MicroPort CPR4 Wired Inductive Programming Head User Manual
- June 5, 2024
- MicroPort
Table of Contents
CPR4
Wired Inductive Programming Head
USER MANUAL
B10031
US
INTRODUCTION
1.1 Intended purpose
The CPR4 is the inductive programming head intended to be used with suitable
MicroPort CRM programmers for the interaction with the IMDs manufactured by
MicroPort CRM, or by its predecessors Sorin Group and Ela Medical.
The CPR4 is functional to achieve the programmer’s intended purpose:
- Interrogate the device to get information about the device and assist with the diagnosis and monitoring of pathological heart rhythm disturbances,
- Program the device to configure the device therapies according to patients’ needs,
- Run real-time tests to check device functioning.
1.2 Indication(s), target population(s) and intended user(s)
1.2.1 Indication(s)
The CPR4 provides communication with MicroPort implantable pacemakers and
defibrillators and is thus indicated in patients requiring atrial or
ventricular pacing and synchronous atrioventricular pacing, or/and ventricular
anti-tachycardia pacing and defibrillation for automated treatment of life-
threatening ventricular arrhythmia, without or with resynchronization.
The indications are detailed below:
According to the guidelines specified below, atrial or ventricular pacing and
synchronous atrioventricular pacing are mainly indicated for the following
conditions:
-
Accepted patient conditions warranting chronic cardiac pacing which include:
o symptomatic paroxysmal or permanent second- or third-degree AV block;
o symptomatic bilateral bundle branch block;
o symptomatic paroxysmal or transient sinus node dysfunction with or without associated AV conduction disorders;
o bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias;
o vasovagal syndromes or hypersensitive carotid sinus syndromes. -
Atrial or ventricular pacing and synchronous atrioventricular pacing are indicated for patients who may benefit from maintenance of AV synchrony and for the treatment of conduction disorders that require restoration of both rates and which include:
o various degrees of AV block to maintain the atrial contribution to cardiac output;
o VVI intolerance (e.g. pacemaker syndrome) in the presence of persistent sinus rhythm;
o Low cardiac output or congestive heart failure secondary to bradycardia. -
Adaptive-rate pacing is indicated for patients exhibiting chronotropic incompetence and who may benefit from increased pacing rates concurrent with increases in physical activity.
Guidelines on cardiac pacing are provided by the European Society of Cardiology, the American College of Cardiology, and the American Heart Association (“2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy.” Eur Heart J. 2021 Sep 14;42(35):3427-3520. doi:10.1093/eurheartj/ehab364. “2012 ACCF/AHA/HRS Focused Update of the 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities”. J Am Coll Cardiol. 2013; 61(3):e675).
According to the guidelines, ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmia without resynchronization is indicated in: -
Patients who are survivors of cardiac arrest due to ventricular fibrillation or hemodynamically unstable sustained VT after evaluation to define the cause of the event and to exclude any completely reversible causes.
-
Patients with structural heart disease and spontaneous sustained VT, whether hemodynamically stable or
unstable. -
Patients with syncope of undetermined origin with clinically relevant, hemodynamically significant sustained VT or ventricular fibrillation induced at electrophysiological study.
-
Patients with reduced LVEF due to prior myocardial infarction who are at least 40 days post-myocardial infarction and with symptomatic heart failure or LV dysfunction.
-
Patients with non-ischemic dilated cardiomyopathy and reduced LVEF with symptomatic heart failure.
-
Patients with non-sustained VT due to prior myocardial infarction reduced LVEF, and inducible ventricular fibrillation or sustained VT at electrophysiological study. For further details, please refer to “2008 ACCF/AHA/HRS Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities” and it’s 2012 Focused Update or “2017 AHA/ACC/HRS Guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death” or “2015 ESC Guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death”.
According to the guidelines specified above, ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life- threatening ventricular arrhythmia with resynchronization is indicated in: -
Patients who are survivors of cardiac arrest due to ventricular fibrillation or hemodynamically unstable sustained VT after evaluation to define the cause of the event and to exclude any completely reversible causes.
