Biobase BFG Series User manual

Biological Isolation Chamber
BFG Series
User Manual
BIOBASE GROUP
Version 2020.03

Preface
Dear Customer:
Thank you for purchasing the BIOBASE infectious disease patient transport Biological
Isolation Chamber!
Sincerely hope that our products can bring you the greatest help.
In order to let you know more about the Biological Isolation Chamber for infectious patients,
please read the instructions carefully before use. The contents of this manual are very
important for your safe and correct use of this machine!
After familiarizing yourself with the manual, for easy reference, keep this manual in an
easy-to-use place.
In all cases marked, the instructions need to be consulted to understand the nature of the
potential danger and any countermeasures that must be taken.

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1.Product introduction
The transportation of negative pressure isolation compartments for infectious patients
(hereinafter referred to as "negative pressure isolation compartments") is based on the
principle of "negative pressure air isolation", which implements the safe isolation and
transfer of new and sudden infectious patients during the transfer process to prevent further
epidemic situation. Spreading protects the external environment from pollution and reduces
the chances of infection for a healthy public.
1.1 A ppl i ca t i on
The negative pressure isolation compartment is suitable for the safe isolation and transfer of
infectious patients.
1.2 Eq uip ment wo rking con dit ion s
a-Ambient temperature: 10 ℃to 40 ℃;
b-Relative humidity：≤75%；
c-The atmospheric pressure: 70 KPa to 106 KPa
d-Internal power supply DC12V
e-No strong magnetic field interference and mechanical vibration, no corrosive gas, no
direct light

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2. Installation and commissioning
2.1 Before removing the box, carefully inspect the box for damage. If you find that the
equipment is damaged, please contact our staff in time.
2.2 After opening the box, check whether the accessories and random documents are
complete according to the packing list shown in the appendix.
2.3 Biological Isolation Chamber can be used with stretcher cart. Place the Biological
Isolation Chamber on the unfolded stretcher, wrap the fixing strap connected to the stretcher
around the bottom of the stretcher, close it with the buckles on both ends of the strap, adjust
the length of the shortened strap to be fixed, and then tie the straps to the stretcher rod on.
2.4 Press the power button to start the negative pressure isolation compartment and check
whether the product is operating normally.
3.Technical Parameters
3.1 The technical parameters
Model technical
parameters
BFG -Ⅰ
Medical Device Registration
Certificate Number
Lu mechanical focus 20202150137
Product technical requirement
number
Lu mechanical focus20202150137
Dimensions(L×W×H)mm
1900×680×500
Internal power
DC 12V
Ventilation
Not less than 50L/min
Negative pressure
Not less than 15Pa(with in 2min)
Cleanliness
Aerosol leakage rate ≤0.01%

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noise
65dB(A)
equipment weight
20kg
Software release version
V1
Period of use
6 years
Note: The company reserves the right to change the design of the product, and the product is
subject to change without notice.
3.2 Product features
a). Classification by electric shock prevention type: internal power equipment
b). Classified by the degree of protection against electric shock: Type B application part
c). Classified by the degree of protection against incoming fluid: IPX0
d). Classified according to the degree of safety when used with flammable anesthetic gas
mixed with air or with flammable anesthetic gas mixed with oxygen or nitrous oxide: it must
not be used in the presence of flammable anesthetic gas mixed with air or with oxygen or
oxygen Use in the case of flammable anesthetic gas mixed with nitrous acid;
e). Classification by operation mode: continuous operation
3.3 Performance
The technical indicators of the Biological Isolation Chamber products have been verified to
meet the "Product Technical Requirements" formulated by the company.
(A) Negative pressure value: A negative pressure of not less than 15 Pa shall be established
in the negative pressure isolating compartment within 2 minutes.
(B) Noise: In normal operation, the noise in the Biological Isolation Chamber is not more
than 65dB (A).
(C) Cleanliness: The aerosol leakage rate at the air outlet of the negative pressure isolation
compartment should not exceed 0.01% during normal operation.

