Spot Vital Signs 4200 Training Binder April 2008

4200 (SPOT) Vital Signs

Versions

PRODUCT ACCESSORIES • Nellcor SPO2 sensor, DS-100A • Nellcor extension cable, DEC-4 / 8 • NIBP Cuff and tubing • 9ft or 4ft Temperature probe • Stand

BATTERY PACK PART NO. 4200-84

TEMPERATURE MODULE PART NO.

DISPLAY MODULE PART NO. 421020-501

SPOT EXTENSIONS MODULE PART NO. 421267-501

NELLCOR SATS MODULE PART NO. 703444

SPOT KEYAPD PART NO. 703430

BREAKDOWN DIAGRAM

COMMON ERROR CODES ERROR CODE

DESCRIPTION

RECTIFICATION

C02

Auto-zero failure

Calibrate NIBP

C03

Inflation too rapid

Incorrect cuff size

C04

Excessive inflation time

Leaky cuff / Internal

C05

Excessive noise

Minor cuff / internal leak

E10

Over pressure violation

Calibrate NIBP / Replace extensions PCB

E32

Factory EEPROM checksum

New extensions PCB installed, set Serial No.

E38

Real time clock failure

Low/disconnected battery, reset date and time

E7

Internal malfunction

Replace SpO2 module

C8

Bad sensor

Replace SpO2 sensor / extension cable

BIOMEDICAL MODE SOFTWARE 1 VERSION

BIOMEDICAL MODE SOFTWARE 2 VERSION

BIOMEDICAL MODE NIBP CALIBRATION CHECK

BIOMEDICAL MODE NIBP PRESET TARGET PRESSURE

BIOMEDICAL MODE BACKLIGHT ON/OFF

BIOMEDICAL MODE NIBP MEAN ARTIRIAL PRESSURE ON/OFF

BIOMEDICAL MODE DATE SETTINGS

BIOMEDICAL MODE TIME SETTINGS

BIOMEDICAL MODE TEMPERATURE MODE

BIOMEDICAL MODE BLOOD PRESSURE UNITS

BIOMEDICAL MODE BATTERY VOLTAGE

BIOMEDICAL MODE NUMBER OF NIBP CYCLES

Software

Calibrate NIBP ZERO •

Unit must be in Biomed Mode, (Turn Off hold white keys down and turn on)

Calibrate NIBP

Calibrate Battery Voltage

Results

Button Test • Normal Mode

QUESTIONS

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3 Functional overview This functional verification procedure helps to confirm the proper operation of the Spot Vital Signs and options. This procedure supports the requirements of routine preventative maintenance. It is not necessary to disassemble the Spot Vital Signs to perform this procedure. For the calibration procedures, see “Calibration” on page 25. If the Spot Vital Signs fails certain functional tests or a circuit board is replaced, the device may require calibration. It is necessary to disassemble the Spot Vital Signs for calibration. Always perform this functional verification procedure after performing any calibration. This procedure contains additional tests that are not included in calibration procedures.

Power on/off and system check procedure Press the Power button to turn the device on or off. Upon each power up, all the LCD segments in each display turn on briefly and two beeps sound. If the internal self-check is successful, the display shows its normal functions (see page 15) and the device is ready for operation. If the self-check fails, an error code is shown in the on the display. To turn the unit off, press the Power button. Note

Turning the unit off erases measurement data.

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Functional overview

Welch Allyn Spot Vital Signs

Internal configuration mode You can change several device operating parameters in the Internal Configuration Mode. When changed, these settings become the default power-up settings. You will also see non-changeable device configurations for technical service purposes. To enter the Configuration Mode: 1.

Turn the Spot Vital Signs off.