-
Patients with structural heart disease and spontaneous sustained VT, whether hemodynamically stable or unstable.
-
Patients with syncope of undetermined origin with clinically relevant, hemodynamically significant sustained VT or ventricular fibrillation induced at electrophysiological study.
-
Patients with reduced LVEF due to prior myocardial infarction who are at least 40 days post-myocardial infarction and with symptomatic heart failure or LV dysfunction.
-
Patients with non-ischemic dilated cardiomyopathy and reduced LVEF with symptomatic heart failure.
-
Patients with non-sustained VT due to prior myocardial infarction reduced LVEF and inducible ventricular fibrillation or sustained VT at electrophysiological study.
Biventricular pacing therapy is indicated in patients with symptomatic heart
failure despite optimal pharmacological therapy, with reduced LVEF and wide
QRS.
For further details, please refer to “2008 ACCF/AHA/HRS Guidelines for Device-
Based Therapy of Cardiac Rhythm Abnormalities” and its 2012 Focused Update or
“2017 AHA/ACC/HRS Guidelines for management of patients with ventricular
arrhythmias and the prevention of sudden cardiac death” or “2015 ESC
Guidelines for management of patients with ventricular arrhythmias and the
prevention of sudden cardiac death”. For biventricular pacing therapy, please
also refer to “2013 ESC Guidelines on cardiac pacing and cardiac
resynchronization therapy”.
1.2.2 Target population(s)
The target populations are patient groups indicated for the implantation of
either a pacemaker or a defibrillator, with or without resynchronization, and
implanted with a MicroPort CRM device. For further details regarding pacemaker
indications, please refer to the “2013 ESC Guidelines on cardiac pacing and
cardiac resynchronization therapy”, or the “2012 ACCF/AHA/HRS Focused Update
of the 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm
Abnormalities”. For further details regarding defibrillator indications,
please refer to “ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of
Cardiac Rhythm Abnormalities” or “ACC/AHA/ESC 2006 Guidelines for management
of patients with ventricular arrhythmias and the prevention of sudden cardiac
death”. For biventricular pacing therapy, please also refer to “2013 ESC
Guidelines on cardiac pacing and cardiac resynchronization therapy”.
1.2.3 Intended user(s)
The CPR4 is intended to be used by electrophysiologists, cardiologists, or
specialized nurses and/or technicians trained or experienced in device implant
and/or follow-up procedures in order to interrogate and program implantable
cardiac devices in a cardiology practice (hospital, clinic, outpatient
practice…).
1.3 Contra-indications
No known contraindications to the use of the CPR4.
** Any serious incident in relation to the device should be reported to
MicroPort CRM and the local Competent Authority.
1.4 Intended Clinical benefits
By using the CPR4, clinicians can improve the patient’s treatment in several
ways, including changing the implanted device’s settings, fine-tuning or
adapting the therapy to suit patients’ needs, and detecting issues with the
implanted device or the lead(s) that may result in a required re-intervention
(repositioning, replacement…).
1.5 Warnings and precautions
**
- Same as the programmer system, the CPR4 is Magnetic Resonance (MR) unsafe. Don’t bring the CPR4 into MRI site Zone 3 or 4 as defined by the Guidance Document for Safe MR Practices published by the American College of Radiology 1.
- The equipment must be operated by qualified personnel only: physicians, nurses, technical members of hospital staff, and company representatives. All of them being trained and have a comprehensive or partial knowledge of cardiac rhythm management, in keeping with their assigned task: surgery, follow-up, servicing, etc. For additional information please contact your company representative.
- To avoid damage or hazards, NEVER make any changes or modifications to the equipment. For maintenance services and support, please contact your company representative.
- Do not use the CPR4 should there be any sign of visible damage.
- Shocks or rough handling could damage the device’s housing. Mishandling may affect the CPR4’s operation. Even if the device appears to be operating well after the impact, damage that is not immediately detectable may arise.
