Physio Control TrueCPR 80596-000001 User manual

INSTRUCTIONS FOR USE

Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Operating Principle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Basic Orientation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Using the TrueCPR Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Performing CPR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Screen Illustrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Troubleshooting Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Operator’s Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Data Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Troubleshooting Tips for Data Management. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Cleaning the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Storing the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Maintaining and Recycling the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Battery Replacement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Service and Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Service Life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Recycling the Device and Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Product Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Safety Classifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Electromagnetic Compatibility Guidance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Regulatory Compliance Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

©2018 Physio-Control, Inc. 1
Introduction
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 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.
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.

2TrueCPR Device Instructions for Use
Safety Information
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.
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 21 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.

©2018 Physio-Control, Inc. 3
Basic Orientation
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 25 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 (2–2.4 in).
12 Compression Depth History: Dark green or gray segment in outer circle shows depth of
previous compression.
5
1
24
3
11
6
7
8
10
12
9

4TrueCPR 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.
4Pressthe (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).
Back Pad
Item Description
1
Battery Readiness Indicator: Flashing LED on back pad handle indicates
battery capacity is sufficient for at least 25 minutes of operation.
Note: LED flashes approximately once every 4 seconds.
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
2
3

©2018 Physio-Control, Inc. 5
Using the TrueCPR Device
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. See “Alert
Indicators” on page 9 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
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 and release each compression completely.
Back Pad in Vertical Position Chest Pad in Vertical Position
Back Pad in Side Position Chest Pad in Rotated Position
AND
AND

6TrueCPR Device Instructions for Use
Using the TrueCPR Device
9 Follow the device metronome to maintain your compression 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 ventilation screens and tones. Three short tones
indicate when you should prepare to ventilate. Two longer tones indicate when ventilations should
occur. Resume chest compressions immediately after the two longer tones.
Note: When in No Airway mode, the device provides ventilation prompts at a ratio of 30 compressions
to 2 ventilations (30:2). When in Airway mode, ventilation prompts are not provided. See “Using the
TrueCPR Device with Secured Airway” on page 6 for more information.
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.
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.
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

©2018 Physio-Control, Inc. 7
Using the TrueCPR Device
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 magnetic fields used by the TrueCPR device have passed all interaction testing and known safety
standards for implanted pacemaker and ICD systems.
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 2.4 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 9) may appear if the manikin contains large metal
plates.
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

8TrueCPR Device Instructions for Use
Using the TrueCPR Device
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.
Incorrect Compression Indicators
Calibration in progress.
• Do not apply pressure to
chest pad.
• Ensure chest pad and back
pad are separated during
calibration.
Calibration complete.
Begin chest compressions.
Compression in progress:
Gray fan representing
compression depth moves
across screen.
Sufficient depth: Dark green
wedge in compression
target zone.
Sufficient recoil: Dark green
wedge in recoil target zone.
Compression too shallow:
Arrow appears.
Compression > 6 cm:
Orange wedge appears
outside compression
target zone.
Recoil incomplete:
Arrow appears.

©2018 Physio-Control, Inc. 9
Using the TrueCPR Device
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.
Alert Indicators
Countdown to ventilation prompts. Three short tones sound.
Ventilation prompts. Two long tones indicate when
ventilations should occur. Resume chest compressions
immediately after the two tones.
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.

10 TrueCPR Device Instructions for Use
Using the TrueCPR Device
Shut-down Screen
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.
Progress bar appears during shut-down.
Note: Shut-down may take several minutes. Do not
remove batteries while shut-down is in progress.
Percent of compressions with depth > 5 cm (2 in).
Percent of compressions with proper recoil.
Average compression rate (compressions per minute).
Total event duration.
Percent of total event with compressions.

©2018 Physio-Control, Inc. 11
Troubleshooting Tips
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.
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).
• Remove batteries, wait 30 seconds, and then re-install
batteries.
• 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.

TrueCPR™Coaching Device Operator’s Checklist Use this checklist to inspect the TrueCPR device. This form may be reproduced. Year: ______Unit Serial Number: ______________Location: ________________
Date
Initials
Instruction and Recommended Corrective Action Check each box after completing
Check that battery readiness indicator on back pad is flashing. If not, replace batteries with two new, nonrechargeable Duracell®DL123 batteries.
Check device and cable for wear or damage. If present, remove device from service and contact your Physio-Control representative for assistance.
Operator’s Checklist

©2018 Physio-Control, Inc. 13
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:
WARNINGS
SHOCK HAZARD:
• To avoid potential shock hazard, any device connected to the TrueCPR device through the USB
connector should be battery powered or certified to IEC 60601-1.
• 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.

14 TrueCPR Device Instructions for Use
Cleaning the Device
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
• 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 is
heard.
• Confirm USB cable is properly connected.
• Confirm computer is on.
• Replace USB cable.
• Use recommended USB cable (see Step 1 on page 13).
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.

©2018 Physio-Control, Inc. 15
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 on page 12 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.
Service Life
During product development, the TrueCPR coaching device is subjected to rigorous life testing. However,
both rapid technological changes and the availability of replacement parts limit the useful life of all
modern medical devices. The routine cleaning and inspection program recommended in this manual will
assist in reliable operation.
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.

16 TrueCPR Device Instructions for Use
Symbols
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