PC-900B User Manual Rev 1 May 2018

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Welcome to using the Capnograph and Oximeter manual. This manual is copyright reserved. It is prohibited to copy, duplicate or translate into other languages without our written permission. Please to 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.

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CONTENTS Chapter I Chapter II Chapter III Chapter IV Chapter V Chapter VI Chapter VII Appendix 1. Appendix 2. Appendix 3.

Preface ... 4 Technical specifications and characteristics ... 5 Introduction of Monitor ... 7 Patient connection ... 9 Screen display and Operation ... 13 Charging, Maintenance, Cleaning ... 23 Trouble Shooting Analysis ... 25 Explanations of Terms in this Manual ... 26 ENGINEER MENU: Changing compensation of balance gas ... 27 Calibration of EtCO2 Accuracy ... 28

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Chapter I Preface I. 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 device can monitor four physiological parameters for the patient at the same time: End tidal CO2 concentration (EtCO2), Respiration Rate (RR), functional Oxygen Saturation (SpO2) and Pulse Rate (PR). The monitor you bought may have functions with two or more parameters mentioned above, but this manual can be used in common for the applicable functions.

II. Warranty and Maintenance Warranty on Hardware and Battery This Monitor has a warranty of 12 Months from the date of purchase. 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 accidentally damaged or dropped • if the user modifies or changes the monitor without written authority of the company. • 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/calibration place depends on actual conditions. Re-packing for Repair or Calibration It is recommended to use the original packing boxes and packing materials when returning for repair or maintenance.

III. Safety Requirements For the purposes of safety, please read the following and abide by these instructions of medical instrumental products. Warning: Indicating the possible injury on patient or operator.

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• This monitor is not suitable for use during the operation of MRI or CT. This Monitor is not MRI Compatible. • To ensure that the monitor is safely grounded when charging use a three-pole socket. • 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 End tidal CO2 (EtCO2) concentration, 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.

Chapter II Technical specifications and Characteristics EtCO2 Method:

Creative proprietary 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 Over 100mmHg ±10% 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 Patient Modes: Adult and Neonatal Memory: 24 hours on Screen Trend and Numeric Sensor: <25g Single Use Gas Sample Line and Adapter for Intubated and /or Non Intubated Patients Color Change: Connector housing has additional built-in LED Colour change feature. Purple (or Red) during occlusion or pump err. Respiration Rate Range: 3 - 150 breaths/minute

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Accuracy: Memory: SpO2 (optional) Method: Range: Accuracy:

±1% of reading or ±1 breaths/min whichever is greater 24 hours on Screen Trend and Numeric

Memory:

Creative Patented Proprietary Pulse Oximetry 0 - 100% ±2% for SpO2 range from 70 - 100% ±3% for SpO2 range from 50 - 69% 24 hours on Screen Trend and Numeric

Pulse Rate (optional) Range: Accuracy: Memory:

30 – 250bpm ±2% for PR range from 30 – 250bpm 24 hours on Screen Trend and Numeric

Power AC Input:

Battery Type:

100V - 250V, 50Hz/60 Hz to 5VDC Adapter with 5V mini USB adapter Cable Optional Vehicle 12V to 5V Mini USB Charger Lead.

Charging Time: Operating Time:

Built-in rechargeable lithium battery pack (3.6V, 3000mAH) 4 hours from flat 10 hours on full charge

Operating Conditions Temperature: Humidity: Atmospheric pressure:

-5 to +50°C < 93% % (non-condensing) = < 29.45 hPa 70 - 120 kPa

Storage Conditions Temperature: Relative Humidity: Atmospheric pressure:

-30 to +70°C <93% (non-condensing) 50 - 120 kPa

Dimensions of Monitor Size: 70x160x40mm (W x H x D) Weight: Weight on Airway ETT/LMA <25g. Monitor 600g Warranty & Maintenance/ Calibration 24 Months warranty on Main Unit and Lithium Ion Rechargeable Battery. Auto self-zeroing calibration, annual calibration check recommended.

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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 Degree of Protection: Type BF-Applied Part Mode of Operation: Continuous 93/42/EEC Medical Device Directive Compliant CE 0123 Shenzhen Creative Industry Co. Ltd

Chapter III Introduction of Monitor I. Introduction

Figure 1

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1. 2.

Screen: Displays waves, menu, alarm and all measuring parameters. / : 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. b) In the main display screen, to press this button to freeze the display wavefor m (if frozen, the data to print is the data of the frozen moment) 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, to press this button to turn on the pump directly if it has automatically time 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 T3 is off. when the filter T3 is plugged in ,the indicator color will change to be blue all the time, and it will change to be 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.

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Chapter IV Patient connection I. CO2 measurement Push in and twist 45° clockwise to connect the filter/water trap T3 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 Patient or the Ventilator Breathing Circuit.

