Manual Book Defibrillator

DEFIBRILLATOR MONITOR
Mod. 3850B-BIPHASIC - SERVICE MANUAL
TABLE OF CONTENTS
INTRODUCTION ......................................................................................................................................................................... 1
IMPORTANT! ........................................................................................................................................................... 1
SAFETY INFORMATION ............................................................................................................................................ 2
NOTES AND WARNINGS .......................................................................................................................................................... 3
SCREEN MESSAGES ................................................................................................................................................................ 9
SYMBOLS AND REFERENCES LIST .................................................................................................................................... 14
INFORMATION FOR SERVICE ............................................................................................................................................... 15
COMPONENTS OF EQUIPMENT ........................................................................................................................................... 16
INTRODUCTION ..................................................................................................................................................... 16
DEVICE DESCRIPTION AND INTENDED USE ............................................................................................................ 16
Description ......................................................................................................................................................... 16
Intended Use ...................................................................................................................................................... 16
INDICATIONS AND CONTRAINDICATIONS .............................................................................................................. 16
Defibrillation and Cardioversion.......................................................................................................................... 16
Transcutaneous pacing therapy (optional) .......................................................................................................... 17
Pulse Oximeter (optional) ................................................................................................................................... 17
FRONT PANEL ........................................................................................................................................................ 18
Monitor section .................................................................................................................................................. 18
Defibrillation section .......................................................................................................................................... 18
Recorder section ................................................................................................................................................ 18
Oximetry section ................................................................................................................................................ 19
Transcutaneous Pacer section ............................................................................................................................. 19
REAR PANEL .......................................................................................................................................................... 19
ACCESSORIES ......................................................................................................................................................... 20
CONTROL AND INDICATORS .................................................................................................................................. 22
Control ............................................................................................................................................................... 22
Indicators ........................................................................................................................................................... 22
OPTIONAL ............................................................................................................................................................. 23
SPECIFICATIONS .................................................................................................................................................................... 24
GENERAL ............................................................................................................................................................... 24
DEFIBRILLATOR...................................................................................................................................................... 25
ECG........................................................................................................................................................................ 26
RECORDER ............................................................................................................................................................. 29
TRANSCUTANEOUS PACER .................................................................................................................................... 29
PULSE OXIMETER................................................................................................................................................... 29
AUDITORY ALARM SIGNALS .................................................................................................................................. 30
QRS BEEP SOUND .................................................................................................................................................. 32
CONFIRMATION SOUND OF KEY PRESSED ............................................................................................................. 32
MANUFACTURER’S GUIDANCE AND DECLARATION REGARDING ELECTROMAGNETIC COMPATIBILITY......... 33
INSTALLING AND TURNING ON THE DEVICE .................................................................................................................... 36
INSTALLING ........................................................................................................................................................... 36
CONNECTIONS AND TURNING ON THE DEVICE ...................................................................................................... 37
TURN OFF THE EQUIPMENT ................................................................................................................................... 38
INTERNAL BATTERY ............................................................................................................................................... 38
WARNING MESSAGES ......................................................................................................................................... 38
DESCRIPTION ...................................................................................................................................................... 38
CHECKING THE BATTERY STATUS ........................................................................................................................ 39
EXTERNAL POWER SOURCE ................................................................................................................................... 39
MAINTAINING THE EQUIPMENT ........................................................................................................................................... 41
GENERAL INSPECTION ........................................................................................................................................... 41
CLEANING .............................................................................................................................................................. 41
PADDLE CLEANING ............................................................................................................................................. 41
ELECTRODES ....................................................................................................................................................... 42
POWER CORD ..................................................................................................................................................... 42
CLEANING OF PAPER CHAMBER AND PRINTHEAD ............................................................................................... 42
i
OXIMETRY SENSOR CLEANING ............................................................................................................................ 42
DISINFECTION METHODS....................................................................................................................................... 42
STERILIZATION METHODS ..................................................................................................................................... 42
PAPER REPLACEMENT ........................................................................................................................................... 42
POWER SELECTOR ................................................................................................................................................. 42
VERIFICATION OF ENERGY DELIVERED ................................................................................................................... 43
ALARM VERIFICATION ........................................................................................................................................... 44
FUSE CHANGE ........................................................................................................................................................ 45
RECHARGEABLE BATTERY ...................................................................................................................................... 45
VERIFICATION INSTRUCTIONS IEC 601 ................................................................................................................... 47
PERFORMANCE TEST OF THE EQUIPMENT ............................................................................................................. 48
TROUBLESHOOTING .............................................................................................................................................................. 52
MESSAGES AND ALARMS OF THE BATTERY ........................................................................................................... 52
GENERAL ............................................................................................................................................................... 52
DESFIBRILADOR ..................................................................................................................................................... 53
ECG........................................................................................................................................................................ 53
SpO2 ...................................................................................................................................................................... 54
Printer ................................................................................................................................................................... 54
Power supply tests ................................................................................................................................................ 55
Data Acquisition Tests ........................................................................................................................................... 57
Screens and Connection for simulation and realization of Output Protocol .......................................................... 59
ECG with ECG cable 5‐leads ................................................................................................................................ 59
ECG (RRMC) with ECG cable 5‐leads .................................................................................................................... 59
ECG with ECG cable 3‐leads ................................................................................................................................ 61
ECG (RRMC) with ECG cable 3‐leads .................................................................................................................... 61
Oximetry ............................................................................................................................................................ 63
Transcutaneous Pacer......................................................................................................................................... 64
Recorder ............................................................................................................................................................ 65
Test of energy delivered ..................................................................................................................................... 67
CALIBRATION .......................................................................................................................................................................... 68
ADJUSTING OF THE HARDWARE ............................................................................................................................ 68
ADJUSTING AND CUSTOMIZING THE DISPLAY ....................................................................................................... 68
MECHANICAL DRAWINGS, ELECTRICAL DIAGRAMS AND MATERIALS LIST ............................................................ 68
INTRODUCTION ..................................................................................................................................................... 68
THEORY OF OPERATION ........................................................................................................................................ 68
General .............................................................................................................................................................. 68
Components ....................................................................................................................................................... 68
General Block Diagram ....................................................................................................................................... 69
User Interface ..................................................................................................................................................... 70
Paddles .............................................................................................................................................................. 70
Power................................................................................................................................................................. 70
Boards ................................................................................................................................................................ 71
Optionals ............................................................................................................................................................ 71
EXPLODED VIEW OF THE EQUIPMENT ................................................................................................................... 72
EQUIPMENT PARTS LIST ........................................................................................................................................ 75
PORT CONNECTIONS ............................................................................................................................................. 77
Input connector ECG ........................................................................................................................................... 77
Input connector SpO2 ......................................................................................................................................... 77
Output connector TPM ....................................................................................................................................... 77
CPC connector .................................................................................................................................................... 78
Line Input ........................................................................................................................................................... 78
12V Power Supply Input...................................................................................................................................... 78
ii
INTRODUCTION
IMPORTANT!
This Service Manual of DEFIBRILLATOR MONITOR Mod. 3850B-BIPHASIC is intended for use by personnel authorised and
qualified for:
• Iinstalation
• Manteinnance
• Repairing
… of this device.
This manual provides the technical information necessary for installation and service personnel.
Use it as a guide for maintenance and repairs on field.
Identify the auxiliary sources of information and technical assistance where necessary.
Read the User´s Manual for the instructions necessary to operate the equipment according to their functions
RESPONSIBILITY FOR INFORMATION

It is the responsibility of our customers to ensure that the appropriate person(s) within their organization have access to this
information, including general safety information provided in section “NOTES AND WARNINGS”.
VERSION HISTORY
This Service Manual (ref. 14769/0913A - Manual de Servicio de Desfibrilador 3850 B, en inglés) describes the Defibrillator Monitor
Mod 3850B-Biphasic, CE marked, with software version 3.27.
You can verify the software version of the device during power up. The software version is displayed on screen.
Edition Date: 2018/12/17
MANUFACTURER
Av. Colón 5756/60 – C.P.X5003DFP –

CÓRDOBA – REPÚBLICA ARGENTINA.
TEL: +54 351 484 8016 – FAX: +54 351 485 0750.
E-mail: soporte@feaselectronica.com.ar
Web: www.feaselectronica.com.ar
DT: Jorge F. Feas, Eng. - PM: 12341991.

The equipment is authorized by A.N.M.A.T. PM-1125-15.
The equipment is sold exclusively to medical professionals and medical
institutions.
AUTHORIZED EU-REPRESENTATIVE Cinterqual, Lda.

Rua Fran Pacheco Nº220
2º And 2900-374
EC REP
Setúbal, Portugal
Tel/Fax: +351 265238237.
PRESAFE
Veritasveien 3,
N-1363 Høvik, Norway.
Postbox 116,
N-1300 Sandvika.
NOTIFIED BODY
Page 1 of 79
SAFETY INFORMATION
Manufacturer’s feas ELECTRÓNICA is responsible for security and performance purposes only if:
responsibility: • Assembly operations, installation, adaptations, adjustments, modifications or repairs have
been carried out by personnel authorized by the company.
• The electrical installation of the relevant room meets with the local regulation requirements,
for medical rooms.
• The equipment is used in accordance with instructions for use.
General: • This equipment is designed to be used under the direct supervision of a health
professional.
• Not intended for home use.
• Contact the Customer Service of feas ELECTRÓNICA before connected any device
that is not recommended in this manual, to the equipment.
• The parts and accessories must meet electrical safety requirements specified in the
standards IEC 60601 series, and/or configuration of the system must meet the standard of
medical electrical systems IEC60601-1-1.
• Periodically, and when equipment integrity is in doubt, perform a test of all functions.
• The use of accessory not complying with the equivalent safety requirements can lead to
reduced safety for the patient or operator. The choice of accessory will depend on the
patient in which is to be used, also check that the accessory meets the electrical safety
requirements specified in the standards IEC 60601 series.
• The device is supplied with a voltage of 90V~ to 240V~ and filters are selected on factory
according to the electrical network frequency of the country of destination (50Hz or 60Hz).
Warnings, Cautions The terms “DANGER”, “WARNING” and “CAUTION” are used in this manual to point out hazards
and Notes: and to designate a severity level. While the terms “NOTE” is used to provide useful information in
order to make better use of the equipment.
DANGER: indicates an imminently hazardous situation which, if not avoided could result in serious
injury or death.
CAUTION: indicates a potential hazard or unsafe practice, which if not avoided could result in
serious injury or death.
PRECAUTION: indicates a potential hazard or unsafe practice, which if not avoided may result in
minor damage to the person or the elements.
Page 2 of 79
NOTES AND WARNINGS

