Portable Bedside Capnograph/Pulse Oximeter Service Manual CI05225E
Notice: Purchase of this instrument confers no express or implied license under any Oridion Medical patent or Nellcor Puritan Bennett patent to use the instrument with any accessory that is not manufactured or licensed by Oridion Medical 1987 Ltd. Capnography is covered by one or more of the following United States patents: 6,491,643; 6,656,127; 6,168,958; 5,300,859 and 4,755,675 and their foreign equivalents.
TABLE OF CONTENTS List of Figures List of Tables Section 1: Introduction........................................................................ 1-1 1.1 Manual Overview ............................................................... 1-1 1.2 Warnings, Cautions, and Notes ......................................... 1-1 1.2.1 Warning.............................................................. 1-1 1.2.2 Caution............................................................... 1-1 1.2.3 Note........................
Table of Contents 7.8 Replacing Housing Components ..................................... 7-12 7.8.1 ON-OFF Button and Gas Outlet....................... 7-12 7.8.2 Keypads ........................................................... 7-12 7.8.3 Front Cover ...................................................... 7-13 7.8.4 SpO2 Connector Latch, Rear Cover and SpO2 Insulation Plate ....................................... 7-13 7.9 Updating Software Version ..............................................
Table of Contents LIST OF FIGURES 1-1 1-2 7-1 7-2 7-3 7-4 7-5 7-6 7-7 7-8 7-9 7-10 7-11 7-12 7-13 7-14 10-1 10-2 10-3 10-4 10-5 10-6 11-1 Handheld Capnograph/Pulse Oximeter ............................. 1-2 LCD Graphic Display and 7 Segment Digital Displays ...... 1-2 Removing the Battery Pack ............................................... 7-2 Removing Mounting Screws .............................................. 7-3 Separating Rear and Front Covers....................................
Table of Contents
SECTION 1: INTRODUCTION 1.1 1.2 1.3 1.1 Manual Overview Warnings, Cautions, and Notes Product Description MANUAL OVERVIEW This manual contains information for servicing the handheld capnograph/ pulse oximeter (the monitor). Only authorized service personnel should service this product. The Handheld Capnograph/Pulse Oximeter Operator’s Manual (the operator’s manual) is an integral part of the service procedures.
Section 1: Introduction 1.3 PRODUCT DESCRIPTION The handheld capnograph/pulse oximeter is used to continuously monitor end-tidal carbon dioxide (EtCO2), respiratory rate, oxygen saturation (SpO2), and pulse rate. The monitor is for attended monitoring only and must be used in the continuous presence of a qualified healthcare provider. The monitor can be used on adult, pediatric, and infant/neonatal patients.
SECTION 2: REQUIRED EQUIPMENT 2.1 2.1 Required Equipment REQUIRED EQUIPMENT You will need the following equipment to disassemble, replace parts, check, adjust, or calibrate the monitor. For disassembly and replacement: • Phillips-head screwdriver (medium) • Flat-head screwdriver (small) • IC Extractor for PLCC socket • Threadlocker glue e.g.
SECTION 3: CLEANING 3.1 3.1 Cleaning CLEANING Always clean the outer surface of the monitor before servicing. Warning: Always wear latex or surgical gloves when cleaning or servicing the monitor after hospital use. Warning: Do not allow liquids to drip inside the housing. Warning: Do not clean internal components. Warning: Do not use preparations based on: phenols, halogen producing compounds, strong organic acids, or oxygen producing compounds. 3.1.1 Procedure 1. Unplug the unit from AC power. 2.
SECTION 4: SERVICE MODE 4.1 4.2 4.3 4.1 Introduction Service Level 1 Service Level 2 INTRODUCTION The monitor supports a service mode built into the instrument’s firmware. To access the service mode, refer to Table 4-1: "Accessing Service Mode and Changing Parameter Settings". The architecture of the monitor’s service mode divides the service mode into two levels as described in the sections below. • Service Level 1 • Service Level 2 4.
Section 4: Service Mode Note: 4.2.3 To exit the service mode and save event messages, turn off the monitor. Event messages will be erased when exiting the service mode by a long press of . Interface Test Screen The interface test screen shows four parameters (listed below) that provide tools for the user to test, adjust, and calibrate the unit’s interfacing systems. • HMI Test • Light Detector • Contrast Cal. (Calibration) • CO2 Calib. (Calibration) 4.2.3.
