- EN 60601-1: 1990 + A1:1993 + A2: 1995 Medical Electrical Equipment, Part 1, General
Requirements for Safety.
- IEC/EN 60601-1-2 :2001 Electromagnetic compatibility -Requirements and tests.
- EN 1060-1:1995 Non-invasive sphygmomanometers - Part 1: General requirements
- EN 1060-3:1997 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for
electro-mechanical blood pressure measuring systems
- EN ISO 9919:2005 Medical electrical equipment - Particular requirements for the basic safety and
essential performance
of pulse oximeter equipment for medical use (ISO 9919:2005)
- EN 60601-2-27:2006 Medical electrical equipment - Part 2-27: Particular requirements for the
safety, including essential performance,
of electrocardiographic monitoring equipment
- EN 60601-2-30:2000 Medical electrical equipment - Part 2-30: Particular requirements for the
safety, including essential performance,
of automatic cycling non-invasive blood pressure monitoring equipment
- EN 12470-4:2000 Clinical thermometers - Part 4: Performance of electrical thermometers for
continuous measurement
- EN 60601-2-49:2001 Medical electrical equipment - Part 2-49: Particular requirements for the
safety of multifunction animal monitoring equipment
Rev. 2.4 1. BASIC
8
Electromechanical safety standards met:
BM3Vet User Manual
1.2 Read before Use
GIMA services are always available to you.
In the event of malfunction or failure, contact us along with the model name, serial number, and
product name of the equipment.
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9
BM3Vet User Manual
Warranty Period
This product is manufactured and passed through strict quality control and thorough
inspection.
We provide a 1-year warranty period.
We will repair or replace any part of the BM3Vet found to be defective in usual operating
circumstance at no cost to you.
This warranty does not apply to any defect caused by improper use, abuse, misuse or improper
handling.
Rev. 2.4 1. BASIC
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y
y
y
y
BM3Vet User Manual
Warning, Caution, Note
For special emphasis on agreement, terms are defined as listed below in user manual. Users should
operate the equipment according to all the warnings and cautions.
To inform that it may cause serious injury or death to the animal, property damage, material
losses
To inform that it may cause no harm in life but lead to injury
To inform that it is not dangerous but important “note” sign for proper installation, operation, and
maintenance of the equipment.
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11
Warning
Caution
Note
BM3Vet User Manual
General Precaution on Environment
- Do not keep or operate the equipment in the environment listed below.
Avoid placing in an area
exposed to moisture.
Avoid exposure to direct
Do not touch the equipment
sunlight
with wet hands.
Avoid placing in an area
where there is a high variation
Do not use or store in
of temperature.
the vicinity of an Electric
Operating temperature
heater
ranges from 10(C to
40(C. Operating humidity
ranges from 30% to 85%.
Avoid placing in an area
Avoid placing in an area where
where there is an
there is an excessive
excessive shocks or
humidity or poor ventilation.
vibration.
Avoid placing in an area where
Avoid inserting dust and
chemicals are
especially metal
stored or where there is danger
material into the
of gas leakage.
equipment
Do not open or disassemble
Power off when the
the equipment. Bionet accepts
equipment is not fully
no responsibility for
installed.
unauthorized tampering
Otherwise, equipment
service or repair.
could be damaged.
Rev. 2.4 1. BASIC
12
CAUTIONS
Compatibility is critical to safe and effective use of this device. Please contact your local sales or
service representative prior to installation to verify equipment compatibility.
Animal signal inputs labeled with the CF and BF symbols with paddles are protected against
damage resulting from defibrillation voltages. To ensure proper defibrillator protection, use only the
recommended cables and lead wires.
Proper placement of defibrillator paddles in relation to the electrodes is required to ensure
successful defibrillation.
Disposable devices are intended for single use only. They should not be reused as performance
could degrade or contamination could occur.
1. When this crossed out wheeled bin symbol is attached to a product it means
the product is covered by the European Directive 2002/96/EC.
2. All electrical and electronic products should be disposed of separately from
the municipal waste stream via designated collection facilities appointed by
the government or the local authorities.
3. The correct disposal of your old appliance will help prevent potential negative
consequences for the environment and human health.
4. For more detailed information about disposal of your old appliance, please
contact your city office, waste disposal service or the shop where you
purchased the product.
To prevent skin burns, apply electrocute electrodes as far as possible from all other electrodes, a
distance of at least 15 cm/6 in. is recommended.
Magnetic and electrical fields are capable of interfering with the proper performance of the device.
