Physio-Control TrueCPR User Manual [en, de, fr]
Coaching-Gerät
Dispositif d’assistance
INSTRUCTIONS FOR USE
Gebrauchsanweisung
Instructions d’utilisation
Contents
English . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Operating Principle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Safety Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Basic Orientation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Recommended Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Using the TrueCPR Device . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Troubleshooting Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Operator’s Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Data Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Cleaning the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Storing the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Maintaining and Recycling the Device . . . . . . . . . . . . . . . . . 16
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Product Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Safety Classifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Electromagnetic Compatibility Guidance . . . . . . . . . . . . . . . 19
Regulatory Compliance Information . . . . . . . . . . . . . . . . . . . 23
German/Deutsch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Einführung. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Verwendungszweck . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Funktionsweise . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Sicherheitsinformationen . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Grundlagen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Empfohlene Schulung. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Verwenden des TrueCPR-Geräts . . . . . . . . . . . . . . . . . . . . . 29
Hinweise zur Fehlersuche/Fehlerbehebung . . . . . . . . . . . . . 38
Bedienerprüfliste. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Datenverwaltung. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Reinigung des Geräts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Contents
Aufbewahrung des Geräts . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Wartung und Recycling des Geräts . . . . . . . . . . . . . . . . . . . 42
Symbole . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Technische Daten zum Produkt . . . . . . . . . . . . . . . . . . . . . . 45
Sicherheitsklassifikationen . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Hinweise zur elektromagnetischen Verträglichkeit . . . . . . . . 46
Konformitätserklärung . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
French/Français . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Utilisation prévue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Principe de fonctionnement . . . . . . . . . . . . . . . . . . . . . . . . . 53
Informations relatives à la sécurité . . . . . . . . . . . . . . . . . . . . 53
Indications de base. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Formation recommandée . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Utilisation de l’appareil TrueCPR . . . . . . . . . . . . . . . . . . . . . 57
Conseils de dépannage . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Liste de contrôle de l’utilisateur . . . . . . . . . . . . . . . . . . . . . . 66
Gestion des données . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Nettoyage de l’appareil. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Stockage de l’appareil . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Maintenance et recyclage de l’appareil . . . . . . . . . . . . . . . . 69
Symboles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Spécifications du produit . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Classifications de sécurité . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Guide de compatibilité électromagnétique. . . . . . . . . . . . . . 73
Informations de conformité règlementaire . . . . . . . . . . . . . . 77
Introduction
English
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.
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.
©2013 Physio-Control, Inc. 1
Safety Information
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:
• The TrueCPR device does not indicate complete compression release. Be
sure to release each compression completely.
• 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.
IMPORTANT! Check the battery readiness indicator regularly. If indicator is not
flashing, replace batteries immediately.
2 TrueCPR Device Instructions for Use
Basic Orientation
5
1
2
4
3
11
6
7
8
10
12
9
Chest Pad Screen
English
Item Description
Power Button: Press green button to turn device on. Press and hold for
1
2 seconds to turn device off.
Mute Button: Press to turn metronome on or off.
2
In Event Review mode, press to switch between screens.
3 Palm Pad: Hand placement area.
Airway Button: Press to switch metronome between Airway
4
(continuous compressions) mode and No Airway mode.
5 Screen: Displays compression feedback and other indicators.
Recoil Reminder: Reminder to release each compression completely.
6
Device does not indicate complete release. Icon is always present
during compression feedback.
Low Battery Indicator: Appears when remaining battery capacity is
7
less than 25 minutes of operation.
©2013 Physio-Control, Inc. 3
Compression Rate Meter: Displays rate as compressions per minute.
8
Changes to Inactivity Timer when compressions stop.
9 Elapsed Time Meter: Displays elapsed time since beginning of event.
10 Airway Indicator: Appears when device is in Airway mode.
Compression Target Zone: Changes from light green to dark green
11
when compression reaches target depth of 5–6 cm (2–2.5 in).
Recommended Training
1
2
3
Item Description
Compression Depth History: Dark green or gray segment in outer
12
circle shows depth of previous compression. Each tick mark represents
0.5 cm (0.2 in) of depth.
Back Pad
Item Description
Battery Readiness Indicator: Flashing LED on back pad handle
1
indicates battery capacity is sufficient for at least 25 minutes of
operation. Note: LED flashes approximately once every 4 seconds.
USB Port Cover: Provides access to USB port. Use a coin or similar
2
tool to open.
Battery Compartment: Holds two nonrechargeable Duracell
3
batteries. Use a coin or similar tool to open.
Recommended Training
Before using the TrueCPR device on a patient, the operator should be trained in
the proper technique for performing CPR with the TrueCPR device. It is
recommended that CPR performance metrics be included in your TrueCPR
device training program.
4 TrueCPR Device Instructions for Use
®
DL123
English
AND
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.
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
Back Pad in Vertical Position Chest Pad in Vertical Position
Notes:
• If the Reposition Back Pad alert indicator appears, adjust the back pad
position. See “Alert Indicators” on page 11 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.