WARNING! The followings are descriptions of the general dangers and unsafe usage of the Defibrillator Monitor Mod 3850B-
Biphasic, which can lead to death or severe damage to the user or the equipment.
• You should read this manual before beginning installation and use of equipment.
• This equipment is meant to be used by persons trained in professional health care.
• Defibrillator Monitor Mod. 3850B-Biphasic use is limited to a single patient at a time.
• This equipment must be used in conjunction with signs and symptoms of the patient. The equipment is designed to be an
aid in clinical diagnosis.
• Do not reuse any element disposable or single use. The time limit of use thereof is that indicated by the manufacturer.
• The expiration date of this equipment is of 5 years from its purchase, when that time is over, dismiss the equipment and it’s
accessories following the local regulations in force.
• In case of discarding the equipment or one of its accessories, at the end of its useful life, do it according to the local
regulations, normative or laws in force.
• In order to take care of the environment, you can send the equipment to feas ELECTRÓNICA for its disposal.
• RISK OF ELECTRICAL SHOCK, if you remove the equipment’s lead. Do not remove the equipment’s lead. Ask for
assistance from qualified and authorized personnel.
• There is a risk of Electrical Shock and death. Do not use this equipment if you doubt of the integrity of any cable. Check the
cables periodically (disconnect them before) to verify their integrity; paying special attention to cable points close to
connectors and paddles. In case you find an irregularity, request the part to our Customer’s Service.
• Do not touch the Power Line connectors with wet hands.
• The Defibrillator Monitor Mod 3850B-Biphasic is designed with covers and plastic handles to minimize the risk of electrical
shock. When it is not plugged to the line power its energy will be provided by the battery, without ground reference.
• The multi-outlet power extension cord shall not be placed on the floor.
• The multi-outlet power extension cord should only be used to power equipment that is part of the system.
• All combinations of medical equipment with non-medical equipment must comply with the total leakage current specified in
IEC 60601-1-1.
• When combined instruments, the sum of the leakage currents can be dangerous for both the patient and the operator. If
you can’t determine the leakage current of each team on the specifications of each, technical staff will take measurements
to ensure the installation complies with the requirements of EN 60601-1-1. In any case, the user should consult the
manufacturer to ensure that the sum of leakage currents will not jeopardize patient safety.
• The device is intended to be connected to:
- Installations in medical rooms belonging to Groups 0, 1, 2a and 2b, according to AEA90364-7-710 (IEC 60364-7-710).
- Installations according to AEA90364-7-771, installations in buildings in general, to grounded outlets according to IRAM
2071.
- Mobile units, to the cigarette lighter connector of the vehicle.
• The equipment must be connected to an approved electrical installation that includes a correct grounding according to the
local legislation in force. Do not use adapters or replace the device’s original cables. If the plug does not match the
installation, please contact our Customer Service for the provision of a suitable cable.
• You must make sure that the AC outlet, to which you will plug the device, has a groundling and is in good condition.
• Do not connect this device to an outlet controlled by a switch on/off.
• Verify the AC voltage range matches the voltage at which the equipment is to be connected. If does not match, contact
feas ELECTRÓNICA’s Service Customer.
• Verify the AC frequency indicated on the back panel matches the AC frequency which the device is to be connected. If
does not match, contact feas ELECTRÓNICA’s Service Customer. Do not use the device in those conditions. The ECG
curve will be affected by noise and will not be able to use SYNC mode.
• If you have any doubts about the integrity of the ground, either the cable or the installation of the building, use the device
from the internal battery. In case that the battery is discharge or damage, don't use the equipment.
• The disconnection of the equipment from the Power Line does not de-energize it, since it has an internal battery, so you
must also set the selector switch to OFF.
• Caution, leave one end of the power cord accessible so that in the event of an emergency, it is easy to disconnect the
equipment from the Power Line.
• Do not disconnect power by pulling the cord. Disconnect the connector firmly grasping.
• Do not excessively bend the plug or power cord or place heavy objects on them, which could cause damage.
• Do not immerse the electrical connector in liquids. This can damage the cable or connector by corrosion.
• RISK OF FIRE AND/OR EXPLOSION: do not use this equipment in the presence of flammable gases (anesthetics,
oxygen, etc).
• Not use or store inflammable substances near the equipment.
Page 3 of 79
• Avoid installing this equipment in places where liquids can be spilled on it. Avoid direct exposure to splatter, sprayer or air
vented from nebulizers or humidifiers.
• Do not place containers with water, chemicals or any small metal objects on the equipment.
• Do not use this equipment under the rain. You have to make sure that the equipment, the cables and paddles are dry
before you start using them.
• Do not place the equipment on the patient or where it can fall over the patient. Place it next to the patient where it’s
comfortable for its use.
• Never attempt to introduce sharp, metallic or other objects into any aperture on the equipment.
CAUTION! The followings are the general descriptions of precautions and unsafe usage that could cause slight injuries, damage or
wrong performance of the equipment.
¾ The operation of the equipment can be affected by the presence of CAT scanner.
¾ The operation of the equipment can be affected by the presence of portable and mobile RF communications equipment.
¾ Do not use this equipment near Magnetic resonance imaging equipment (MR o MRI).
¾ The operation of the equipment below the specified amplitudes can cause inaccurate results.
¾ The Defibrillator should not be used adjacent or stacked with other equipment, if it is necessary to use it adjacent or
stacked with other equipment, the Defibrillator should be observed to verify its normal functioning in the configuration in
which it is being used.
¾ To attach wires and sensors always use hypoallergenic tape.
¾ Do not store the equipment in deposits or between periods of use in places where the sun shine directly on it. Risk of
damage to the cover of the equipment, parts and accessories.
¾ Avoid installing this equipment in those places where the sun hits directly.
¾ Do not place heavy objects on the equipment.
¾ Do not drop the equipment when moving it.
¾ Use the equipment on a flat and stable surface.
¾ Important!! If using a bracket, make sure that the bracket holds at least twice the weight of the equipment. If you have any
questions, please contact feas ELECTRÓNICA.
¾ Do not push the keys of the frontal panel with pushing or slicing elements. This will produce permanent damage to the
keypad. Only push the keys of the frontal panel with your fingers. Do not press the buttons with your nails.
ACCESSORIES MESSAGES
WARNINGS
• The proper operation of the equipment and protection against the effects of the discharge of a cardiac defibrillator requires
the use of original accessories intended for this equipment. Only use original accessories provided with the equipment or
those accessories specially indicated for this equipment.
• The use of accessories, transducers and cables other than those specified, with the exception of the transducers and
cables sold by the equipment manufacturer as replaceable parts of internal components, may cause an increase in
emissions or a decrease.
• The user shall be responsible to check the compatibility between the accessories used and this medical device.
CAUTIONS
• Do not clean or disinfect the accessory’s cable, accessories, and parts of the equipment or its main body with sodium
hypochlorite, solvents, acids or abrasive products. For cleaning and disinfection of equipment follow the instructions given
in this manual.
• Risk of equipment breakdown. Do not sterilize this equipment or its parts or accessories in autoclave or ethylene oxide. Do
not submerge any part of this equipment in water or other liquids or use abrasive cleaners. Do not spray or spill liquids on
the equipment or its accessories. Do not allow any liquid entering the connectors or other openings of the housing. If you
accidentally spill liquid on the equipment, turn the energy switch OFF (because the equipment has internal battery) and
disconnect it the power line (in case it is connected to the power line), clean it and dry it before reuse. If in doubt about
equipment security, send it to an authorized technical service.
BATTERY MESSAGES
WARNINGS
• The battery must be replaced by an original battery for this equipment. Replacement with another type of battery can result
in an unacceptable risk of temperature rise, fire and/or explosion of the battery or the equipment.
CAUTIONS
• The equipment has rechargeable battery type must remain connected to the power line during periods when it is not used.
• If the capacity of the internal battery is below 80% the equipment will be able to function from line power or Ext +12Vdc.
• Do not discharge the battery completely.
• Recharge the battery immediately after it’s been used.
Page 4 of 79
• The internal battery of this equipment cannot be replaced by the user. It has to be replaced by qualified and authorized
personnel.
• In case you replace the battery follow the local instructions to dispose Ni-Mh batteries or send them to feas
ELECTRÓNICA for disposal.
• When the device is stored in warehouse, should be put to charge at least once every 60 days for at least 3hrs at 25ºC
±3ºC temperature, to prevent battery damage.
DEFIBRILLATOR MESSAGES
WARNINGS
• Discharging a defibrillator directly to a healthy person’s chest can be lethal.
• In order to decrease the time pre-shock should follow the specific CPR protocols of the place.
• Neonatal and pediatric defibrillation energy levels should be set based on the specific clinical protocols.
• Conscious patients must be anesthetized or sedated before performing synchronized cardioversion.
• Before performing cardioversion, correct synchronism with R wave must be assess.
• When defibrillating the patient be careful to avoid the contact between patient’s body parts (exposed skin, head, arms and
legs) with metallic objects (such as parts of the bed) that might generate non desired paths for the defibrillation current.
• Rescuers performing chest compressions during external defibrillation are exposed to leakage currents.
• Do not touch the bed, patient’s body, or any equipment connected to the patient during defibrillation. A severe electrical
shock can result.
• It is not necessary to disconnect the ECG electrodes, Pacemaker electrodes and/or Oximetry sensor for defibrillation since
the equipment is electrically isolated; although the paddles should not be positioned close to or on the electrodes or metal
parts in contact with the patient, if this is not possible remove the electrodes or metal parts before positioning the paddles.
• This equipment is protected against the effects of defibrillation.
• Make sure you know where and how to position the paddles for monitoring and defibrillation. See section External
paddles positioning.
• When defibrillating with paddles, use your thumbs to operate the SHOCK buttons in order to avoid inadvertent operator
shock.
• When positioning the paddles on the patient for energy discharge, make sure no one is near or in contact with the patient.
• Avoid spilling conductive paste or gel over hand or in the paddles handles as this might cause and electric shock to the
operator.
• Avoid the excess of conductive paste or gel over the patient’s thorax as it could generate and electric path over the
patient’s skin.
• To avoid risk of electrical shock, do not touch the gelled area of the pads while pacing.
• Take special care to keep the paddles pressing firmly on the patient, since a poor contact with the patient may cause
interference (noise) resulting in a false trigger and shocks the patient, as well as cause burns at the shock time.
• Never defibrillate a patient with the paddles wet.
• Never defibrillate a patient on a wet surface.
• More than 10 energy discharges should not be performed during the Test of Energy Delivered; considering that the
minimum waiting time is 1 minute, between discharges.
CAUTIONS
• For safety reasons, after completion of the energy charge and elapsed the “automatic disarm time”, the defibrillator will
discharged the energy internally automatically. By default, the “automatic disarm time” is 60 seconds. For more information
on how to configure the “automatic disarm time” refer to SETUP MENU section.
• Verify that the devices connected to the patient are protected against defibrillation before shock to the patient. If necessary
disconnect the patient from those devices that are not protected against defibrillation so that they are not damaged by the
shock.
• It is recommended DO NOT USE Xylocaine to apply a shock.
• Be sure to know the methods used to discharge the energy charged in the Defibrillator Monitor Model 3850B.
• Do not discharge the Defibrillator Monitor placing paddle against paddle or in the paddle support.
• It is suggested to perform the Test of Energy Delivered according to the domestic policy of the Institution Health or at least
once a week.
• Before performing the Test of Energy Delivered, external paddles must be connected and place on the paddles holder.
Perform the verification with the equipment connected to line power.
ELECTROSURGERY MESSAGES
WARNINGS
• It is recommended to place the ECG electrodes, Pacemaker electrodes and/or Oximetry sensor away from the surgical
field in the case in which it will use an electrocautery; this is to prevent burns on the patient’s body in the area of the
electrode.
Page 5 of 79
• The neutral electrode of the electrocautery must have adequate contact with the patient, otherwise it may cause burns to
the patient.
• It is not necessary to disconnect the ECG electrodes, Pacemaker electrodes and/or Oximetry sensor for electrosurgery
since the equipment is electrically isolated; although the paddles should not be positioned close to or on the electrodes or
metal parts in contact with the patient, if this is not possible remove the electrodes or metal parts before positioning the
paddles.
• The use of an electrocautery it can cause interference in the operation of this device.
CAUTIONS
• Operation of this equipment may be affected by the presence of strong electromagnetic or radio frequency fields such as
those produced by electrocautery.
ECG MESSAGES
WARNINGS
• Conductive parts of electrodes and associated connectors for applicable parts shall not contact with other conductive parts
of equipment (metal part), including metal parts of equipment connected to ground.
• Make sure you know where and how to position the electrodes for monitoring. See section “Placing electrodes”.
• After the delivery of a defibrillator shock, if monitoring is undertaken with a combination of gel and patch/paddle, the ECG
may initially display no signal or asystole, regardless of the true rhythm.
electrode.
• The heart rate may be affected in the presence of arrhythmias. The cardiotachometer uses an algorithm to determine the
heart rate.
• This equipment may reject pacemaker pulses of the following characteristics: with amplitude of ±2mV to ±700mV and a
pulse width of 0.1ms to 2ms, anyway keep the patients with pacemaker under close surveillance.
• Electrocardiographic monitoring equipment and its accessories shall not be considered life-supporting medical equipment.
• PATIENTS WITH PACEMAKERS. The rate meter may continue to count the pacemaker rate during some occurrences of
cardiac arrest or some arrhythmias. Not based entirely on the rate meter alarms. Keep patients under close surveillance.
• Be careful when making a temporary suspension audible alarm signal (silence), keep the patient under close surveillance
at all times. If the alarm signals are selected, the visual alarm signal will continue to indicate an alarm condition if this
occurs.
• Maximum channel height: 21.2mm. Suitable for use as a monitor up to 2 meters away.
• Carefully route the patient cables, extension cables, oximetry sensors and/or pacemaker electrodes to reduce the
possibility of patient entanglement or strangulation.
CAUTIONS
paddles.
• During monitoring, the ECG electrodes should be re-positioned every 48 hours to maintain good signal quality. After 48
hours, the electrode’s conductive paste or gel begins to dry and the patient’s skin may begin to chafe.
• For ECG monitoring using hypoallergenic adhesive electrodes. The company recommends 3M ECG electrodes.
PACEMAKER MESSAGES
WARNINGS
• Conductive parts of electrodes and associated connectors for applicable parts shall not contact with other conductive parts
of equipment (metal part), including metal parts of equipment connected to ground.
• Make sure you know where and how to position the pacer electrode for monitoring. See section Transcutaneous pacer
usage.
electrode.
• Use demand mode whenever possible. Use asynchronous mode when the presence of motion artifacts or other sources of
artifacts, of the ECG, render the R-wave detection is not reliable.
• To change the pacing mode is necessary that the pacemaker is off.
Page 6 of 79
• When pacing in demand mode is performed, the patient cable must be connected from the patient to the equipment. If you
do not connect the cable patient cannot turn on the pacemaker. If the pacemaker is on and disconnect the patient cable,
the pacemaker will turn off.
• If you will shock the patient, at move the selector switch from the MONITOR position to the selected energy value, the
pacemaker will turn off.
• Verify mechanical capture by radial pulse when electrical stimulation (pacing) is applied.
CAUTIONS
paddles.
• If the pacemaker function is used in demand mode for extended periods of time, may be necessary to apply new ECG
electrodes.
OXIMETRY MESSAGES
WARNINGS
• This is a functional measuring cannot be used to evaluate the accuracy of a pulse oximeter probe or a pulse oximeter
monitor.
• The pulse oximeter cannot measure the contribution to total error of a probe/monitor system.
• The oximeter is calibrated to display the visualization of functional oxygen saturation.
• Significant dysfunctions of hemoglobin affect the accuracy of the SpO2 measurement.
• SpO2 measurement can be affected by excessive ambient light. If necessary, cover the sensor area with an opaque
material (e.g. surgical gauze).
• Contrast inks introduced into the bloodstream, such as methylene blue, indocyanine green, indigo carmine and fluorescent,
can affect the accuracy of SpO2 reading.
• Any condition that may reduce the blood flow, like the usage of cuff to measure the blood pressure or extreme systemic
vascular resistance might cause an improper result in the SpO2 and pulse rate measurements.
• Avoid using the Oximetery sensor in any extremity were a baumanometer or any type of catheter is placed.
• Before placing the Oximetry sensor remove nail polish or fake nails, they might cause mistakes in the SpO2 reading.
• If the extremity is in an elevated position, could compromise venous return and provide lower saturation measurements.
Therefore, it is recommended to keep the Oximetry sensor at the height of the heart.
• Do not place the Oximetry sensor across the foot of a pediatric patient or on the foot itself.
• All necessary information regarding the toxicity and/or action on the tissues of the materials with which the patient or
anyone else can contact is indicated in each attachment
• It should be noted that values between 70% and 100% SpO2 measured by the pulse oximeter will be within ± 2% of the
value measured by a co-oximeter, due to the statistical distribution.
• If the equipment power is interrupted, when returning energy, the equipment will start with the last configuration set by the
operator, except for the minimum oximetry alarm limit, that if it was off or set to less than 85%, will be adjusted to 85%, by
regulatory requirement, and if has been set to more than 85% will retain the value set by the operator.
electrode.
• Be careful when making a temporary suspension audible alarm signal (silence), keep the patient under close surveillance
at all times. If the alarm signals are selected, the visual alarm signal will continue to indicate an alarm condition if this
occurs.
CAUTIONS
• Only use the Oximetry sensor provided with the equipment or those specially indicated for this equipment.
• The user is responsible for ensuring compatibility between the sensor, extension cable and this equipment.
Page 7 of 79
paddles.
• When placing the Oximetry sensor “Y” with tape does not stretch or tighten it. If the tape is too tight can cause inaccurate
readings and blisters on the skin of the patient (the blisters are caused by lack of skin breath, not by heat).
• Replace the Oximetry sensor every 2 hours to allow the patient’s skin to breathe.
• The operation of the Oximeter can be affected by the presence of Computed Tomography equipment.
• In the presence of strong electromagnetic fields, the reading of SpO2 may not be stable, displaying different values in every
second. The device reading will stabilize after the interference ceases or when the device moves away from the emission
source.
• The maximum time of application of the Oximetry sensor is indicated in its own manual.
• The specific use of the Oximetry sensor concerning: the patient population (e.g. age, weight), body part or tissue type to
which it applies and application (e.g. environment, frequency of use, anatomical place, mobility) is indicated in its own
manual.
• Be sure to know where and how to position the Oximetry sensor. Refer to the user manual that accompanies the sensor.
MAINTENANCE MESSAGES
WARNINGS
• Before any cleaning, make sure the device is turned off. REMEMBER: The device has internal battery, so even
disconnected from the AC line, may be turn on. Verify the selection switch is in the OFF position and the display doesn’t
contain instructions and is turned off.
• Risk of explosion or fire! Do not allow spill water or other liquid on the device. Unplug the power cord before cleaning or
disinfecting equipment.
• It is not allowed to modify the equipment.
• Not modify this equipment without authorization from the manufacturer.
• If you modify this equipment must perform appropriate tests and inspections to ensure continued safe use of equipment.
CAUTIONS
• Risk of equipment breakdown. Do not sterilize this equipment or its parts or accessories in autoclave or ethylene oxide. Do
not submerge any part of this equipment in water or other liquids or use abrasive cleaners. Do not spray or spill liquids on
the equipment or its accessories. Do not allow any liquid entering the connectors or other openings of the housing. If you
accidentally spill liquid on the equipment, turn the energy switch OFF (because the equipment has internal battery) and
disconnect it the power line (in case it is connected to the power line), clean it and dry it before reuse. If in doubt about
equipment security, send the same to an authorized technical service.
• Risk of equipment breakdown. No sterilize defibrillation paddles of this device in autoclave or ethylene oxide.
• Do not clean the external cover, the cables or the paddles with abrasive or acid products.
• Do not clean or disinfect accessory cables, accessories and parts of the equipment or the main body thereof with sodium
hypochlorite (bleach water), solvents, acids or abrasive products. For cleaning and disinfection of the equipment and its
accessories, follow the instructions in this manual.
• During storage in warehouses and between uses, respects the conditions of temperature, pressure and humidity as
defined in this manual and periods of recharge the internal battery specified.
• It suggests an annual contrasting against calibrated simulators.
• In case of fuses are damage replace with fuses of the same type and value. If the failure persists, please contact our
Customer Service.
• This equipment has line fuses in both the neutral pole and Phase Line.
• Neither this equipment nor any of its parts are sterile or sterilizable.
• The user shall be responsible to check the compatibility between the accessories used and this medical device.
Screen visualization
The data visualized in the screen are updated once every second, same for SpO2 and pulse rate. The visualized data is the
measured values; they are not averaged and are not perform any other process.
The alarm gets activated at the first pulse rate or SpO2 value, out of range, it might have one second delayed to generate and
display the alarm signal.
Calibration
An annual contrasting the equipment with calibrated simulators is suggested.
Page 8 of 79
SCREEN MESSAGES
Warning messages from Configuration
“Setup error” This message is displayed when, turning on the device, is located that there are differences between the stored
configuration of factory and the current configuration.
Warning messages from the ECG

“Lead off” This message is shown when one of the ECG electrodes looses connection with the patient. When this message is
displayed can be selected only the leads DI, DII and DIII.
“ECG Saturated (Override)” This message is displayed when, for some reason, ECG channels receive more than ±5mV signal at
its inputs, making inoperative ECG monitoring (Paddles or Patient ECG Cable).
Indicator of pacemaker spike detection

The following figure shows the indication of the presence of pacemaker’s spikes on screen:
Page 9 of 79
Error message during the energy charge
“Charge error” This message is shown when, once the charging command is started, for some reason and after a certain time the
charged energy does not reach the chosen energy value.
Test messages of energy delivered
“Passed test”: This message is displayed upon completion of the energy test in the event of a successful outcome.
“Failed test”: This message is displayed upon completion of the energy test in case of a failed result.
Warning messages from the oximeter
This message will be displayed while the Oximetry sensor is not plugged to the device.
Without sensor
Once connected the Oximetry sensor, this message will be displayed while the sensor is
not placed to the patient.
Without patient
Page 10 of 79
After placing the sensor on the patient, the message “Searching” is displayed while the
oximeter detects pulse.
Searching
If pulse is not found after a long period of time, the message “Not found” will be
displayed.
Not found
Once connected the Oximetry sensor and if the device detects patient movement, this
message will be displayed.
Movement
In the presence of a weak signal or low perfusion will display the message “Low
perfusion”.
Low perfusion
If there is no communication with the Oximeter module the message “SpO2 module
error” will be displayed.
SpO2 module error
Indicates a power supply failure in the Oximeter module.
Power fault
Page 11 of 79
Indicates that there is a problem with the Oximetry sensor.
Sensor fault
When interference is detected by ambient light, the message "Light Ambient".
Interference by
ambient light
Warning messages Transcutaneous Pacer (TPM)

“Pacer lead off” This message is displayed when an electrode pacer loses contact with the patient and pacer pulse is not applied.
“Pacer Off” This message is displayed when the pacemaker is on and the selector switch moves from position “MONITOR” to the “2
Joules” position, or when the pacemaker is on and mode demand (DEM), and the patient cable is disconnected from the equipment.
“Select monitor mode” This message is displayed when you try to turn on the pacemaker, regardless of the selected mode, and
the selector switch is in a position of energy selection.
Page 12 of 79
“No ECG patient cable” This message is displayed when you try to turn on the pacemaker in demand mode (DEM) and patient
cable is not connected to the equipment.
Warning messages RECORDER module
The error message will continue as long as the cause or causes that generate it.
Warning messages BATTERY

When the device’s battery is fully discharged and the device is about to power down, the screen will display messages “Battery
discharged” and “Powering down” (see figure below), and in 120 seconds the device automatically turns off. These messages are
accompanied with auditory alarms signal of high priority as described in section “AUDITORY ALARM SIGNALS OF HIGH
PRIORITY”.
Page 13 of 79
SYMBOLS AND REFERENCES LIST

Attention! Consult accompanying documents. Defibrillation-proof type CF.
Protection against electric shock: “CLASS I”
CLASS I (with protective earth (ground)).
Serial number.
Protected against vertical water falls with a
Reference code.
maximum tilted of 15 degrees.
Authorized representative. Battery fully charged.
Line/Battery charge. Low battery.
Date of manufacture. Battery discharged.
Not suitable for explosive atmosphere. Sound volume.
Connected to line or external 12Vdc. Screen contrast.
Right. Up.
Left. Down.
Protective earth (ground). Warning! High voltage.
Protect from rain. Do not pile more than 3 boxes.
Fragile. Box orientation.
Charge button. Shock button.
Sync key. Recorder.
Disarm key. Alarm key.
Manufacture. Follow the instructions.
Alarm silence. For disposal follow local regulations.
Storage and transport temperature, maximum and