- When designing and manufacturing the device, every precaution is taken to minimize the risks of infiltration. However, any liquid penetration shall alter its operation.
- Prolonged storage in a high-humidity location may alter the device’s operation. For detailed information about the storage humidity constraints please refer to section 8.6.
- The CPR4 must be stored in a secure and locked room when not in use.
- The CPR4 inductive programming head must come into contact with intact skin only.
1.6 Residual risk and undesirable effects
The potential hazards related to the use of the CPR4 have been carefully
evaluated by the manufacturer’s risk management team. This evaluation
concludes that the residual risk is at the lowest possible level.
This assessment is based on the assumption that the CPR4 is used according to
its intended purpose and all of the prescriptions contained in this User
Manual are carefully followed.
Based on the literature and on inductive wands’ use experience, possible
adverse events are:
- Prolonged follow-up programming/real-life test sessions
- Nonoptimal patient management (related to the programming or the diagnosis)
WARRANTY CONDITIONS
The manufacturer agrees to replace any defective material.
** If a technical problem occurs, please contact your company
representative or the company’s service department.
WARNING:** Never modify the configuration of the CPR4.
The CPR4 contains no internal parts that can be repaired by the user. In the
event of a problem, please return the equipment to your company representative
in the condition in which it was received.
The manufacturer waives all responsibility if a malfunction occurs following
manipulation by the user as described above.
PACKAGE CONTENTS
Inside the box, you will find the CPR4 and the related documentation
DESCRIPTION
The programming head provides inductive communication between the programmer
and the implanted cardiac device.
For detailed information about the compatibility of programming devices and
implantable patient devices, please refer to the Device-Compatibility-Matrix
that is available under the reference number UA193 at
www.microportmanuals.com.
The inductive programming head is used to:
- activate the telemetry,
- identify the implanted device model,
- conduct telemetry in order to communicate with the implanted device when telemetry is performed in inductive mode.
WARNING: there is no magnet in the head. However, it may temporarily disturb the rate response function during interrogation.
4.1 COMPONENTS²
²Images and diagrams are non-contractual and are for illustrative purposes
only.
-
Collimator LEDs (white) 3) USB connector - Locator LEDs (blue)
4.2 CONNECTION TO THE PROGRAMMER
- Connect the inductive programming head CPR4 to a programmer’s USB port.
- The head is automatically turned on when the programmer is switched on.
- The programming head is functional when the related icon is displayed in the programmer’s User Interface.
**** Do not unplug the CPR4 cable from the USB port during a follow-up or any
telemetry action, as this would stop data transmission and request to restart
the entire session.
Same way, if the CPR4 is connected to the SmartTouch tablet through the
docking station, do not disconnect the tablet from the docking station during
a follow-up or a telemetry action.
USING THE CPR4
To perform a follow-up, CPR4 has to be placed directly on the patient’s intact (unbroken) skin or over his/her clothes above the part of the body where the implanted device has been implanted (usually left and right clavicle). The side with the LEDs shall be facing up.
5.1 How to position the CPR4
The antenna, lying on the bottom side of the head, is positioned corresponding to the zone framed by the collimator LEDs. To help find the best placement, the LEDs behave as follows:
- when the head is not detecting the implant, the LEDs flashing on the opposite corners of the collimator will be alternating;
- when the head detects the implant partially, two of the LEDs will display a steady illumination and the others will be off. This indicates to the user that a full detection is possible by moving the CPR4 in the direction pointed by the LEDs;
- when the implant has fully been detected, all of the collimator LEDs will emit a steady white light and the array of blue LEDs will enable more accurate positioning to find the optimal level of telemetry, corresponding to a position where all the blue LEDs are illuminated. If not all the blue LEDs are illuminated, the level of telemetry is not optimal and a better positioning is necessary.
The following pictures show how to use the LEDs to find the best position for the CPR4:
|
---|---
No detection (pair of white alternating LEDs )| Partial detection (two steady
white LEDs). Indication to mode the head downwards.
|
Full detection (four steady white LEDs) but not optimal position (only two
blue LEDs)| Full detection (four steady white LEDs) and best position (four
blue LEDs)
For optimal telemetry, you are advised to keep the inductive programming head
away from electromagnetic interference, which can be generated by any
electronic equipment including medical equipment.
