Pure line M6000 User manual

OXYGEN CONCENTRATORS
M6000 & M6100
Operators Manual
For Veterinary Use Only
Model M6000
*Shown with optional vaporizer
Model M6100
*Shown with optional vaporizer
©
Scivena Scientic , LLC Copyright 2021

Examination and Preparation for Use
Thank you for ordering an Scivena Scientic anesthesia machine!
We are delighted to have you as a Scivena Scientic customer and want you to
be completely satised with your purchase. Please inspect the contents of your
order to see if everything is as you expected. Should anything not be exactly right
or if anything was damaged in shipping, please contact your sales representative
right away for help.
Our goal is to make your new anesthesia machine as easy to use and care for as
possible.
This device is meant to be operated under the normal supervision and control of a
veterinarian trained in its use. However, you need to know more about this device
than just how to operate it.
Please read this manual in its entirety before using the anesthesia
machine.
If you have any comments or questions, we welcome the opportunity to address
them.
Please contact us directly at 877–615-5632.
Thank you!
Brian Lawson
President,
Scivena Scientic
Proudly Designed and
Made In Oregon, USA

TABLE OF CONTENTS
Machine Assembly
Attaching the top assembly to frame
Attaching the oxygen concentrator
Connecting the supply hose
Oxygen Concentrator Features
Operation Instructions
Maintenance
Features & Accessories
Safety Pop O󰀨 Valve
Rebreathing circuits
Non-rebreathing circuits
I.V. Pole
Optional Items
Waste gas evacuation
Universal control arm for Bain circuits
Technical Information
Maintenance
Warranty /Return
Machine & Service notes

Machine Assembly
3. Assemble the top assembly with the frame by installing the two 1/4-20
X 1 3/4” long screws and washers provided.
4. Tighten both screws with the 3/16” allen wrench provided VERY tightly.
* NOTE: THIS REQUIRES TWO PEOPLE TO SAFELY ASSEM-
BLE *
1. Carefully unpack the top assembly and
frame from the box
2. Align the top to the frame as shown.
NOTE: The frames base has two cross
bars with holes in them for mounting
the concentrator. That is the front of the
frame.

1. Remove the oxygen concentrator from the box and guide the four threaded post
into the frame
2. Install and tighten the nuts.
* DO NOT OVER TIGHTEN THE NUTS, SNUG FIT IS ALL THAT IS NEEDED *

1. Attach the green hose to
the threaded tting.
* DO NOT OVER TIGHTEN *

Model M6100 non-rebreathing anesthesia machine
Includes a stainless steel storage tray and 3/8” post bulkheads for
mounting accessories (i.e. I.V. poles, multi-port manifolds, etc)

USER'S GUIDE
OC4000
OXYGEN CONCENTRATOR
FOR VETERINARY USE
ONLY
: ON (power switched on)
: OFF (power switched o󰀨)
: Class II protection
: Do not expose to open ames
: Do not use oil or grease
: Technical information
: Consult the accompanying documents
: Keep in the vertical position
: Fragile - handle with care
: Oxygen concentration warning light
GLOSSARY OF SYMBOLS
I
O
OXYGEN CONCENTRATORS

.
The WARNINGS below indicate a potential
hazardous situation. If conditions are not
avoided a situation could occur that results
in serious injury or death.
• Oxygen is not a ammable gas, but
it accelerates the combustion of
materials. Do not use in explosive
atmosphere. To avoid risk of re and
explosion the concentrator should be
kept away from Flames, Heat sources,
Incandescent sources, Smoking
Materials, Matches, Oil, Grease,
Solvents, Aerosols, etc.
• Use of other accessories not
described in this User's Guide are not
recommended.
•
• No modication to the equipment is
allowed.
• Device must have power to operate.
In the event of power loss and for
continued operation a backup source
is recommended.
• DO NOT disassemble due to danger
of electrical shock. Refer servicing to
qualied service personnel.
GENERAL SAFETY GUIDELINES
Only persons who have read and understood this entire manual
should be allowed to operate the O2 concentrator
The CAUTIONS below indicate a potentially
hazardous situation. If conditions are not
avoided a situation could occur that results
in property damage or minor injury or both.
• Use the power cord provided, and
check that the electrical characteristics
of the power socket used match those
indicated on the manufacturer’s plate
on the rear panel of the device.
• We recommend against the use of
extension cords and adapters, as they
are potential sources of sparks and re.
• The concentrator has an audible alarm
to warn the user of problems. In order
that the alarm may be heard, the maxi-
mum distance that the user can move
away from it must be determined to suit
the surrounding noise level.
• Do not use in a specically magnetic
environment (MRI, X-ray, etc.). May
cause device malfunction.
• This unit may be equipped with a
polarized plug. That is one blade wider
than the other. If it does not t into the
outlet, reverse the plug. If it still does
not t, contact a qualied electrician.
Do not defeat this safety feature.

