Physio Control TrueCPR User manual

Coaching-Gerät
Dispositif d’assistance
Dispositivo de orientación
INSTRUCTIONS FOR USE
Gebrauchsanweisung
Instructions d’utilisation
Instrucciones de uso

English . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
German/Deutsch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
French/Francais . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Spanish/Espanol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Electromagnetic Compatibility Guidance . . . . . . . . 73
CONTENTS

©2012 Physio-Control, Inc. 1
Introduction
The Physio-Control TrueCPR coaching device provides rescuers with real-time
feedback on chest compressions during cardiopulmonary resuscitation (CPR) in
accordance with current CPR guidelines.
IMPORTANT! Read these instructions carefully before use, and keep for future
reference.
These operating instructions provide the procedural steps for proper use of the
TrueCPR device, and can be used for training purposes. Operators should read
these instructions and be thoroughly familiar with the device before use.
For information about electromagnetic compatibility, see “Electromagnetic
Compatibility Guidance” on page 19.
Intended Use
The TrueCPR device is intended to provide feedback to assist rescuers to
perform CPR. Rescuers must be trained in CPR and use of the device.
The TrueCPR device is intended for use on patients eight years of age and older.
Indications
The TrueCPR device is indicated for use on patients in cardiac arrest
(unconscious, pulseless, not breathing normally).
Operating Principle
The TrueCPR device consists of a chest pad, which is placed on the sternum,
and a back pad, which is placed beneath the patient. The device determines the
depth of chest compressions during CPR by measuring the distance between the
chest pad and back pad. The device measures distance by sending and
receiving electromagnetic signals between the chest pad and back pad.
Safety Information
The following terms are used in these operating instructions:
Warning: Hazards or unsafe practices that may result in serious personal
injury or death.
Caution: Hazards or unsafe practices that may result in minor personal injury,
product damage, or property damage.
English

2 TrueCPR Device Instructions for Use
Safety Information
IMPORTANT! Check the battery readiness indicator regularly. If indicator is not
flashing, replace batteries immediately.
WARNINGS
POSSIBLE PATIENT INJURY:
• The TrueCPR device is not intended for use on children or infants. Only
use the device on patients who are 8 years of age or older.
POSSIBLE INEFFECTIVE CPR:
• After use, inspect device and cable for wear or damage. Remove from
service if damaged.
• Do not use the TrueCPR device over very large metal surfaces. Perform
CPR unaided instead.*
• The TrueCPR device may provide incorrect feedback if not positioned
properly.
• Check back pad and chest pad position after patient movement and
during transport.
• If patient is on a mattress, place a backboard beneath the patient
according to standard protocols. Then insert the device back pad
between the patient and backboard.
• If the device cannot be positioned correctly on the patient or fails to
operate, remove the device and perform CPR unaided.
POSSIBLE DEVICE FAILURE: Do not modify the TrueCPR device.
POSSIBLE ELECTRICAL INTERFERENCE WITH DEVICE
PERFORMANCE: Equipment operating in close proximity may emit strong
electromagnetic or radio frequency interference (RFI), which could affect the
performance of this device. Avoid operating the device near cauterizers,
diathermy equipment, or other portable and mobile RF communications
equipment. See “Separation Distances” on page 22 for recommended
distances of equipment. Contact Physio-Control Technical Support if
assistance is required.
POSSIBLE EXPLOSION HAZARD: Do not use this device in the presence of
flammable gases or anesthetics.
* The TrueCPR device has been designed for use on hospital beds,
stretchers, gurneys, and in ambulances. The device is compatible with
common patient-worn or implanted metal, such as jewelry, ICDs, or
pacemakers.