Rev. 2.4 1. BASIC
13
Before Installation
Defibrillator Precaution
Disposables
BM3Vet User Manual
Disposal of your old appliance
Electrocute Precautions
EMC
BM3Vet User Manual
For this reason make sure that all external devices operated in the vicinity of the monitor comply with
the relevant EMC requirements. X-ray equipment or MRI devices are possible sources of
interference as they may emit higher levels of electromagnetic radiation.
Also, keep cellular phones and other telecommunication equipment away from the monitor.
Rev. 2.4 1. BASIC
14
CAUTIONS
For continued safe use of this equipment, it is necessary that the instructions are followed. However,
instructions listed in this in no way supersede established medical practices concerning animal care.
Should the monitor at any time temporarily lose animal data, the potential exists that active
monitoring is not being done. Close animal observation or alternate monitoring devices should be
used until monitor function is restored.
If the monitor does not automatically resume operation within 60 seconds, power cycle the monitor
using the power on/off switch. Once monitoring is restored, you should verify correct monitoring
state and alarm function.
Regular preventive maintenance should be carried out annually (Technical inspections). You are
responsible for any requirements specific to your country.
The use of a multiple portable socket outlet (MPSO) for a system will result in an enclosure leakage
current equal to the sum of all individual earth leakage currents of the system if there is an
interruption of the MPSO protective earth conductor. Do not use an additional extension cable with
the MPSO as it will increase the chance of the single protective earth conductor interruption.
BIONET does not assume responsibility for damage to the equipment caused by improperly vented
cabinets, improper or faulty power, or insufficient wall strength to support equipment mounted on
such walls.
Rev. 2.4 1. BASIC
15
Instruction for Use
Loss of Data
Maintenance
BM3Vet User Manual
MPSO
Negligence
NOTES
Before connecting the device to the power line, check that the voltage and frequency ratings of the
power line are the same as those indicated on the unit’s label. If this is not the case, do not connect
the system to the power line until you adjust the unit to match the power source.
In U.S.A, if the installation of this equipment will use 240V rather than 120V, the source must
be a center-tapped, 240V, single-phase circuit.
U.S.A federal law restricts this device to sale by or on the order of a physician.
This equipment is intended for use under the direct supervision of a licensed health care practitioner.
Set up the device in a location which affords sufficient ventilation. The ventilation openings of the
device must not be obstructed. The ambient conditions specified in the technical specifications must
be ensured at all times.
·Put the monitor in a location where you can easily see the screen and access the operating controls.
·This product is protected against the effects of cardiac defibrillator discharges to ensure proper
recovery, as required by test standards. (the screen may blank during a defibrillator discharge but
recovers within second as required by test standards.)
Medical Device Directive 93/42/EEC
EN 60601-1/1990 +A1: 1993 +A2 : 1995 : Medical electrical equipment.
General requirements for safety
EN 60601-1-1/9. 1994 +A1 12.95: General requirements for safety.
Rev. 2.4 1. BASIC
16
Power Requirements
Restricted Sale
Supervised Use
Ventilation Requirements
BM3Vet User Manual
Reference Literature
BM3Vet User Manual
General Precaution on Electric Safety
BM3VET OPERATION MANUAL
Check the items listed below before operating the equipment.
NOT
1. Be sure that AC power supply line is appropriate to use. (AC100 - 240V)
2. Be sure that the power adapter is the one supplied from Bionet. (DC18V, 2.5A)
3. Be sure that all cables are properly and firmly fixed.
4. Be sure that the equipment is properly grounded. (If not, this might cause a malfunction to occur
in the product.)
5. The equipment should not be placed in the vicinity of electric generators, X-rays, broadcasting
apparatus to eliminate the risk of electric noise during operation. This may cause incorrect results.
The Equipment should be placed far from generator, X-ray equipment, broadcasting equipment
or transmitting wires, so as to prevent the electrical noises from being generated during the
operation, When these devices are near the Equipment, it can produce inaccurate
measurements. For BM3Vet, both independent circuit and stable grounding are essentially
required. In the event that the same power source is shared with other electronic equipment, it
can also produce inaccurate output.
Do not operate the machine while in contact with the animal. It may cause serious danger to the
user. Use only the provided patient cable.
In case the Equipment does not operate as usual or is damaged, do not use on animal, and
immediately refer to the medical equipment technician of the hospital or the equipment supply
division.
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Warning
Note
Warning
Warning
BM3Vet User Manual
BM3Vet is classified as follows:
- BM3Vet classifies as Class
BF
CF concerning electric shock. It is not proper to operate
this Equipment around combustible anesthetic or dissolvent.