CONFORMITY WITH IEC60601-1 (2nd
Edition)
"The manufacturer, assembler, installer
or distributor are not considered to
be responsible themselves for the
consequences on the safety, reliability and
characteristics of a device unless the:
• Assembly, fitting, extensions,
adjustments, modications or repairs
have been performed by persons
authorized by the party in question.
• Electrical installation of the
corresponding premises complies with
local electrical codes. (e.g. IEC / NEC).
• Device is used in accordance with the
instructions for use.
If the replacement parts used for the periodic
servicing by an approved technician do not
comply with the manufacturer’s specica-
tions, the manufacturer is not responsible
in the event of an accident.
1. UNPACKING and PACKAGING
The Oxygen Concentrator is packaged
to protect the device from damage while
being transported and stored. Check for
damage to the packaging. After device
is removed from the package inspect for
damage. If damage is detected please
contact your equipment provider. Operat-
ing environmental condition guidelines
are discussed later in another section of
this User's Guide.
1.1 METHOD FOR WASTE DISPOSAL
All waste from the device (Patient Circut,
Filters, Etc.) must be disposed of using
methods appropriate to the civil authority
of the location where disposed.
2.0 METHOD FOR DISPOSING OF
DEVICE
This device has been supplied by an envi-
ronmentally aware manufacturer. A majority
of the parts in the device are recyclable.
Follow local governing ordinances and recy-
cling plans regarding disposal of the device
or components normally used in operation.
Any accessories not original to the device
must be disposed of in accordance with
the individual product markings for disposal.

2.1. Front panel (Fig. 2.1)
1 - I/O (ON/OFF) switch
2 - Indicator lights
3 - Oxygen product outlet
4 - Circuit breaker
5 - Pre-set ow meter (non-adjustable)

3.1 Turning on device
a. Plug the power cable into a power outlet
(Fig. 3.3) of the correct voltage and frequency
as dened on the manufacturer's technical
label (Fig 2.2).
b. Press the power switch (I/O) (item 1 in
Fig.2.1) to the ON position (I). The green
indicator light ashes until concentration is
achieved.
IMPORTAINT!
TURN THE ANESTHESIA MACHINES
OXYGEN FLOW METER ON TO A
MINUMUM FLOW RATE OF 0.25 LPM
A “NO FLOW” ALARM MAY SOUND IF
THE FLOW METER ISN’T OPEN
3.2 Turning o󰀨 device
At the end of the usage, press the I/OSwitch
to place it in the O(OFF) position to stop the
device. The oxygen enriched air ow contin-
ues for approximately one minute after the
device is stopped.
1. Filter / Silencer
2. Cabinet lter
3. Ventilation grill
Note: Shown with grate removed
Fig. 4.1
4. CLEANING - MAINTENANCE
Only the outside of the concentrator is to
be cleaned. Use a damp sponge or cloth
with water only.
Acetone, solvents or any other inammable
products must not be used.
Do not use abrasive powders.
FILTERS - IMPORTAINT!
Fine Filter (#1 g. 4.1)
and Cabinet Filter Cleaning (#2)
The cabinet lter (#2 Fig.4.1) must be
cleaned in warm water and household
detergent weekly or after approximately
100 hours of use. Dry before reinstalling.
More frequent cleaning is recommended
in dusty environments.
Cabinet lter: p/n OC4000-1
The ne intake lter should be replaced
annually or every 2000 hours of use. More
frequently dusty /dirty environments.
Fine lter p/n OC4000-2