Section 4: Service Mode 4.2.4 Accessing Service Mode and Service Level 1. Table 4-1: "Accessing Service Mode and Changing Parameter Settings" describes the process to access the service mode, change parameter settings and how to change Contrast Cal. settings.
Section 4: Service Mode Table 4-1: Accessing Service Mode and Changing Parameter Settings (Continued) Objective Action Response To change Contrast Cal. setting to set short press To start Contrast Cal. short press To adjust Contrast Cal. middle point “Contrast Cal.” flashes. press until desired setting is reached. (Pressing on the left lightens the screen, and pressing on the right darkens the screen.
Section 4: Service Mode 4.3 SERVICE LEVEL 2 The Service Level 2 gives the service technician tools on three service screens: • Default Alarm Limits • Default Settings • Flow Calibration To access this service level, the service technician must enter a valid password (1627), refer to Table 4-2: "Accessing Service Level 2". Note: The password should not be disclosed to avoid unauthorized setting of parameters.
Section 4: Service Mode Table 4-2: Accessing Service Level 2 (Continued) Objective To accept the last digit and access the Default Alarm Limits menu Action short press In case you entered a wrong digit: 4-6 To restart password validation process long press To return to the Interface Test Screen long press To exit service mode and save event messages Turn off the monitor.
Section 4: Service Mode 4.3.1 Default Alarm Limits The service technician can change the default alarm limits for either patient mode (Adult or Neonatal) as described in Table 4-3: "Changing Default Alarm Limits".
Section 4: Service Mode Table 4-3: Changing Default Alarm Limits (Continued) Objective To reset to measuring mode (automatically erasing event messages) Action long press then long press To exit service mode and save event messages 4-8 Turn off the monitor.
Section 4: Service Mode 4.3.2 Default Settings The service technician can change two default settings (refer to Table 4-4: "Changing Default Settings"): • 3 Min Alert When the 3 Min Alert is ON, the unit will beep every three minutes to remind the user that an alarm (or all alarms) are set to OFF. • BTPS (body temperature, pressure, saturation) When BTPS is ON, the CO2 value is corrected for this factor • Pulse Tone Pulse Tone default is ON.
Section 4: Service Mode 4.3.3 Flow Calibration The Flow Calibration screen allows the service technician to perform flow calibration after flow adjustment and/or pump or flow system replacement, refer to Table 4-5: "Accessing Flow Calibration" Note: When changing the pump voltage setting, refer to Section 6: Flow Calibration Check for change guidelines.
SECTION 5: TROUBLESHOOTING 5.1 5.2 5.3 5.4 5.5 5.6 5.1 Introduction Who Should Perform Repairs Repair Level Supported How to Use This Section Obtaining Replacement Parts Troubleshooting Guide INTRODUCTION This section provides information for troubleshooting the monitor and isolating a failure on the unit. 5.2 WHO SHOULD PERFORM REPAIRS Only qualified service personnel should remove and replace components of the monitor.
Section 5: Troubleshooting 5.6 TROUBLESHOOTING GUIDE If you encounter a problem that cannot be resolved through a visual inspection, refer to Table 5-1: “Troubleshooting Guide” which provides a list of symptoms, probable causes, and recommended actions to take to correct the problem. It is recommended that corrective actions be performed in the order presented. For a symptom that is not listed in Table 5-1: “Troubleshooting Guide”, contact your local distributor.
Section 5: Troubleshooting Table 5-1: Troubleshooting Guide (Continued) Symptom Probable Cause Corrective Action The unit does not turn on when the ON/OFF button is switched ON when the monitor is connected to main lines power. The wall socket is not receiving power or is defective. Check the wall socket for power supply or mechanical defects. If necessary, use a different wall socket. The AC adapter is defective. Replace with new AC adapter. A CO2 board component is defective.