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(D) Air exchange volume: The air exchange volume of the negative pressure isolation tank
is not less than 50L / min.
(E) Alarm
Negative pressure abnormal alarm
When the negative pressure in the cabin is less than 15Pa, the negative pressure alarm
indicator lights up and the alarm starts.
Abnormal voltage alarm
When the internal power supply voltage is less than 10V, the voltage alarm indicator lights
up and the alarm starts.
4 . Product composition
4.1 Structure and composition
Biological isolation chamber is mainly composed of negative pressure cabin and exhaust
filtering device. The negative pressure cabin is mainly composed of a movable hatch and a
bilge; the exhaust filter device is mainly composed of a fan, a high-efficiency filter and a
control system that generate a negative pressure. Specifically is as shown in Picture 1:
Picture 1 biological isolation chamber 4b
1-Hatch 2- Bilge 3- Fan 4-Control System 5- High efficiency filter

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4.2 Operation panel
1-Negative pressure in the cabin 2-Battery power 3-Zero button
4-Battery level alarm 5- Inner negative pressure alarm
(1) Negative pressure value in the cabin: used to display the negative pressure value in the
biological isolation chamber in real time;
(2) Battery capacity: used to display the battery capacity of the biological isolation chamber
in real time;
(3) Zero adjustment button: Unplug the negative pressure pipe on the biological isolation
chamber from the cabin, and after receiving the atmospheric pressure test, press the zero
key to calibrate the displayed negative pressure in the cabin;
(4) Battery power alarm: When the battery output voltage on the biological isolation
chamber is lower than 10V, the battery power alarm is activated and the alarm indicator
lights up to indicate that the battery needs to be replaced;
(5) Negative pressure alarm in the cabin: When the negative pressure value in the
biological isolation chamber is lower than 15Pa, the negative pressure alarm in the
cabin is activated and the alarm indicator lights up.

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5.Operation Instruction
5.1.Check before operation
(1) Cabin is not damaged
(2)The zipper is not damaged
(3) Gloves are not broken
(4)Filter looks normal
(5)No foreign objects are blocked or blocked at the air outlet;
(6)Turn on and check that the battery has sufficient power;
(7)Turn on and check that the alarm system is normal.
5.2. Preparation
After the correct assembly, close the cover by pulling the zipper, and open the power switch
of the biological isolation chamber, and it can be used safely after 2min. When the negative
pressure in the cabin is lower than 15Pa, the cause must be found and used.
5.3.Transport
Medical staff in protective clothing first open the zipper between the bottom of the
biological isolation chamber and the cabin. After the cabin was opened, the patient was
placed in the cabin, then close the zipper, the cabin was closed, and the fan was turned on.
Medical personnel can be transported safely or perform other operations after 2 min.
5.4. Medical staff can perform simple operations in the cabin through gloves.
5.5. After arriving at the destination, medical staff should open the closed cabin with
protective clothing and remove the patient.

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Alarm description:
1) The alarm signal is an immediate response to the status of the isolation cabin and reflects
the current status of the isolation cabin.
2) When an alarm occurs, the operator should be in front of the display panel to find and
process the alarm information in time.
3) When turning on the machine, the negative pressure alarm indicator and the battery alarm
indicator light up, accompanied by a periodic alarm sound, indicating the alarm system is
normal.
4)The alarm information of the biological isolation chamber is as follows:：
Alarm category
priority
Indicator light
Sound pressure level
Negative pressure alarm
in the cabin
high priority
Red light
80dB(A)
Battery level alarm
Middle priority
Red light
70 dB(A)
5.6.Product contraindications
There are no known contraindications for this product
6. Maintenance
6.1 Cabin maintenance instructions
only qualified staff for instrument can conduct maintenance work. Need to refer to a
general warning and the first part of the manual and the following safety rules for
instrument maintenance operations.
1). Keep the isolation chamber clean and avoid sharp objects piercing.
2). Clean unit shouldn’t be disassembled, remade and repaired without authorization.
During long-term storage process, every three months should have a maintenance, test
machine 10min with powering on, observe operating conditions, if appear abnormal
conditions, should carry out maintenance timely.
3). HEPA filter should be stored in a cool and dry place to prevent falling, the fallen
HEPA filters should be discarded. HEPA filter is the main safety component of the
isolation chamber, so should be provided by the BIOBASE; if using HEPA filters from