4.3. Maintenance
NO INTERNAL MAINTENANCE
IS REQUIRED OR SHOULD BE
PERFORMED.
OPENING THE CASE WILL
VOID THE WARRANTY.
5. USEFUL INFORMATION
5.1. Accessories and spare parts
The accessories used with the O2 concen-
trator must:
• be oxygen compatible.
• be biocompatible.
The connectors, tubes must be designed for
oxygen usage.
5.2. Materials in direct or indirect contact
with the product output
Concentrator casing ................................ABS
Power Cord ........................................... PVC
Cabinet Air Filter ..............................Polyester
I/0 (On/O󰀨) switch................................Nylon
Casters..................................................Nylon
Oxygen product outlet ...................Aluminum
Printed labels...........................Polycarbonate
Pipe/Tubing..........................Aluminium,PVC,
polyurethane or silicone
5.3. Operating principle
The compressor sends ltered room air to a
solenoid valve, which allows compressed air to
pass to the column in production. The columns
contain a molecular sieve, whose function is
to adsorb the nitrogen and thus allow oxygen
to pass. The oxygen enriched product is then
directed through a pressure reducing valve
continuing to the oxygen product outlet tting.
During this time, the column which is being
"regenerated" is connected to the ambient air
and ow of oxygen enriched product is passed
through it (from the column "in production").
In this way, when one column is in produc-
tion, the other is in a nitrogen desorption or
"regeneration" phase. The oxygen enriched
product nally passes through a nal product
lter located prior to the oxygen outlet tting.
5.4. Alarms - Safety devices - Indications
5.4.1. Alarms
• No voltage detection
In the event of a loss of mains power, an in-
termittent audible alarm is activated and the
green light turns o󰀨. Test alarm by actuating
the I/O (ON/OFF) switch when the power cord
is not plugged into the wall outlet.

• Process fault
In the case of a process fault, a visible and
audible alarm is activated (continuous red
light or lighted alarm and audible alarm).
• Oxygen Concentration
If the oxygen concentration level falls below
the required range the red light comes on and
the green light goes out. After a 15 minute
delay the audible alarm will sound.
5.4.2. Safety devices
• Compressor motor
Thermal safety is ensured by a thermal switch
situated in the motor winding (145 ± 5 oC).
• Electrical protection
A 5 amp circuit breaker is incorporated into
the front cabinet of all models.
Class II devices with insulated casings
(EN60601-1 standard)
• Safety valve
This is tted on the compressor outlet and
is calibrated to 2.7 bar (40 psig).
5.4.3 Indicators
• The green indicator light (Fig.5.1) indi-
cates that power is applied to the device.
When rst turned on the indicator will
ash until correct oxygen concentration
is achieved. At that time the green
indicator will remain illuminated and
the device is ready to provide oxygen
enriched air to the patient.
5.4.3 Indicators (continued)
• The red indicator warns of a process
fault. One event that can cause the
red indicator to be illuminated is low
oxygen concentration. The low oxy-
gen concentration red indicator will
light when oxygen concentration falls
below a predetermined set point.
Another event that will cause the red
indicator to light is a blocked oxygen
ow. In this case the green indicator
and red indicator will be illuminated
simultaneously.

5. 5. OCSI (oxygen concentration status
indication module) function
5.5.1. Operating principle
The oxygen monitor (Item 2 Fig 2.1) is an
electronic module capable of checking the
e󰀨ective oxygen concentration supplied by
the concentrator.
The oxygen monitor measures the con-
centration and activates an audible and
visual alarm if it falls below the alarm set
point percentage.
(Refer to Section 5.4 for information on the
operation of the indicators and alarms for
the OCSI function)
to the output of the device. The maximum
outlet pressure is 50 kPa (7 psig).
5.5.4 Maintenance of the Device Alarms
No special maintenance is required. The
alarm set-point is factory set and the setting
cannot be adjusted. All models are set at 84%.
The equipment supplier veries that the
device is still operating correctly when the
routine checks are performed.
5.6. Technical characteristics
Dimensions:
LxWxH: 36 x 23 x 58.5 cm (14 x 9 x 23 in.)
Caster diameter: 3.8 cm (1.5 in.).
Weight: 14.5 kg. (32 lbs) varies by model.
Noise level conforms to ISO 8359 Standards.
Oxygen Concentration - USP93%
• at 2 l/min: >90%.
• at 5 l/min: 90%. (+6.5%/-3%)
(Values at 21oC and at one atmosphere
pressure).
Maximum ow: 5 lpm.
The variation of the maximum ow does not
exceed ± 10 % of the indicated value when
a back pressure of 7 kPa (1 psig) is applied
(Fig. 5.1)
Red Indicator Green Indicator