Figure 2

Filter/water trap T3: WARNING Do not use the Monitor if the filter/water trap T3 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 T3.

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Figure 3

Instruction for use of the filter/water trap T3: 1. Insert the convex cleat of filter/water trap T3 into the notch of the inlet port of device and turn T3 45°clockwise. 2. Attach male luer lock sample line connector to filter/water trap T3 (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 Patient or Ventilator Circuit. 4. Change the filter/water trap T3 as needed – This item may dried if very wet and re-used, subject to local Infection Control requirements. If the filter/water trap T3 becomes dirty or the Occlusion Alarm is activated when it is dry then the filter/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 T3 to ensure accuracy.

II. Respiration rate measurement The calculation of respiration rate derives from monitoring the CO2 waveform.

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III. Theory introduction 1 The measuring principle: The device working theory is NON-DISPERSIVE INFRA RED GAS ANALYZER. The device has an AUTO ZERO ADJUSTMENT SYSTEM and GAIN CONTROL 2 Automatic Offset Calibrations 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 a patented filter/water trap T3 which can filter a large amount of moisture whilst maintaining a minimum dead space thereby improving the accuracy of the waveform. PLEASE NOTE that if the filter/water trap becomes full of water or dirt the display will show "OCCLUSION ', the operator needs to change the filter/water trap T3. The old filter can be reused after natural drying in a ventilated and dry environment. Discard the old filter/water trap if dirty.

IV. Oxygen saturation measurement (optional) 1. It is also recommended to use Pulse Oximetry for ventilated or sedated patients. Measurement will begin when your finger is put into the sensor clip, meanwhile, the photoplethysmogram wave will appear on the screen, after several seconds 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

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2. 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”.

V. Notice 1. Caution: Under conditions of electromagnetic influence, for example: electrosurgical devices, MRI, CT etc. they may cause incorrect operation. This device is not MRI/CT Compatible. The filter/water trap T3 should be taken off and replaced when it is nearly full of water, otherwise water ingress may cause irreversible damage for IR measurement detector cell. Be sure that the collecting pipe is not occluded to avoid stressing the inner sampling pump 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.

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Only use Creative 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, very body low temperature, artery block near sensor or incomplete heart asystole occur the pulse signal may disappear.

Chapter V Screen display and Operation I. Screen main display menu

Figure 5

The first line of data shows time (hour, minute)/patient ID, patient type: Adult (ADU) or Neonate (NEO), the memory area full indicator ( ) alarm sound closing (!), silence () or non silence (), bluetooth symbol ( ) and battery indicator . Attention: a) When the memory full indicator is displayed, further patient data cannot be stored. If you want to save the new data effectively, you need to enter the NEW PATIENT menu toe delete the data in the storage area, or to change patient ID., beside you can set up trend RENEW into AOTO mode,

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please see the details in VIII. NEW 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 compensation of balance gas) c) The symbol ( ) appears if the bluetooth module is equipped. If this symbol is green, it indicates that no bluetooth equipment is connected (e.g, bluetooth printer), if this symbol becomes white, it indicates that some bluetooth equipment is connected (e.g, bluetooth printer). d) The middle part of the screen shows results data: EtCO2 concentration, respiratory rate, inhaling CO2 concentration (optional), oxygen PLETH, exhaling or inhaling state (during exhaling,

becomes blue color).

The bottom area shows CO2 respiratory wave. If it is equipped with SpO2, it will show SpO2, pulse, oxygen PLETH waveform and histogram. When the 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 off to prevent ingress to the unprotected 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. 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.

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II. The Main Menu

Figure 6

Press the MENU button  to enter the Main Menu to set monitor parameters (as FIGURE 6). WARNING All Menu Settings are LATCHING and remain when the Monitor is powered off. Ensure that all necessary settings are reviewed and are suitable for the patient BEFORE use. This menu includes the following options: The setting menu for CO2: CO2_SETUP The setting menu for SpO2: SpO2_SETUP The trend menu: TREND The time menu: TIME_SETUP The sound menu: SOUND_SETUP The new patient menu: NEW PATIENT In this menu, to press  or  button to move the cursor up or down to highlight an option and Press the ENTER button to select and enter the next level of the menu. To return to the Main menu select EXIT option and press ENTER (not available on Trend screen).

