Gima PC-900B User manual

Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]
www.gimaitaly.com
PROFESSIONAL MEDICAL PRODUCTS
PC-900B CAPNOGRAPH AND
OXIMETER
User Manual
M33698-GB-Rev.2-11.23
PC-900B (Gima 33698)
Shenzhen Creative Industry Co., Ltd.
Floor 5, BLD 9, BaiWangxin High-Tech Industrial Park,
Songbai Road, Xili Street, Nanshan District,
518110 Shenzhen, P.R. China
Made in China
Shanghai International Holding Corp. GmbH (Europe)
Eiffestrasse 80, 20537 Hamburg, Germany
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[email protected]om - [e-mail]
www.gimaitaly.com

I
Notice
Thanks for buying PC -900B Capnograph and Oximeter.
This manual is copyright reserved. It is prohibited to copy, duplicate or translate
into other languages without our written permission.
Please read this manual carefully and then follow its instructions when
operating this monitor.
It is not permitted to open the monitor’s main cover, modify or disassemble it
without our permission or official service training.
The buyer will not be advised of technology updates which do not influence the
monitor’s key functionality. Furthermore, please pay attention to the difference
between the parts or components provided as information in this manual.
Shenzhen Creative Industry Co., Ltd.
Floor 5, BLD 9, Baiwangxin High-Tech Industrial Park,
Songbai Road, Xili Street, Nanshan District,
518110, Shenzhen, China

II
CONTENTS
1 Preface.............................................................................................................1
1.1 Brief...............................................................................................................1
1.2 Warranty and Maintenance........................................................................ 1
1.3 Safety Requirements...................................................................................2
2 Technical specifications and characteristics...................................................3
3 Introduction of Monitor .................................................................................6
4 Patient connection..........................................................................................8
4.1 CO2 and Respiration rate measurement.....................................................8
4.2 CO2 Measure principle..............................................................................10
4.3 Oximeter density measurement (optional).............................................11
4.4 Notice.........................................................................................................12
5 Screen display and Operation......................................................................15
5.1. Screen main display menu.......................................................................15
5.2 Initial Monitoring Screen...........................................................................17
5.3 The Main Menu.........................................................................................18
5.4 CO2 SET Menu............................................................................................19
5.5 SpO2 SET Menu..........................................................................................21
5.6. TIME SET Menu.........................................................................................22
5.7. Sound SET Menu.......................................................................................24
5.8. Trend..........................................................................................................24
5.9. NEW PATIENT Menu.................................................................................27
6 Charging, Maintenance, Cleaning................................................................29
6.1 Charging......................................................................................................29
6.2 Maintenance..............................................................................................29
6.3 Cleaning......................................................................................................30
7 Trouble Shooting Analysis.............................................................................32
Appendix 1. Explanations of Terms in this Manual........................................34
Appendix 2. Changing compensation of balance gas....................................35
Appendix 3. Calibration of EtCO2 Accuracy....................................................37
Appendix 4. Part Numbers and Consumables listing.....................................41
Appendix 5. Guidance and manufacturer’s declaration -Electromagnetic
compatibility.....................................................................................................43

Page 1 of 50
1 Preface
1.1 Brief
The purpose of this manual is to provide the user with a brief understanding of
the characteristics, functions and operation of the monitor thereby preventing
incorrect operation and user error.
This monitor can measure four physical patient/animal parameters at the same
time: concentration of EtCO2, respiration rate, heart pulse rate and saturation of
SpO2 (optional). The monitor you bought may have two or more functions
mentioned above but this manual can be used in common for the applicable
functions.
1.2 Warranty and Maintenance
Warranty
This monitor has a warranty of 12 months from the date of purchase. Reusable
SpO2 sensors and the battery included have a 12 month warranty. All other
accessories have a warranty of 3 months or an “out of box” warranty for
disposable items.
The following will invalidate the warranty:
•if the monitor is damaged due to misuse or incorrect operation (i.e.
without following the user manual instruction)
•the monitor is damaged due to incorrect connection with another
instrument
•the monitor is accidently damaged or dropped
•if the user modifies or changes the monitor without written authority of
the company
•if the serial number is deliberately damaged, torn off or unreadable.
Maintenance
If the monitor is non-functional outside of the warranty period, the
manufacturer or distributor will offer an estimate for repair. The maintenance,
repair or calibration would be carried out at local distributor, unless detailed in a