PREVENTIVE MAINTENANCE
a. Wash cabinet lter weekly.
b. Replace lter every 2000 hours or more often depending on environment.
c. Check oxygen concentration every 15,000 hours or 3 years of operation to verify the
continuing OCSI function.
Use original parts only
Contact us directly for additiional information
Electrical power supply:
Rating: 115/230V 60Hz 230V 50Hz
Average Power: 330W(avg) 300 W(avg)
Protection Class: Class II Class II
Mains Protection: 5A 5A
Filters:
At the rear of the device: a cabinet air lter.
At the compressor input: an inlet air lter, 5 µm, located behind
the cabinet air lter.
Air circulation
A tubeaxial fan cools the compressor compartment.
Environmental limit conditions
The performances of the device (especially the oxygen concentra-
tion) are quoted at 21oC (70oF) and one atmosphere. They may
change with temperature and altitude.
• The device must be stored, transported and used in the vertical
position only.
• Ambient temperature of between 5oC and 40oC (40oF to 104oF)
operation.
• Storage temperature from -20oC to 60oC (-4oF to 140oF).
• Relative humidity of between 15% and 95% operation and
storage, both non-condensing.
• Altitude(21oC): Up to 2,286m (7,500ft) without degradation;
Consult your equipment provider for further information
regarding 2,286m to 4000m (7500 to 13000 ft)
• Complies with EN60601-1 standard; spilling a glass of water.
5.7. Standards
EN 60601-1[UL60601-1:2003],
CAN/CSA-C22.2 No.601.1-M90 w/A1&A2:
Electrical Safety- Medical Devices.
EN60601-1-2:2001
Electromagnetic Compatibility

5.8. Troubleshooting.
Solutions
Check the cable connection.
Check the circuit breaker (5)
on the front of the unit; Reset if
necessary.
Contact your equipment supplier.
Backup capacitor has discharged
operate unit for approximately 10
minutes and retest
Contact your equipment supplier.
Contact your equipment supplier.
Stop the device by pressing the
I/O (ON/OFF) button and contact
your equipment supplier.
Stop the device and contact your
equipment supplier.
Clean cabinet lter. Restart.
Clear blockage. Restart
Reset circuit breaker. If the de-
vice does not start, contact your
equipment supplier.
Power cord is not correctly
plugged into the wall outlet.
Power failure.
Oxygen concentration is too
low.
Capacitor is not charged
Internal electrical fault.
Faulty indicator.
Pneumatic connection broken
or other pressure problem.
Internal electrical fault.
Pneumatic circuit fault.
Dirty Filters, blockage
Fan is not working.
Observations
The I/O (ON/OFF) button is in the "I"
(ON) position but the device does
not operate.
The audible alarm sounds intermit-
tently.
Red light remains lighted.
The alarm test does not work.
See 5.4.1.
The compressor operates and the
I/O (ON/OFF) button is in the "I"
(ON) position but the green indica-
tor is not lighted.
The I/O (ON/OFF) button is in the
"I" (ON) position but there is no
ow. The audible alarm sounds
continuously.
The I/O (ON/OFF) button is in the
"I" (ON) position, the compres-
sor is operating and there is a
ow but the audible alarm sounds
continuously.
The compressor stops in mid-
cycle, then starts again after a few
minutes.
Maintenance Items
Cabinet Air Filter: Ref: OC4000-1; Wash weekly; Replace as needed.
Inlet Air Filter: Ref: OC4000-2; Replace minimum every 2000 hours
(depending on environment)
Possible Causes

Anesthesia Machine Operation
&
Optional Accessories

Safety Pop O󰀨 Valve
Manual Ventilation
Screw-down pop-o󰀨 valve open with push-button valve de-
pressed.
In this position the breathing circuit is closed but will leak at
pressures of 20-25 cm H2O. This allows enough pressure to
manually ventilate the patient without risking excessive pressure
(which can cause pulmonary damage and death).
User Error Safety (pop o󰀨 valve left closed)
Screw-down pop-o󰀨 valve closed with push-button valve open
In this position the breathing circuit is partially closed but will
leak at 0.5 cm H2O. This will not cause injury to the patient,
however depressing the push-button valve to ventilate the
patient would allow excessive pressure and could injure the
patient.
This setting is designed to prevent patient deaths associated
with leaving the pop-o󰀨 valve closed but it is not recommended
for normal operation.
Normal Operation
Screw-down pop-o󰀨 valve open with push-button valve up
In this position the breathing circuit is fully open. The manom-
eter should read "0" with slight uctuations during respiration.
Squeezing the rebreathing bag should not create pressure in the
breathing circuit.