©2012 Physio-Control, Inc. 3
English
Basic Orientation
Chest Pad Screen
Item Description
1Power Button: Press green button to turn device on. Press and hold for
2 seconds to turn device off.
2Mute Button: Press to turn metronome on or off.
In Event Review mode, press to switch between screens.
3Palm Pad: Hand placement area.
4Airway Button: Press to switch metronome between Airway
(continuous compressions) mode and No Airway mode.
5Screen: Displays compression feedback and other indicators.
6Recoil Target Zone: Changes from light green to dark green when
compression is completely released.
7Low Battery Indicator: Appears when remaining battery capacity is
less than 30 minutes of operation.
8Compression Rate Meter: Displays rate as compressions per minute.
Changes to Inactivity Timer when compressions stop.
9Elapsed Time Meter: Displays elapsed time since beginning of event.
10 Airway Indicator: Appears when device is in Airway mode.
11 Compression Target Zone: Changes from light green to dark green
when compression reaches target depth of 5–6 cm (2–2.5 in).
12 Compression Depth History: Dark green or gray segment in outer
circle shows depth of previous compression.
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24
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11
6
7
8
10
12
9

4 TrueCPR Device Instructions for Use
Using the TrueCPR Device
Using the TrueCPR Device
Performing CPR
To use the TrueCPR device:
1 Confirm patient is in cardiac arrest.
2 Remove the device from the carrying bag.
3 Separate the chest pad and back pad.
Back Pad
Item Description
1
Battery Readiness Indicator: Flashing LED on back pad handle
indicates battery capacity is sufficient for at least 30 minutes of
operation.
2USB Port Cover: Provides access to USB port. Use a coin or similar
tool to open.
3Battery Compartment: Holds two nonrechargeable Duracell®DL123
batteries. Use a coin or similar tool to open.
1
23

©2012 Physio-Control, Inc. 5
English
4 Press the (POWER) button to turn the device on. The calibration screen
appears.
IMPORTANT! Do not press on the chest pad until calibration is complete
and feedback screen appears (approximately 3 seconds).
5 Position the back pad beneath the patient as shown in Figure 1. This helps
the back pad stay in position. The back pad may be placed on either side of
the patient.
6 Dry chest if necessary to prevent the chest pad from slipping.
7 Place the chest pad so that the palm pad is in the middle of the chest, on the
lower half of the sternum.
Figure 1 Recommended Device Position
Notes:
• If the Reposition Back Pad alert indicator appears, adjust the back pad
position to be closer to the chest pad if possible. See “Alert Indicators” on
page 10 for more information. If the Reposition Back Pad alert persists,
perform CPR unaided.
• If the device cannot be placed in the recommended position, the
alternative position shown in Figure 2 may be used. When the back pad is
placed in the side position, the chest pad must be rotated 180°. Keep the
palm pad in the middle of the chest on the lower half of the sternum. If the
device cannot be positioned properly, perform CPR unaided.
Figure 2 Alternative Device Position
Back Pad in Vertical Position Chest Pad in Vertical Position
Back Pad in Side Position Chest Pad in Rotated Position
AND
AND

6 TrueCPR Device Instructions for Use
Using the TrueCPR Device
8 Place the heel of your hand on the palm pad and begin compressions in time
with the metronome. Be sure to maintain correct CPR hand position.
9 Follow the device metronome to maintain your rhythm.
Note: To silence the metronome, press the (MUTE) button.
10 Observe the screen for depth feedback and any alert indications. Adjust your
technique based on the feedback. See the screen illustrations beginning on
page 8 for descriptions of the feedback.
11 Provide rescue breaths when prompted by the screen and ventilation tones.
12 Continue CPR as long as indicated by your local protocols. When
compressions stop, the inactivity timer appears in place of the compression
rate meter. If compressions resume within 10 minutes, compression
feedback resumes. The device turns off automatically after 10 minutes with
no activity.
13 To turn the device off, press and hold the (POWER) button for 2 seconds.
WARNING
POSSIBLE INEFFECTIVE CPR: If the screen on the TrueCPR device is
unreadable, unresponsive, or otherwise visibly damaged, do not use the
device. Perform CPR unaided instead.
Inactivity timer