Section 5: Troubleshooting Table 5-1: Troubleshooting Guide (Continued) Symptom Probable Cause Corrective Action LED display The Power Management option is set at LOW. Refer to the monitor’s operator’s manual to change the Power Management option to NORMAL or HIGH. An LED display has failed. Replace with new LED Display. A CO2 board component has failed. Replace with a new CO2 board. The Pulse Tone option on the Alarm Silence menu has been disabled. Turn the Pulse Tone ON.
Section 5: Troubleshooting Table 5-3: Event Messages Event Message Probable Cause Corrective Action CO2 board A CO2 board component failed. Replace with a new CO2 board. SpO2 board Flow Replace with a new SpO2 board. - Loose connections - Inspect all tubing ends for loose connections and ensure tight connections - Kinks or twists in tubing - Straighten kinks and undo any twists in the tubing. - Flow system blocked - Check flow rate and if necessary change Flow System.
SECTION 6: FLOW CALIBRATION CHECK 6.1 6.2 6.3 6.1 Introduction Flow Rate Check Flow Calibration Process INTRODUCTION Perform a Flow Calibration Check after replacing the Flow System and/or Pump. Flow Calibration Check includes Flow Rate Check and Flow Calibration Process. 6.2 FLOW RATE CHECK To perform the Flow Rate Check, follow the steps below: 1. Connect the FilterLine to the Handheld Capnograph/Pulse Oximeter. 2. Turn on the monitor. 3.
Section 6: Flow Calibration Check 6.3 FLOW CALIBRATION PROCESS To perform the Flow Calibration Process, refer to Table 6-1: "Flow Calibration". Table 6-1: Flow Calibration Objective To access Flow Calibration screen Action Response Simultaneously long press and To change the parameter setting or value short press To move to the next parameter (and save the changed setting) short press To select Flow Cal.
Section 6: Flow Calibration Check Table 6-1: Flow Calibration (Continued) Objective Action If Fail is displayed Replace Flow System and/or Pump (refer to Section 5: Troubleshooting) and repeat above procedure If Pass is displayed To reset and return to measuring mode To exit service mode and save event messages Response Pump volt. 2.0 Pump volt. 2.
SECTION 7: DISASSEMBLY GUIDE 7.1 7.2 7.3 7.4 7.5 7.6 7.7 7.8 7.9 7.
Section 7: Disassembly Guide 7.2 OPENING THE MONITOR CASE 1. Be sure the monitor is disconnected from mains power and remove the battery pack from the monitor; press the release button at the bottom of the monitor and pull out the battery pack as shown in Figure 7-1: Removing the Battery Pack.
Section 7: Disassembly Guide 2. Place the monitor on a clean, dry, nonabrasive surface with the back of the monitor facing up. 3. Remove the two Bottom Mounting and two Back Mounting Screws from the rear panel of the monitor as shown in Figure 7-2: Removing Mounting Screws. . Figure 7-2: Removing Mounting Screws 4. Carefully lift the rear case cover up and remove the 14-pin flat cable from the CO2 Board as shown in Figure 7-3: Separating Rear and Front Covers.
Section 7: Disassembly Guide 7.3 REPLACING THE CO2 BOARD Refer to Figure 7-4: Replacing CO2 Board and Housing Components 1. Open the monitor case as described in section 7.2 "Opening the Monitor Case". 2. Remove the two CO2 Board Mounting Screws. 3. Remove the CO2 Connector Screw from the CO2 Input Connector. 4. Remove the ON-OFF Button and save for reassembly. 5. Pull out and remove the Gas Outlet and save for reassembly. 6.
Section 7: Disassembly Guide 7.4 REPLACING THE SPO2 BOARD (Refer to Figure 7-5: Replacing SpO2 Board.) 1. Open the monitor case as described in section 7.2 "Opening the Monitor Case". 2. Pull out the Internal SpO2 Connector Lock. 3. Remove the three SpO2 Board Mounting Screws and Washers. 4. Remove the SpO2 Board with attached cables and replace with a new SpO2 Board. Be sure to reattach the cables and use the new Internal SpO2 Connector Lock.
Section 7: Disassembly Guide 7.5 REPLACING THE PUMP Refer to Figure 7-6: Replacing the Pump. 1 Open the monitor case described in section 7.2 "Opening the Monitor Case". 2 Remove the Damping cover from the Pump. 3 Locate the two tubings, Main line and Exhaust line, connected to the Pump, refer to Figure 7-7: Flow System. 4 Locate the purple Main line restrictor and the green Exhaust line restrictor, refer to Figure 7-7: Flow System. 5 Disconnect both tubings from their restrictors.
