case of serious harm from the use of this medical device,
you need to report this to SimCPR Medical BV and the relevant
authority of the Member State where the user/patient is
located.
5 Precautions
First check if the patient needs to be resuscitated.
Resuscitation is needed when the patient is unresponsive and
has no (normal) breathing.
Make sure the EMS (Emergency Medical Service) is activated
and someone is gone to get an AED (Automated External
Defibrillator) to the patient.
It is strongly recommended that first responders using a
SimCPR® Pro, are trained on a regular basis to keep their
skills up-to-date.
6 Use
Put the SimCPR® Pro wristband on the left or right wrist of the
upper or lower hand.
Ensure that the wristband is tight enough around the wrist to
ensure that there is no slackness, so that the wristband exactly
follows the movement of the wrist.
First turn on the SimCPR®Pro by pressing the ON/OFF
symbol on the sensor.
You should press the button hard enough to hear it click.
The SimCPR® Pro is active once the red LED-light starts
flashing.
After the device is activated, you continue with placing your
hands in the middle of the chest on the nipple-line.
Straighten your back, stretch your arms and place your
shoulders perpendicular above the chest.
Start chest compressions by pushing the chest down and let it
come up again.
As instructed, both hands of the rescuer should always keep in
contact with the chest of the patient during compressions.
If the SimCPR® Pro is worn on the upper hand, this hand
should keep in contact with the underlying hand on the chest.
This ensures the most accurate measurement of depth.
Note:
First focus on getting a correct depth and then on getting a
correct tempo.
As long as the measured chest compression movements are
less than 2 inches (5 cm), the red LED keeps flashing.
Push harder until the green LED flashes or lights up
continuously.
As soon as the measured chest compression movements are
equal or above 2 inches (5 cm), the green LED starts flashing
or lights up continuously when also tempo is within 100-120/
min.
⚠
It is not unusual for ribs to break during chest
compressions.
Despite breaking ribs, continue with CPR!
⚠
Make sure there is a full chest recoil before
you start pushing the chest down again.
Do not lean keep leaning on the chest.
SimCPR Medical BV
1e Energieweg 13
9301 LK Roden
The Netherlands
ww.simcpr.com
Date: 29-08-2022 V1.3 ENGLISH
Press the ON/OFF-button to
start.
⚠
Releasing hands from the chest increases the
distance traveled.
⚠
Leaning on the chest after recoil, reduces the
distance traveled.
Make sure the LED’s are
clearly visible.

Continue CPR until EMS-professionals take over or till the
patient shows signs of life (= patient responds or has normal
breathing).
After use
You can turn off the SimCPR® Pro by pushing the ON/OFF-
button for 3 seconds.
When the SimCPR® Pro is activated and doesn’t move for 5
minutes, the device will turn off automatically.
Remark: Check the battery after every use (see section 7).
If necessary the medical device can be disinfected after every
use with a 70% isopropyl alcohol solution.
Do not submerge the device in water or hold it under running
water. Do not sterilize the device.
7 Periodic monitoring and replacement batteries
The service life of the 3V lithium button cell battery is six years
in standby mode or 100 active operating hours.
Check the battery capacity anytime by switching the SimCPR®
Pro on and then off again. After you switch it off (by pressing
the ON/OFF button for at least 3 seconds), the green or red
LED will light up briefly. If the green LED lights up, there is
sufficient battery charge available. If the red LED lights up, you
need to replace the battery of the device by a new one.
Battery replacement
SimCPR®Pro comes with a replaceable battery (CR2032).
Only use Lithium UL-approved batteries from e.g. Varta,
Panasonic, Sony, Philips or Duracell.
1. Remove the 4 screws at the back of the device (Torx 6).
2. Remove the upper green part of the housing.
3. Remove the white cover (with light guides).
4. Take out the sensor and push the battery out to the metal
holder (do not dispose of the battery with household waste
but take it to a suitable waste station).