©2012 Physio-Control, Inc. 7
English
Using the TrueCPR Device on a Mattress
If the patient is on a mattress, place a backboard beneath the patient according
to standard protocols. Then insert the TrueCPR device back pad between the
patient and backboard.
Using the TrueCPR Device with Secured Airway
When the TrueCPR device turns on, it defaults to No Airway mode. Ventilation
prompts are provided at a ratio of 30 compressions to 2 ventilations (30:2). If an
artificial airway is in place, press the (AIRWAY) button to switch the device to
Airway (continuous compressions) mode.
The following two changes occur when the device is switched to Airway mode.
• The airway indicator appears on the screen.
• Ventilation prompts are not provided.
Each time you press the AIRWAY button, the device switches between Airway
mode and No Airway mode.
Using the TrueCPR Device During Defibrillation
Using the TrueCPR Device on Patients with Sternal Incisions
Establish and follow local protocols for use of the TrueCPR device on patients
with sternal incisions or injuries.
Using the TrueCPR Device on Patients with Implantable Devices
The emitted magnetic fields used by the TrueCPR device meet existing
electromagnetic compatibility safety standards for medical devices. It is
It is acceptable to keep the TrueCPR device on the patient during defibrillation.
Observe the following precautions:
• Position the chest pad and defibrillator electrodes
as shown.
• Do not touch the TrueCPR device during defibrillation.
• Do not apply defibrillator electrodes on top of the
TrueCPR device cable.
Airway indicator

8 TrueCPR Device Instructions for Use
Using the TrueCPR Device
recommended that routine post-event confirmation of implantable device
function be performed by a trained clinician to ensure programming and system
integrity.
Using the TrueCPR Device for Training
The TrueCPR device may be used on a manikin for training purposes. Some
manikins may require updates to reach compression depths of 5 to 6 cm (2 to
2.5 in), consistent with AHA and ERC guidelines. You can use a manikin that
does not allow these depths, but the TrueCPR device will not reach the
compression target zone.
Note: The Reposition Back Pad indicator (see page 10) may appear if the
manikin contains large metal plates.
Screen Illustrations
Calibration Screen
When you turn on the TrueCPR device, the calibration screen appears.
Compression Indicators
During compressions, the gray fan moves between the recoil zone and
compression zone as shown.
Calibration in progress Calibration complete
Compression in
progress: Gray fan
moves across screen.
Sufficient depth: Dark
green wedge in
compression target
zone.
Sufficient recoil: Dark
green wedge in recoil
target zone.

©2012 Physio-Control, Inc. 9
English
Incorrect Compression Indicators
Rescue Breath Indicators and Tones
In No Airway mode, the device provides a countdown screen and tones to
indicate when you should prepare to give rescue breaths. The countdown is
followed by two ventilation prompts. The compression to breath ratio is 30:2.
Recoil incomplete:
Arrow appears.
Compression too
shallow: Arrow appears.
Compression > 6 cm:
Orange wedge appears
outside compression
target zone.
Countdown to ventilation prompts
Ventilation prompts

10 TrueCPR Device Instructions for Use
Using the TrueCPR Device
Alert Indicators
Shut-down Screen
Electronic noise is
interfering with device.
Locate and remove
source of interference.
If indicator persists,
perform CPR unaided.
Device cannot provide
feedback. Turn device off
and back on. If indicator
persists, perform CPR
unaided.
Back pad is incorrect
distance from chest pad.
Reposition back pad. If
indicator persists,
perform CPR unaided.
Progress bar appears during shut-down.
Note: Shut-down may take several minutes.
Do not remove batteries while shut-down is in
progress.

©2012 Physio-Control, Inc. 11
English
Event Review Screens
Two event review screens display data for the most recent device use. To display
the event review screens, start with the device turned off. Press the (AIRWAY)
and (POWER) buttons simultaneously to turn the device on in Event Review
mode. To switch between the screens, press the (MUTE) button.
Troubleshooting Tips
These troubleshooting tips provide immediate corrective actions for possible
problems. If a problem persists, contact your local Physio-Control representative
for assistance. In the USA, call Technical Support at 800.442.1142.
Percent of compressions with depth in target
range.
Percent of compressions with proper recoil.
Average compression rate (compressions per
minute).
Total event duration.
Percent of total event with compressions.
OBSERVATION CORRECTIVE ACTION
No audible metronome. • Use compression rate meter for guidance.
Device does not function. • Only use device within specified operating
temperature range of 0°–40°C (32°–104°F).
• Perform CPR unaided.
Display is visible, but does not
provide compression feedback. • Turn device off and back on. Do not apply pressure to chest pad until calibration is
complete and feedback screen appears.
• Perform CPR unaided.
Alert indicator persists. • Turn device off and back on. If indicator
persists, perform CPR unaided.
• Contact Technical Support or your local
Physio-Control representative for
assistance.