2. Press and hold the Power - Blood Pressure Start/Stop buttons. The device enters the Internal Configuration Mode and displays the software version. 3. Press the Mode button to cycle through the Internal Configuration menu until you see the menu option displayed on the screen. 4. Use the Next Patient/Clear/Cancel or Blood Pressure Start/Stop button to change the default setting. 5. Press the Mode button once to save the change and press the Power button to exit the Internal Configuration Mode. Table 3. Configuration Menu Options Setting

Description

Blood Pressure Calibration Displays “Cal”

Prepares the Spot Vital Signs for calibration. Only qualified personnel should verify the Spot Vital Signs blood pressure calibration. For more details, see “Blood pressure calibration” on page 27.

Inflation Pressure Preset Level 120, 140, 160, 180, 200, 240, 280 mmHg. Factory default is 160 mmHg. Displays “PrP” Pressure Preset Level Displays “PrP“

On or off. Disables or enables the front panel Pressure Preset button.

Backlight Displays “BLT”

On or off.

Mean Arterial Pressure Displays “MAP”

On or off.

Date/Time

Changes or updates the actual date and time.

Temperature Scale Displays “TMP MOD”

Fahrenheit (°F) or Celsius (°C) Normal Mode / Fahrenheit (°F) or Celsius (°C) Monitor Mode

Blood Pressure Units Displays “BP”

mmHg or kPa.

Battery Readings Displays “BAT”

Displays the total battery voltage.

Battery Life Displays “LFE”

Total number unit measurements. Displayed information only; operator cannot change.

Service Manual

Functional overview

21

Functional verification Complete all steps in this section before returning a Spot Vital Signs for service. Verify that the pressure meter used (if not specified by this service manual) is calibrated and the calibration certificate of the meter is traceable to NIST. The pressure meter testing the Spot Vital Signs must have an accuracy of better than 3 mmHg. Subtract the rated accuracy of the pressure measurement standard from the 3 mmHg rated accuracy of Spot Vital Signs. This is the pass/fail criteria to determine if the device is within calibration. If the differences between Spot Vital Signs and the pressure measurement standard are within the pass/fail criteria at all specified pressures, then the device is within calibration. All test specifications are found in Appendix A. 1.

Use the pneumatic tubing to connect the Spot Vital Signs to the test station (page 26). Disconnect the battery and connect the power supply. Verify the IR Data Interface is free from obstacles.

2. Open the Spot Vital Signs repair software and verify the computer is communicating with the Spot Vital Signs. 3. Hold down the Blood Pressure Start/Stop button while powering on the Spot Vital Signs. The Spot Vital Signs enters the configuration test mode. After the LCD displays the software versions press the Mode button to display CAL. Spot Vital Signs automatically performs an auto zero. 4. Attach a pneumatic clamp to the 100 cc and the 250 cc cylinder and then remove the clamp from the 500 cc cylinder. 5. Select Test/Calibration on the computer screen. The dialog box displays the Spot Vital Signs manometer and battery readings and the valve and pump status. To verify the blood pressure calibration: 1.

Push the Spot Vital Signs Blood Pressure Start/Stop button to close the valve.

2. Pump the hand bulb to the set the pressures: 0 mmHg, 50 5 mmHg, 150 5 mmHg, 250 5 mmHg. Verify each pressure is within 3 mmHg of the target pressure (except for 0 mmHg which should be within 1.0 mmHg). 3. Press the Mode button until the LCD window reads “bat.” To verify the voltage reading: 1.

Set the power supply to 5.6 (+0.3 / -0.0 Vdc).

2. Verify that the voltage reading meets the test specification. 3. Return the power supply to 6.5 Vdc (+0/- 0.25 Vdc) upon completion of this test. 4. Select OK to exit the Test Calibration dialog box.