- Noise level is B class regarding IEC/EN 60601-1 and the subject of Nose is B level concerning
IEC/EN60601-1-2.
In the hospital, doctors and animals are exposed to dangerous, uncontrollable compensating
currents. These currents are due to the potential differences between connected equipment.
The safety solution to the problem is accomplished with EN60601-1;1993.
When used as intended, the parts of the product described in this operator manual, including
accessories that come in contact with the animal during the intended use, fulfill the biocompatibility
requirements of the applicable standards. If you have questions about this matter, please contact
BIONET or its representatives.
Various methods can be used to clean BM3Vet and its accessories. Please follow the methods
mentioned below to avoid unnecessary damage or contamination to the Equipment.
We do not repair free of charge regardless of warranty period if it is contaminated or damaged due
to use of dangerous materials not designated for washing.
Rev. 2.4 1. BASIC
18
Note
I, &
Equipment Connection
Caution
Biocompatibility
Maintenance and Washing Equipment Connection
Cables and Leadwires
Cleaning Applied Parts
Do not use acetone or ketone solvents for cleaning; do not use an autoclave or steam cleaner.
Cables and leadwires can be cleaned with a warm, damp cloth and mild soap, or isopropyl alcohol
wipes. For more intensive disinfecting (near sterile) Ethylene Oxide (ETO) is acceptable but will
reduce the useful lifetime of the cable or leadwire.
The decision to sterilize must be made per your institution’s requirements with an awareness of
the effect on the integrity of the cable or leadwire.
The Equipment needs safety inspection once a year. Please refer to user’s guide or service
manual for the specifications.
Please check carefully both frame and sensor, after cleaning the Equipment, Do not use any
equipment that is worn out or damaged.
At least once a month, clean and wipe off the frame by using the soft cloth after wetting it with water
and alcohol. Do not use lacquer thinner, ethylene, or oxidizers which may lead to damage to the
equipment.
Make sure both cables and accessories are free of dust or contaminants, and wipe them off with soft
cloth wetted with warm water (40°), and at least once a week, clean them by using clinical alcohol.
Do not submerge the accessories under any liquid or detergent. Also, make sure any liquids do not
Rev. 2.4 1. BASIC
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BM3Vet User Manual
CAUTION
CAUTION
Note
BM3Vet User Manual
penetrate into the Equipment or probe.
Do not dispose of single use probe improperly. Always think about environmental
contamination.
There is back-up battery on board inside system. When users dispose this battery, Please
follow local laws for waste disposal.
Check the electrodes of batteries before changing them.
· Operate BM3Vet with internal electric power supply when unsure of external ground connection or
installation occur.
· Remove the 1st Battery when not using equipment for an extended period of time.
For other applied parts such as temperature sensors, pulse oximetry probes, and NiBP cuffs, you
must consult the manufacturer for cleaning, sterilization, or disinfecting methods.
Rev. 2.4 1. BASIC
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Caution
Caution
Warning
BM3Vet User Manual
1.3 Product Components
BM3VET OPERATION MANUAL
Product Outline
BM3Vet monitor is a product used for monitoring the biological vital signs of an animal. Main
functions of the product include displaying information such as ECG, respiration, SpO2, NIBP and
temperature on its LCD screen and monitoring parameter, and alarming. It also prints out waves and
parameters via a printer.
Principal Characters of Product
BM3Vet is a compact, multifunctional monitoring equipment for an animal designed for portability. It
features devices for auto power supply (DC 10V-16V) and DC power supply (DC 18V). The
equipment also measures major parameters such as ECG, SpO2, NIBP, temperature and pulse,
displaying it on a 7-inch color LCD screen. It also enables users to check waves and parameters
and other vital signs of a animal via the 58mm thermal printer and monitor the animal by the remote-
controlled alarm system. It also enables to build a central monitoring system by linking devices used
for separate animals so that one can monitor several animals at a time.
Use only the supplement accessories provided by us. Otherwise, animal and user may be
exposed to danger.
BEFORE USE — Before putting the system into operation visually inspect all connecting cables
for signs of damage. Damaged cables and connectors must be replaced immediately.
Before using the system, the operator must verify that it is in correct working order and
operating condition. Periodically, and whenever the integrity of the product is in doubt, test all
functions.