** Avoid establishing telemetry communication between the programmer and
the implanted device when the Programmer is close to monitors, high-frequency
electrocautery equipment, external defibrillator, or strong magnetic fields.
The telemetry link might be impaired.
5.2 Troubleshooting**
As the CPR4 is powered through the USB port of the programmer, the first
requirement for the CPR4 to properly work is that the programmer is fully
functional, and suitable for use with the CPR4. Please consult your MicroPort
correspondent in case of any doubt about the compatibility of your programmer
with the CPR4.
For the same reason, if the CPR4 does not turn on, check at first that the USB
cable is properly and completely inserted into a working USB port of the
programmer. Also, try changing ports.
5.3 UPGRADE OF THE PROGRAMMING HEAD’S SOFTWARE
The CPR4 contains dedicated embedded software. When a new release of this
software is available, it will be included in a comprehensive upgrade of the
programmer’s software (SmartView).
In this case, the first time the head is connected to the programmer after the
SmartView upgrade, its software is automatically updated. During this task,
the white LEDs on the CPR4 will illuminate in circle, one after the other,
while a message on the screen informs the user about the progression.
MAINTENANCE
6.1 Cleaning
**** The CPR4 should never be immersed in any liquid or cleaned with
sterilization products. Avoid spilling liquid on the equipment.
In order to clean the CPR4:
- Visually inspect it for contaminants and remove loose material with a dry or water-moistened cloth.
- Then clean it with a tissue pad or a wipe moistened with one of the following agents:
• Ethyl alcohol
• Isopropyl alcohol
The above-mentioned agents have been tested by the manufacturer and validated
to neither cause physical damage nor degradation to the CPR4.
6.2 Disinfection and sterilization
** The CPR4 is delivered non-sterile, and cannot be disinfected or
sterilized. It must be covered with a sterile sleeve when used in sterile
environments.
6.3 System end-of-life
At its end of life, the CPR4 shall be sent back to the manufacturer for
recycling.
6.4 Regular maintenance
All of the tasks relative to regular (i.e. periodical, preventive) maintenance
of CPR4 consist of cleaning the outer surfaces.
Please note that, in some jurisdictions, local regulation may require the
execution of some specific safety inspections.
** It is recommended to visually inspect the CPR4 before use. In case of
any visible damage, please contact your Microsoft representative.
GUIDANCE AND MANUFACTURER’S DECLARATION
All information below is based on the normative requirements to which the
manufacturers of electro-medical devices are subject, in the sense of
IEC60601-1-2.
The medical device complies with applicable electromagnetic compatibility
standards, however, the user will ensure that any electromagnetic interference
does not create an additional hazard, such as radiofrequency transmitters or
other electronic devices.
In this chapter, you will find the information necessary to ensure the
installation and commissioning of your medical device under the best
conditions in terms of electromagnetic compatibility.
The different cords/cables of the medical device must be separated from each
other.
Certain types of mobile telecommunication devices such as mobile phones are
likely to interfere with the medical device. The separation distances
recommended in this chapter must therefore be strictly observed.
The medical device must not be used near or on another device. If this cannot
be avoided, it must be checked for proper operation under the conditions of
use before use.
There is no risk of reciprocal interference during normal use of the CPR4.
The use of accessories other than those specified or sold by MicroPort CRM as
replacement parts may result in an increase in the emission or a decrease in
the immunity of the medical device and may cause an inappropriate operation.
7.1 Radio equipment emission
Transmitter Frequency Bands/ Maximal Power | Receiver Frequency Bands |
---|---|
Fast mode: frequency ~70 kHz modulation pulsed, 17.4 dBµA/m at 3m | 16kHz |
[2400 – 2483,5] MHz ; + 6dBm | [2402 – 2480] MHz |
7.2 Recommended separation distances according to the maximum output power
of the communications equipment
The CPR4 is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. Portable RF communication devices
(including peripherals such as antenna cables and external antennas) should
not be closer than 30 cm (12 inches) from any part of the programmer.