Section 7: Disassembly Guide 7.6 REPLACING THE FLOW SYSTEM 1. Open the monitor case as described in section 7.2 "Opening the Monitor Case". The Flow System has 5 lines, refer to Figure 7-7: Flow System.
Section 7: Disassembly Guide 7.6.1 Replacing the lines to the pump 7.6.1.1 Replacing the Main line (Refer to Figure 7-8: Main line and Figure 7-9: Exhaust line) 1. 2. 3. 4. 5. Note: Locate the purple restrictor. Carefully disconnect the Main line from the tubing connected to the Pump, leaving the purple restrictor on the Main line. Remove the tubing from the Sensor. Remove the tubing from the Pressure sensor. Reassemble the new Main line in reverse order.
Section 7: Disassembly Guide 7.6.2 Replacing the lines to the solenoid Refer to: Figure 7-10: Lines to Solenoid (Zero line, Input line 1, Input line 2) 7.6.2.1 Removing the lines to the solenoid 1. Carefully disconnect the Zero line from the solenoid. Warning: The scrubber on the Zero line is filled with a lithium based compound. Follow local governing ordinances for disposal. 2. Remove Input line 1 from the solenoid connector and the other end from the FilterLine input connector. 3.
Section 7: Disassembly Guide 7.6.2.2 Reassembly of the lines to Solenoid Refer to Figure 7-10: Lines to Solenoid (Zero line, Input line 1, Input line 2) and Figure 7-11: Zero line 1. 2. 3. Connect the new Input line1 to the line 1 solenoid connector. Connect the new Input line 2 to the line 2 solenoid connector. Bring the Input line 2 tubing over Input line 1, and connect to the sensor connector.
Section 7: Disassembly Guide 7.7 7.7.1 7.7.2 REPLACING LCD AND LED DISPLAY (Refer to Figure 7-12: Replacing LCD and LED display) Replacing the LCD 1. Remove the CO2 Board as described in Figure 7-4: Replacing CO2 Board and Housing Components. 2. Unscrew and remove the four LCD mounting screws. 3. Carefully remove the LCD and replace with a new LCD. Replacing the LED Display 1. Remove the CO2 Board as described in section 7.3 "Replacing the CO2 Board". 2.
Section 7: Disassembly Guide 7.8 REPLACING HOUSING COMPONENTS The Housing kit includes the following replaceable components: • • • • • • • • • • • Note: 7.8.1 7.8.
Section 7: Disassembly Guide 7.8.3 7.8.4 Front Cover (Refer to Figure 7-4: Replacing CO2 Board and Housing Components) 1. Open the monitor as described in section 7.2 "Opening the Monitor Case". 2. Remove the CO2 Board as described in section 7.3 "Replacing the CO2 Board". 3. Remove the keypad and ON-OFF Button. Place them in the new Front Cover. When replacing the keypad, be sure the icons are facing the correct direction. (Refer to Figure 1-1: Handheld Capnograph/Pulse Oximeter.) 4.
Section 7: Disassembly Guide 7.9 UPDATING SOFTWARE VERSION Warning: Observe ESD (electrostatic discharge) precautions when disassembling and reassembling the monitor and when handling any of the components of the monitor. 1. Open the monitor as described in section 7.2 "Opening the Monitor Case". 2. Remove the EPROM from its socket (on the CO2 board) using an IC extractor. (Refer to Figure 7-14: Replacing EPROM.) 3. Insert the new EPROM.
SECTION 8: ELECTRICAL SAFETY TESTS 8.1 8.1 Electrical Safety Tests ELECTRICAL SAFETY TESTS Do not return the monitor to the user until the conditions are met in the following “Warning” statement. Warning: After servicing the monitor, always verify product performance per the procedures in Section 10: Performance Verification and perform any safety tests required by local regulatory bodies or mandated by your institution.