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other suppliers and lead to safety problems, BIOBASE will not in charge of it.
4). If appear abnormal conditions, please stop using it immediately; Please inform our
service department or our agent in your local place.
6.2 Rechargeable battery for safe use and maintenance
1) Check the battery level before use. If the battery level is in the alarm state, please
replace the battery in time.
2)Battery replacement method
a) Open the controller cover, find the battery pack, unplug the battery pack when
confirming the power switch is off, and remove the battery that needs to be replaced;
b) Put the new battery in the battery compartment and plug in the battery pack;
c) Close the back cover of the controller and fasten it with screws.
3) notice: 1. When replacing the battery, only the battery provided by our
company is allowed to be replaced, and the user is strictly forbidden to purchase the
battery replacement at will.
2. The maximum allowable working temperature of the battery is 50 ℃
4)Battery charging
a. When charging the replaced battery, you need to choose a suitable charger. It is
recommended to use a DC12V 2A charger
b. The selected charger needs to meet the requirements of GB9706.1-2007 or equivalent
conversion standards.
6.3 Replacement cycle and method of high-efficiency filter
(1)Replacement cycle
Biological isolation chamber use is related to the external environment and frequency.
Generally, it is recommended to replace it once a year. In the case of frequent use, it is
recommended to replace it once every six months.
(2)Replacement method

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Notice : Before replacing the filter, be sure to disinfect the cabin and the filter.
①After disinfection is completed, open the operation ports near the high-efficiency filter
respectively;
②Put your hand deep into the cabin and rotate it counterclockwise to remove the filter
installation box, and then take it out of the cabin;
③Take the new filter housing and screw it to the corresponding thread of the cabin. After
the installation is completed, check the filter leakage rate to ensure the integrity and
tightness of the filter;
(3) Verification of filter efficiency
The filtration efficiency of the newly replaced and in-use filters can be verified as follows:
Place the negative pressure isolating chamber under normal working conditions, install an
aerosol generator, and introduce aerosol (dioctyl phthalate (DOP) or α-olefin, etc.) into the
negative pressure isolating chamber to ensure efficient air outlets. The light scattering
intensity at the filter is at least equal to the light scattering intensity produced by the 10 μg /
L DOP. Use an aerosol photometer to scan the aerosol leakage rate at the air outlet. The
aerosol leakage rate for the 0.3 μm particle size should not exceed 0.01%.
Note: This validation protocol has not been clinically validated.
6.4 Cleaning and disinfection
(1) Internal disinfection
The Biological Isolation Chamber is suitable for the safe isolation and transfer of infectious
patients. Therefore, after use, the user should wear protective clothing to immediately
perform the disinfection procedure. It is recommended to use vaporized hydrogen peroxide
or peracetic acid fumigation or formaldehyde fumigation for disinfection of Biological
Isolation Chambers for infectious patients, and neutralization and disinfection with
ammonium bicarbonate.

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The specific operation steps of gasified hydrogen peroxide disinfection are as follows:
a. Put the used Biological Isolation Chamber into a relatively small sealed room, fully
stretch it out, and place it on a tile;
b. Open the zipper at the bottom of the cabin and place the installed hydrogen peroxide
sterilizer on the side close to the air inlet in the Biological Isolation Chamber. The spray port
of the hydrogen peroxide sterilizer faces the air outlet. Install the hydrogen peroxide. Close
the bottom zipper of the Biological Isolation Chamber after disinfectant;
c. Extend the power cord of the hydrogen peroxide sterilizer from the operation port at the
air inlet and close the zipper of the operation port;
Note: Be sure to ensure that the zipper of the operation port is closed to prevent the overflow
of hydrogen peroxide vapor and affect the disinfection effect.
d. Turn on the hydrogen peroxide sterilizer and turn on the power switch. Calculate the
amount of hydrogen peroxide sterilizer used according to the volume of the Biological
Isolation Chamber (0.5m3) and set it on the hydrogen peroxide sterilizer.
e. Carefully check that all the zippers of the Biological Isolation Chamber are closed to
make it a closed system, start the hydrogen peroxide sterilizer, and atomize the required
amount of disinfectant;
f. After the sterilizer stops after atomization, let it stand for 90-120 minutes for disinfection
and record the time;
g. Turn on the power supply equipment of the Biological Isolation Chamber for half an hour
after standing still;
h. Close the Biological Isolation Chamber, turn off the power switch of the hydrogen
peroxide sterilizer, unplug the power, and remove the sterilizer from the Biological Isolation
Chamber;
i. Wipe and clean the inner and outer surfaces of the negative pressure isolation chamber
with 75% medical alcohol. Dry the negative pressure isolation chamber naturally and