Page 2 of 50
specific written agreement.
Re-packing for Repair or Calibration
It is recommended to use the original packing boxes and packing materials when
returning for repair or maintenance.
1.3 Safety Requirements
For the purposes of safety, please read the following and abide by these
instructions for medical instrumental products.
Warning: Indicating the possible injury on patient or operator.
•This monitor is not MRI compatible and is not suitable for use within the
magnetic field during the operation of MRI or CT. However, the sample
lines supplied alongside the unit by the distributor are MRI compatible
and may be extended into the MR or CT field. In this case, the monitor
must remain outside of the room.
•The use of accessories and cable other than those specified, with the
exception of cables sold by the manufacturer of the device as
replacement parts for internal component, may result in increased
emissions or decreased accuracy of the device.
•Only use manufacturer designated accessories to ensure compliance with
appropriate standards
•It is not allowed to remove the cover of the monitor.
•This monitor provides concentration of EtCO2, respiration rate, oxygen
saturation and pulse rate. This data only provides assistance for diagnosis
and actual diagnosis shall be made by suitably qualified clinical staff using
all the clinical information and symptoms.
•In order to prevent pressure sores and correct circulation the SpO2 sensor
must be repositioned regularly, depending on the type of sensor used.

Page 3 of 50
2 Technical specifications and characteristics
Intended Use
The Capnograph and Oximeter is designed for monitoring the vital physiological
signs of the patient. It is used for non-invasive continuous monitoring of oxygen
saturation (SpO2), pulse rate, CO2 and respiration rate.
The Capnograph and Oximeter is intended for use in adults, pediatrics and infants
in a hospital environment. It is intended to be used only under regular supervision
of clinical personnel.
EtCO2
Sampling Mode: Sidestream
Method: Non-dispersive Infrared Spectroscopy
Range: 0 – 150mmHg or 0 – 20kPa or 0 – 20% (v/v)
Accuracy: ±2mmHg for EtCO2 range 0 - 40mmHg
±5% for EtCO2 range from 41 - 70mmHg
±8% for EtCO2 range from 71 - 100mmHg
±10% Over 100mmHg
Note: The accuracy of CO2 concentration measurement is influenced by any
interfering gas and/or vapour, for example N2O gas can raise the CO2 reading (2-
10%), and Helium and O2 can reduce the CO2 reading (1-10%), so compensation
should be set in the balance gas MENU to meet the accuracy requirements if such
gases or vapours are present.
Update/Averaging Time: Option of every breath or 10, 20 or 30 seconds
Warm Up Time: <20 seconds
Sample Flow Rate: 50–250ml/min User Adjustable. Default=100ml/min
Memory: 24 hours on Screen Trend and Numeric
Sensor: <25g Single Use Gas Sample Line and Adaptor for Intubated
and /or Non Intubated Patients
Respiration Rate
Range: 3 - 150 breaths/minute
Accuracy: ±1% of reading or ±1 breaths/min whichever is greater

Page 4 of 50
Memory: 24 hours on Screen Trend and Numeric
SpO2 (optional)
Transducer: Dual-wavelength LED
Range: 0 - 100%
Accuracy: ±2% for SpO2 range from 70 - 100%,
±3% for SpO2 range from 50 - 69%
Memory: 24 hours on Screen Trend and Numeric
Patient Modes: Adult and Pediatric
Pulse Rate (optional)
Range: 30 – 250bpm
Accuracy: ±2% for PR range from 30 - 250bpm
Memory: 24 hours on Screen Trend and Numeric
Power
AC Input: 100V - 250V, 50Hz/60 Hz to 5VDC Adapter with
5V mini USB adapter Cable.
Optional Vehicle 12V to 5V Mini USB Charger Lead.
Battery
Type: Built-in rechargeable lithium battery pack ,(3.6V, 3000mAH)
Charging Time: 4 hours from flat
Operating Time: 10 hours on full charge
Operating Conditions
Temperature: +5 to +50oC
Humidity: < 93% % (non-condensing) = < 29.45 hPa
Atmospheric pressure: 70 - 120 kPa
Storage Conditions
Temperature: -30to +70oC
Relative Humidity: <93% (non-condensing)
Atmospheric pressure: 50 - 120 kPa