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III. CO2 SET Menu

Figure 7

In this menu, press  or  button to move the cursor up or down, press + button or - button to change the data highlighted by the cursor. To return to the main menu highlight EXIT and press the ENTER button. If you want to return the monitor to its default settings highlight LOAD DEFAULTS and Press the ENTER button. This menu includes the following setups: 1. The high alarm limits of EtCO2: EtCO2 ALARM_H: 22-99mmHg, off 2. The low alarm limits of EtCO2: EtCO2 ALARM_L: off, 10-60mmHg 3. The high alarm limits of respiration rate: RESP ALARM_H: 5-60 breaths/min, off 4. The low alarm limits of respiration rate: RESP ALARM_L: off, 4-40 breaths/min 5. Pump flow rate setup: FLOW-SET: 50cc/min-250cc/min 6. The setup of apnea time: APNEA TIME: 15s-44s, off 7. The unit of CO2: CO2 UNIT: %, mmHg or kPa 8. Pump switch: ON or OFF 9. Pump auto-closing time: AUTO-OFF-TIME: 10-30min 10. Screen speed of capnograph: SWEEP SPEED: SLOW, NORMAL or FAST 11. CO2 Wave scale: WAVE SCALE: 54mmHG or 76mmHG 12. EtCO2 average computation time: EtCO2 Averaging: every breath, 10sec, 20sec, 30sec 13. Default reload: LOAD-DEFAULTS 14. Exit: EXIT Attention: Pump auto-closing time means that the pump will automatically be closed down when no respiration occurs in the set period (default 10 min).

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The wave scale means the maximum value of waveform amplitude display but it does not mean data on full-scale. Data on full-scale still means 99mmHg. Default values are as follows: EtCO2 alarm high limit: 50 mmHg EtCO2 alarm low limit: 19 mmHg RESP alarm high limit: 30 breaths/min RESP alarm low limit: 08 breaths/min FiCO2 alarm high limit: OFF FLOW_SET: 100 CC/Min Apnea time: 30S CO2 unit: % CO2_PUMP: ON AUTO_OFF_TIME: 10 Min SWEEP SPEED: NORMAL EtCO2 Averaging: 1 Breath WAVE SCALE: 54mmHg

IV. SpO2 SET Menu

Figure 8

In this menu, press  or  button to move the cursor up or down, press + button or - button to change the data highlighted by the cursor. To return to the main menu highlight EXIT and press the ENTER button. If you want to return the monitor to its default settings highlight LOAD DEFAULTS and Press the ENTER button.

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This menu includes the following setups: 1. The high alarm limits of SpO2: SpO2 ALARM_H: 50%-100%, off 2. The low alarm limits of SpO2: SpO2 ALARM_L: off, 50%-99% 3. The high alarm limits of pulse rate: P_RATE ALARM_H: 70-250 beats/m, OFF 4. The low alarm limits of pulse rate: P_RATE ALARM_L: OFF, 40-100 beats/m 5. Wave curve selection: CURVE WAVE: FILL or LINE 6. Renewing of defaults. LOAD DEFAULTS The wave curve selection means that: FILL indicates the beneath part of photoplethsmogram is filled. LINE indicates the photoplethysmogram is drawn in curve line. Default values as follow: SpO2 alarm high limit: 100% SpO2 alarm low limit: 92% Pulse Rate alarm high limit: 130 beats/min. Pulse Rate alarm low limit: 50 beats/min. Curve: Line

V. TIME SET Menu

Figure 9

In this menu, press  or  button to move the cursor up or down, press + button or - button to change the data highlighted by the cursor. Attention: Any time adjustment will delete any stored trend data, so please take care before making this adjustment. The procedure is as follows: 1. Change time. 2. Move the cursor to SAVE then press the ENTER button to enter the

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following menu FIGURE 9.; 3. YES is already selected (highlighted in white) and if you wish to confirm this change press Enter if you do not wish to confirm the change move the cursor and highlight NO and press Enter. 4. Only by confirming can the time adjustments be made.

Figure 10

VI. Sound SET Menu

Figure 11

In this menu, press  or  button to move the cursor up or down, press + button or - button to change the data highlighted by the cursor. This menu includes following setups: Pulse sound volume: BEEP_VOLUME: 0(OFF)-8 Alarm sound volume: ALARM_VOLUME: 0(OFF)-8

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If the alarm volume is 0, the top line in the main menu will show '!'

VII. Trend

1. The graph trend

Figure 12

The monitor stores EtCO2, PR, SpO2 and PR as a group of data every 12 seconds (Adjustable in Store Interval under New Patient menu) with accumulated trend up to 24hours respectively. The stored data is retained even the device is shut off. The symbol will appear on screen when the storage is full. There are three options to further store the data. 1. Change patient ID under NEW PATIENT menu. 2. Change store mode to AUTO under NEW PATIENT menu, in auto mode data will be stored and renewed when reaches its limits. 3. Select CLEAR MEMORY under NEW PATIENT menu to empty the stored data. Figure 12 shows that the time base for the trend page is 1 hours and every point indicates the result of every 12 second. The top line of this page indicates patient’s ID number, the start time of this page (date/month/year hour : minute), current page no. and sum pages (24 pages in total).