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Functional overview

Welch Allyn Spot Vital Signs

NOTE: The pass/fail criteria for the blood pressure calibration check depends upon the accuracy of the pressure measurement standard used. •

•

If the pressure measurement standard used is rated with an accuracy of ±0.1 mmHg, the pass/fail criteria is ±2.9 mmHg in order to guarantee that the instrument under test is within ±3 mmHg of NIST. If the pressure measurement standard used is rated with an accuracy of ±1.0 mmHg, the pass/fail criteria is ±2.0 mmHg in order to guarantee that the instrument under test is within ±3 mmHg of NIST

Temperature functional check The 9600 Plus Calibration Tester takes approximately 20 minutes to heat to the lowest setting. When testing several thermometers at all three temperatures, it is recommended to test all probes at one Calibration Set Point Temperature before proceeding to the next Calibration Set Point Temperature. To further expedite testing start at the lowest Calibration Set Point Temperature. The 9600 Plus Calibration Tester does not have an internal fan, this causes a longer cool down time than warm up time. Refer to the 9600 Plus Calibration Tester Directions for Use manual for specific information regarding the LCD window or the control buttons. 1.

Choose the proper mains plug insert and slide it over the two prongs in the power converter.

Figure 4. Power Adapter and Mains Plug Inserts Two prongs in the power adapter

US

UK

AUS

EU

2. Plug the power adapter into the 9600 Plus Calibration Tester (Figure 4) and the opposite end into a wall outlet. 3. Place the 9600 Plus Calibration Tester on a level surface away from sunlight, drafts, and other sources of heat or cold. 4. Observe the Set Point Mode in the upper left hand corner of the LCD display. If the unit displays a "D", it is in Default Mode and will heat to the lowest Set Point Temperature. If you do not want to conduct testing at this Set Point Temperature, press and hold the Temperature Selection button to select the desired setting. The temperature display will flash before staying on continuously to indicate the 9600 Plus Calibration Tester has stabilized and is ready for use.

Service Manual

Functional overview

23

To begin functional verification of the SureTemp thermometer: Caution Store thermometers for testing in the same room as the 9600 Plus Calibration Tester for approximately 30 minutes prior to testing to allow for thermal accommodation.

1.

Remove the probe from the probe well and clean it with either a 70% isopropyl alcohol solution, a 10% chlorine bleach solution, or a non-staining disinfectant. Let the probe air dry. Do not apply a probe cover.

2. Place the thermometer in Monitor Mode, refer to the thermometer’s Operator's Manual. 3. Insert the probe into the Thermistor Device Port.

4. Wait for approximately one minute or until temperature on the thermometer is stable for ten seconds. Compare the thermometer's temperature reading to the 9600 Plus Calibration Set Point Temperature. If the temperatures are within ±0.1° C (±0.2° F), the thermometer is within calibration. 5. Test all available thermometers for calibration verification at the current Calibration Set Point Temperature. Proceed to the next Calibration Set Point Temperature, see “Changing the calibration set point temperature” on page 23.

Changing the calibration set point temperature To scroll from one set point to the next, press and hold the Temperature Selection button until a beep is heard. The newly selected set point appears in the upper left corner of the LCD display. The device’s current temperature is displayed, starts to flash, and continues flashing until the cavity reaches the equilibrium at the new set point.

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Functional overview

Welch Allyn Spot Vital Signs

SpO2 functional check There is no way to change the functionality of the SpO2 module. If the SpO2 is not functioning properly, contact Technical Service.

Masimo This section applies to Version 2 only. Use the Masimo Tester to perform to functionally check the Masimo sensors. 1.

Orient the Masimo extension cable such that the DB-9 connector connects to the SpO2 connector on Spot Vital Signs. Connect the opposite end of the extension cord to the Masimo Tester (part number 11593).

2. Power on Spot Vital Signs and confirm the SpO2 reading in the Display Window is 81%± 3% and the pulse reading is 61 bpm ± 1 bpm. If the reading is outside the range, contact Welch Allyn Technical Service. 3. Place the thumb and index finger on the gray buttons on either side of the Masimo Tester connector, press the buttons firmly, and gently pull to remove the tester.

Nellcor Nellcor MP205 SpO2 module This section applies to Version 1 only. Use a Nellcor-approved SpO2 simulator (SRC-2 ) to check the SpO2 functionality. 1.