Page 5 of 50
Dimensions of Monitor
Size: 70 x 160 x 40mm (W x H x D)
Weight: Monitor 380g,Weight on Airway ETT/LMA <25g.
Warranty & Maintenance/ Calibration
One year warranty on main unit and lithium ion rechargeable battery
Auto self-zeroing calibration, annual calibration check recommended
IP rating
IP32 when used in specified carry case.
CE & Product classification
As per IEC 60601- 1/ CSA601.1/UL2601-1
Type of Protection
Class II (When used with UK/EU Power Supplies)
Degree of Protection: Type BF-Applied Part
Mode of Operation: Continuous
Electro-Magnetic Compatibility: Group I, Class A
93/42/EEC Medical Device Directive Compliant
EC-Representative:
Shanghai International Holding Corp. Gmbh (Europe)
Eiffestraβe 80, 20537 Hamburg Germany
CE 0123

Page 6 of 50
3 Introduction of Monitor
Figure 3.1
(1) Screen: Displays waves, menu, alarm and all measuring parameters.
(2) /▲: Function button:
▲ a) When menu (except the TREND menu) is activated, press this button to move the
cursor.
b) When the TREND menu is activated, this button changes between the trend graph
and data table
On the main display, to press this button to silence alarms for 2 minutes.
(3) ▼: Press this button to move the cursor when menu is activated.
(4) +: Multifunction button.
a) Press this button to increase figures on the menu.

Page 7 of 50
b) In themaindisplay screen,pressthisbuttonto freezethedisplaywaveform(if
frozen, thedatawhichprintswill bethatshownonthescreen).
(5) -: Press this button to decrease figures.
(6) ENTER: Confirmation button;
a) Press this button to “Confirm” on the menu.
b) In the main menu, press this button restart the pump if it has automatically switched
OFF.
c) If the device is connecting with Bluetooth printer, press this button for 2 seconds to
print capnography and other result parameters (EtCO2, RR, SpO2, PR).
(7) Press this button to enter or quit menu or change display
(8) Power button: hold for >2 seconds to activate
(9) Indicator POWER: Blue LED is lit when the Monitor is either switched ON or
subject to external power when not switched ON.
If the yellow LED is lit, the internal battery is being charged.
(10) CO2: The faucet of filter, blue color indicator flashes if the filter is off. When
the filter is plugged in, the indicator color will change to blue, and it will change
to red during occlusion or pump err.
(11) SpO2: The socket of SpO2 (optional).
(12) DC5V Mini USB Charging interface. Note: this interface must only be
connected to a device which meets safety standards.
(13) Exhaust outlet: Do not occlude.
(14) Speaker location
(15) Battery Compartment with clip on Battery Door
(16) Hanging Point for Lanyard if required.

Page 8 of 50
4 Patient connection
4.1 CO2and Respiration rate measurement
Push in and twist 45° clockwise to connect the Filter/Water Trap to the
Connector on the top of the Monitor. Attach the selected Gas Sampling Line to
the CO2 filter/Water Trap Female Luer Connector (Use a Male to Male Luer
adapter if necessary) and then select a sampling point as close as possible to
either the Animal or the Ventilator Breathing Circuit.
Figure 4.1
WARNING ：
Do not use the Monitor if the filter/water trap is not installed to avoid
contamination and damage to the IR measurement cell.
In order to avoid vapor and respiratory mucus entering into the IR Cell, the
machine must be used with the Filter/Water Trap .

Page 9 of 50
Figure 4.2
Instruction for use of the Filter/Water Trap
1.)Insert the convex cleat of Filter/water Trap into the notch of the inlet port
of device and turn 45°clockwise.2.)Attach male luer lock sample line
connector to Filter/Water Trap (Use a Male to Male Luer adapter if the
sample line has Female Luer connector)
3.) Connect the other end of the Sample line to the chosen sampling point of
Animal or Ventilator Circuit.4.) Change the Filter/Water Trap as needed. If the
Filter/Water Trap becomes dirty or the occlusion alarm is activated when it is
dry then the Filer/Water Trap must be replaced.
WARNING ：
Ensure that connections are air tight as if there is leakage, measured values are
likely to be inaccurate.
WARNING ：
Use only recommended original bespoke Filter Water Trap to ensure accuracy.