Storage and transport relative humidity
minimum.
(non-condensing), maximum and
minimum.
Storage and transport pressure, maximum and

minimum.
Label layout as Annex III.B A.N.M.A.T. 2318/02. Back label: CE and power supply.
Page 14 of 79
INFORMATION FOR SERVICE

Requirements for Service: You must follow service requirements that listed below:
• Use only service personnel authorized by feas ELECTRÓNICA.
• Any repairs not authorized the equipment during the warranty period will void the
warranty.
• The lack of regular maintenance can cause equipment failure and possible health
risks.
• Regular maintenance, irrespective of usage, is essential so that the equipment
always be operational when needed.
Identification of the equipment: Each feas ELECTRÓNICA’s equipment has a unique serial number that identifies it
(see the figure below).
Where it says:
BAT: Internal Battery.
REC: With Thermal Recorder.
TPM: With Transcutaneous Pacer.
SpO2: With Pulse Oximeter.
This acronym describes the optional configuration of your defibrillator.
Page 15 of 79
COMPONENTS OF EQUIPMENT
INTRODUCTION
This user’s manual provides instructions for the installation, operation and basic maintenance, also for safe and appropriate use of
the DEFIBRILLATOR MONITOR 3850B-Biphasic.
Before you start using the device, read the manual and get familiar with its content.
DEVICE DESCRIPTION AND INTENDED USE
Description
The model 3850B-Biphasic of feas ELECTRÓNICA is a defibrillator monitor of rectilinear biphasic waveform capable of delivering
up to 200Joules of energy, selectable by steps; it may be used in asynchronous or synchronous mode to perform synchronized
cardioversion by using the R-wave of the patient ECG as a timing reference. The defibrillation is manual, implies that the operator
must set the energy, initiate charge and press shock button.
It also allows ECG monitoring, with measure of Heart Rate, through paddles, or through 5 or 3 wires patient ECG cable allowing the
selection of DI, DII, DIII, aVR, aVL, aVF and V leads depending on the cable. Optional pulse oximetry (SpO2) monitoring is also
available, plotting plethysmographic curve and a bar graph indicating the pulse amplitude, indicating SpO2 and pulse rate values on
display. Both, ECG and SpO2, allow alarm adjustment to monitor heart rate, SpO2 and pulse rate of the patient.
It is portable, powered by an internal rechargeable battery, by ac line 90V~ to 240V~, 50Hz or 60Hz with selection Notch Filter setup
in factory or an external supply of 12Vdc.
Optional transcutaneous pacer is available, to apply temporarily pacing a patient’s heart in external non-invasive way.
A thermal recorder is also optionally available. Two real time curves can be registered: an ECG lead and the plethysmographic
curve, optionally. The record can be initialized in manual mode by the operator when decided or in automatic mode during energy
charge.
The optional parameters combination is detailed in the next table:
Ref. Description
14634 DEFIBRILLATOR MONITOR WITH INTERNAL BATTERY 3850B BIPHASIC.
14635 DEFIBRILLATOR MONITOR WITH INTERNAL BATTERY AND RECORDER 3850B BIPHASIC/R.
14636 DEFIBRILLATOR MONITOR WITH INTERNAL BATTERY AND PACER 3850B BIPHASIC/TPM.
14637 DEFIBRILLATOR MONITOR WITH INTERNAL BATTERY, RECORDER AND PACER 3850B BIPHASIC/R/TPM.
14638 DEFIBRILLATOR MONITOR WITH INTERNAL BATTERY AND SpO2 3850B BIPHASIC/SpO2.
14639 DEFIBRILLATOR MONITOR WITH INTERNAL BATTERY, RECORDER AND SpO2 3850B BIPHASIC/R/SpO2.
14640 DEFIBRILLATOR MONITOR WITH INTERNAL BATTERY, PACER AND SpO2 3850B BIPHASIC/TPM/SpO2.
14641 DEFIBRILLATOR MONITOR WITH INTERNAL BATTERY, RECORDER, PACER AND SpO2 3850B BIPHASIC/R/TPM/SpO2.
Intended Use
The Defibrillator Monitor 3850B-Biphasic should be used only by qualified medical personnel in the use of the device, Advanced
Cardiac Life Support, defibrillation procedures, electrical cardioversion, life signals monitoring and pacers. It can be also used by
paramedics or nurses under a medical direct supervision and order.
The Defibrillator Monitor 3850B-Biphasic is intended to be used in a great variety clinical/hospital ambient such Intensives Cares,
Coronary Care Unit, Operating Room, Emergency Room, and Out-Of-Hospital or mobile units such an ambulance.
It is intended to be used in neonates, pediatric, adults and senior adults, victims of cardiac arrest, ventricular fibrillation, ventricular or
supraventricular tachycardia, atrial fibrillation, bradycardia or other fatal arrhythmias.
INDICATIONS AND CONTRAINDICATIONS

Defibrillation and Cardioversion
Indications:
Asynchronous defibrillation is the initial treatment for ventricular fibrillation and ventricular tachycardia in patients who are pulse less,
unconscious and not breathing by itself. The synchronous fibrillation or cardioversion is indicated for termination of atrial fibrillation,
atrial flutter or atrial tachycardia.
Page 16 of 79
Contraindications:
Asynchronous defibrillation therapy is contraindicated in patients that exhibit one or any combination of the following:
• Responsiveness.
• Spontaneous breathing.
• Palpable pulse.
Inappropriate defibrillation or cardioversion of a patient (e.g. without malignant arrhythmia) can cause ventricular fibrillation, asystole
or other dangerous arrhythmias.
The defibrillation asystole may inhibit recovery of the heart’s natural pacemaker and completely eliminate any possibility of recovery.
Energy should not be applied routinely during asystole.
The incorrect application of the paddles or gel pad in defibrillation can lead to inefficacy and produce burns, particularly when
multiple shocks are delivered.
Erythema or hyperemia of the skin under the paddles can often be caused; this redness should decrease in term of 72 hours.
Transcutaneous pacing therapy (optional)

Defibrillator Monitor 3850B-Biphasic with TPM provides non-invasive transcutaneous pacing by delivering a monophasic, electrical
stimulus to the heart. This stimulus is intended to cause cardiac depolarization and myocardial contraction. The medical care
provider selects the stimulus current and rate settings. The energy is delivered through electrodes applied to the patient’s bare chest.
Indications:
Non-invasive pacing is one method of treating patients with symptomatic bradycardia. It can also be helpful in patients with asystole,
if performed early.
Contraindications:
Non-invasive pacing is contraindicated in the treatment of ventricular fibrillation, it not respond to electrical stimulation and requires
immediate defibrillation. For that reason, the patient arrhythmia should be immediate determinate to apply the correct treatment. If
the patient is suffering ventricular fibrillation and the defibrillation was successful but asystole is produced, pacing should be applied.
Ventricular or supraventricular tachycardia could be interrupted with pacing, but synchronized cardioversion is quicker and safer
during emergency to circulatory collapse. An electromechanical dissociation can occurs after a prolonged cardiac arrest; in this case
effective ECG response without mechanical contractions can be produced by pacing, whereby another treatment is required.
Undesirable repetitive responses, tachycardia, fibrillation with generalized hypoxia, myocardial ischemia, cardiac drug toxicity,
electrolyte imbalance or other heart diseases can be caused by pacing.
Stimulation by any method tends to inhibit the intrinsic rhythm. Abrupt rate, especially in high heart rates, may cause ventricular stop.
Non-invasive Temporary Pacing may cause discomfort of varying intensity, which can sometimes be serious and oppose the
continued use in conscious patients.
Similarly, inevitable muscle contraction can be problematic in very ill patients and may limit continuous use to a few hours.
Often can be produce erythema or hyperemia of the skin under the electrodes.
Non-invasive pacing in the presence of severe hypothermia may be contraindicated.
Pulse Oximeter (optional)

Indications:
SpO2 monitoring is indicated for use when it is beneficial to assess a patient’s oxygen saturation level. It is indicated for use in any
patient who is at risk of developing hypoxemia.
Contraindications:
There are no known contraindications for SpO2 monitoring through a Pulse Oximeter.
Page 17 of 79
FRONT PANEL
Monitor section
- Connector for patient ECG cable.
- Liquid Crystal Display with backlight.
- CURSOR keys that let you use the monitor menu.
- RECORDER key: To start or stop the paper record (if the device has the optional recorder).
- SILENCE key: To cancel the alarm sound for 2 minutes.
Defibrillation section
- SELECTOR SWITCH: This selector switch allows the device turn on or turn off, selecting mode MONITOR (which
doesn’t allow energy charge) and selecting the desired energy.
- CHARGE Key: Initiates energy charge.
- DISARM Key: Disarm energy charge.
- SYNC key: For SYNCHRONOUS mode selection.
- The shock is performed using the keys placed in the paddles (you must press both them simultaneously) or with the
key (in the front panel).
Recorder section
- Cover.
- Cover open button.
Page 18 of 79
Oximetry section
- Connector for SpO2 sensor.
- Indication of saturation percentage (SpO2) and pulse rate (PR).
- Plethysmographic curve.
- Pulse intensity bar.
- Function of SpO2 Alarm.
- Function of pulse rate Alarm.
Transcutaneous Pacer section
- CF pacer output type.
- Through external stimulation electrodes.
- Pacer output connector polarized.
- Selection and display of current and programmed pacing rate.
- Frequency Range: 40ppm to 180ppm ±5%.
- Output Current: 10mA to 200mA ±5%.
- Constant current impedances up to 1000Ω.
- Pulse Width: 20ms ±5%.
- Mode: NOT on demand.
REAR PANEL
BAT: With Internal Battery.

REC: With Thermal Recorder.
TPM: With Transcutaneous Pacer.
SpO2: With Pulse Oximeter.
Page 19 of 79
ACCESSORIES
WARNING! The proper operation of the equipment and protection against the effects of the discharge of a cardiac defibrillator
requires the use of original accessories intended for this equipment. Only use original accessories provided with the equipment or
those accessories specially indicated for this equipment.
WARNING! The user shall be responsible to check the compatibility between the accessories used and this medical device.
WARNING! The use of accessories, transducers and cables other than those specified, with the exception of the transducers and
cables sold by the equipment manufacturer as replaceable parts of internal components, may cause an increase or decrease in
emissions.
ATTENTION! Do not clean or disinfect the accessory’s cable, accessories, and parts of the equipment or its main body with sodium
hypochlorite, solvents, acids or abrasive products. For cleaning and disinfection of equipment follow the instructions given in this
manual.
ATTENTION! There is a risk that the equipment will break. Do not sterilize this equipment or its parts or accessories in autoclave or
ethylene oxide. Do not submerge any part of this equipment in water or other liquids or use abrasive cleaners. Do not spray or spill
liquids on the equipment or its accessories. Do not allow any liquid entering the connectors or other openings of the housing. If you
accidentally spill liquid on the equipment, turn the energy switch OFF (because the equipment has internal battery) and disconnect it
the power line (in case it is connected to the power line), clean it and dry it before reuse. If in doubt about equipment security, send
the same to an authorized technical service.
Ref. Description Quantity Image Adult Pediatric neonatal
PATIENT ECG CABLE DB9M/G - 3

1879
WIRES. R R ---

1880
WIRES. R R ---
1 unit (patient
ECG cable that
might be chosen
PATIENT ECG CABLE DB9M/G - 5 by the client).
16474 R R R
MINI CLIP 60cm.

16475 R R R
MINI CLIP 60cm.
DISPOSABLE ELECTRODOS x 10
1902
unit.
1 set. R R R
POWER CORD 220V IRAM

238 1 unit. R R R
CONNECTOR.
EXTERNAL BATTERY POWER
1846 CORD 12Vdc FOR VEHICLE 1 unit. R R R
(OPTIONAL).
USER’S MANUAL DEFIBRILLATOR

16184 1 unit. R R R
3850 B.
THERMAL PAPER FOR ECG:

14520 1 unit. R R R
WIDTH 55mm x 25m. (OPTIONAL).
1261 PACER ELECTRODES (OPTIONAL). 1 set. R --- ---
Page 20 of 79
Ref. Description Quantity Image Adult Pediatric neonatal
PACER ELECTRODE CABLE 2 PIN

10024
2mm - DB9M/G (OPTIONAL).
1 unit. R --- ---
VELCRO BELT FOR PACER

6467
(OPTIONAL).
1 unit. R --- ---
ADULT OXIMETER FINGER
12138 SENSOR DB9M/G feas R R ---
ELECTRÓNICA 512F (OPTIONAL).
PULSE OXIMETER SENSOR,
PEDIATRIC, FINGER, DB9M/G,
15463
feas ELECTRÓNICA, 512H
--- R ---
(OPTIONAL).
ADULT, DISPOSABLE, DB9M/G,
17364
feas ELECTRÓNICA, 520A
R R ---
(OPTIONAL).
PEDIATRIC, DISPOSABLE,
17365
DB9M/G, feas ELECTRÓNICA,
1 unit (sensor --- R ---
cable that might
520P (OPTIONAL). be chosen by
PULSE OXIMETER SENSOR, the client).
17366 INFANT (3kg-20kg), DISPOSABLE, --- R R
DB9M/G, 520I (OPTIONAL).

17367 NEONATAL (< 3kg), DISPOSABLE, --- --- R
DB9M/G, 520N (OPTIONAL).
PULSE OXIMETER REUSABLE “Y”

SENSOR, NEONATAL, FOOT,
15037
feas ELECTRÓNICA, 518B
--- --- R
(OPTIONAL).
SpO2 ADAPTER CABLE DB9MG-

10629 1 unit. R R R
DB9F (OPTIONAL).
ADULT TO PEDIATRIC PADDLES

17122
ADAPTER (OPTIONAL).
1 set. --- R ---
17121 EXTERNAL PADDLES 3850. 1 set. R --- ---
DEFIBRILLATOR 3850B
7094
PACKAGING.
1 set. R R R
NOTE: The images of accessories are for illustrative purposes.
Page 21 of 79
CONTROL AND INDICATORS

Control
Cursor movement keys.
Selection keys of menu items.
Alarm silence key. Activates and deactivates the alarm sound.
Key to RECORD on thermal paper.
Mode key SYNCHRONOUS/ASYNCHRONOUS: Determines if the shock is synchronized

with the patient’s QRS (synchronous) or not.
Discard the energy stored in the capacitor, internally.
Starts charging the capacitor until it reach the energy value selected by the selector
switch. The indicator flashes until it reaches the value of energy and then stays on.
Shock key: Discharge the stored energy in the device over the patient through external
paddles, internal paddles or self-adhesive patches.
Selector switch: Energy Selection, Monitoring and Off: The energy positions are graded in
joules. In the MONITOR position, the device is inhibited to store energy.
In the OFF position turns off the device.
The energy values indicated are for patient impedance of 50Ω.
Indicators
GREEN LED:
Indicates AC power line presence or external +12Vdc. When on, the internal battery is charging. When is off, the
device is operating at internal battery.
YELLOW LED:
When on, indicates that the device is in synchronous mode and stay on until the energy is discharged.
YELLOW LED:
Off: Indicates no charge on the capacitor of the device.
Flashing: Indicates that the device is in the process of storing energy.
On: Indicates that the selected energy from the selector switch is ready to be discharged on the patient.
Page 22 of 79
STANDARD SCREEN
ECG SCREEN CASCADED
To display the cascade ECG see section “CONFIGURATION MENU”.
OPTIONAL
Recorder module
The Defibrillator 3850 allows the possibility of printing, with the optional recorder module whose output paper is in the top.
Entries optional parameters:

The available options are for measuring SpO2 and the Pacer. See section FRONT PANEL.
Page 23 of 79
SPECIFICATIONS
GENERAL
Device Class I and internally powered.
Degree of protection against electrical shock: Type CF.
Degree of protection against liquids: IPX2.
The equipment is not suitable for use in the presence of explosive atmosphere or flammable mixture.
• Safety Standards:
- EN-60601-1 (Eq. IRAM 4220-1 and IEC 601-1).
- EN-60601-1-2. (Electromagnetic Compatibility)
- EN-60601-1-6.
- EN-60601-1-8.
- EN-60601-2-4.
- EN-60601-2-27.
- EN-60601-2-49.
- ISO 80601-2-61.
• Quality Standards:
- CE marking, Dir. 93/42/CEE (certificate).
- ISO 9001 (certificate).
- ISO13485 (certificate).
- A.N.M.A.T. 3266/2013 Disp.: B.P.F. (certificate).
- A.N.M.A.T. 2319/02 Disp. (certificate).
DT: Eng. Jorge F. Feas - MP: 12341991.
The equipment is authorized by A.N.M.A.T. PM-1125-15.
The equipment is sold exclusively to medical professionals and medical institutions.
Use Mode: Monitoring, Recording and Pacer: continuous use.
Defibrillator: intermittent use, maximum cadence of 200J shock: 3 shock per minute and 1 minute rest.
In both cases, the device will be powered with 90Vac - 240Vac, 50Hz/60Hz.
Electrical Specifications
Power supply: 90Vac - 240Vac (automatic selection) and notch filter 50Hz or 60Hz, factory selectable.
External Power: 12Vdc.
Internal Power Supply
- Battery.
- 12V-3500mAh Pack.
- Weight: 750grs.
- Ni-Mh battery.
Battery Autonomy: Continuous Monitoring 8hs or at least 150 shocks of 200J.
Battery Charging Time from exhausted till at least 90%: 2hrs 15min.
Maximum power consumption during maximum energy charge: 180W.
Power consumption during standby: 7W.
Power supply in Ambulance:
- Be medical grade and meet the requirements of standard IEC 60601-1 or come from a vehicle battery
(cigarette lighter connector ambulance).
- Voltage: 12Vdc.
- Maximum Current: 10A.
Line fuse:
- Quantity: 2 (two).
- Dimensions: 20mm x 5mm.
- Type: Slow Blow.
- Voltage: 250V.
- Current: 2,5A (Inom).
- Speed:
100% of Inom for 4 hours minimum.
135% of Inom for 1 hour maximum.
200% of Inom for 120 seconds maximum.
- Breaking capacity: 100A to 250Vac.
+12V external fuse:
- Type: Slow Blow.
- Voltage: 250V.
- Current: 10A (Inom).
- Speed:
Page 24 of 79
Internal Battery fuse:
- Type: Slow Blow.
- Voltage: 250V.
- Current: 10A (Inom).
- Speed:
Mechanical Specifications
Dimensions: 295mm (width) x 200mm (height) x 345mm (length).