Otherwise, the performance of these devices may
be impaired.
7.3 Cable length
Cables and accessories| Maximum length| Test type| In
compliance with
---|---|---|---
Cables/Cords| < 3m| RF emission| CISPR 11, Class B
Harmonic current emission| IEC61000-3-2
Voltage fluctuation andflickers| IEC61000-3-3
Electrostatic discharge immunity| IEC61000-4-2
Radiated immunity – Electromagnetic fields| IEC61000-4-3
Electrical fast transient/burst immunity| IEC61000-4-4
| | Surge immunity| IEC61000-4-5
---|---|---|---
Immunity to conducted disturbances, induced by radio-frequency fields|
IEC61000-4-6
Radiated immunity -Magnetic fields| IEC61000-4-8
Voltage dips, short interruptions, and voltage variation immunity| IEC
61000-4-11
7.4 Electromagnetic emissions
The programmer is intended for use in the electromagnetic environment
specified below. The customer or the user of the programmer should ensure that
it is used in such an environment.
Emissions test| Compliance| Electromagnetic environment –
guidance
---|---|---
Electromagnetic radiation disturbance (radiated EMISSIONS) CISPR 11| Group 1|
The programmer uses RF energy only for its own function. Its RF emissions are
very low and are not likely to cause any interference to nearby electronic
equipment.
Disturbing voltage at supply terminals conducted emissions CISPR 11| Class B|
The programmer is suitable for use in a professional health care establishment
and home
care environment.
Harmonic current EMISSIONS IEC61000-3-2| NA|
Voltage variations, voltage fluctuations, and flicker IEC61000-3-3| NA|
7.5 Magnetic and Electromagnetic Immunity
The CPR4 is intended for use in the electromagnetic environment specified
below. The customer or the user of the CPR4 should ensure that it is used in
such an environment.
Immunity test| IEC 60601 test level| Compliance level|
Electromagnetic environment – guidance
---|---|---|---
Electrostatic discharge (ESD) IEC61000-4-2| ± 8 kV contact ± 15 kV air| ± 8 kV
contact ± 15 kV air| Professional health care establishment and home care
environment.
Electrical fast transient/burst IEC 61000-4-4| ± 2 kV for power supply lines|
± 2 kV for power supply lines| Professional health care establishment and home
care environment.
± 1 kV for input/output lines| ± 1 kV for input/output
lines
Surge
IEC 61000-4-5
| ± 1 kVbetween phases± 2 kV between line(s) to earth| NA| Professional health
care establishment and home care environment.
Magnetic field at industrial rated frequency (IEC61000-4-8)| 30 A/m| 30 A/m|
Professional health care establishment and home care environment.
Voltage dips (IEC 61000-4-11)| 0% U T For 0.5 cycle A 0°, 45°, 90°, 135°,
180°, 225°,| 0% U T For 0.5 cycle A 0°, 45°,90°, 135°, 180°, 225°,|
Professional health care establishment and home care environment.
| 270° and
315°
0% U T for 1 cycle
and
70% U T for
25 cycles, 50Hz
30 cycles,
60 Hz,
Monophase:
0°| 270° and
315°
0% U T for 1 cycle
and
70% U T for
25 cycles, 50Hz
30 cycles,
60 Hz,
Monophase:
0°|
---|---|---|---
Voltage Interruptions (IEC 61000-4-11)| 0 % U T;
For 250 cy-
cles, 50 Hz
For 300 cy-
cles, 60 Hz| NA|
NOTE: UT is the a.c. mains voltage prior to application of the test
level.
7.6 Electromagnetic Immunity, Portable Radio Frequency Equipment
The CPR4 is intended for use in the electromagnetic environment specified
below. The customer or the user of the CPR4 should ensure that it is used in
such an environment.