5. Insert a new 3V battery (CR2032) in the same way (+ side
up).
6. Place back the sensor (this is only possible in one way)
and push the battery down for optimal LED-light effect.
7. Place back the white cover with light guides (also this is
only possible in one way).
8. Place back the upper green part (fits one way) and finally
put the 4 screws back.
Turn the SimCPR® Pro on and check if the red LED flashes
and that you can see both LED-lights clearly. The device is
now ready for use again.
You can visit the SimCPR® Youtube-channel for a video on
battery replacement.
The battery and SimCPR® Pro should not be disposed off with
household waste. Please dispose of the battery separately
according to the guidelines for toxic waste through the special
collection points.
Dispose of the SimCPR® Pro at a specialized electronic
collection point.
8 Troubleshooting
9 Technical specifications
Model: SimCPR®Pro
Catalog number: 30476
Dimensions: 45x40x20 mm (1.77”x1.57”x0.97”)
Weight: 23 g
Transmitter module: 12155A-EMBC22
Batteries: CR2032 (3V Lithium)
Battery lifetime: 6 years/100 hours operational use
Use conditions:
• Temperature: Between 0°C and +40°C
• Relative humidity: 15 to 90% RH
• Atmospheric pressure: 860 hPa to 1060 hPa
Ingress protection: IP54
The device complies with the general safety and performance
requirements of (EU) 2017/745 (Class 1) .
This device complies with the European standards EN
61000-4-2 and EN 61000-4-3 and is subject to electromagnetic
compatibility safety precautions.
10 Warranty/service
The manufacturer's warranty is 5 years. Please contact your
dealer for more information regarding the warranty and
conditions.
11 Explanation of symbols
⚠
Allow the patient’s chest expand fully before
compressing it again.
Do not keep leaning on the patient’s chest!
⚠
When the chest of a patient is very stiff, it can
be difficult to compress the chest the full 2
inches in order to activate the green LED.
Continue CPR anyway and try to push as hard
as you can or change places with another first
responder.
⚠
Check the battery at least every 3 months.
In this way you prevent the battery is empty
during a rescue event.
⚠
There is a danger of explosion when batteries
are replaced by an incorrect type.
Problem
Possible
cause
Solution
Red LED
does not
start to flash.
ON/OFF
button has not
been pressed
hard enough.
Press the ON/OFF
button firmly until you
hear a ‘click’.
Battery is flat.
Replace the battery or
device.
Device is
defective.
Contact your dealer or
SimCPR Medical BV.
Green LED
does not
start to flash.
Your
compressions
are not deep
enough.
Press the patient's
chest deeper (≥
2 inches) and do not
lean.
You are
continuing to
lean on the
patient's chest.
Allow the patient's
chest to come all the
way up and do not
continue to lean on it.
Device is
defective.
Contact your dealer or
SimCPR Medical BV.
Green LED
will not light
up
continuously.
Tempo of
compressions
is too slow or
too fast.
Push faster or slower
to get a correct tempo
of 100-120/min.
This product complies with the requirements of
the European Medical Device Regulation: (EU)
2017/745
Manufacturer
Consult instructions for use or consult
electronic instructions for use
Warning: Consult the instructions
Catalogue number
Batch code/Lot number
Medical Device
Unique Device Identifier
Stand-by
Separate collection for waste electrical and
electronic equipment recycling: electronic
equipment. WEEE Directive 2012/19/EU
Do not use on children under 12
Ingress Protection rating - protected from limited
dust ingress and sprays from all direction.
3V lithium button cell battery
SimCPR®-Feedback
Red LED flashes:
Compression-decompression depth < 2inches/5cm.
Green LED flashes:
Compression-decompression depth ≥2 inches/5cm.*
Solid green LED:
Compression-decompression depth ≥2 inches/5cm and
tempo 100-120/min.
* When the green LED is activated, the software must
first measure a value < 2inches/5cm three times, before
the red LED starts flashing. Depth accuracy
accelerometer: ± 5%