Weight: 6.0Kg (including external paddles, battery and recorder).
Display: Type - High Brightness Liquid Crystal.
Dimensions: 132mm x 38.5mm.
Environmental Specifications
During storage and transportation

Ambient Pressure: 500mmHg to 797mmHg.
Ambient Humidity: 0% to 95% (non-condensing).
Temperature: -5ºC to 55ºC.
During operation
Ambient Pressure: 500mmHg to 797mmHg.
Ambient Humidity: 0% to 90% (non-condensing).
Temperature: 0ºC to 45ºC.
DEFIBRILLATOR
Capacitor: 195μF x 2.30KV.
Inductance: 23mHy.
Internal resistance: 8Ω.
Maximum charge energy: 200 Joules.
Waveform: Biphasic.
Charge time to 200J
Nominal Line: 6s.
90% of nominal line: 7s.
Full battery: 6s.
After 15 shocks of 200J: 6s.
Number of shocks of 200J with fully charged battery: 150 shocks at a rate of 3 shocks/minute and 1 minute rest.
Energy Values Selection: on steps of 2J, 3J, 5J, 7J, 10J, 20J, 30J, 50J, 70J, 100J, 150J and 200J.
Energy values are indicated in the selector for a patient impedance of 50Ω.
Charging and Charged Indication: Visual and auditory.
Energy charge Indication: Visual and auditory.
Automatic Internal Disarm Time: 60s.
SYNC: Started by keyboard, indicated on display.
Minimum amplitude detection of ECG R: 0.3mV.
Trigger delay: Within 60ms after detection of R-wave.
Waveform discharge at maximum energy
200joules Load 25Ω 200joules Load 50Ω 200joules Load 75Ω
Page 25 of 79
200joules Load 100Ω 200joules Load 125Ω 200joules Load 150Ω
200joules Load 175Ω
Scale on the vertical axis: 10A/div.

Scale on the horizontal axis: 5ms/div.
Precision of delivered energy
Energy
Min. Max. 25Ω 50Ω 75Ω 100Ω 125Ω 150Ω 175Ω PRECISION
[Joules]
2 0 5 1.8 2.1 2.1 2.2 2.0 2.1 1.8 ±3J
3 0 6 3.0 3.2 3.2 3.0 3.3 3.0 2.8 ±3J
5 2 8 4.6 5.3 5.3 5.2 5.3 5.1 4.9 ±3J
7 4 10 6.5 7.3 7.4 7.4 7.3 7.2 7.0 ±3J
10 7 13 9.3 10.4 10.5 10.4 10.5 10.2 10.4 ±3J
20 17 23 18.8 19.8 20.7 20.6 20.8 20.4 20.3 ±15%
30 25.5 34.5 29.6 31.0 31.4 31.2 31.4 31.2 31.2 ±15%
50 42.5 57.5 46.6 51.6 52.2 51.9 52.6 50.8 51.0 ±15%
70 59.5 80.5 65.4 71.5 72.3 72.9 72.7 72.7 71.7 ±15%
100 85 115 94.0 103.0 104.6 104.3 105.8 102.6 102.7 ±15%
150 127.5 172.5 142.4 154.3 156.3 152.6 153.3 154.7 152.3 ±15%
200 170 230 187.6 205.7 207.8 205.0 205.4 206.0 201.9 ±15%
ECG
FUNCTIONAL SPECIFICATIONS
Input on Paddles: Type CF.
Patient ECG Cable: 3 wires or 5 wires.
Input Electrodes: Type CF.
Notch Filter: 50Hz or 60Hz (factory Determined).
Indication of QRS: QRS Beep and image (♥).
Alarm Silence: keyboard, 2 minutes.
Lead Selection: Keyboard DI, DII, DIII and PAD (Paddles) or DI, DII, DIII, aVR, aVF, aVL, precordial and PAD.
Amplitude Accuracy: ± 20% of reading or ± 100μV (whichever is greater).
Input Noise Specification is <30μVpp.
Input impedance
Common Mode: Greater than 10MΩ at 50Hz/60Hz.
Differential Mode: Greater than 25MΩ from direct current up to 60Hz.
Common Mode Rejection Ratio: 90dB minimum at 50Hz or 60Hz.
Page 26 of 79
Sweep speed: 25mm/s or 50mm/s.
Gain Selection: 1/6 [cm/mV], 1/4 [cm/mV], 1/2 [cm/mV], 1 [cm/mV] and 2 [cm/mV].
Detection, rejection and indication of pacer pulse.
CARDIOTACHOMETER
Precision and response of the heart rate monitor with regular rhythms:
Heart Rate Measurement:
Range = 20 [1/min] to 250 [1/min].
Resolution = 1 [1/min].
Calculation and display of heart rate: It is updated every 2 seconds, average of the last 4 values.
Heart Rate Accuracy: ± 10% of reading or ± 5 [1 / min] (whichever is greater).
Bradycardia Alarm: 20 [1/min] to 245 [1/min], in steps of 5 [1/min].
Tachycardia Alarm: 25 [1/min] to 250 [1/min], in steps of 5 [1/min].
Maximum HR alarm system delay
Tachycardia: 3.8s ± 0.1s.
Bradycardia: 6.13s ± 0.1s.
Average HR alarm system delay
Maximum T-wave amplitude rejected: 1.2 times the amplitude of the QRS complex.
Precision and response of the heart rate monitor with irregular rhythms:
Signal A1: Ventricular Bigeminy
Measured and indicated frequency on display, after 20s of establishment: 80 [1/min] ± 5 [1/min].
Signal A2: Slow alternating Ventricular Bigeminy
Page 27 of 79
Signal A3: Fast alternating ventricular bigeminy
Signal A4: Bidirectional Systole
Maximum timing:
From 80 [1/min] to 120 [1/min]: 4s ± 1s.
From 80 [1/min] to 40 [1/min]: 11s ± 1s.
Response timing:
From 80 [1/min] to 120 [1/min]: 3s ± 1s. This is the time from the first QRS complex of the new frequency to the time taken to indicate
105 [1/min] on the display (37% of 80 [1/min] + 63% of 120 [1/min]).
From 80 [1/min] to 40 [1/min]: 6s ± 1s. This is the time from the first QRS complex of the new frequency to the time taken to indicate 55
[1/min] on the display (37% of 80 [1/min] + 63% of 40 [1/min]).
Tachycardia alarm time: 3s ± 0.5s, for the signal shown below.
Signal B2: ventricular tachycardia 2mVpp, 195 [1/min].
For signal B1: ventricular tachycardia 1mVpp, 206 [1/min] the time is the same.
For different amplitudes of B1 and B2 (half and twice) the alarm time is still the same.
Rejection capacity of high T wave

Maximum T-wave amplitude rejected: 1.2 times the amplitude of the QRS complex.
Page 28 of 79
Detection, rejection and indication of pacemaker pulse

The cardiotachometer has a detector and rejecter of pacer pulse for measuring heart rate. In the next picture is showed the pacer pulse indication
in the display:
This equipment may reject pacemaker pulses of the following characteristics: with amplitude of ±2mV to ±700mV and a pulse width of 0.1ms to
2ms, anyway keep the patients with pacemaker under close surveillance.
RECORDER
The writing method: Thermal array.
Registry speed: 25mm/s.
Register mode: keyboard.
Resolution - Y Axis: 8 dots per mm.
X Axis: 16 dots per mm.
Print width: 48mm.
Paper type: Width 50mm and maximum diameter 45mm.
TRANSCUTANEOUS PACER
Output pacer electrodes: Type CF.
Stimulation: External, trough electrodes.
Frequency range: 40ppm to 180ppm. – Choose it from keyboard, in 5ppm steps.
Output current: 10mA to 200mA. – Choose it from keyboard, in 5mA steps.
Pulse width: 20ms ±5%.
Amplitude accuracy: within ±5% of displayed value.
Frequency accuracy: within ±5% of displayed value.
Mode: selectable, demand or asynchronous.
Refractory Period: 340ms for frequencies less than or equal to 80ppm; 240ms for frequencies greater than 80ppm.
PULSE OXIMETER
SpO2 sensor input: Type CF.
LED
Wavelength: Red is 660nm.
Infrared is 940nm.
Optical Power: 4mW.
SpO2
Range: 0% a 100%.
Adult accuracy: ±2% de 70% a 100%, (<70% is not defined).
Neonatal accuracy: ±3% de 70% a 100%, (<70% is not defined).
Movement accuracy: ±3% de 70% a 100%.
Resolution: 1%.
The specified accuracy is the root mean square (RMS) difference between the measured values and reference values.
Pulse rate
Range: 30 [1/min] a 250 [1/min].
Adult accuracy: ±3 [1/min].
Neonatal accuracy: ±3 [1/min].
Movement accuracy: ±5 [1/min].
Resolution: 1 [1/min].
Pulse Indicator: variable beep tone.
The specified accuracy is the root mean square (RMS) difference between the measured values and reference values.
Page 29 of 79
Pulse’s beep tone

The beep sound increases when the SpO2 percentage does, as you can see in the image below:
Maximum delay of the SpO2 ALARM system: 9.15s ± 0.2s.

Medium delay of the SpO2 ALARM system: 9s ± 0.2s.
Maximum delay of the FP ALARM system
Tachycardia: 12s ± 0.5s.
Medium delay of the FP ALARM system
AUDITORY ALARM SIGNALS

Sound pressure: Between 45dB and 85dB.
Auditory alarm signals of High priority

All physiological alarms are high priority.
The auditory alarm signal of a physiological alarm is composed of a burst of 10 pulses of 1000Hz as show below.
Detail of one of these pulses is shown in the figure below.
Rise time (from 10% to 90%) of pulse, tr: 20ms.

Effective duration time of pulse, td: 100ms.
Fall time (from 90% to 10%) of pulse, tf: 20ms.
Page 30 of 79
If the physiological alarm condition is maintained, the pulse burst is repeated every 7.5s as shown in the next figure.
The auditory alarm signal of a technical alarm condition of high priority is equal to the auditory alarm signal of the physiological
alarms, regarding the burst of pulses and pulse characteristics, but the repetition of the pulse burst is every 2.5s as shown in the next
figure.
Auditory alarm signals of medium priority

The auditory alarm signal of medium priority is formed by a burst of three pulses of 1000Hz, as shown below.
The characteristic of each pulse is shown in the next figure.

If the alarm condition of medium priority is maintained, the pulse burst is repeated every 15 seconds as shown in the next figure.
Page 31 of 79
Auditory alarm signals of low priority

The auditory alarm signal of low priority is manifested by a single pulse of 1000Hz.
The detail of the pulse shown in the next figure:

The pulse of the auditory alarm signal of low priority is repeated every 60s.
QRS BEEP SOUND
The auditory indication of the presence of a QRS complex is manifested by a pulse of 1000 Hz; see the figure below.

The sound pressure is adjusted from the volume adjustment function.
CONFIRMATION SOUND OF KEY PRESSED
Pressing a key generates a pulse of 1000Hz confirming the activation of the key; this pulse has the following characteristics:

Page 32 of 79
MANUFACTURER’S GUIDANCE AND DECLARATION

REGARDING ELECTROMAGNETIC COMPATIBILITY
Electromagnetic emissions
The feas ELECTRÓNICA’s DEFIBRILLATOR Monitor Mod. 3850B-Biphasic REC/TPM/SpO2 is intended for use in the
electromagnetic environment specified below. The customer or the user of the Defibrillator should assure that it is
used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
The feas ELECTRÓNICA’s DEFIBRILLATOR Monitor Mod.
3850B-Biphasic REC/TPM/SpO2 head uses RF energy only for
RF emissions CISPR 11 Group 1 its internal function. Therefore, its RF emissions are very low
and are not likely to cause any interference in nearby electronic
equipment.
RF emissions CISPR 11 Class B
The feas ELECTRÓNICA’s DEFIBRILLATOR Monitor Mod.
Harmonic emissions 3850B-Biphasic REC/TPM/SpO2 is suitable for use in all
Class A
IEC 61000-3-2 establishments different from domestic establishments and
Voltage fluctuations/ flicker those directly connected to the public low-voltage power that
emissions Complies supplies buildings used for domestic purposes.
IEC 61000-3-3
Electromagnetic Immunity
Electromagnetic environment
Immunity test IEC 60601 test level Compliance level
– guidance
Electrostatic discharge Floors should be wood, concrete
±6kV by contact ±6kV by contact
(ESD) or ceramic tile. If floors are
covered with synthetic material,
IEC 61000-4-2 ±8kV by air ±8kV by air the relative humidity should be
at least 30%.
±2kV for power supply ±2kV for power supply
lines lines Power supply quality should be
Electrical fast transient/burst
typical of commercial or hospital
IEC 61000-4-4
±1kV for input/output ±1kV for input/output environment.
lines lines
±1kV line(s) to line(s) ±1kV line(s) to line(s) Power supply quality should be
Surge
typical of commercial or hospital
IEC 61000-4-5
±2kV line(s) to earth ±2kV line(s) to earth environment.
Voltage dips, short <5% UT <5% UT Power supply quality should be

interruptions and voltage (dip >95% in UT) (dip >95% in UT) typical of commercial or hospital
variations on power supply for 0,5 cycles for 0,5 cycles environment. If the user of the
input lines feas ELECTRÓNICA’s
40% UT 40% UT DEFIBRILLATOR Monitor Mod.
IEC 61000-4-11 (60% dip in UT) (60% dip in UT) 3850B-Biphasic REC/TPM/SpO2
for 5 cycles for 5 cycles requires continuous operation
during power supply
70% UT 70% UT interruptions, it is recommended
(30% dip in UT) (30% dip in UT) that the feas ELECTRÓNICA’s
for 25 cycles for 25 cycles DEFIBRILLATOR Monitor Mod.
3850B-Biphasic REC/TPM/SpO2
<5% UT <5% UT be powered from an
(dip >95% in UT) (dip >95% in UT) uninterruptible power supply or
for 5s for 5s an internal battery.
Magnetic fields at power

Power frequency (50/60Hz)
frequency should be at levels
magnetic field
3A/m 3A/m characteristic of a typical
location in a typical commercial
IEC 61000-4-8
or hospital.
Note: UT is the a.c. mains voltage prior to application of the test level
Page 33 of 79
Electromagnetic Immunity
Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance
Portable and mobile RF communications

equipment should be used no closer to any part
of the feas ELECTRÓNICA’s DEFIBRILLATOR
Monitor Mod. 3850B-Biphasic REC/TPM/SpO2,
including cables, than the recommended
separation distance to the transmitter frequency.
Recommended separation distance

Conducted RF 10Vrms
10Vrms d= 1.17 x
IEC 61000-4-6 of 150kHz to 80MHz
Radiated RF 10V/m
20V/m d= 1.17 x 80MHz a 800MHz
IEC 61000-4-3 of 80MHz to 2.5GHz
d= 2.33 x 800MHz a 2.5GHz
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

a
determined by an electromagnetic site survey,
should be less than the compliance level in each
b
frequency range.
Interference may occur in the vicinity of

equipment marked with the following symbol:
Note 1: At 80MHz and 800MHz, 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.
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 feas ELECTRÓNICA’s
DEFIBRILLATOR Monitor Mod. 3850B-Biphasic REC/TPM/SpO2 is used exceeds the applicable RF compliance level
above, the feas ELECTRÓNICA’s DEFIBRILLATOR Monitor Mod. 3850B-Biphasic REC/TPM/SpO2 should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary,
such as reorienting or relocating feas ELECTRÓNICA’s DEFIBRILLATOR Monitor Mod. 3850B-Biphasic
REC/TPM/SpO2.
b
Over the frequency range 150kHz to 80MHz, field strengths should be less than 10V/m.
Page 34 of 79
Recommended separation distances between portable and mobile RF communications and the feas
ELECTRÓNICA’s DEFIBRILLATOR Monitor Mod. 3850B-Biphasic REC/TPM/SpO2
The feas ELECTRÓNICA’s DEFIBRILLATOR Monitor Mod. 3850B-Biphasic REC/TPM/SpO2 is intended for use in an
electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the feas
ELECTRÓNICA’s DEFIBRILLATOR Monitor Mod. 3850B-Biphasic REC/TPM/SpO2 can help to prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the feas ELECTRÓNICA’s DEFIBRILLATOR Monitor Mod. 3850B-Biphasic
REC/TPM/SpO2 as recommended below, according to the maximum output power of the communications equipment.
Separation distance according to transmitter frequency [m]

Maximum output power
150kHz to 80MHz 80MHz to 800MHz 800MHz to 2.5GHz
assigned to transmitter
[W] d= 1.17 x d= 1.17 x d= 2.33 x
0.01 0.117 0.117 0.233
0.1 0.3699 0.3699 0.7368
1 1.17 1.17 2.33
10 3.6998 3.6998 7.3681
100 11.7 11.7 23.3
For transmitters assigned with a maximum output power not listed above, the recommended separation distance d in
meters (m) can be determined using the equation applicable to the transmitter frequency, where P is the maximum
output power assigned in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80MHz and 800MHz, applies the separation distance for the higher frequency range.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
Page 35 of 79
INSTALLING AND TURNING ON THE DEVICE