Page 10 of 50
4.2 CO2 Measureprinciple
1. Theory introduction
The device working theory is NON-DISPERSIVE INFRA GAS ANALYZER. The
device has an AUTO ZERO ADJUSTMENT SYSTEM and GAIN CONTROL
The principle is based on the fact that CO2 molecules absorb infrared light
energy of specific wavelengths, with the amount of energy absorbed being
directly related to the CO2 concentration. When an IR light beam is passed
through a gas sample containing CO2, the electronic signal from an infrared
sensor(which measures the remaining light energy), can be obtained. This
signal is then compared to the energy of the IR source, and calibrated to
accurately reflect CO2 concentration in the sample. To calibrated, the infrared
sensor’s response to a known concentration of CO2 is stored in the monitor’s
memory.
Further, on the passage of the sample gas with a three-way valve, with the
change of temperature and time, the valve leading to the pure air will take 3-4
seconds in order to adjust the zero point.
In addition, the circuit module has the atmospheres absolute pressure sensors
and the flow measurement and control of pressure sensor. Modules can
measure atmospheric pressure, and atmospheric can compensate the
calculation for the concentrations of carbon dioxide which improve the design
accuracy.
Then the monitor (CO2 module) determines CO2 concentration in the breathing
gases by measuring the amount of light absorbed by these gases.EtCO2 is
display as a numerical value in millimeters of mercury (mmHg), percent (%), or
kilopascals (kPa). In addition, a CO2 waveform (capnogram) may be displayed
which is a valuable clinical tool that can be used to assess patient airway
integrity and proper endotracheal tube placement. Respiration rate is
calculated by measuring the time interval between detected breaths.
2. Automatic Offset Calibrations:

Page 11 of 50
The device was designed to automatically perform calibrations in order to
correct for changes in temperature, altitude and electronic component drift.
The air surrounding the device may have elevated concentrations of CO2 present
(such as in an enclosed compartment or room with poor ventilation). Therefore,
we recommend use in well ventilated locations to ensure that the CO2 baseline
does not cause inaccuracy.
3. The Moisture Separation System:
This instrument uses apatented filter/water trap which can filter a large
amount of moisture whilst maintaining a minimumdead space thereby
improving theaccuracy ofthe waveform. Pleasenote that ifthe Filter/Water
Trap becomes full of waterordirt thedisplay willshow "OCCLUSION ', the
operatorneeds to changethe filter/water trap.The old filter can be reused
after natural drying in a ventilated and dry environment. Discard the old
filter/water trap if dirty.
4.3 Oximeter density measurement (optional)
Theory introduction
SpO2 is measured by Pulsating oximetry. This is a continuous, non-invasive
method to measuring hemoglobin oxygenation saturation. It is determined the
number of sensor light emitted from the light source side penetrating the
animal tissue (such as a finger or ear), to the receiver sensor. Sensors measure
the wavelength of the red LED is typically 660nm, infrared LED is 940nm. The
maximum output power of the optional LED is 4mW.
The amount of light passing through depends on several factors, most of which
is constant. However, the arterial blood flow that is one of these factors varies
with time, because it is pulsating. By measuring the light absorption of the
pulsation period, it is possible to obtain the oxygen saturation of arterial blood.
Detect pulsating itself can give a "plethysmography" wave and pulse rate signal.
It is also recommended to use Pulse Oximetry for ventilated or sedated animals.
Measurement will begin when a finger is put into the sensor clip, meanwhile,
the photoplethysmogram wave will appear on the screen, after several seconds

Page 12 of 50
the oxygen saturation and pulse rate appear. The monitor will give a pulse tone
sound when each heart beat happens. The tone will change to an alarm tone if
the values of SpO2 and Pulse Rate breach the alarm level settings. The volume
of pulse beep can be adjusted by the item BEEP VOLUME in the SOUND SET
menu. The pulse beep tone will disappear under the silent condition.
Figure 4.3
The use of different SpO2 sensors
There are a number of different SpO2 Sensors for use with this monitor. Please
see brochure or listing at rear of Manual for details.
PLEASE NOTE: when SpO2 is not being monitored the probe should be
disconnected from the monitor to save battery life, or the two windows of
sensor should be kept face to face, otherwise the light window will remain
operational and the photoplethysmogram wave will be disordered and the
screen will display “FAIL SEARCH”.
4.4 Notice
1. Caution:
Conditions of electromagnetic influence, for example: electrosurgical devices, MRI,
CT etc., may cause incorrect operation.
This device is not MRI/CT Compatible.
The filter/water trap should be taken off and replaced when it is nearly full of water,
otherwise water ingress may cause irreversible damage for IR measurement