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complete all disinfection steps.
2. External cleaning
The outside of the negative pressure isolation chamber needs to be cleaned regularly. After
each use, it should be wiped with 75% alcohol to ensure the exterior is clean and tidy.
7. Troubleshooting
Common fault analysis and troubleshooting:
Common
malfunctions
Cause of issue
Solution
Fan does not Work
Power problems
Fan failure
1. Check whether the
connectors and sockets are
connected properly, and check
whether the battery is low.
2. Send it to a professional
repair station for repair.
Negative pressure
cannot reach 15Pa
1.Leave a gap in the zipper
2.The fixing kit of the
high-efficiency filter is loose
3.The exhaust interface
connection is loose
4.The compartment is pierced
1. Close the sealed zipper
completely.
2. Tighten with the nut on the
fixing kit.
3. Tighten the exhaust port.
4. Send to a professional repair
station for repair.

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(1) The operation of the above electrical components must be performed by a qualified
electrician under safe conditions (cut off the power). The other parts are not allowed to be
disassembled, otherwise the consequences will be borne by the user;
(2) When the equipment fails other than the above, and the operator can not remove it
immediately, please notify our company's maintenance department immediately. For your
safety, please do not repair the equipment by yourself;
(3) The maintenance work of the Biological Isolation Chamber shall only be undertaken by
trained and approved technicians;
(4) If you need to order parts, you can find our technical service department, please indicate
the model and number you purchased.
8.Transportation
Negative pressure isolation cabins are stored in warehouses with relative humidity not
exceeding 75%, temperature range between 10 ° C and 40 °C, good ventilation, and no
corrosive gases such as acids and alkalis. The storage period must not exceed one year. After
more than one year, unpacking inspection is required. After passing the unpacking
inspection, it can enter the circulation field.
9. Notes
1. When connecting the pipeline of the negative pressure device, the screw of each port of
the high-efficiency filter must be tightened.
2. Before each use, the pressure must be tested according to the prescribed method. The
negative pressure device is turned on for 2 minutes, and the cause is found when the
negative pressure in the cabin is lower than 15Pa.
3. It is strictly forbidden to touch sharp objects during use to prevent the cabin from being
punctured.
4. It should not be used close to or stacked with other equipment. If it must be used close to
or stacked, it should be observed to verify that it can operate normally in its used

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configuration.
5. Discarded batteries or cabins must be disposed of as medical waste in accordance with
local regulations.
10. Label
10.1 Company Logo
Figure 3 Company logo
10.2 Protection against electric shock
Figure 4 Degree of protection against electric shock Type B
10.3 Power Type
Figure 5 DC power supply
10.4 Warning symbols
Figure 6 Warning symbol

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11. Electromagnetic compatibility
11.1 The negative pressure isolating compartment complies with the requirements of
YY0505-2012.
11.2 It is recommended that the device evaluate the electromagnetic environment before use.
It is forbidden to use a negative pressure isolation compartment near strong radiation
sources (such as unshielded RF sources), otherwise it may interfere with the normal
operation of the equipment.
11.3 Caution: Except for transducers and cables sold by the manufacturer of the
Biological Isolation Chamber as spare parts for internal components, the use of
unspecified accessories, transducers and cables may lead to increased emissions or
immunity of the Biological Isolation Chamber The reduction.
11.4 Warning: The negative pressure isolation compartment should not be used in
close proximity to or stacked with other equipment. If it must be used close to or
stacked, it should be observed to verify that it can operate normally in the
configuration in which it is used.
11.5 Basic performance of electromagnetic compatibility:
(1) A negative pressure of not less than 15Pa should be established in the negative pressure
isolation compartment within 2 minutes of starting up;
(2) The ventilation volume of the negative pressure isolation tank is not to be less than 50 L
/ min.