INSTALLING
WARNING
• You should read this manual before beginning installation and use of equipment.
• This equipment is meant to be used by persons trained in professional health care.
• Defibrillator Monitor Mod. 3850B-Biphasic use is limited to a single patient at a time.
• This equipment must be used in conjunction with signs and symptoms of the patient. The equipment is designed to be an aid in
clinical diagnosis.
• Do not reuse any element disposable or single use. The time limit of use thereof is that indicated by the manufacturer.
• The expiration date of this equipment is of 5 years from its purchase, when that time is over, dismiss the equipment and it’s
accessories following the local regulations in force.
• In case of discarding the equipment or one of its accessories, at the end of its useful life, do it according to the local regulations,
normative or laws in force.
• In order to take care of the environment, you can send the equipment to feas ELECTRÓNICA for its disposal.
• RISK OF ELECTRICAL SHOCK, if you remove the equipment’s lead. Do not remove the equipment’s lead. Ask for assistance
from qualified and authorized personnel.
• There is a risk of Electrical Shock and death. Do not use this equipment if you doubt of the integrity of any cable. Check the
cables periodically (disconnect them before) to verify their integrity; paying special attention to cable points close to connectors
and paddles. In case you find an irregularity, request the part to our Customer’s Service.
• Do not touch the Power Line connectors with wet hands.
• The Defibrillator Monitor Mod 3850B-Biphasic is designed with covers and plastic handles to minimize the risk of electrical shock.
When it is not plugged to the line power its energy will be provided by the battery, without ground reference.
• All combinations of medical equipment with non-medical equipment must comply with the total leakage current specified in IEC
60601-1-1.
• When combined instruments, the sum of the leakage currents can be dangerous for both the patient and the operator. If you
can’t determine the leakage current of each team on the specifications of each, technical staff will take measurements to ensure
the installation complies with the requirements of EN 60601-1-1. In any case, the user should consult the manufacturer to ensure
that the sum of leakage currents will not jeopardize patient safety.
• The device is intended to be connected to:
- Installations in medical rooms belonging to Groups 0, 1, 2a and 2b, according to AEA90364-7-710 (IEC 60364-7-710).
- Installations according to AEA90364-7-771, installations in buildings in general, to grounded outlets according to IRAM
2071.
- Mobile units, to the cigarette lighter connector of the vehicle.
• The disconnection of the equipment from the Power Line does not de-energize it, since it has an internal battery, so you must
also set the selector switch to OFF.
• Caution, leave one end of the power cord accessible so that in the event of an emergency, it is easy to disconnect the equipment
from the Power Line.
• Do not disconnect power by pulling the cord. Disconnect the connector firmly grasping.
• Do not excessively bend the plug or power cord or place heavy objects on them, which could cause damage.
• Do not immerse the electrical connector in liquids. This can damage the cable or connector by corrosion.
• RISK OF FIRE AND/OR EXPLOSION: do not use this equipment in the presence of flammable gases (anesthetics, oxygen, etc).
• Not use or store inflammable substances near the equipment.
• Avoid installing this equipment in places where liquids can be spilled on it. Avoid direct exposure to splatter, sprayer or air vented
from nebulizers or humidifiers.
• Do not place containers with water, chemicals or any small metal objects on the equipment.
• Do not use this equipment under the rain. You have to make sure that the equipment, the cables and paddles are dry before you
start using them.
• Do not place the equipment on the patient or where it can fall over the patient. Place it next to the patient where it’s comfortable
for its use.
• Never attempt to introduce sharp, metallic or other objects into any aperture on the equipment.
CAUTION
• The performance of equipment might be affected by the presence of CAT scanner.
• Do not use this equipment near Magnetic resonance imaging equipment (MR o MRI).
• To attach wires and sensors always use hypoallergenic tape.
• Do not store the equipment in deposits or between periods of use in places where the sun shine directly on it. Risk of damage to
the cover of the equipment, parts and accessories.
Page 36 of 79
• Avoid installing this equipment in those places where the sun hits directly.
• Do not place heavy objects on the equipment.
• Do not drop the equipment when moving it.
• Use the equipment on a flat and stable surface.
• Important!! If using a bracket, make sure that the bracket holds at least twice the weight of the equipment. If you have any
questions, please contact feas ELECTRÓNICA.
• Do not push the keys of the frontal panel with pushing or slicing elements. This will produce permanent damage to the keypad.
Only push the keys of the frontal panel with your fingers. Do not press the buttons with your nails.
Opening the package and verification
Remove the device and its accessories from the packaging carefully and properly keep packaging materials in case of future
transportation or storage.
Check the accessories with the list of accessories purchased. Check if there is any mechanical damage, check the status of all
cables and plug some accessories to review its operation, in case of any problems observed please contact immediately to feas
ELECTRÓNICA’s Customer Service.
Installing the device

When installing the device makes sure that the distance from to the wall is 5cm or more, for adequate ventilation.
If the device is installed in a cubicle, you must ensure that the distance between the equipment and any of the walls is 10cm or more.
The device must be supported on a surface capable of supporting twice its weight, with an angle no greater than 10º inclination.
The company guarantees that the device will operate properly and meet all specifications, only if properly installed, as is described in
this User Manual.
CONNECTIONS AND TURNING ON THE DEVICE
Before connecting any cables, ensure the value of the mains voltage is within the voltage range of the device, also check that the
power frequency indicated on the back panel matches the network’s frequency that will connect the device, if it is different please
contact immediately with feas ELECTRÓNICA’s Customer Service. Do not use the device in these conditions, the ECG curve will
be affected by noise and cannot use the SYNC mode.
Also verify that the output jack of the power cord matches the wall power outlet to which it will connect and possesses electrical
energy.
WARINING! The equipment must be connected to an approved electrical installation that includes a correct grounding according to
the local legislation in force. Do not use adapters or replace the device’s original cables. If the plug does not match the installation,
please contact our Customer Service for the provision of a suitable cable.
WARINING! You must make sure that the AC outlet, to which you will plug the device, has a groundling and is in good condition.
WARINING! Do not connect this device to an outlet controlled by a switch on/off.
WARINING! Verify the AC voltage range matches the voltage at which the equipment is to be connected. If does not match, contact
WARINING! Verify the AC frequency indicated on the back panel matches the AC frequency which the device is to be connected. If
does not match, contact feas ELECTRÓNICA’s Service Customer. Do not use the device in those conditions. The ECG curve will
be affected by noise and will not be able to use SYNC mode.
WARINING! If you have any doubts about the integrity of the ground, either the cable or the installation of the building, use the
device from the internal battery. In case that the battery is discharge or damage, don't use the equipment.
WARINING! The multi-outlet power extension cord shall not be placed on the floor.
WARINING! The multi-outlet power extension cord should only be used to power equipment that is part of the system.
Once completed these checks, connect the input jack of the power cord to the device, firmly pressing the jack until it stops at the
bottom of the device connector. Then connect the output jack to the wall outlet. Verify that the connection is correct by observing the
green triangular light “Battery Charge”.
Do not attempt to operate this device unless you are thoroughly familiar with these operating
instructions and the function of all controls, indicators, connectors, and accessories.
Turn on the device by turning the selector switch to the MONITOR position (if you only want to use this function) or to the position of
some energy value (if you want to defibrillate). The MONITOR is set initially with ECG input PADDLES (if you do not have the cable
connected to the patient, if you have the cable connected to the patient will start showing the curve of the lead I (DI) on display), OFF
ALARMS (except the lower limit of SpO2 alarm which defaults to 85%), 25mm/s in sweep speed and 1V/cm in gain.
“Setup error” This message is displayed when, turning on the device, is located that there are
differences between the stored configuration of factory and the current configuration.
The defibrillator has three power modes:
• 90Vac - 240Vac (automatic selection) and notch filter 50Hz or 60Hz, factory selectable.
• Internal rechargeable battery 12Vdc.
• External 12Vdc battery.
Page 37 of 79
TURN OFF THE EQUIPMENT

To turn the equipment off, turn the selector switch to the OFF position (see next figure).
INTERNAL BATTERY
WARNING MESSAGES
WARNINGS
• The battery must be replaced by an original battery for this equipment. Replacement with another type of battery can result
in an unacceptable risk of temperature rise, fire and/or explosion of the battery or the equipment.
CAUTIONS
• The equipment has rechargeable battery type must remain connected to the power line during periods when it is not used.
• If the capacity of the internal battery is below 80% the equipment will be able to function from line power or from External
+12Vdc.
• Do not discharge the battery completely.
• Recharge the battery immediately after it’s been used.
• The internal battery of this equipment cannot be replaced by the user. It has to be replaced by qualified and authorized
personnel.
• In case you replace the battery follow the local instructions to dispose Ni-Mh batteries or send them to feas
ELECTRÓNICA for disposal.
DESCRIPTION
The device has rechargeable battery type must remain connected to the power line during periods when it is not used.
In case of disconnection or failure of the Power Line or external 12Vdc, the equipment may still be operated via the internal battery.
If, in addition, the internal battery is discharged or damaged, the unit will shut down. It will remain off until the operator turns it back
on (move the power selector switch to any position except OFF) by restoring the power. The Power Line presence is indicated on the
front of the equipment with a green light on the symbol. When you reconnect the equipment to the Power Line or external
12Vdc (no matter the elapsed time), will remain off until you turn on the device. Moreover, the device will turn on with the same setup
which was shut down with, except for the minimum alarm limit SpO2, which if it was off or set to less than 85%, will be adjusted to
85%, by regulatory requirement. If there been set to more than 85%, it retains the value set by the operator.
When connected to the power line or external 12Vdc, is charging the internal battery, whether the device is off or on. This condition
is expressed in the green light over the symbol.

There is no need disconnecting and reconnecting the device periodically. This device has an automatic charging system that allows
you to keep the battery at full charge state.
To power the device with external 12Vdc (ambulance or other vehicle), you have to use the cable with lighter plug. In this condition, it
also recharges the battery and is expressed in the green light over the symbol.
Page 38 of 79
The state of battery charge is indicated on the screen and, therefore, requires the device have to be switched on (in MONITOR mode
or selection of energy), and operating from the internal battery (disconnected from AC line and from external 12Vdc). When battery is
fully charged, the display shows the symbol. When the display shows the symbol indicates that the battery is partially charged
and should be charged as soon as possible to preserve battery life.
When battery is discharged, the display shows the symbol and the technical alarm sound is activated. When battery is fully
discharged will be displayed the message “Battery Discharged – Power is down” the technical alarm sound change and the
device will automatically turn off 120 seconds after the message, to avoid damaging the battery. The technical alarm sound is
detailed in section “AUDITORY ALARM SIGNALS”.
In the latter case, the device will operate correctly from the AC line or +12Vdc external, in both conditions, the display shows the
symbol.
The internal battery should be checked visually once a year to ensure their safety.
Check monthly its autonomy, if it decreases to 80% of the value indicated the technical specifications; the battery should be replaced
with another battery of the same type.
CHECKING THE BATTERY STATUS

Procedure for check the battery status:
1) Connect the device to AC line (or +12Vdc external) for 3 hours to achieve a full charge the internal battery.
2) Unplug the device from the AC line (or +12Vdc external).
3) Turn the device on (this test requires the device cannot be used for two hours).
4) Register the time you turned on the device.
5) Verify that at 2 hours the device is still on. If the device is off, you must request the replacement of the internal battery.
This device, with a new internal battery, fully charged, at a temperature of 20ºC, can discharge at least 150 shots at 200Joules
without recharging the battery, with a maximum cadence of 3 shots/minute and 1 minute rest.
EXTERNAL POWER SOURCE
Defibrillator feas ELECTRÓNICA Defibrillator X has on the back a connector for receiving power from an external power source,
as seen in the following figure:
There you must connect the power cable reference 1846, to do this follow the following steps:
a) Position the cable so that the connectors face each other and the male connector guides match the grooves of the female
connector, in the following figure you can see the female connector viewed from the front, where you can see the grooves
for the male connector guides:
Page 39 of 79
Once positioned, plug the cable until it stops, see following figure.
b) Finally turn the nut until it lock and make sure that the cable is firmly connected without the possibility of disconnect it, see
next figure.
The external power source must meet the following requirements:

Be medical grade and meet the requirements of standard IEC 60601-1 or come from a vehicle battery (cigarette
lighter connector ambulance).
Voltage: 12Vdc.
Current: 10A.
Page 40 of 79
MAINTAINING THE EQUIPMENT

Preventive maintenance
feas ELECTRÓNICA recommended that check the device by qualified and authorized personnel, at least every 12 months. We
recommend contacting our Customer Service for the maintenance.
feas ELECTRÓNICA recommended periodic inspections of the power cords, patient ECG cable, SpO2 sensor, defibrillation
electrodes cables and pacer electrodes cables, looking for any breakage or cracks in the wires or conductors insulation.
Cleaning time is a good opportunity for a General Inspection.
feas ELECTRÓNICA recommends functional testing every time you start a new work shift.
Corrective Maintenance
When necessary repair the equipment, request the assistance of qualified and authorised by feas ELECTRÓNICA to preserve
the warranty conditions and electrical safety parameters.
In case to request assistance from Customer Service, will be asked the device serial number, for a faster and efficient assistance.
In case of sending the device to feas ELECTRÓNICA, if possible, use the original packaging. If is not possible, protect the device
so well as possible.
GENERAL INSPECTION
Periodically, inspect the defibrillator case, the power cord and paddles cables, paying special attention to sectors of the cables near
the connectors and paddles, as these are the sectors most likely to break due to rotations, tractions and bending at these points.
At any sign of deterioration require assistance to feas ELECTRÓNICA’s Customer Service.
Cleaning time is a good opportunity for a General Inspection.
WARNING! There is a risk of electrical shock and death. Do not use this equipment if you doubt of the integrity of any
cable. Check the cables periodically (disconnect them before) to verify their integrity; paying special attention to cable
points close to connectors and paddles. In case you find an irregularity, request the part to our Customer’s Service.
WARNING! It is not allowed to modify the equipment.
WARNING! Not modify this equipment without authorization from the manufacturer.
WARNING! If you modify this equipment must perform appropriate tests and inspections to ensure continued safe use of
equipment.
ATTENTION! It suggests an annual contrasting against calibrated simulators.
CLEANING
WARNING! Before any cleaning, make sure the device is turned off. REMEMBER: The device has internal battery, so even
disconnected from the AC line, may be turn on. Verify the selection switch is in the off position and the display doesn’t contain
instructions and is turned off.
feas ELECTRÓNICA recommended clean the device and its accessories in periods of 3 months or shorter, when the dirt or the
contamination were evident.
For procedures for cleaning, disinfection and sterilization, see below.
To clean the device or its accessories, use soap neutral water to wet a piece of clean cotton cloth, wipe the device and then dry with
a cotton cloth, soft and dry.
Keep the device case free of dirt and dust.
DO NOT allow liquids to enter the device, and do not place liquids in the device while cleaning. DO NOT use abrasive cleaners or
strong solvents such as acetone or acetone-based components.
Be careful when cleaning the monitor display, is particularly sensitive to rough surfaces and susceptible to scratched.
WARNING! Risk of explosion or fire! Do not spill water or liquid on the device. Unplug the power cord and paddle
before cleaning or disinfecting the device.
ATTENTION! Do not clean the outer casing, cables or paddles with solvents, abrasives or acids.
ATTENTION! Do not clean or disinfect accessory cables, accessories and parts of the equipment or the main body
thereof with sodium hypochlorite (bleach water), solvents, acids or abrasive products. For cleaning and
disinfection of the equipment and its accessories, follow the instructions in this manual.
PADDLE CLEANING
NOT sterilize the external paddles with vapor or gas (ethylene oxide (ETO)), do not immerse in liquids or heat above 50ºC.
Clean the paddles, including its handle, with a solution of neutral soap and disinfect them by following the method described in
section “DISINFECTION METHODS”.
If metal parts starts to be oxidized, clean them with a soft abrasive (toothpaste can clean them well). DO NOT use strong abrasive
(steel wool).
Page 41 of 79
ELECTRODES
This device is intended for use disposable adhesive ECG electrodes. Do not reuse the electrodes. Replace them and repositioning
them in accordance with the manufacturer’s instructions. Check expiration date of disposable electrodes weekly, and their state, to
ensure sealing integrity.
POWER CORD
If you notice the power cord is damaged, the ground is not correct; either by cable damage or the Power plug does not fit tightly
into wall outlet, disconnect the device immediately and continue operating it from the internal battery. Contact the technical service
to fix the problem.
CLEANING OF PAPER CHAMBER AND PRINTHEAD

Press the gate release button, once ajar; raise it until it is fully opened. Take the roll of paper and pull it smoothly toward you.
With cloth moistened alcohol, clean the chamber; then with another clean cloth dampened with alcohol, clean the thermal array.
To replace the paper see PAPER REPLACEMENT procedure.
OXIMETRY SENSOR CLEANING