©2013 Physio-Control, Inc. 5
Using the TrueCPR Device
AND
Figure 2 Alternative Device Position
Back Pad in Side Position Chest Pad in Rotated 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.
IMPORTANT! Be sure to release each compression completely. The device
indicates compression depth and rate. It does not indicate recoil.
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.
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 9 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
6 TrueCPR Device Instructions for Use
English
Inactivity timer
Airway indicator
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 7 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.
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.
©2013 Physio-Control, Inc. 7
Using the TrueCPR Device
Using the TrueCPR Device During Defibrillation
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.
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
2.5 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 11) may appear if the
manikin contains large metal plates.
8 TrueCPR Device Instructions for Use
Screen Illustrations
Calibration Screen
When you turn on the TrueCPR device, the calibration screen appears.
English
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 Indicators
During compressions, the gray fan moves between the baseline and
compression zone as shown.
Compression in progress:
Gray fan representing
compression depth
moves across screen.
Depth indication begins
when compression depth
reaches 1.5 cm (0.6 in),
and moves across screen
as depth increases.
Sufficient depth:
Dark green wedge in
compression target
zone.
Recoil reminder:
Continue lifting your
hands off patient’s chest
after gray fan disappears.
Device does not indicate
complete release.
©2013 Physio-Control, Inc. 9
Using the TrueCPR Device
Incorrect Compression Indicators
Compression too
shallow: Arrow
appears.
Compression > 6 cm:
Orange wedge appears
outside compression target
zone.
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.
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.
10 TrueCPR Device Instructions for Use
Alert Indicators
English
Electronic noise is
interfering with device.
Locate and remove
source of interference.
If indicator persists,
perform CPR unaided.
Shut-down Screen
Device cannot provide
feedback. Turn device off
and back on. If indicator
persists, perform CPR
unaided.
Progress bar appears during shut-down.
Back pad is incorrect
distance from chest pad.
Reposition back pad. If
indicator persists,
perform CPR unaided.
Note: Shut-down may take several minutes.
Do not remove batteries while shut-down is in
progress.
©2013 Physio-Control, Inc. 11
Troubleshooting Tips
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.
Percent of compressions with depth > 5 cm
(2 in).
Average compression rate (compressions per
minute).
Total event duration.
Percent of total event with compressions.
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
Display is visible, but does not
provide compression feedback.
Alert indicator persists. • Turn device off and back on. If indicator
12 TrueCPR Device Instructions for Use
temperature range of 0°–40°C (32°–104°F).
• Remove batteries, wait 30 seconds, and
then re-install batteries.
• Perform CPR unaided.
• Turn device off and back on. Do not apply
pressure to chest pad until calibration is
complete and feedback screen appears.
• Perform CPR unaided.
persists, perform CPR unaided.
• Contact Technical Support or your local
Physio-Control representative for
assistance.
Check each box after completing
Year: ______ Unit Serial Number: ______________ Location: ________________
Date
Initials
DL123 batteries.
®
Coaching Device Operator’s Checklist
™
Operator’s Checklist
TrueCPR
Use this checklist to inspect the TrueCPR device. This form may be reproduced.
Instruction and Recommended Corrective Action
Check that battery readiness indicator on back pad
is flashing.
If not, replace batteries with two new,
nonrechargeable Duracell
Check device and cable for wear or damage.
If present, remove device from service and contact
your Physio-Control representative for assistance.
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.
WARNING
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.
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:
Data transfer in
progress.
14 TrueCPR Device Instructions for Use
Data transfer successful. Data transfer failed.
English
Troubleshooting Tips for Data Management
OBSERVATION CORRECTIVE ACTION
Feedback screen appears on
TrueCPR device and
metronome sounds.
Data Transfer Failed screen
appears.
• Confirm USB cable is properly connected.
• Confirm computer is on.
• Replace USB cable.
• Use recommended USB cable (see Step 1
on page 14).
• Turn TrueCPR device off and check
connections. Then turn device on and
attempt data transfer again.
• If problem persists, contact Technical
Support.
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.
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.
©2013 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 13 for
instructions.
Battery Replacement
Use only Duracell DL123 batteries for reliable performance.
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.
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.
16 TrueCPR Device Instructions for Use
English
IP55
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.
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
©2013 Physio-Control, Inc. 17
Product Specifications
or
or
YYYY
SYMBOL DESCRIPTION
Mark of conformity to Canadian and US standards
Mark of conformity to ACA standards
Alert sign associated with a Class 2 device under the R&TTE Directive
(Radio and Telecommunications Terminal Equipment)
Manufacturer’s identification number (part number)
Catalog number
Serial number
Date of manufacture
Manufacturer
Authorized EC representative
Product Specifications
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
Weight Less than 0.75 kg (1.65 lb) with batteries installed
Ventilation Prompts 2 ventilation prompts every 30 compressions in No Airway mode.