Immunity test| IEC 60601 test level| Compliance level|
Electromagnetic environment – guidance
---|---|---|---
ATTENTION: Portable RF communication devices (including peripherals such as
antenna cables and external antennae) should not be used closer to 30 cm (12
inches) to the CPR4. Otherwise, the performance of this device may be
impaired.
Radiated RF IEC 61000-4-3 Proximity fields emitted by RF wireless
communication devices IEC 61000-4-3 (provisional method)| 3 V/m
80 MHz to 2.7 GHz
80% MA at
1 KHz
9 V/m
710 MHz,
745 MHZ,
780 MHz,
5240 MHz,
5550 MHz,
5785 MHz
27 V/m
385 MHz
28 V/m
450 MHz,
810 MHz,
870 MHz,
930 MHz,
1720 MHz,
1845 MHz,
1970 MHz,
2450 MHz| 3 V/m
80 MHz to 2.7 GHz
80% MA at
1 KHz
9 V/m
710 MHz,
745 MHZ,
780 MHz,
5240 MHz,
5550 MHz,
5785 MHz
27 V/m
385 MHz
28 V/m
450 MHz,
810 MHz,
870 MHz,
930 MHz,
1720 MHz,
1845 MHz,
1970 MHz,
2450 MHz| Professional health care establishment and home care environment.
Conducted disturbances, IEC 61000-4-6| 3 V
150 kHz to
80 MHz
6V in ISM
Band between
0.15 MHz – 80 MHz 80% MA to
1 KHz| 3 V
150 kHz to
80 MHz
6V in ISM
Band between
0.15 MHz – 80 MHz 80% MA to
1 KHz| Professional health care establishment and home care environment.
7.7 Raw materials
Item | Material | Description |
---|---|---|
Plastic parts | Cycoloy C2100 HF (ABS/PC, UL 94 V-0, White RAL9016) |
POLYCARBONATE ABS (ABS-
PC) White for outer parts and
grey for the middle part
Label| Glossy white polyester B423| POLYESTER
Main cable| Polyurethane (UL 94 V-2)| PU
Non-slip pad| Polyurethane Bumpon SJ6032 Black| PU
TECHNICAL DATA
8.1 Conformity of the device
Conformity with European Regulation and Directive(s)| MDR 2017/745, 2014/53/EU
2012/19/EU (WEEE)
2011/65/EU (RoHS)
Regulation (EC) 1907/2006 (REACH)
---|---
Patient safety| IEC 60601-1, Class I, BF Type
EMC| IEC 60601-1-2
EN 301 489-1
EN 301 489-31
ERM| EN 302-195
EN 62311: 2020
FCC CFR 47
8.2 FCC
This device complies with part 15 of the FCC rules. Operation is subject to
the following two conditions: (1) this device may not cause harmful
interference, and (2) this device must accept any interference received,
including interference that may cause undesired operation of the device.
This equipment has been tested and found to comply with the limits for a Class
B digital device, pursuant to Part 15 of the FCC Rules. These limits are
designed to provide reasonable protection against harmful interference in a
residential installation. This equipment generates uses and can radiate radio
frequency energy and, if not installed and used in accordance with the
instructions, may cause harmful interference to radio communications. However,
there is no guarantee that interference will not occur in a particular
installation. If this equipment does cause harmful interference to radio or
television reception, which can be determined by turning the equipment off and
on, the user is encouraged to try to correct the interference by one of the
following measures:
- Reorient or relocate the receiving antenna.
- Increase the separation between the equipment and receiver.
- Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
- Consult the dealer or an experienced radio/TV technician for help.
CAUTION: This equipment may not be modified, altered, or changed in any
way without signed written permission from MicroPort CRM. Unauthorized
modification may void the equipment authorization from the FCC and will void
the MicroPort CRM warranty.
This equipment complies with FCC radiation exposure limits set forth for an
uncontrolled environment and meets the FCC radio frequency (RF) Exposure
Guidelines.
This equipment has very low levels of RF energy that is deemed to comply
without testing of specific absorption rate(SAR).