Rev. 2.4 1. BASIC
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Warning
Warning
BM3Vet User Manual
Product Configuration
1. Main body of BM3 Vet Monitor 1 EA
2. 3-Lead Animal Cable 1EA (3CBL-400, 3WIRE-400)
3. Disposable electrodes
10 EA (ECGSENS-400)
4. NIBP tubing (3M long)
1EA (NBPCBL-400)
5. Adult cuff (25-35 Cm) 1EA (ACUFF-400)
6. SpO2 sensor extension cable (2M)
1EA (SPCBL-400)
7. SpO2 Probe
1 EA (SPASENS-400)
8. DC Adaptor (MW160 made in AULT Co., Ltd.)
1 EA
9. Chart Paper (PAPER-400) 2ROLL
Option Product
1. Temperature (TEMPSENS-400)
Rev. 2.4 1. BASIC
22
Warning
In order to avoid electrical shock, do not open the cover. Disassembling of the
equipment should be done only by the service personnel authorized by BIONET
Warning
Users must pay attention on connection any auxiliary device via LAN port or nurse
calling. Always consider about summation of leakage current, please check if the
auxiliary device is qualified by IEC 60601-1, or consult your hospital biomedical engineer.
BM3Vet User Manual
Product Body Configuration
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BM3Vet User Manual
Rev. 2.4 1. BASIC
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BM3Vet User Manual
Accessories
ECG Cable +
Extension Cable
SpO2 Cable +
Extension Cable
NIBP Cuff+
Extension cable
Temperature
sensor (Option)
Rev. 2.4 1. BASIC
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BM3Vet User Manual
Equipment Sign
ATTENTION :
Consult accompanying documents
TYPE CF APPLIED PART :
Insulated (floating) applied part suitable for intentional external and internal
application to the animal including direct cardiac application. "Paddles"
outside the box indicate the applied part is defibrillator proof.
Medical Standard Definition :
F-type applied part(floating/insulated) complying with the specified
requirements of IEC 60601-1/UL 2601-1/CSA 601.1
Medical Standards to provide a higher degree of protection against electric
shock tan that provided by type CF applied parts.
TYPE BF APPLIED PART :
Insulated (floating) applied part suitable for intentional external and internal
application to the animal excluding direct cardiac application. "Paddles"
outside the box indicate the applied part is defibrillator proof.
Medical Standard Definition :
F-type applied part (floating/insulated) complying with the specified
requirements of IEC 60601-1/UL 2601-1/CSA 601.1
Medical Standards to provide a higher degree of protection against electric
shock than that provided by type BF applied parts.
Rev. 2.4 1. BASIC
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BM3Vet User Manual
Rev. 2.4 1. BASIC
27
External Ground
Printer
Serial Port
LAN Port
AUX Connector Port
DC Input Indicator
Battery Operation Indicator
DC Input Connector
BM3Vet User Manual
Rev. 2.4 1. BASIC
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NIBP
Temperature
Function
Power on
Power off
Respiration
ECG
Heart Pulse
BM3Vet User Manual
1.4 Function and Key
External Function
The front panel of this product consists of an LCD screen and five function keys and one trim knob.
Operation Key
1. Power :
Switches on and off the Power.
2. Function Key : Change Display mode.
3. Blood Pressure:Manually completes measuring blood pressure when this key is pressed with
the cuff placed on the patient.
4. Printer:
Prints out the waves selected from the menu until the key is pressed to stop.
5. Alarm:
Stop alarm sound.
First press stops the current alarm for one minute
Second press stops the current alarm for five minutes.
Third press resets the alarm back to the original setting.
6. Trim Knob: This key is used to select menu options by turning it clockwise or
counterclockwise to move cursors.
Rev. 2.4 1. BASIC
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Parameter windows
Alarm
Printer
Measure Blood Pressure
Function
Screen
Trim Knob
Power ON/OFF
Battery Power LED
DC Power LED
BM3Vet User Manual
Rev. 2.4 1. BASIC
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BM3Vet User Manual
1.5 Standard Power Supply Application
DC Power
DC Power LED is lighted on when the DC Power is plugged into the inlet at the back of the product.
A press of the power key makes the machine ready for use.
This equipment must only be connected to a grounded main.
Rev. 2.4 1. BASIC
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Warning
BM3Vet User Manual
1.6 Battery Power Supply Application
Battery power can be supplied for enabling portable use or use during AC power failure.
Operation
1. Battery Power LED is lit when the machine is in use.
2. The DC/battery power is only sustainable for 1 hour.
3. Battery is automatically charged when the machine is connected to DC Power Supply. Battery
LED is lit on after blinking.
4. The charging status of the batteries is displayed with 5 green boxes, each indicating a different