SECTION 9: PERIODIC MAINTENANCE 9.1 9.1 Periodic Maintenance PERIODIC MAINTENANCE Periodic maintenance is recommended according to operating hours (refer to section 4.2 "Service Level 1"): The Pump and Flow System should be replaced every 7,000 operating hours. For replacing the pump, refer to section 7.5 "Replacing the Pump". For replacing the flow system, refer to section 7.6 "Replacing the Flow System".
SECTION 10: PERFORMANCE VERIFICATION 10.1 Flow System Leak Check 10.2 Performance Verification Procedure The performance of the monitor must be verified after all service procedures. Perform all procedures in this section to verify the correct functioning of the monitor. 10.1 FLOW SYSTEM LEAK CHECK Perform the Flow System Leak Check after all service procedures described in this manual. 10.1.1 Flow System Leak Check Procedure 1.
Section 10: Performance Verification 9. 10.2 If the reading drops more than 20 mBar, there is a leak in the flow system. • Open the unit. • Check for loose fittings and if any are found, reconnect them. • Repeat the above process (steps 1-8). • If the reading continues to show more than 20 mBar, replace the Flow System, refer to section 7.6 "Replacing the Flow System". PERFORMANCE VERIFICATION PROCEDURE Verify the performance of the monitor using the following procedure. 1.
Section 10: Performance Verification 10. Reconnect the FilterLine and verify that the message FilterLine disappears and the pump is operating. 11. Disconnect the DS-100A - OXIMAX Durasensor® and verify that the message SpO2 Sensor is displayed in the Silent Advisory Message area. 12. Reconnect the DS-100A - OXIMAX Durasensor® and verify that the message SpO2 Sensor disappears. 13. Verify that all buttons on the unit work properly. Refer to the monitor’s Quick Guide for their applications.
Section 10: Performance Verification CO2 Calibration Check Caution: Do not check CO2 values from the measuring mode if the BTPS setting is ON (factory default). This mode corrects the CO2 value for BTPS. The calibration check mode disables this correction automatically. In order to ensure accuracy, a CO2 calibration check needs to be done once a year. Calibration gas and a FilterLine are needed for this procedure.
Section 10: Performance Verification Table 10-1: CO2 Calibration Check (Continued) Objective Action Check the measured values shown in Vol% in the EtCO2 digital display. Press the gas valve for 15 seconds until the readings stabilize Result Calibration is not required if the measured value is the same as the concentration of the calibration gas (±0.3 Vol%) e.g. Concentration of calibration gas used is 5% (CO2); the measured value should be between 4.7%-5.3%, therefore, calibration is not required.
Section 10: Performance Verification Calibration Process If calibration is required, perform the Calibration Process (after performing CO2 Calibration Check) as shown in Table 10-2: "Calibration Process". Table 10-2: Calibration Process Objective To start calibration. Action Press the gas valve and long press To start calibration process after calibration check. No action required. To activate calibration process. long press Adjust the display value to the gas concentration you are using.
Section 10: Performance Verification Table 10-2: Calibration Process (Continued) Objective Action To reset and return to measuring mode long press To exit service mode and save event messages Turn off the monitor. Result Calibration Errors Table 10-3: "Calibration Process - Troubleshooting" describes calibration problems that can occur, the message displayed and the appropriate corrective action.
Section 10: Performance Verification 15. Advance to the Plethysmograph Display Screen as described in Table 10-4: "Plethysmograph Waveform" below. Table 10-4: Plethysmograph Waveform To View CO2 waveform (Measuring Mode) Plethysmograph Action Screen No action required. short press (x4) 16. Connect the DS-100A - OXIMAX Durasensor® to your finger. Verify the SpO2 value appears on the LED digital display and the Pulse rate appears on the LCD graphic display. 17.
Section 10: Performance Verification To verify printing functions: 19. Adjust the printer to the following communication settings: Input Serial Data Length 8 bits Parity Settings None Baud 9600 bps 20. Using the Communication Adapter Kit, connect the printer to the monitor. (Refer to Figure 10-6: Connecting the monitor to Printer/ PC with Communication Adapter Kit) Figure 10-6: Connecting the monitor to Printer/PC with Communication Adapter Kit 21. Turn the printer ON and select on-line mode. 22.