To clean the oximetry sensor, disconnect it, rinse with a solution of neutral soap and then dry carefully with a cotton cloth.
CAUTION! Do not sterilize with vapor in autoclave or immerse in water or other solutions.
DISINFECTION METHODS
Case, external paddles, pediatric adapter and cables: Use a broad spectrum disinfectant cleaner, free of aldehydes, alcohol, non-
abrasive, non-corrosive, low toxicity; like ADOX LT8.
The electrodes and catheters are disposable.
STERILIZATION METHODS
ATTENTION! There is a risk of equipment breakdown. Do not sterilize this device or its parts or accessories in autoclave
or ethylene oxide. Do not submerge any part of this equipment in water or other liquids or use abrasive cleaners. Do not
spray or spill liquids on the equipment or its accessories. Do not allow any liquid entering the connectors or other
openings of the housing. If you accidentally spill liquid on the equipment, turn the energy switch OFF (because the
equipment has internal battery) and disconnect it the power line (in case it is connected to the power line), clean it and
dry it before reuse. If in doubt about equipment security, send the same to an authorized technical service.
ATTENTION! There is a risk of equipment breakdown. No sterilize defibrillation paddles of this device in autoclave or
ethylene oxide.
ATTENTION! Neither this equipment nor any of its parts are sterile or sterilizable.
Do not sterilize this device or its accessories. Refer to the cleaning and disinfection methods.
PAPER REPLACEMENT
a) Press the gate release button and lift the cover until fully open.
b) Take the paper support tube and pull smoothly towards you to remove it.
c) Place the new paper roll between the two round supports.
d) Pull out some paper. Make sure the paper sensitive side (brightest) is faced with the RECORD array. The brighter side of paper,
generally, is inside the roll.
e) Align the paper with the roll at the cover.
f) Hold the paper against the roller and close the cover.
g) To verify the correct installation of paper, make a test RECORD. If the paper does not move, open the cover and repeat from e)
step.
POWER SELECTOR
The defibrillator has three power modes:
• 90Vac - 240Vac (automatic selection) and notch filter 50Hz or 60Hz, factory selectable.
• Internal rechargeable battery 12Vdc.
• External 12Vdc.
Page 42 of 79
WARNING! Verify the AC voltage range matches the voltage at which the device is to be connected. If does not match, contact
WARNING! Verify the AC frequency indicated on the back panel matches the AC frequency which the device is to be connected. If
does not match, contact feas ELECTRÓNICA’s Service Customer. Do not use the device in those conditions. The ECG curve
will be affected by noise and will not be able to use SYNC mode.
WARNING! You must make sure that the AC inlet, to which you will plug the device, has a ground line and is in good condition.
WARNING! The equipment must be connected to an approved electrical installation that includes a correct grounding according to
the local legislation in force. Do not use adapters or replace the device’s original cables. If the plug does not match the
installation, please contact our Customer Service for the provision of a suitable cable.
WARNING! Do not connect this device to an outlet controlled by a switch on/off.
In mobile units, you can power the Monitor Defibrillator from the lighter socket of the unit, through the external 12Vdc power cable.
To connect the device, follow these steps:
1) Connect the output jack 12Vdc power cable on the back panel.
2) Connect the plug on the lighter socket.
3) Verify that the connection is correct and the energy reaches the device, watching green triangular light over battery symbol,
located on the front panel.
VERIFICATION OF ENERGY DELIVERED

Verification or energy test ensures that the equipment is able to deliver energy on paddles or determine that, due to a fault, does not
allow delivery of energy on paddles. If the test failed, contact the feas ELECTRÓNICA ´s Customer Service to arrange repair.
ATTENTION! It is suggested to perform the Test of Energy Delivered according to the domestic policy of the Institution Health or at
least once a week.
ATTENTION! Before performing the Test of Energy Delivered, external paddles must be connected and place on the paddles holder.
Perform the verification with the equipment connected to line power.
WARNING! More than 10 energy discharges should not be performed during Test of Energy Delivered; considering that the
minimum waiting time is 1 minute, between discharges.
For verification of energy delivered perform the following steps:
i. Turn on the equipment, while pressing the DISARM key, then the equipment will start in energy delivered test mode and you
should see the following message on screen:
ii. Place the Selector Switch in 200 Joules, as shown in figure above.
iii. When the Selector Switch is in 200 Joules, and the external paddles are connected to the equipment and placed on the
paddles holder, as indicated in the message of figure above, press the CHARGE key. Then begins a count that is increased up
to the value of about 200 Joules, this number indicates the value of the stored energy, and then the following message is
showed in the screen:
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iv. Press the SHOCK button. If the verification result is correct, which means that energy was supplied to the paddles, then you
will see the following message on screen:
If the device has a thermal recorder, after the Test a report will be printed as follows:
v. If the verification result is wrong the following message is displayed onscreen:
If the device has a thermal recorder, after the Test a report will be printed as follows:
In case the equipment does not pass the energy test, please contact to the Customer Service of feas ELECTRÓNICA to
agree on the repair.
vi. When the verification is complete, turn the power selector switch to the OFF position.
ALARM VERIFICATION
This device alarms are indicated audibly and visually. You must ensure, before checking the alarm function, the symbol does not
appear on display.
Quick check
Before using the device for monitoring the patient through the alarm system, we recommend a quick check of the alarm signals. For
this set the lower alarm limit of 20 [1/min] heart rate without connecting the cable to patient, is thereby activate the alarm system, the
alarm condition manifested by auditory (see section “AUDITORY ALARM SIGNALS”) and visual signals (on screen, the lower limit
of heart rate is highlighted with inverted text).
Technical check
It is recommended that a technical check at least once a year.
The verification method is analogous to SpO2 alarms. We’ll use as illustrative case the heart rate.
Connect the ECG simulator with a 3 or 5 wire patient ECG cable, selecting in the simulator the following values: normal ECG,
amplitude = 1mV, frequency = 60 [1/min].
Then, set alarm limits as follows: Lower Alarm Limit = 30 [1/min]; Upper Alarm Limit = 120 [1/min] and Detection of QRS from DII.
Page 44 of 79
In that condition, shouldn’t sound or be indicated any alarm and should indicate 60 [1/min] in the upper right corner of the screen.
Adjust the frequency of simulator to 29 [1/min] and observe the display. The heart rate indicator will diminish its value until 29. At that
time, the lower alarm limit for heart rate (bradycardia) will activate and begin to hear the alarm sound. The heart rate lower limit is
highlighted by presenting a white background. Check that pressing the mute key, the audible alarm went off at the lower left corner of
the display shows the symbol, and it still indicates the visual alarm with white background in the lower limit. Press the mute key
again and you will hear the alarm sound.
Adjust the frequency of the simulator to 60 [1/min] again and observe the display. The heart rate indicator will increase its value until
it indicates 60. When indicating over 30 [1/min] the sound of the alarm and visual indication shall cease.
Now adjust the frequency of the simulator to 121 [1/min] and observe the display. The heart rate indicator will increase its value until
it indicates 121. At that time, will activate upper alarm limit heart rate (tachycardia) and begin to hear the alarm sound. The upper
limit heart rate is highlighted by presenting a white background. Check that pressing the mute key, the audible alarm went off and at
the lower left corner of the display shows the symbol, and it still indicates the visual alarm with white background in the upper
limit. Press the mute key again and you will hear the alarm sound.
Adjust the frequency of the simulator to 60 [1/min] again and observe the display. The heart rate indicator will diminish its value until
60. When indicating less than 120 [1/min] the alarm sound and visual indication shall cease.
Similarly, and with the corresponding patient simulators, can perform verification of alarm operation of each parameter.
FUSE CHANGE
Before starting operation, make sure the device is disconnected from the power line, and also is off. To perform the operation must
have a small screwdriver and a set of replacement fuses.
You must enter a screwdriver to unlock the switch, pull the wire and cover will come out. Remove both fuses and check if are broken,
by measuring electrical continuity between the terminals (broken = no continuity). Should you find one or two broken, you must
replace them with new fuses.
ATTENTION! In case of fuses are damage replace with fuses of the same type and value. If the failure persists, please contact our
Customer Service.
ATTENTION! This equipment has line fuses in both the neutral pole and Phase Line.
RECHARGEABLE BATTERY
The device is provided with an internal rechargeable battery allowing it to operate without connection to AC line voltage or 12Vdc
external. To charge the internal batteries, connect it to the AC line voltage or external 12Vdc, permanently. It is not necessary that
the device is turned on to charge the battery. The battery charge is indicated on the front panel by turning on the green triangular
light over symbol.

The state of charge of the battery is indicated on the screen, and therefore requires that the device is on (MONITOR or energy
selection) and operating from the internal battery (disconnected from AC line or external 12Vdc).If the battery is charged, the display
shows the symbol. When the display shows the symbol indicates that the battery is partially charged and should be charged
as soon as possible to preserve battery life.
When battery is discharged, the display shows the symbol and the alarm sound is activated. When battery is fully discharged will
be displayed the message “Battery Discharged – Power is down” the technical alarm sound change and the device will
automatically turn off 120 seconds after the message, to avoid damaging the battery. The audible indication is detailed in section
“Technical Alarms”.
In the latter case, the device will operate correctly from AC line or external 12Vdc, in both conditions, the display shows the
symbol.
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Battery Autonomy: This device, with new internal battery fully charged, at a temperature of 20ºC, can deliver a minimum of 150
shocks at 200Joules without recharging the battery.
Battery Charging Time from exhausted till at least 90%: 2hrs 15min.
Charge Cycle: When is not used, the device must stay connected to AC line or external 12Vdc to recharge the batteries. There is no
need to disconnect from AC line or external 12Vdc, because it has an automatic device to keep the battery fully charged.
The internal battery should be checked visually once a year to determine there are no damages.
Check monthly its autonomy, if it decreases to 80% of the value indicated the technical specifications; the battery should be replaced
with another battery of the same type.
To ensure long battery life:
9 ATTENTION! No fully discharge the battery.

9 ATTENTION! Recharge the battery immediately after use.
9 ATTENTION! When the device is stored in warehouse, should be put to charge at least once every 60 days for at least
3hours at 25ºC ± 3ºC temperature, to prevent battery damage.
9 ATTENTION! Do not store the device in deposits, or leave it between periods of use, in places where the sun shine
directly into the device. Risk of damage to the cover device, parts and accessories.
9 ATTENTION! During storage in warehouses and between uses, respects the conditions of temperature, pressure and
humidity as defined in this manual and periods of recharge the internal battery specified.
9 ATTENTION! The internal battery of this equipment cannot be replaced by the user. Necessarily must be replaced by a
qualified technician.
ATTENTION! In case you replace the battery follow the local instructions to dispose Ni-Mh batteries
or send them to feas ELECTRÓNICA for disposal.
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VERIFICATION INSTRUCTIONS IEC 601

feas ELECTRONICA S.A. VERIFICATION INSTRUCTIONS
IEC 601 with MedTester 6000 Ver: 0-1
MATERIALS NECESSARY TO PERFORM THE TASK
EQUIPMENT: medTester 6000 WITH HIS BRIEFCASE WITH CABLES AND ACCESSORIES.
EQUIPMENT TO BE TESTED WITH POWER CORD AND PATIENT CABLE.
ITEM Description Cond./Tolerance/Obs.
1 Connect the medTester 6000 to the 220v mains and turn it on. With its original cable.
Connect the equipment under test to the 220v connector that is on the front of the
2
medTester 6000 and turn it on.
Connect the patient cable in the banana connectors for ECG output of the
3
medTester 6000 and the equipment under test.
Connect banana jack to crocodile clip connector red cable into the banana jack of
4 the medTester 6000 and in the equipment under test connect the red crocodile clip Red female banana plug.
in the grounding screw or other metal part that this earthing.
Press the “0” (class/type) until the display indicates the class and type of device
5 Example: “CLASS I, TYPE CF”.
under test.
6 Press “AUTO MODES” in order to automatically perform all tests.
7 Select “AUTO” with arrows and press “ENTER” to begin.

Verify that the display shows:
CLASS/TYPE : X XX. (Where X XX are the Class and Type selected in
PATIENT LEACAGE : z. the point 5 and Z is the number of electrodes
8 PRINT: INTERNAL. applied to the patient or applied parts to the
TEST CURRENT: 25A. patient).
If no, use the keys associated to set each parameter and then press “ENTER”.
When the display shows: "CONTROL#"

9 Enter the number of Technical Record or number of Order Form depending on if is
service or production and then press “ENTER”.
In PROCEDURE ID: Enter “IEC 601” and then press “ENTER”.
In LOC: Enter “Taller” and then press “ENTER”.
In DEVICE TYPE: Enter the name and model of the equipment under tests and then Example: DEFI3600, Multipar, Simplex,
press “ENTER”. Oximetry, Polygraph, etc.
In MANUFACTURER: Enter the name of the manufacturer and then press
FEAS ELECTRONICA S.A.
“ENTER”.
In SERIAL #: Enter the serial number of the equipment and then press “ENTER”.
In TECHNICIAN: Enter the name of the technician and then press “ENTER”.
When the display shows:
TEST DATE: XX-XX-XX
LEADS: Y (Where XX-XX-XX is the date, for example: 10-
10 STANDARD: IEC-601-1 CLASS/TYPE: ICF 12-03; where Y is the amount of snap button of
SOURCE= CURRENT SETUP MORE to change the patient cable).
6000 ENTER to START, ARROWS to Advance
Press the “ENTER” key.

When the display shows:
PROT EARTH RESISTANCE:TEST CURR (25A)
11 OHM [LIMIT 0.200]
Press “4” in the medTester 6000 and after to performing the test press “ENTER”.
12 When the display shows: OUTPUT WAVEFORMS: press “ENTER”.
13 When the display shows: COMMENTS: press “ENTER”.
14 Finally press “ENTER” to return to the beginning and then press escape.
Make sign the printing and then paste it on
15 Signature of Area Manager. Configuration Record or Final Test of the
equipment under test.
Page 47 of 79
PERFORMANCE TEST OF THE EQUIPMENT
Page 48 of 79
Page 49 of 79
Page 50 of 79
Page 51 of 79
TROUBLESHOOTING
MESSAGES AND ALARMS OF THE BATTERY
Indicators:
Alarm of Line - Battery Charging
GREEN - On
Indicates the presence of mains voltage or external +12 volts.
When the led is on, the battery is being charged.
(The charge state of the battery is indicated on display).
Off
Indicates the presence of mains voltage or external +12 volts.
When the led is off, the equipment is operating on internal
battery.
(The charge state of the battery is indicated on display).
The state of charge of the battery is indicated on display and, therefore, requires that the equipment is turned on (MONITOR or
energy selection), disconnected from the electrical network and disconnected from 12 Vdc external.
Depending on the state of the battery on the defibrillator screen will display the following symbols:
Alarmas del Módulo de Baterías
THE BATTERY IS FULLY CHARGED
When the equipment is powered from the internal battery, and the
battery is fully charged, the display will show the symbol on the left.
THE BATTERY IS PARTIALLY CHARGED
When the equipment is powered from the internal battery and since the
battery is discharged, the display will show the symbol on the left. In
view of this message, the battery should be charged as soon as
possible to preserve the battery life
THE BATTERY IS DISCHARGED
When the equipment is powered from the internal battery and the
battery is fully discharged, the display will show the symbol on the left,
and then the equipment will automatically turn off 10 seconds after to
this message, to avoid damaging the battery.
In the latter case, the equipment will operate correctly from the AC line
or +12Vdc external, in both conditions, the displays shows the

symbol.
GENERAL
Trouble Probable cause Action
Pushes the power on key, but the The equipment is disconnected from To connect firmly the cable to the mains
equipment no power on. mains or +12Vext. and to the equipment.
The display is dark; the waveforms Adjust the contrast as explained in
The contrast is adjusted incorrectly.
and characters are not sees. “Contrast”.
The date and/or time on screen and Set Date and Time according “Adjust Date
The date and/or time are incorrect.
on the paper record is not correct. and Time”.
Send the equipment to our Customer
No sync sound (QRS beep). The motherboard is faulty.
Service for repair.
The key (Alarm silence) is

Pres the key (Alarm silence) again.
activated.
The alarms are disabled “---” in all Select, on screen, the upper and lower
No audible alarm signal. alarm limits. limits of each parameter alarm.
If the problem persists, the motherboard is
The speaker, your cable or the
the cause, Send the equipment to our
motherboard is faulty.
Customer Service for repair.
Page 52 of 79
DESFIBRILADOR
The defibrillator doesn’t Charge Connect the equipment to an outlet and
energy. The message “Charge Error”. Operating from the battery, it is recharge the battery. The battery is charged
Take more than 10 seconds to almost empty. automatically when the equipment is
complete the charge. connected to the mains.
The defibrillator doesn’t Charge
energy. The message “Charge Error”. Operating from the mains breakage in Send the equipment to our Customer
Take more than 10 seconds to the power system charge. Service for repair.
complete the charge.
Pressing paddle buttons don’t If discharge is performed from “Shot”
Replace external paddles.
discharge energy to the patient. key, then extern paddles are faulty.
Pressing the “Shock” key, don’t Send the equipment to our Customer
Faulty keyboard.
discharge energy to the patient. Service for repair.
Pressing paddle buttons or discharge
front button, don’t discharge energy to Faulty equipment.
Service for repair.
the patient.
ECG
One of ECG electrodes is loose. Check that the electrodes are perfectly
attached and make contact with the
One of the electrodes wires is disconnected patient’s skin. If necessary replace (the)
from electrode. electrode (s).
Selected ECG curve isn’t properly
Check that each pins of patient wire are
viewed, and Lead Off message
correctly connected to its corresponding
appear. One of the electrodes wires is faulty. electrode.
If problem persists, then motherboard is
Faulty motherboard. the cause, Send the equipment to our
The ECG connecting wire is disconnected Check patient wire connection to the
from the defibrillator. equipment.
Selected ECG curve isn’t viewed, ECG input signal greater than ± 5mV, this Wait a few seconds until the signal is
it´s shows a straight line. can occur during defibrillation. restored automatically.
Faulty motherboard.
Service for repair.
There is a very powerful source of electrical Separate the patient and equipment of
noise emission in patient vicinity. the noise source.
Connect the equipment to the facility,
without adapters, to a grounded outlet.
Equipment isn’t connected to ground Contact the After sale customer
because it uses an adapter plug. assistance of Feas Electrónica to
supply the appropriate wire for
installation.
In case of need to use a multi-socket
Selected ECG curve isn’t viewed basis, make sure that it’s earthed and
and message “ECG Saturated” The equipment isn’t connected to ground
connected to the facility. Contact After
appear. because it uses a base of multiple sockets
sale customer assistance of Feas
ungrounded.
Electrónica to providing multiple
sockets base suitable for installation.
Contact a licensed electrician to
The facility has no grounding or is faulty. normalize installation and outlets, and
that they have normalized ground.