Page 13 of 50
detector cell. Be sure that the collecting pipe is not occluded to avoid stressing the
inner sampling pump and reduction of pump life.
2. Attention: other important information.
1.) CO2:
The approved sampling lines provided by or specified by the manufacturer or
distributor, shall be used, otherwise readings may be inaccurate.
Fast changes in ambient Temperature may cause inaccuracy and in this instance
the Display will show “TEMP IMBALANCE”.
The measured data may be influenced by different kinds of anaesthetic gases. If it
is required to calibrate interference gases please refer to Appendix 2.
Any circumstances of blocking of the gas sampling line, such as bending, folding,
contamination blocking the sampling tube and filter or water trap etc. may lead
to inaccurate measurement.
Serious respiratory conditions leading to exhaled CO2 concentration being
extremely high or low, e.g. EtCO2 lower than 0.5% or higher than 11%, may
generate inaccurate measurement.
Any air leaks in the sampling line circuit will seriously influence accuracy of data
measured and waveform shape.
2.) Oximeter:
The monitor’s measurement of SpO2 may be influenced by strong ambient light.
Therefore the user should unplug the SpO2 Sensor when it is not being used.
Accuracy of oximeter readings will be influenced if there is imaging dye in the
blood or if CO has been inhaled by the Patient.
Only use original SpO2 probes approved for use with this Monitor.
Always make sure that the sensor is not contaminated or broken before use.
Always take care to check that the sensor is applied correctly.
Warning:
Do not use the SpO2 sensor if it is damaged or dirty.
If shock, low blood pressure, serious blood vessel constriction, serious anemia,

Page 14 of 50
very body low temperature, artery block near sensor or incomplete heart asystole
occur the pulse signal may disappear.

Page 15 of 50
5 Screen display and Operation
5.1. Screen main display menu
Figure 5.1
1. The first line of data shows time (hour, minute)/patient ID, animal type: THICK
orTHINtissue,thememoryareafullindicator （），alarmsoundclosing(!),
silence ( ) or non silence(), Bluetooth symbol ( ) and battery indicator
.
Attention:
a)When the memory fullindicatoris displayed, further data cannotbestored.
If you want to savethe new data effectively, you need to enter the NEW

Page 16 of 50
PATIENT menu to delete the data in thestorage area, or to change patient ID.
Alternatively, select AUTO LOOPto overwritethe oldest data when memory is
full, please see the details in 5.9NEW PATIENT
b) If the symbol appears, the menu is locked, the setting menu will be
disabled unless user press the three buttons ,▼, -at the same time, or
enters engineer menu to unlock the menu（Refer to Appendix 2. ENGINEER
MENU: Changing compensationofbalancegas)
c) The middle part of the screen shows results data: EtCO2concentration,
respiratory rate, inhaling CO2concentration (optional), oxygen PLETH, exhaling
orinhaling state (during exhaling, becomes blue color).
The bottom area shows CO2respiratory wave. If it is equipped with SpO2, it will
showSpO2, pulse, oxygen PLETH waveform and histogram. Whenthe pump is not
operating “PUMP OFF” will appear on the screen. If the filter/water trap is NOT
inserted into the inlet port, the screen will show ‘LINE OFF, the pump will also be
automatically switched offtoprevent ingress to theunprotected IR detector cell.
Alarm indication:
1.) If the EtCO2’s value exceeds the limit of high or low alarm level, the word
‘EtCO2’ will flash and alert with the audible high priority alarm. This high priority
alarm will also sound for respiration rate, SpO2 and pulse rate alarms.
2.) If the battery level is almost fully depleted the battery indicates
completely empty, the monitor will alarm continuously and will shut down
automatically.
3.) When the apnea alarm is turned on and apnea occurs the monitor will give
a high priority audio/visual alarm. The screen will flash the message ‘APNEA’
(meaning no EtCO2 has been detected for a certain time period) and if the
sound alarm is turned on, it will alert a high priority audible alarm.

Page 17 of 50
4.) When the SpO2 sensor is disconnected or not applied, the screen will flash
the message ‘SENSOR OFF’. If a heart beat pulse is not detected for a period of
time, the screen will flash the message ‘FAIL SEARCH’.
5.) The volume of continuous or interval alarm tone sounds mentioned above
can be adjusted up and down by the menu item ALARM_VOLUME. The sound
will inaudible under the silent condition. If the alarm volume is 0, the silence
indicator in the main menu will show '!'
6.)All the parameter alarms for over limits and apnea alarm, will lead to the
flashing of the red alarm indicator on the panel.
5.2 Initial MonitoringScreen
Long press (about 3 seconds) power key " " to start the monitor, the
initial monitoring screen is as shown below:
Figure 5.2
In this menu, press ▲ / + button or ▼/ - button to move the cursor,
then press the ENTER button to select YES or NO. If selecting "YES" then the
monitor enters the New Patient menu directly. If selecting "NO" or there is no