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11.6 Cable name: battery charging cable, length: 70cm, unshielded cable.
Guide and manufacturer's declaration-electromagnetic emissions
The Biological Isolation Chamber is expected to be used in the electromagnetic environment
specified below, and the purchaser or user should ensure that it is used in this electromagnetic
environment:
Launch test
Compliance
Electromagnetic Environment--Guide
Radio frequency
emission
GB4824
1 Group
Biological Isolation Chamber use radio frequency
energy only for their internal functions. Therefore, its
RF emissions are very low and there is little chance
of causing interference to nearby electronic
equipment
Radio frequency
emission
GB4824
A Type
Biological Isolation Chamber are suitable for use in
all facilities that are not domestic and are not directly
connected to the public low-voltage power supply
network of domestic residences.
Harmonic
emission
GB17625.1
Not applicable
Voltage
fluctuation /
flicker emission
GB17625.2
Not applicable

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Guidance and manufacturer's declaration-electromagnetic immunity
The Biological Isolation Chamber is expected to be used in the electromagnetic environment
specified below, and the purchaser or user should ensure that it is used in this electromagnetic
environment:
Immunity test
IEC60601 test level
Coincidence level
Electromagnetic
Environment-Guide
Electrostatic
discharge
GB/T 17626.2
± 6kV contact
discharge
±8kV Air discharge
± 6kV contact
discharge
±8kV Air discharge
The floor should be wood,
concrete or tile, and if the
floor is covered with
synthetic material, the
relative humidity should be at
least 30%
Electrical fast
transient burst
GB / T 17626.4
± 2kV to power line
± 1kV to input /
output line
± 2kV to power line
Grid power should be of the
quality used in a typical
commercial or hospital
environment
surge
GB/T 17626.5
± 1kV wire-to-wire
± 2kV line to
ground
± 1kV wire-to-wire
Not applicable
Grid power should be of the
quality used in a typical
commercial or hospital
environment

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Voltage sags,
short
interruptions,
and voltage
changes on
power input lines
GB/T 17626.11
<5% UT for 0.5
cycles
(On UT,> 95%
dips)
40% UT for 0.5
cycles
(60% sag on UT)
70% UT for 0.5
cycles
(30% sag on UT)
<5% UT for 5s
(On UT,> 95%
dips)
<5% UT for 0.5
cycles
(On UT,> 95% dips)
40% UT for 0.5
cycles
(60% sag on UT)
70% UT for 0.5
cycles
(30% sag on UT)
<5% UT for 5s
(On UT,> 95% dips)
Grid power should be of the
quality used in a typical
commercial or hospital
environment. The user of the
negative pressure isolation
compartment needs
continuous operation during
power interruption, so it is
recommended that the
negative pressure isolation
compartment be powered by
an uninterruptible power
supply or battery.
Power frequency
magnetic field
（50Hz）
GB/T 17626.8
3A/m
3A/m
Power frequency magnetic
field should have power
frequency magnetic field
level characteristics in a
typical place in a typical
commercial or hospital
environment
Note: UTrefers to the AC network voltage before the test voltage is applied.

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Guidance and manufacturer's declaration-electromagnetic immunity
The Biological Isolation Chamber is expected to be used in the electromagnetic environment
specified below, and the purchaser or user should ensure that it is used in this electromagnetic
environment:
Immunity test
IEC60601 Test
level
Coincidenc
e level
Electromagnetic Environment-Guide
Radio frequency
conduction
GB / T 17626.6
Radio frequency
radiation
GB/T 17626.3
3V(Valid
value)
150kHz～
80MHz
3V/m
80MHz～
2.5GHz
3V(Valid
value)
3V/m
Portable and mobile RF communications
equipment should not be used closer to any
part of the negative pressure compartment
than the recommended isolation distance,
including cables. This distance should be
calculated from the formula with the
frequency response of the transmitter.
Recommended isolation distance
d=1.2√P
d=1.2√P 80MHz～800MHz
d=2.3√P 800MHz～2.5GHz
In the formula:
P—based on the transmitter's maximum
rated output power provided by the
transmitter manufacturer, in watts (W);
d—Recommended isolation distance in
meters (m).
The field strength of the fixed RF transmitter
is determined by surveying the