None of the above.
Service for repair.
Page 53 of 79
SpO2
The SpO2 adapter cable is disconnected Connect the SpO2 adapter to SpO2
Not displayed SpO2 value nor the PR from the SpO2 connector. connector.
and the message “Without sensor” The SpO2 sensor is disconnected of SpO2 Firmly connect the SpO2 sensor to the
appear. adapter. adapter.
SpO2 adapter cable or the sensor era cut. Replace the SpO2 adapter or sensor.
Not displayed SpO2 value nor the PR
Lost connection between sensor and
and the message “Without Patient” Set firmly the sensor to the patient.
patient.
appear.
If the message “Not Found” appear
change patient finger. If the problem
This message should appear while the
persists, and has another sensor,
Not displayed SpO2 value nor the PR equipment is searching patient's pulse
replace it. If this solves the problem,
and the message “Searching” appear. and disappears when curve and values
send the sensor for repair; else send the
appears.
sensor and equipment to our Customer
Service for repair.
Not displayed SpO2 value nor the PR Appears if there is no pulse after a
See previous point.
and the message “Not Found” appear. sufficiently long period.
Attach the sensor to the patient with
gauze or hypoallergenic tape without
pressing too hard. If problem persists,
Not displayed SpO2 value nor the PR Indicates that patient is moving and the and has another sensor, replace it. If this
and the message “Movement” appear. sensor isn´t properly attached to him. solves the problem, send the sensor for
repair; else send the sensor and
equipment to our Customer Service for
repair.
Reposition the sensor. If problem
persists, and has another sensor,
Indicates that where the sensor is placed replace it. If this solves the problem,
The message “Low Perfusion” appears.
have low perfusion. send the sensor for repair; else send the
sensor and equipment to our Customer
Service for repair.
Send the sensor and equipment to our
The message “Low Perfusion” appears. The internal SpO2 module is faulty.
Dotted lines appear in place of the pulse Faulty SpO2 sensor. Replace SpO2 sensor.
waveform. Faulty SpO2 adapter. Replace SpO2 adapter.
Printer
Not using the correct paper. Use the specified paper for performed type printing.
Clean the thermal head with a head cleaning device.
Printing is fuzzy. Missing points.
The thermal head is dirty. If the problem persists, the printer unit is faulty.
Replace the print unit.
No paper is loaded in the printer. Load paper in printer.
Printer compartment isn’t properly
Close the compartment until it clicks.
closed.
Paper is loaded with the print side
Load the paper correctly.
facing up.
No prints. If the light does not turn on when you press the print
key, make an impression through the System
Faulty keys.
Maintenance. If printing is checked, then the key is
faulty, replace it.
Faulty printer. If the light turns on when you press print key, check
Faulty motherboard. the printer with the maintenance system.
Cool the printer. If the problem continues, the printer
The printing light is on. The printer temperature is too high. unit or the motherboard is faulty. Replace the print
unit or the motherboard.
Page 54 of 79
Power supply tests
MEASURE
OR AVERAGE
DESCRIPTION CONNECT VALUE
MIN MAX
IN
CABLE
Check the condition of the power cord.

-- -- -- --
That is not damaged and that this continuity in the leads.
Check that the board has fuses 10A 250V 20mm Slow Blow (type 51S).
-- -- -- --
CHECK=OK.
PRIMARY POWER SUPPLY
Connect resistive load, with 4 elements (5.875 ohms) between TP32 (Vb) and TP37
(GND). -- -- -- --
CHECK=OK.
Power the board, with Variac to 85 Vac and record the voltage at TP32. TP32 20.8 VDC 20.4 21.2
Bring the Variac to 120 Vac and record the voltage at TP32. TP32 20.8 VDC 20.4 21.2
Bring the Variac to 240 Vac and record the voltage at TP32. TP32 20.8 VDC 20.4 21.2
Check +5V / Line TP15. TP15 5 VDC 4.8 5.2

Disconnect the board of power supply line.
-- -- -- --
CHECK=OK
UP EXTERNAL BATTERY
Connect a load of 13ohms-50W between TP33 and TP37. CHECK=OK

POWER SUPPLY STEP-
-- -- -- --
Connect the External Battery charged. CHECK=OK -- -- -- --
Record the voltage on the load of 13 ohms. -- -- 15 21

Disconnect the external battery. CHECK=OK -- -- -- --
Disconnect load of 13 ohms. CHECK=OK -- -- -- --

Connect the Battery Simulator to the motherboard, connect the Tester Fluke to the
Battery Simulator, connect the relay board to the Battery Simulator, and connect the
Power Supply Protek P6000 to the Battery Simulator. (The electrical connection -- -- -- --
drawings are in the folder of SMVA). The AUTOMATIC-MANUAL key must be in
AUTOMATIC. CHECK=OK
Command to relay board (KEY IN AUTOMATIC = OPEN) -- -- -- --
In the power supply Protek, set the Maximum Current = 2A. -- -- -- --
Set the power supply Protek to 0V. -- -- -- --
It supplies power to the Equipment from the Variac (220 Vac). CHECK=OK -- -- -- --
Charging current of the Battery (Pre-Charge). -- 310 mA 280 340
Disconnect power from the Variac. CHECK=OK -- -- -- --

BATTERY CHARGER
Set the power supply Protek to 9.5V -- -- -- --
Charging current of the Battery (Fast Charge). -- 1.55 A 1.5 1.6
Set the power supply Protek to 14.5V. -- -- -- --
Charging current of the Battery (Fast Charge). (Wait 30 seconds). -- 1.55 A 1.5 1.6
Command to relay board (KEY IN MANUAL = CLOSED). -- -- -- --
Verification of the Charge disconnection. (Wait 2 minutes). -- 0A -0.01 0.01
Page 55 of 79
Connect the Real Battery. CHECK=OK -- -- -- --

Check fixed +5V. TP19 5 Vdc 4.8 5.2
Connect the cable from the front panel to the motherboard. CHECK=OK -- -- -- --
CIRCUIT BOARD SOURCES
Turn on the equipment. CHECK=OK -- -- -- --

+5V. TP21 +5 VDC 4.7 5.3
+12V. TP22 +12.5 VDC 12 13
+8V. TP23 +8 VDC 7.5 8.5
-8V. TP24 -8 VDC -8.5 -7.5

-2.5 V. TP25 -2.5 VDC -2.6 -2.4
Isolated +8V. TP42 +8 VDC 7.7 8.3
Isolated -8V. TP41 -8 VDC -8.3 -7.7
Connect the high voltage module simulator. CHECK=OK -- -- -- --
In 2J, load, cancel the load and defibrillate. PERFORM THE 3 ACTIONS=OK -- -- -- --
In 2J, load from paddles and defibrillate. PERFORMS THE ACTION PROPERLY=OK -- -- -- --
Check the self-discharge in a minute. IS SELF-DISCHARGE AFTER ONE

-- -- -- --
MINUTE=OK
Load 50J, recording voltage and load time in TP13. CHECK=OK -- -- -- --
Load voltage for 50J. -- 1.44 VDC 1.296 1.584

Load time for 50J. -- 2.5s 2 3

HIGH VOLTAGE
Load time for 100J. -- 3.5s 3 4
Load time for 200J. -- 4.75s 4.25 5.25

Load time for 300J. -- 5.75s 4.9 6.6
Load time for 360J. -- 6.5s 5.5 7.5

Connect Internal Paddles. CHECK=OK -- -- -- --
Set 360J. Load and verify that cuts 100J. CHECK=OK -- -- -- --
Connect the Real Battery. CHECK=OK -- -- -- --

CONSUMPTION
Measure battery consumption in mode “On”. -- < 360 mA 0 360
Measure battery consumption in mode “Off”. -- < 2 mA 0 2
Place the high-voltage module. CHECK=OK -- -- -- --
Page 56 of 79
Data Acquisition Tests

MEASURE OR AVERAGE
DESCRIPTION SIMULATE ADJUST MIN MAX
CONNECT IN VALUE
Put the cable of 3 leads and see DI, DII, DIII and pal.
-- -- -- -- -- --
CHECK=OK
Put the cable of 5 leads and all leads. CHECK=OK -- -- -- -- -- --
ECG - STEP
Set the MedSim300B Simulator at ECG - Perf - Wave -

-- -- -- -- -- --
Zero.
Adjust the position. CHECK=OK ZERO TP8 TMP3 0 Vpp -- --
Set the MedSim300B Simulator at ECG - Perf - Wave -
-- -- -- -- -- --
Squ. CHECK=OK
Adjust the amplitude of DII. CHECK=OK SQU TP10 TMP2 1 Vpp -- --
Set the MedSim300B Simulator at ECG BPM: 30. -- -- -- -- -- --
Record the Heart Rate. -- Display -- 30 BPM 29 31
ECG – QRS

Record the Heart Rate. -- -- -- 60 BPM 58 62
Record the Heart Rate. -- -- -- 240 BPM 232 248
Set the Notch Filter at 50 or 60 Hz, on request.
-- -- -- -- -- --
CHECK=OK
Verify the synchronous defibrillation. CHECK=OK -- -- -- -- -- --
Check blockade in changes of shunts and defibrillation.
-- -- -- -- -- --
BLOCKS=OK
Select lead DII. CHECK=OK -- -- -- -- -- --
Disconnect of the simulator, the red lead of the patient
GENERAL
cable and touch the snap button with your fingers. -- -- -- -- -- --

REALIZADO=OK
Verify that appears on the screen the message “Lead off”.
-- -- -- -- -- --
MESSAGE APPEARS=OK.
Reconnect the red lead of the patient cable in the
-- -- -- -- -- --
simulator. CHECK=OK
Put the recorder module and record all leads.
-- -- -- -- -- --
CHECK=OK
Verify the record during defibrillation. RECORD=OK -- -- -- -- -- --
Put the TPM Simulator and verify detection.
-- -- -- -- -- --
CHECK=OK
Verify the disable and stimulus. PERFORMS BOTH
-- -- -- -- -- --
ACTIONS=OK
Verify pulse width. -- -- -- 20 ms 18 22
Check the frequency of TPM to 60 PPM. 60 PPM -- -- 60 PPM 58 62
TPM
Check the amplitude of TPM to 10 mA. 10 mA -- -- 328 mV 324 332
Check the amplitude of TPM to 100 mA. 100 mA -- -- 1.2 V 1.1 1.3
Check the amplitude of TPM to 200 mA. 200 mA -- -- 2.2 V 2.1 2.3
In 2J, check the load; cancel the load and defibrillate.
-- -- -- -- -- --
PERFORM THE 3 ACTIONS=OK
Check ECG for paddles and synchronous defibrillation.
-- -- -- -- -- --
DEFIBRILLATION
PERFORM THE 2 ACTIONS=OK

Connect the equipment to the mains line. CHECK=OK -- -- -- -- -- --
Defibrillate with 10 Joules and record the value. -- -- -- 10 J 8 12
Again defibrillate with 10 Joules and record the value. -- -- -- 10 J 8 12
Page 57 of 79
Turn off the equipment. CHECK=OK -- -- -- -- -- --
Connect the Oximeter Board. CHECK=OK -- -- -- -- -- --
OXIMETER
Turn on the equipment. CHECK=OK -- -- -- -- -- --

Verify that within 10 seconds turn on the equipment,
-- -- -- -- -- --
SPO2 menu appears. CHECK=OK
Simulate with Cardiosat 100 simulator, 98% of SPO2 and
-- -- -- -- -- --
connect the sensor to the simulator. CHECK=OK
Record the value of SPO2. -- -- -- 98% 97 99
Page 58 of 79
Screens and Connection for simulation and realization of Output Protocol
ECG with ECG cable 5-leads

Required equipment:
MedSim 300.
ECG cable 5-leads.
Settings:
Set up MedSim300B in 60 [1/min].
Set up MedSim300B: Output ECG 1mVpp.
Set up Defibrillator ECG Gain in 1.
Connection: Screen view (DI):
ECG (RRMC) with ECG cable 5-leads

Required equipment:
MedSim 300.
Generator for measuring of RRMC.
ECG cable 5-leads.
Settings:
Set up MedSim300B: ECG output in zero.
Measure the RRMC with respect to the isolated reference and with respect to earth with generator for measurement of RRMC.
Connection:
Page 59 of 79
With respect to isolated reference Screen view

220v connection
Battery connection
With respect to earth: Screen view

220v connection
Battery connection
Note: The LED must light.
Page 60 of 79
ECG with ECG cable 3-leads

Required equipment:
MedSim 300.
ECG cable 3-leads.
Settings:
Connection: Screen view:
ECG (RRMC) with ECG cable 3-leads

Required equipment:
MedSim 300.
Generator for measuring of RRMC.
ECG cable 3-leads.
Settings:
Set up MedSim300B: ECG output in zero.
Measure the RRMC with respect to the isolated reference.
Connection:
Page 61 of 79
With respect to isolated reference: Screen view:

220v connection
Battery connection
Page 62 of 79
Oximetry
Required equipment:
Prosim 8.
Oximetry sensor.
Settings:
Simulate 96% Spo2 - 75 [1/min].
Tipe Mindray.
Pulse amplitude 3%.
Connection failures:
Without sensor Whithout patient
Searching Low perfusion
Page 63 of 79
Transcutaneous Pacer
Required equipment:
Impulse 4000.
Settings:
1) PACER / NO PRINT / INT 50Ω / PULSE.
Screen view of Impulse 4000
Settings:
1) PACER / NO PRINT / INT 50Ω / DEMAND.
Screen view of Impulse 4000
Page 64 of 79
Recorder
Required equipment:
MedSim 300.
ECG cable 5-leads.
Settings:
Connection:
Press “RECORD” key. Output of the print
Page 65 of 79
Connect the Impulse 4000
Settings:
1) DEFIB / NO PRINT / CARDIO / HIGH.
Connection:
Press “RECORD” key. Output of the print
Page 66 of 79
Test of energy delivered

Required equipment:
None.
Setting:
Turn on the equipment, while pressing the DISARM key, then the equipment will start in energy delivered test mode.
Follow the instructions on the screen.
Press the “CHARGE” key Press the “SHOCK” key
Message on screen
If the verification result is wrong the following message is displayed onscreen
Page 67 of 79
CALIBRATION
For calibration of this equipment, refer to form Final Test.
ADJUSTING OF THE HARDWARE

This equipment has no hardware adjustments that can be performed by the maintenance technician.
ADJUSTING AND CUSTOMIZING THE DISPLAY

See chapter SETUP MENU of the Defibrillator 3850B-Biphasic user manual.
There is indicated as adjusting the date, time, volume adjustment and the LCD display contrast.
MECHANICAL DRAWINGS, ELECTRICAL DIAGRAMS AND

MATERIALS LIST
INTRODUCTION
This chapter presents the theory of operation of the equipment, with diagrams and assembly plans for the Defibrillator 3850B.
Included in this chapter: block diagrams of the operation, wiring diagrams, interconnection plans Internal and External wiring, parts
listings, mechanical drawings of the cabinet and views of the serigraphs.
Schemes refer to a Defibrillator 3850B-Biphasic configured with all possible options. See which configuration of Defibrillator 3850B-
Biphasic applies, according to the equipment that is about to install or repair.
THEORY OF OPERATION
General
The 3850B-Biphasic model of feas ELECTRÓNICA is a Defibrillator Monitor of pulse biphasic, in synchronous (using the R wave
of the patient as sync) and Asynchronous (from the buttons on paddles) mode; has an output pulse synchronous with QRS.
It is portable, powered from line 90V~ to 240V~, 50Hz or 60Hz, to internal battery and external 12Vdc source. It is designed for use
in intensive care units, coronary care units, emergency rooms, ambulances due to its small size and weight.
The Defibrillator 3850B-Biphasic allows the observation of ECG and heart rate on the screen. Using the digital keyboard, you can
select the sweep speed, the gain of electrocardiogram (ECG), leads and put, adjust or remove the alarm limits, in addition, with the
use of the key selection, you can determine the energy to charged when you press the CHARGE button and you can print the record
of the derivation that is watching on the screen. Includes Oximetry module as optional, allows you to view values of SpO2, pulse
values and can also adjust the alarm limits for two values (maximum and minimum). On the screen, on the right bank of the ECG
curve, shows the pulse strength bar.
The Defibrillator 3850B-Biphasic can be configured with the following optional features:
o Thermal Recorder (REC).
o Transcutaneous Pacer (TPM).
o Pulse Oximeter (SpO2).
Components
The Defibrillator 3850B-Biphasic is, constructively, integrated into a single unit.
Its main components are:
• User Interface:
o Inputs parameters: ECG, SPO2, and TPM.
o Commands: Energy selector and keys for different functions (charge, shock, alarms, etc).
o Information: Display LCD and led indicator of batteries.
• Paddles to apply the electrical shocks.
• Power supply and Internal Batteries pack.
• Data Acquisition circuits and processor (motherboard).
• High Voltage Board.
• Interconnection circuits between the user interface and the rest of the boards, and screen operation board (frontal board).
• Optional:
o Transcutaneous Pacer Board.
o Oximeter Board.
o Recorder.
Page 68 of 79
General Block Diagram