Confirm the settings of the simulator:

• Rate: 112 • Light: High 1 • Modulation: High • RCAL Mode: RCAL63/local 2. Connect the Nellcor SpO2 simulator test cable to the Spot Vital Signs. 3. Verify the Spot Vital Signs reading meets the requirements of the Repair Test Specification in Appendix C. 4. Reconnect the SpO2 sensor. Place the sensor onto your finger and check Spot vital Signs for a reading. Nellcor MP506 and Nell-3 SpO2 modules Use a Nellcor-approved SpO2 simulator (SRC-MAX ) to check the SpO2 functionality. 1.

Confirm the settings of the simulator:

• HR: 60 and 200 • SpO2%: 75 and 90 2. Connect the Nellcor SpO2 simulator test cable to the Spot Vital Signs. 3. Verify the Spot Vital Signs reading meets the requirements of the Repair Test Specification in Appendix A. 4. Reconnect the SpO2 sensor. Place the sensor onto your finger and check Spot Vital Signs for a reading.

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4 Calibration This chapter provides procedures to perform all adjustments required to calibrate the Spot Vital Signs to conform to Welch Allyn specifications. Calibration requires qualified personnel to open the device housing. WARNING Electric shock hazard. There are no user-serviceable parts inside Spot Vital Signs other than battery replacement (see “Battery removal and replacement” on page 70). An operator may only perform maintenance procedures specifically described in this manual. For service, refer the device to an Authorized Service Center. Note

Always disconnect the sealed lead-acid battery in the Spot Vital Signs before performing any calibration function.

Gather the tools listed on page 39 to have available during the procedures.

Connections 1.

Connect the blood pressure pneumatic tubing to the Spot Vital Signs and to the test station (part number 401028).

2. Connect the IR Data Interface cable to the computer. 3. Start the Spot Vital Signs repair software on the computer. 4. Remove the battery and connect the power supply to the Spot Vital Signs. 5. Confirm the IR Data Interface is not obstructed.

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Calibration

Welch Allyn Spot Vital Signs

Figure 5. Connect Diagram

Part Number 401028

100 ml Vol

250 ml Vol

200 ml Vol

mmHg

500 ml Vol MODE

CALIBRATION RAT RA T

MasimoSET.

Spot Vital Signs

C

Service Manual

Calibration

27

Voltage calibration 1.

Follow the steps in “Connections”.

2. Adjust the power supply to 5.6 Vdc ±0.1 Vdc (+0.3/-0.0 Vdc). 3. Hold down the Blood Pressure Start/Stop button while powering up to enter the "configuration test mode". After the software versions are displayed, press the Mode button until the Spot Vital Signs displays "BAT" in the LCD window. 4. Select Calibrate > Voltage in the repair software. The Spot Vital Signs display window goes blank. 5. Read the voltage on the digital multi-meter (DMM) connected to the power supply. 6. Type the voltage reading in the Calibrated Voltage box and select Update. 7.

Enter your initials in the Calibration Signature field to complete the voltage calibration. and select OK. The voltage on the LCD display matches that of the DMM.

Blood pressure calibration 1.

Follow the steps in “Connections” on page 25.

2. Adjust the power supply to 6.5 Vdc (+0/- 0.25 Vdc). 3. Hold down the Blood Pressure Start/Stop button while powering up to enter the "configuration test mode". After the software versions are displayed, press the Mode button until the Spot Vital Signs displays "CAL" in the LCD window. 4. Select the Calibrate > Manometer on the computer. 5. Verify the valve is “open” and select Calibrate 0. 6. Press the Blood Pressure Start/Stop button to close the valve and verify the 500 cc cylinder is the only volume in the system. 7.

Increase the pressure to 250 mmHg ±5 mmHg using the bulb and valve.

8. Use the bulb and the calibrated digital pressure meter to manually inflate the device to 200 mmHg and enter the pressure meter reading from Spot Vital Signs in the Calibration Gain text field. 9. Place the cursor into the box below the Calibrate 0 button and type in the value of the pressure reading seen on the pressure meter. Select Calibrate 250.