12 TrueCPR Device Instructions for Use
Data Management
Data Management
The TrueCPR device can store compression data for three 60-minute sessions,
or up to six sessions totaling 180 minutes. When all available memory has been
used, the data from the oldest use is overwritten automatically.
Data can be transferred to a computer with TrueCPR device-compatible software
via USB connection. Event reports can be printed directly from the software. For
information on TrueCPR device reports and full event review functionality,
contact your local Physio-Control representative.
To initiate data transfer:
1 Connect a USB cable between the TrueCPR device and a computer with
compatible software.
Note: Use only a USB cable that meets the following specifications: USB 2.0
A-Male to Mini-B 5-pin Male, 28/24 AWG cable with ferrite core (gold plated),
1 m (3 ft).
2 Turn on the TrueCPR device. If the software on the computer does not start
automatically, open the program manually.
3 Follow the instructions in the software on the computer to select the TrueCPR
device and initiate data transfer. Data transfer may take up to 5 minutes if
memory is full. The following screens may appear on the TrueCPR device:
WARNING
SHOCK HAZARD: Do not use the USB connector if the TrueCPR device
is damaged.
POSSIBLE ELECTRICAL INTERFERENCE: Using cables or accessories
that are not specified for use with the TrueCPR device may result in increased
emissions or decreased immunity from electromagnetic or radio frequency
interference (RFI) for this device. This could affect the performance of the
TrueCPR device or equipment in close proximity. Use only cables and
accessories specified in these instructions for use.
Data transfer in
progress.
Data transfer successful. Data transfer failed.

©2012 Physio-Control, Inc. 13
English
Troubleshooting Tips for Data Management
Cleaning the Device
The TrueCPR device should be cleaned and inspected after each use.
1 Clean the device with a sponge or cloth that has been dampened with one of
the cleaning agents shown below:
• Quaternary ammonium compounds
• Isopropyl alcohol
• Hydrogen peroxide, 3% solution
• Sodium dichloroisocyanurate (NaDCC), 3000 ppm solution
• Chlorine bleach, 1:10 dilution with water
2 Inspect the device and cable for wear or damage. Remove from service if
damaged.
3 After cleaning, wipe off solution with a clean, damp cloth.
IMPORTANT! Do not immerse or soak the chest pad or back pad.
Storing the Device
Place chest pad onto back pad. Store in carrying bag so that battery readiness
indicator is visible.
OBSERVATION CORRECTIVE ACTION
Feedback screen appears on
TrueCPR device and
metronome sounds.
• Confirm USB cable is properly connected.
• Confirm computer is on.
• Replace USB cable.
• Use recommended USB cable (see Step 1
on page 12).
Data Transfer Failed screen
appears. • Turn TrueCPR device off and check connections. Then turn device on and
attempt data transfer again.
• If problem persists, contact Technical
Support.
CAUTION
POSSIBLE DEVICE DAMAGE: If the TrueCPR device will be stored for an
extended period of time, remove the batteries to prevent possible damage
due to battery leakage.