The following graph shows the block diagram of the Defibrillator 3850B-Biphasic, where are represented the boards and the internal
wiring.
Next, will be explained, briefly, the function of each block:
Page 69 of 79
User Interface
The User Interface consists of the LCD screen, the inputs of parameters and the handling of commands as described below:
Inputs and parameter measurement
ECG:
ECG is the green connector for data input from the electrocardiogram (ECG) of the patient.
ECG function detects heart rate and displays the waveforms of various derivations. Using calipers, allows measuring the ST
segment and indicates, in audible and visual way, the occurrence of a QRS segment. It also contains tachycardia and bradycardia
alarms, whose volume is adjustable from the menu, with the option of a hot key to silence the alarm for 2 minutes. It also allows
detecting if the patient cable is disconnected and accepts cables of 3 or 5 leads with the connector polarized, which makes it
impossible to connect another cable by mistake.
Pulse Oximeter (SpO2):
SpO2 is the blue connector for data input from the SpO2 of the patient. The connector that plugs into the equipment is polarized;
which makes it impossible to connect another cable by mistake.
See the section Optional Oximetry.
Transcutaneous Pacer (TPM):
TPM is the yellow connector for data input from the transcutaneous pacer of the patient. The connector that plugs into the
equipment is polarized; which makes it impossible to connect another cable by mistake.
See the section Optional Transcutaneous Pacer.
Commands
On/Off and Energy Selector
This selector switch allows the device turn on or turn off, select the MONITOR mode (which does not allow energy charge) and
selecting the desired energy when use the CHARGE key.
Keys for different functions
Using the digital keyboard, you can select the sweep speed, the gain of ECG, leads and put, adjust or remove the alarm limits, for
it has keys: of synchronization, alarm silence, record, charge, disarm, shock and 4 arrows to scroll through the menu.
Information
LCD display
The equipment has an LCD display that allows observation of the curves of electrocardiogram and heart rate on the screen.
It also shows the following values and indicators:
• Value of pulse frequency, pulse rate alarms, heart rate, bradycardia alarm, tachycardia alarm, leads, sweep speed and ECG
gain.
• QRS indicator, indication synchronous-asynchronous mode.
• Pulse strength bar.
• Value of the charge in joules.
• Alarms silence, option to freeze.
• State of charge of the internal battery.
• Date, time, volume and contrast.
• SpO2 value, type of patient and SpO2 alarms, actives when the equipment includes this option.
• State of the TPM, current and TPM frequency; actives when the equipment includes this option.
LED battery indicator
With this indicator you know if the equipment is connected to the main line, to an external power supply or to the battery pack.
Paddles
Through the paddles is performed the energy discharge to the patient during defibrillation.
The same can be triggered, once charged, by the shock button on the paddles or the shock button in front of the equipment.
In addition, monitoring of the QRS complex is carried out by the paddles, since the discharge can be done in asynchronous mode or
in synchronous mode with the QRS.
Power
The defibrillator monitor has three power modes:
- From mains: 90V~ to 240V~, 50 or 60 Hz.
- 12 Vdc from internal rechargeable battery.
- 12 Vdc from the external power supply.
The equipment with rechargeable battery, must remain connected to the mains during periods when not in use.
In case of disconnection of the mains or external 12Vdc, the equipment may continue to operate using the internal battery.
Page 70 of 79
Boards
Motherboard
On the Motherboard are located the power supply and the circuits of data acquisition and control. In the control units is handled the
on/off, controlling the user interface, charging control, shock control and further (if the equipment has the optional), the recorder
control and the pacemaker control.
High Voltage board

In the High Voltage board, are located the circuit that generates the high voltage, the circuit that control the charging of the capacitor
and the circuit that controls the shock.
Frontal board
On the frontal board are located the necessary circuitry to handled the signals from the user interface.
Optionals
Optional Transcutaneous Pacer
The Optional TPM allows transcutaneous cardiac stimulation by electrical current pulses controlled by the equipment, pulses of fixed
width 20ms. The operator can adjust the frequency of the pulses between 40ppm and 180ppm in steps of 5ppm, and the applied
current in the range of 10mA to 200mA in 10mA steps.
Optional Oximetry
The optional allows to measure and observe percentage values of oxygen saturation, the values of pulse rate peripheral and the
plethysmographic curve, in addition, on the screen, on the right bank of the ECG curve, shows the pulse strength bar. Also has the
pulse rate alarms for tachycardia and bradycardia, QRS detection from pulse oximeter, with variation of the audio frequency (with the
percentage of saturation) and oxygen saturation alarms from 50% to 100% with limits upper and lower, where the default lower limit
is 80%. Its volume is adjustable from the menu, with the option of a hot key to silence the alarm for 2 minutes.
Optional Record
The equipment has a thermal recorder on top of it that allows you to record on paper from the derivation that is observing on the
screen.
Page 71 of 79
EXPLODED VIEW OF THE EQUIPMENT

In this section: the mechanical drawings of the cabinet exploded view.
Page 72 of 79
Page 73 of 79
Page 74 of 79
EQUIPMENT PARTS LIST

The following section provides a list of equipment components, with the reference and description of each item.
DEFIBRILLATOR MONITOR 3850B-BIPHASIC

DEFIBRILLATOR MONITOR W/BAT-RECORD-PACER-SpO2 3850B-BIPHASIC
Level - Reference - Description Use
0. 14641/0913A - DEFIBRILLATOR MONITOR W/BAT-RECORD-PACER-SpO2 3850B-BIPHASIC 1
1. 2197/0908A - SUBSET DEFIBRILLATOR 3850B-BIPHASIC TOP CASING 1
2. 19292/0905A - THERMOFORMING TOP CASING, MECHANIZED AND FRES F/DEFIB 3850 1
2. 14996/0003A - THERMOFORMED PLASTIC PADDLE HOLDER, MECHAN AND FRES F/DEFI 3850 2
2. 15428/0000A - ZINC SHEET OF CONDUCTION F/MAGNETS IN TOP CASE DEFI 3850 2
2. 13984/000xA - BOARD NP 209.x 1
2. 19074/0001A - DISPLAY 240 x 64 LED 1
2. 14216/0100A - INTERCONNECTION CABLE FRONTAL BOARD AND MOTHERBOARD D3850 1
2. 8397/000D - ACRYLIC FRONTAGE FOR DEFI 3850 137x45x3 DOUBLE PROTECTED 1
2. 3437/0 - POLARIZED GREEN PLASTIC BOX, WITH SCREWS 1
2. 9737/0100A - INPUT CABLE OF PATIENT CABLE F/ DEFIBRILLATOR 3850 1
2. 14632/0 - BLACK KNOBS 1
2. 4053/0901A - ON/OFF AND ENERGY SELECTOR, CABLING F/DEFI 3850 BIPHASIC 1
2. 9731/0101A - ADHESIVE KEYPAD FOR DEFI, BIPHASIC 1
2. 3921/0100A - LABEL DO NOT DISCHARGE WITH PADDLES SHORTED TOGETHER OF DEFIB 1
2. 15582/0100A - LABEL SEQUENCE OF USE OF DEFIBRILLATOR 1
2. 11422/0000G - LABEL BACKGROUND LEGENDS FOR DEFIBRILLATOR 3850 BIPH 1
2. 17197/0003A - BACKGROUND LABEL REF_SN F/DEFIBRILLATOR 3850 BIPHASIC 1
2. 6569/0 - INTERNAL LABEL SN F/FEAS EQUIPMENTS, REV. 1-0 1
2. 15050/0 - NEODYMIUM MAGNET NDFEB 35 DIA 22x5 mm 4
2. 17989/0904A – SUBSET OF ENERGY TEST DELIVERED - BIPHASIC 1
2. 18541/0000A - PAIR OF "TEST OF ENERGY DELIVERED" LABEL FOR 3850B DEFIBRILLATOR 1
1. 7074/0912A - SUBSET DEFIBRILLATOR 3850B-BIPHASIC BOTTOM CASING 1
2. 14004/0004A - ALUMINUM BOTTOM CASING W/RIVET PAINTED F/DEFIBRILLATOR 3850B 1
2. 15057/0101A - WELDED METALLIC BACKGROUND AND PAINTED OF BOTTOM CASING 1
2. 15109/0000A - INTERNAL LABEL HIGH VOLTAGE 3
2. 15110/0000A - INTERNAL LABEL EARTH TERMINAL 2
2. 14984/0000A - EXTERNAL COVER PUNCHED MILLING AND PAINTED FOR CONNECTORS 1
2. 14131/0 - BLACK PLASTIC HANDLE 1
2. 14989/0001A - DRAINAGE THERMOFORMING AND FRONT MACHINING OF DEFIBRILLATOR 1
2. 216/0 - BLACK SELF-ADHESIVE RUBBER FEET 3M REF.SJ 5009 4
2. 2914/0100A - CABLE 0,27MTS 2mm PITCH HOUSING - SPEAKER MYLAR 0,5W 8 OHMS 1
2. 14658/0 - EMI/RFI FILTER 4A 250VAC 1
2. 8644/0100A - POWER OF EQUIPMENT WITH AUTO-SWITCHING POWER SUPPLY 1
2. 10660/0100A - GROUND CABLE BRASS RING- FASTON H. 6.3 mm RED_0.10 1
2. 2885/0 - GROUND CABLE BRASS RING-BRASS RING_0,15m 1
2. 12197/0100B - INPUT CABLE FOR EXTERNAL POWER 12VDC F/DEFI 3850B 1
2. 14397/0000A - EVA FOAM F/BATTERY PACK NIMh 12V-3500mAh 1
2. 12199/0001B - BATTERY PACK NIMh 12V-3500mAh ASSEMBLY 1
2. 14110/000xA - BOARD NP: 210.x 1
2. 12276/0102A - RED HIGH VOLTAGE CABLE F/CAPACITOR ON DEFI 3850B 1
Page 75 of 79
2. 12277/0102A - BLACK HIGH VOLTAGE CABLE F/CAPACITOR ON DEFI 3850B 1

2. 12278/0300A - RED HIGH VOLTAGE CABLE, INTERNAL F/PADDLE, APEX, ON DEF385 1
2. 12279/0300A - BLACK HIGH VOLTAGE CABLE, INTERNAL F/PADDLE STERNUM DEFI3850 1
2. 14497/0200A - CASING THERMOFORMING MACHINING F/HIGH VOLT MOD DEFI 3850 1
2. 14608/0000A - PLAST COVER PUNCH AND MILLING F/CAPAC HIGH VOLTAGE OF D3850 1
2. 9895/0001A - OVAL CAPACITOR 195 µF 5% 2300V 1
2. 6966/0901A - SUBSET OF SERIAL COIL TO DEFIBRILLATOR 1
2. 9838/0802A - SUBSET PADDLES CONNECTOR TO DEFI 3850 1
2. 15171/0002A - POWER CABLE FROM MOTHERBOARD TO HIGH VOLTAGE BOARD D3850 1
2. 6610/0100A - CABLE LATCH 10 TO LATCH 10 - 0.08 m 1
2. 10859/0902A - CABLE INTER MOTHERBOARD - PADDLES CONNEC DEFI 3850 1
2. 13980/000xA - BOARD NP 208.x 1
2. 14256/0001A - BATTERY CONTAINER F/DEFIBRILLATOR 3850B ZINC PLATED 1
2. 14259/0 - INF SUBJECTION OF BATTERY F/DEFIBRILLATOR 3850B REMA Y ZIN 1
2. 6569/0 - INTERNAL LABEL SN F/FEAS EQUIPMENT, REV. 1-0 1
1. 7120/0102A - THERMAL RECORDER OPTIONAL TO DEFIBRILLATOR 3850 1
2. 14467/0000A - THERMAL PRINTER PANEL MOUNT 1
2. 14473/0000A - MOUNTING FOLD-PUNCH-RIVET AND ZINC THERMAL RECORD 1
2. 14505/0001A - RECORDER CABLE ON NP: 208.x OF DEFI3850 1
2. 15050/0 - NEODYMIUM MAGNET NDFEB 35 DIAM 22x5 mm 1
2. 16284/0100A - REGISTER COVER IN DESFI 3850B 1
1. 7119/0102A - OPTIONAL PACEMAKER TO DEFIBRILLATOR 3850 1
2. 12314/000xA - BOARD NP 140.x 1
2. 9778/0300A - OUTPUT TPM CABLE F/DEFIBRILLATOR 3850 1
2. 9960/0 - LABEL OF PACER FOR DEFIBRILLATOR 3850 1
2. 3432/0 - POLARIZED YELLOW PLASTIC BOX, WITH SCREWS 1
1. 11430/0200A - SpO2 OPTIONAL TO DEFIBRILLATOR 3850 1
2. 17529/0000A - SpO2 BOARD 1
2. 12287/0100A - INPUT CABLE OF SpO2 SENSOR (DB9F-PH-V-06) 1
2. 12317/0002A - INTERCONNECTION CABLE OF SpO2 BOARD 1
2. 3433/0 - POLARIZED BLUE PLASTIC BOX, WITH SCREWS 1
2. 9959/0 - SpO2 PARAMETERS LABEL FOR DEFIBRILLATOR 3850 1
2. 11418/0 - SELF-ADH LABEL POLYC VAL SpO2, 200u, F/KEYBOARD DEFI3850B 1
2. 14616/0000B - PLASTIC INSULATION 1mm FOR DEFI3850B WITH TPM AND OXIM 1
1. 10917/0101A - CABLE LATCH10 TO LATCH10 - TO TPM AND RECORDER 1
Page 76 of 79
PORT CONNECTIONS
In this section, we present front and back images of the equipment, identify the connection ports, and then for each of these ports,
and outline of the connector and identifies the signal and the connection of each pin.
Input connector ECG

PIN SIGNAL – DESCRIPTION DIAGRAM PHOTO
1 G1
2 b
3 v
4 a 5 4 3 2 1
5 r 9 8 7 6
6 G1 DB9 female
7 (to Opto2) front view
8 G1
9 (to Opto1)
Input connector SpO2

1 Pin 6 of SPO2 board
4 NC 5 4 3 2 1
5 Pin 1 of SPO2 board 9 8 7 6
6 Pin 5 of SPO2 board DB9 female
7 Pin 5 of SPO2 board front view
8 NC
Output connector TPM

1 Positive (red)
2 NC
3 NC
4 NC 5 4 3 2 1
5 NC 9 8 7 6
6 Positive (red) DB9 female
7 Negative (black) front view
8 Negative (black)
9 NC
Page 77 of 79
CPC connector
1 to 9 NC
10 APEX
11 to 14 NC
15 STERNUM
16 to 28 NC
Paddles
29 and 30
Internal/external
32 Paddles charge
33 NC
34 Isolated Shock CPC Connector
35 and 36 Paddles connector, in place front view
37 Isolated Ground
Line Input
1 2
1 Line
2 Neutral
3 Ground
3
12V Power Supply Input
1 12V
2 12V
3 Ground
4 Ground
Page 78 of 79
Av. Colón 5760 – (X5003DFP) CORDOBA – REPUBLICA ARGENTINA

TE: +54 351 4848016 - FAX: +54 351 4850750
e-mail: soporte@feaselectronica.com.ar
htpp://www.feaselectronica.com.ar
Page 79 of 79

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DEFIBRILLATOR MONITOR

Mod. 3850B-BIPHASIC - SERVICE MANUAL

RESPONSIBILITY FOR INFORMATION

Av. Colón 5756/60 – C.P.X5003DFP –

DT: Jorge F. Feas, Eng. - PM: 12341991.

AUTHORIZED EU-REPRESENTATIVE Cinterqual, Lda.

NOTES AND WARNINGS

Warning messages from the ECG

Indicator of pacemaker spike detection

Error message during the energy charge

Test messages of energy delivered

Warning messages from the oximeter

SpO2 module error

Indicates a power supply failure in the Oximeter module.

Indicates that there is a problem with the Oximetry sensor.

When interference is detected by ambient light, the message "Light Ambient".

Warning messages Transcutaneous Pacer (TPM)

Warning messages RECORDER module

Warning messages BATTERY

SYMBOLS AND REFERENCES LIST

Line/Battery charge. Low battery.

Date of manufacture. Battery discharged.

Not suitable for explosive atmosphere. Sound volume.

Connected to line or external 12Vdc. Screen contrast.

Protective earth (ground). Warning! High voltage.

Protect from rain. Do not pile more than 3 boxes.

Fragile. Box orientation.

Charge button. Shock button.

Sync key. Recorder.

Disarm key. Alarm key.

Manufacture. Follow the instructions.

Alarm silence. For disposal follow local regulations.

Storage and transport temperature, maximum and

Storage and transport pressure, maximum and

INFORMATION FOR SERVICE

DEVICE DESCRIPTION AND INTENDED USE

INDICATIONS AND CONTRAINDICATIONS

Transcutaneous pacing therapy (optional)

Pulse Oximeter (optional)

- CHARGE Key: Initiates energy charge.

- DISARM Key: Disarm energy charge.

- SYNC key: For SYNCHRONOUS mode selection.

BAT: With Internal Battery.

Ref. Description Quantity Image Adult Pediatric neonatal

PATIENT ECG CABLE DB9M/G - 3

PATIENT ECG CABLE DB9M/G - 5

PATIENT ECG CABLE DB9M/G - 3

POWER CORD 220V IRAM

USER’S MANUAL DEFIBRILLATOR

THERMAL PAPER FOR ECG:

1261 PACER ELECTRODES (OPTIONAL). 1 set. R --- ---

Ref. Description Quantity Image Adult Pediatric neonatal

PACER ELECTRODE CABLE 2 PIN

VELCRO BELT FOR PACER

PULSE OXIMETER SENSOR,

PULSE OXIMETER REUSABLE “Y”

SpO2 ADAPTER CABLE DB9MG-

ADULT TO PEDIATRIC PADDLES

17121 EXTERNAL PADDLES 3850. 1 set. R --- ---

NOTE: The images of accessories are for illustrative purposes.

CONTROL AND INDICATORS

Cursor movement keys.

Selection keys of menu items.