Creative PC-900B User Instruction Manual Ver 4.5 May 2016

User Manual of Capnograph and Oximeter

Notice Welcome to Creative PC 900B 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 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. You may contact your local supplier or the manufacturer at the following address: Shenzhen Creative Industry Co., Ltd. 2/F, Block 3, Nanyou Tian’an Industry Town, Shenzhen, GD, 518054 P.R. China Tel: +86-755-2643 3514 Fax: +86-755-2643 0930 E-mail: [email protected] Website: www.creative-sz.com

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User Manual of Capnograph and Oximeter

CONTENTS

1 Preface... 3 1.1 Brief...3 1.2 Warranty and Maintenance...3 1.3 Safety Requirements...4 2 Technical specifications and characteristics...5 3 Introduction of Monitor... 8 3.1 Introduction... 8 4 Patient connection... 10 4.1 CO2 measurement...10 4.2 Respiration rate measurement... 11 4.3 Oximeter density measurement (optional)...12 4.4 Notice...13 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 SETMenu...21 5.6.TIME SETMenu...22 5.7. Sound SETMenu... 24 5.8.Trend... 25 5.9. NEW PATIENT Menu...28 6 Charging, Maintenance, Cleaning... 30 6.1 Charge...30 6.2 Maintenance...30 6.3 Cleaning... 31 7 Trouble ShootingAnalysis... 33 APPENDICES... 35 Appendix 1. Explanations of Terms in this Manual... 35 Appendix 2. ENGINEER MENU: Changing compensation of balance gas36 Appendix 3. Calibration of EtCO2 Accuracy...38 Appendix 4. Part Numbers and Consumables listing... 42 2

User Manual of Capnograph and Oximeter

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 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 3

User Manual of Capnograph and Oximeter

maintenance, repair or calibration would be carried out at PROACT Medical Ltd UK, unless detailed in a 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. 4

User Manual of Capnograph and Oximeter

2 Technical specifications and characteristics EtCO2 Method: Range: Accuracy:

Creative proprietary non-dispersive InfraRed Spectroscopy 0 – 150mmHg or 0 – 20kPa or 0 – 20% (v/v) ±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 UserAdjustable. Default=100ml/min Patient Modes: Adult and Pediatric Memory: 24 hours on Screen Trend and Numeric Sensor: <25g Single Use Gas Sample Line and Adaptor for Intubated and /or Non Intubated Patients Colour Change: Connector housing has additional LED ETCO2 colour change feature built-in and will glow purple during expiration and orange during inspiration. Respiration Rate Range: 3 - 150 breaths/minute Accuracy: ±1% of reading or ±1 breaths/min whichever is greater Memory: 24 hours on Screen Trend and Numeric 5

User Manual of Capnograph and Oximeter

SpO2 (optional) Method: Range: Accuracy: 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: 30 – 250bpm Accuracy: ±2% for PR range from 30 - 250bpm Memory: 24 hours on Screen Trend and Numeric Power AC Input:

Battery Type: Charging Time: Operating Time:

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

Built-in rechargeable lithium battery pack (3.6V, 3000mAH) 4 hours from flat 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 6

User Manual of Capnograph and Oximeter

Dimensions of Monitor Size: 70 x 160 x 40mm (W x H x D) Weight: Weight on Airway ETT/LMA<25g. Monitor 380g 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

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User Manual of Capnograph and Oximeter

3 Introduction of Monitor 3.1 Introduction

Figure 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. 8

User Manual of Capnograph and Oximeter b) In the main display screen, press this button to freeze the display waveform (if frozen, the data which prints will be that shown on the screen).

(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 T3 is

off. When the filter T3 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.

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User Manual of Capnograph and Oximeter

4 Patient connection 4.1 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.

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User Manual of Capnograph and Oximeter

In order to avoid vapor and respiratory mucus entering into the IR Cell, the machine must be used with the Filter/Water Trap T3.

Figure 3 Instruction for use of the Filter/Water TrapT3: 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. If the Filter/Water Trap T3 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 T3 to ensure accuracy.

4.2 Respiration rate measurement

The calculation of respiration rate derives from monitoring the CO2 11

User Manual of Capnograph and Oximeter

waveform. Theory introduction 1 The measure principle: The device working theory is NON-DISPERSIVE INFRAGAS 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.

4.3 Oximeter density measurement (optional) It is also recommended to use Pulse Oximetry for ventilated or sedated patients. Measurement will begin when a 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 12

User Manual of Capnograph and Oximeter

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 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 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 and reduction of pump life. 2. Attention: other important information.

1). CO2:

The approved sampling lines provided by or specified by the 13

User Manual of Capnograph and Oximeter

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 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.

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User Manual of Capnograph and Oximeter

5 Screen display and Operation 5.1. Screen main display menu

Figure 5 1. The first line of data shows time (hour, minute)/patient ID, patient type: Adult (ADULT) or Pediatric (PED), 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 to delete the data in the storage area, 15

User Manual of Capnograph and Oximeter

or to change patient ID. Alternatively, select AUTO LOOP to overwrite the oldest data when memory is full , please see the details in 5.8 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, blue color).

becomes

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 16

User Manual of Capnograph and Oximeter

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.

5.2 Initial Monitoring Screen

Long press (about 3 seconds) power key " " to start the monitor, the initial monitoring screen is as shown in figure 6.

Figure 6 17

User Manual of Capnograph and Oximeter

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 any operation in 8 seconds, then the monitor enters main display screen. To disable this prompt, enter the New Patient menu screen. If "POWER ON ID PROMPT" is set as "NO", the monitor will disregard the initial monitoring screen (see figure 7) and enter into main display screen directly (refer to Section 5.9 NEW PATIENT MENU for details).

5.3 The Main Menu

Figure 7 Press the MENU button

to enter the Main Menu to set monitor

parameters (as FIGURE 7). 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 18

User Manual of Capnograph and Oximeter

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).

5.4 CO2 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. 19