14 TrueCPR Device Instructions for Use
Maintaining and Recycling the Device
Maintaining and Recycling the Device
Maintenance
The TrueCPR device and cable should be inspected regularly as part of your
routine equipment inspections. See the Operator’s Checklist at the back of this
language section for instructions.
Battery Replacement
Use only Duracell DL123 batteries for reliable performance.
To replace the batteries, use a coin or similar tool to open the battery
compartment door. Remove the old batteries, wait 30 seconds, and then insert
new batteries as shown in the diagram on the compartment door. Close the
compartment door securely.
Note: If the battery readiness indicator does not flash after the batteries are
replaced, perform the following corrective actions.
• Verify batteries are installed correctly.
• Remove batteries, wait 30 seconds, and then re-install batteries.
• Turn device on and look for low battery indicator on screen. If low battery
indicator does not appear, battery readiness indicator may be faulty.
Contact Technical Support or your local Physio-Control representative for
assistance.
Service and Repair
The TrueCPR device contains no serviceable parts. If the device does not
function correctly, contact your local Physio-Control representative for
assistance.
Recycling the Device and Batteries
Recycle the device and batteries according to national and local regulations. For
instructions on disposing of this product, see www.physio-control.com/recycling
or contact your local Physio-Control representative.
WARNING
POSSIBLE LEAK, FIRE, OR EXPLOSION:
• Do not disassemble, puncture, crush, heat above 100°C (212°F), or
incinerate the batteries.
• Do not use rechargeable batteries in the TrueCPR device. Use only
nonrechargeable Duracell DL123 batteries.
• Replace both batteries at the same time with new Duracell DL123
batteries. Do not mix partially discharged and new batteries.

©2012 Physio-Control, Inc. 15
English
Symbols
The following symbols may be found on the TrueCPR device or packaging.
SYMBOL DESCRIPTION
Power button
Mute button
Airway button
Device requires two Duracell DL123 batteries (nonrechargeable)
Operating temperature 0° to 40°C (32° to 104°F)
Defibrillation proof, type BF applied part
Attention, consult accompanying documents. (Symbol has blue
background and graphical symbol is white.)
Do not step on the device.
Do not sit on the device.
Do not dispose of this product in the unsorted municipal waste stream.
Dispose of this product according to local regulations. For instructions
on disposing of this product, see www.physio-control.com/recycling.
Enclosure ingress protection code per IEC 60529. This rating provides
for a specified degree of protection against the ingress of particles and
the harmful ingress of water.
Device includes RF transmitter.
Mark of conformity according to the European Medical Device
Directive 93/42/EEC
Mark of conformity to Canadian and US standards
Mark of conformity to ACA standards
Manufacturer’s identification number (part number)
Catalog number
Serial number
Date of manufacture
Manufacturer
Authorized EC representative
IP55
or
or
YYYY

16 TrueCPR Device Instructions for Use
Product Specifications
Product Specifications
Safety Classifications
SPECIFICATION DESCRIPTION
Power Requirements Batteries: 2 Duracell nonrechargeable DL123 cells
Operating Time 180 minutes at room temperature with new batteries
Operating Temperature Device can be used at 0° to 40°C (32° to 104°F).
Applied part temperature may reach 43°C (109°F) during
extended use at ambient temperature of 40°C (104°F).
Shelf Life Provides 30 minutes of CPR feedback after 24 months without
use at 25°C (77°F), starting with new batteries installed.
Storage Temperature -30° to 70°C (-22° to 158°F)
Relative Humidity 5 to 90%, non-condensing
Altitude -382 to 4,572 m (-1,253 to 15,000 ft)
Object and Water
Resistance IP55 per IEC 60529 and EN 1789
Weight Less than 0.75 kg (1.65 lb) with batteries installed
Ventilation Prompts 2 ventilation prompts every 30 compressions in No Airway mode.
No ventilation prompts in Airway mode.
Compression Depth Target depth range of 5 to 6 cm (2 to 2.5 in)
Metronome Rate 104.4 ±1 compressions per minute, consistent with AHA and
ERC guidelines.
Model 80596-000001
CATEGORY CLASSIFICATION
Protection Against Electric Shock Internally powered ME equipment.
Type BF defibrillation proof applied parts.*
Protection Against Solid Object and
Liquid Ingress
IP55
Mode of Operation Continuous operation
* Type BF defibrillation proof applied parts are the underside of the chest pad and the top
of the back pad. See page 15 for symbol illustration.