8.3 Performances
8.3.1 PERFORMANCE CHARACTERISTICS
The table below describes the performance characteristics of the programmer (including programming software) making use of a CPR4.
Performance | Value |
---|---|
Interrogation time | Less than 60 seconds |
AIDA reading time | No more than 180 seconds |
Number of telemetry issues | No more than 5 errors per minute |
Number of telemetry errors pop-ups | No more than 1 pop-up per session |
8.3.2 ESSENTIAL PERFORMANCE (REFERRING TO 60601-1-2 STANDARD)
The essential performance of the CPR4 is to ensure data integrity when it
reads data from the MicroPort implantable device and when it programs data in
the implantable device. Should the CPR4 essential performance deteriorate, it
could induce an inappropriate clinical or medical treatment (wrong
interpretation of data read or misprogramming).
8.4 Dimensions
Height | 136 mm |
---|---|
Width | 73 mm |
Depth | 23.5 mm |
Weight | 0.300 kg |
8.5 Use constraints
Temperature | From +0 °C to +35 °C (non-condensing) |
---|---|
Humidity | From 5% to 95 % HR (non-condensing) |
Pressure | From 700 to 1060 hPa |
8.6 Storage constraints
Temperature | From -20 °C to +70 °C (non-condensing) |
---|---|
Humidity | From 5% to 95% HR (non-condensing) |
Atmospheric pressure | From 500 hPa to 1060 hPa |
EXPLANATION OF SYMBOLS
General symbols | Explanation of symbols |
---|---|
**** | This symbol concerns the inductive programming head. It indicates that |
this is a BF Type applied part, according to standard IEC 60601-1 for
electrical medical
equipment.
| This electronic product is subject to disposal and recycling regulations
that vary by country and region.
Many countries prohibit the disposal of waste electronic equipment in standard
waste receptacles. For more details, please refer to the European Directive
2012/19/EU (WEEE).
---|---
| The device is compliant with ACMA rules.
| This symbol confers the approval of the US Federal Communications
Commission.
| This device holds the Bureau Veritas NTRL/SCC Mark
| Conformité Européenne (European Conformity)
| Consult the documentation and instructions for use.
| Magnetic Resonance (MR) unsafe.
| Consult instructions for use available on the company website
www.microportmanuals.com.
| This icon is used to call your attention to a particularly important
point.
| Manufacturer
MD
| Medical Device
REF| Product reference number.
SN
| Product serial number.
UDI
| Unique Device Identifier
| This symbol indicates the minimum and maximum storage temperature.
| This symbol indicates the minimum and maximum storage humidity.
| The product should be kept dry.
| This symbol indicates the minimum and maximum storage pressure.
| This icon alerts you to a hazard that may result in equipment damage or
personal injury. Carefully read the instructions provided with this icon.
GLOSSARY
Term | Meaning |
---|---|
AC | Alternated current |
ACMA | Australian Communication and Media Authority |
ANSI | American National Standard Institute |
AAMI | Association for the Advancement of Medical Instrumentation |
BF Type | Applied part with high protection against electrical shock |
CISPR | International Electrotechnical Commission |
CPR4 | Inductive Programming Head |
ECG | Electrocardiogram |
EEC | European Economic Community |
EMC | Electromagnetic Compatibility |
ERM | EMC and Radio Spectrum Matters |
FCC | Federal Communications Commission |
IEC | International Electrotechnical Commission |
I/O | Input/Output |
LED | Light Emitting Diode |
MR | Magnetic Resonance |
RF | Radiofrequency |
USB | Universal Serial Bus |
CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN
Manufactured in France for:
MicroPort CRM Srl
Via Crescentino snc
13040 Saluggia (VC) Italy
Tel: +39 0161 487095
www.microport.com
2022-01
CPR4 – UA10821A
Documents / Resources
|
MicroPort CPR4 Wired Inductive Programming
Head
[pdf] User Manual
B10031, YSGB10031, CPR4 Wired Inductive Programming Head, CPR4, Wired
Inductive Programming Head
---|---