Compression Depth Target depth range of 5 to 6 cm (2 to 2.5 in)
Metronome Rate 104.4
Model 80596-000003
IP55 per IEC 60529 and EN 1789
No ventilation prompts in Airway mode.
± 1 compressions per minute, consistent with AHA and
ERC guidelines.
18 TrueCPR Device Instructions for Use
English
Safety Classifications
CATEGORY CLASSIFICATION
Protection Against Electric Shock Internally powered ME equipment.
Type BF defibrillation proof applied parts.*
Protection Against Solid Object and
Liquid Ingress
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 17 for symbol illustration.
IP55
Electromagnetic Compatibility Guidance
Electromagnetic Emissions
Table 1 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions
The TrueCPR coaching device, model 80596-000003, is intended for use in the
electromagnetic environment specified below. The customer or user should ensure that
the TrueCPR device is used in such an environment.
Emissions Test Compliance Electromagnetic Environment - Guidance
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Group 1 The TrueCPR device uses RF energy only for its
Class B The TrueCPR device is suitable for use in all
Not applicable
Not applicable
internal function. Therefore, its RF emissions are
very low and are not likely to cause any interference
in nearby electronic equipment.
establishments including domestic and those
directly connected to the public low-voltage power
supply network that supplies buildings used for
domestic purposes.
The TrueCPR device is battery-powered.
The TrueCPR device emits a continuous wave signal at 12 ± 0.1 kHz. The maximum
Effective Isotropic Radiated Power (EIRP) and Effective Radiated Power (ERP) levels are
-40 dBm, measured at a distance of 3 m (10 ft).
Essential Performance
The TrueCPR device maintains safe and effective performance (accurate depth) when
operated in the electromagnetic environment specified in Table 2 through Table 4 .
©2013 Physio-Control, Inc. 19
Electromagnetic Compatibility Guidance
Electromagnetic Immunity
Table 2 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The TrueCPR device, model 80596-000003, is intended for use in the electromagnetic
environment specified below. The customer or user should ensure that the TrueCPR
device is used in such an environment.
Immunity Test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11
Power
frequency (50/
60 Hz) magnetic
field
IEC 61000-4-8
Note: U
is the AC Mains voltage prior to application of the test level.
T
IEC 60601
Test Level
±6 kV contact
±8 kV air
±2 kV for power
supply lines
±1 kV for input/
output lines
±1 kV line(s) to
line(s)
±2 kV line(s) to
earth
<5% U
T
(>95% dip in UT)
for 0.5 cycle
40% U
T
(60% dip in UT)
for 5 cycles
70% U
T
(30% dip in UT)
for 25 cycles
<5% U
T
(>95% dip in UT)
for 5 sec
3 A/m 3 A/m Power frequency magnetic fields
Compliance
Level
±6 kV contact
±8 kV air
Electromagnetic Environment -
Guidance
Floors should be wood,
concrete, or ceramic tile. If floors
are covered with synthetic
material, the relative humidity
should be at least 30%.
Not applicable The TrueCPR device is battery-
powered.
Not applicable The TrueCPR device is battery-
powered.
Not applicable The TrueCPR device is battery-
powered.
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.
20 TrueCPR Device Instructions for Use
English
d 1.2 P=
d 1.2 P=
d 2.3 P=
Table 3 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The TrueCPR device, model 80596-000003, is intended for use in the electromagnetic
environment specified below. The customer or user should ensure that the TrueCPR
device is used in such an environment.
Immunity Test
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
IEC 60601
Test Level
3 Vrms
150 kHz to
80 MHz
3 V/m
80 MHz to
2.5 GHz
Compliance
Electromagnetic Environment -
Level
Portable and mobile RF
communications equipment should be
used no closer to any part of the
TrueCPR device, including cables, than
the recommended separation distance
calculated from the equation applicable
to the frequency of the transmitter.
Recommended separation distance
3 Vrms
3 V/m
Where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation distance in
meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey,
less than the compliance level in each
frequency range.
Interference may occur in the vicinity of
equipment marked with the following
symbol:
Guidance
80 MHz to 800 MHz
800 MHz to 2.5 GHz
a
should be
b
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
©2013 Physio-Control, Inc. 21
Electromagnetic Compatibility Guidance
PPP
Table 3 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
(Continued)
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in
the location in which the TrueCPR device is used exceeds the applicable RF compliance level above,
the TrueCPR device should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the TrueCPR
device.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Separation Distances
Table 4 Recommended separation distances between portable and mobile RF
communications equipment and the TrueCPR device, model 80596-000003.
The TrueCPR device is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or user of the TrueCPR device can
help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the TrueCPR
device as recommended below, according to the maximum output power of the
communications equipment.
Rated maximum
output power of
transmitter
W
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be determined using the equation applicable to
the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
Separation distance according to frequency of transmitter
m
150 kHz to
80 MHz
d = 1.2
80 MHz to
800 MHz
d = 1.2
800 MHz to 2.5 GHz
d = 2.3
22 TrueCPR Device Instructions for Use
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