Section 10: Performance Verification Table 10-5: Accessing Monitor’s Print Functions Objective Action To access the Instrument Setup menu (first access the Alarm Limits menu from any measuring display) long press (x2) To select Print short press (x4) Be sure the Print option shows Screen; if it doesn’t, change to the Screen option.
SECTION 11: PACKING FOR SHIPMENT 11.1 General Instructions 11.2 Packing Handheld Capnograph in Original Carton 11.3 Packing in a Different Carton 11.1 GENERAL INSTRUCTIONS To ship a monitor or one of its components for any reason, follow the instructions in this section. Failure to follow the instructions in this section may result in loss or damage not covered by any applicable manufacturer warranty. Pack the monitor or component(s) carefully.
Section 11: Packing For Shipment 4. Place the bagged monitor or component on the layer of packing material and fill the box completely with packing material such that there is at least 2 inches of packing material around all sides of the item. 5. Seal the carton with packing tape. 6. Label carton with shipping address, return address and RMA number.
SECTION 12: SPECIFICATIONS 12.1 12.2 12.3 12.4 12.5 12.6 12.1 Physical Environmental Safety Standards Performance Power Specifications Components and User Interface PHYSICAL 12.1.1 Size 206 mm H x 88 mm W x 52.5 mm D (8.11”H x 3.46” W x 2.06”D) 12.1.2 Weight 850 grams (1.87 lb.) (including battery pack) 12.1.3 Noise Emission maximum 45 dB(a) 12.2 ENVIRONMENTAL 12.2.1 Temperature Operating 0oC to 45oC (32oF to 113oF) Storage -35oC to 70oC (-31oF to 158oF) 12.2.
Section 12: Specifications 12.4 PERFORMANCE 12.4.1 Capnograph Sampling Rate 50 ±7.5 ml/min. CO2 Range 0-99 mmHg (0-13.2 kPa and 0-13.0 Vol%) at sea level Accuracy From power-up until steady state is reached, the CO2 reading accuracy is: 0 - 38 mmHg: (+ 4 mmHg) 39 - 99 mmHg: (+ 12% of reading) The CO2 reading reaches its steady state accuracy 20 minutes after power up. 0 - 38 mmHg: (+ 2 mmHg) 39 - 99 mmHg: (+5% of reading + 0.
Section 12: Specifications 12.4.2 Pulse Oximeter 12.4.2.1 Display Ranges SpO2 Saturation Range 0-100% SpO2 Saturation Accuracy (% SpO2, ±1 SD) Adults 70-100%±2 digits 0 - 69% Unspecified Neonates 70-100%±3 digits 0 - 69% Unspecified Pulse Rate Range 20-250 beats per minute (bpm) Pulse Rate Accuracy ± 3 bpm Note: Pulse rate accuracy is expressed as ±3 bpm across the display range. This variation equals ±1 standard deviation (1SD), which encompasses 68% of the population.
Section 12: Specifications 12.5 POWER SPECIFICATIONS 12.5.1 External Power Source 12V DC Medical Grade Adapter 12.5.2 Internal Power Source Ni-MH Rechargeable Battery Pack 7.2V 2100 mA/h (intended for continuous operation) Operating Time (fully charged) Between 3 to 6 hours depending on power management. This spec reflects the performance of a new battery; age and usage will degrade capacity.
SECTION 13: SPARE PARTS 13.1 Spare Parts List 13.1 SPARE PARTS LIST Spare parts are shown below in Table 13-1. For spare part numbers contact your local distributor. Table 13-1: Spare Parts List Item Description 1 CO2 board - includes electronic board, sensor, pump and scrubber, solenoid, LCD, 7-segment display, flow system, CO2 input connector, software EPROM and screws. 2 Software Assembly - includes EPROM chip and last updated software version.
GLOSSARY OF TERMS BIT: Built in Tests. BTPS: Body Temperature, Pressure and Saturation Compensation. Where Body Temperature is assumed 37°C with vapor pressure 47mmHg The Calculations are made according to: PCO2 = FCO2 x (Pb - 47) Where: FCO2 is the Fractional concentration of CO2 in Dry gas, FCO2 = % CO2/100 Pb = the ambient pressure PCO2 = the partial pressure of CO2 at BTPS EPROM: Erasable Programmable Read Only Memory. ESD: Electrostatic Discharge.
