RAPIDLab 348EX Analyzer

Certification
Data Sheet

Account Name Department

Date Serial Number

Performance
Printout set up
Perform 2 point calibration System Tests

Before Error conditions ..........................................................
Sample flow (#32)
Certification
Heater (#33)
Sensors ..............°C (36.8 to 37.2)
Pre-heater ..........°C (36.8 to 37.2)
Electrode mV Test System ...............°C
Cal Electrode Slope (Diff)
pH ...............mV (200 to 350) .......... mV (24.5 to 38.0)
Electronics (#34)
pCO2 .......... mV (-300 to +100)....... mV (12.8 to 20.6)
pO2 ............. pA (170-1700)............. pA (-100 to 200)
Roll printer (#35)
Na .............. mV (35 to 100)............ mV (4.7 to 6.8)
K ................ mV (35 to 100)............ mV (13.5 to 19.6)
Ca .............. mV (35 to 120)............ mV (6.2 to 10.5)
Cl ............... mV (30 to 130)............ mV (5.4 to 10.1)
Hct ............. mV (-10 to +10).......... mV (3 to 10)

Certification Assemblies Cleaned or Inspected Parts replaced

checklist
Manifold
Door & Contact
Reference cassette
Reagent tube cassette

Electrodes
Reference electrode
Probe and tubing kit
Sample tube cassette

Preheater
Sample probe carriage
Connecting tube kit
Probe protector

Drip tray
Pump rollers

Verify Quality Control

Alignment/ Level 1 Level 2 Level 3
Calibration Lot No. ...................... Lot No. ...................... Lot No. ......................
pH .......... .......... pH .......... .......... pH .......... ..........
pCO2 .......... .......... pCO2 .......... .......... pCO2 .......... ..........
pO2 .......... .......... pO2 .......... .......... pO2 .......... ..........
Na .......... .......... Na .......... .......... Na .......... ..........
K .......... .......... K .......... .......... K .......... ..........
Ca .......... .......... Ca .......... .......... Ca .......... ..........
Cl .......... .......... Cl .......... .......... Cl .......... ..........
Hct(A) .......... .......... Hct(B) .......... ..........
(Spec) (Actual) (Spec) (Actual) (Spec) (Actual)

Customer Review

Review Certification Data Sheet and Control Values with the Customer

Review any problems found and recommendations to avoid their future occurrence

Review stocks of consumables and make the necessary recommendations to correct any insufficiencies

Suggest or perform additional training as required

Comments ______________________________________________________________________________________
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Next certification due date Engineer Customer

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 RAPIDLab 348EX Certification Process

1. Introduction

The objective of the certification process is to optimise system performance and minimise
system downtime by regular inspection and maintenance of the system, using the procedures
and parts contained in the 348Ex Visit Kit.

The frequency of certification inspections is based on sample volume, routine maintenance

performed, and the environment where the analyzer is operated. For the average usage and
typical operating conditions, the certification should be carried out yearly.

Certification inspections do not replace the routine maintenance described in the Operator’s
Manual.

Note: When carrying out this procedure, follow the Biological Guidelines contained in
Appendix A of the Operator’s Manual.

2. Parts and Supplies Required

Visit Kit parts (Part number 106987)

Description Part No.

Sample and Reagent pump tubing kit 105673
248 Reagent pump tube kit 673257
Probe and Tubing kit 107275
Bottle tubing kit 105672
Probe protector 673373
Preheater kit 105671
Drip Tray 673255
Electrode fill solutions - Na/K/Ca/Cl 478535
Electrode fill solutions - pH 478533
Electrode fill solutions - Ref 478498
Deproteinizer 105610
Conditioner 478701
Activated Gluteraldehyde 673390

Standard Tools and Equipment

Standard tool kit

Vacuum cleaner

Documentation

348Ex Operators Manual

348Ex Service Manual

DPBG-A05.831.01.02.02 2
 continued

Laboratory Supplies

De-ionized water
Quality control material: - 3 levels of gases/electrolytes
- 2 levels of Hematocrit

3. Certification procedure

3.1 Print the set-up report (#67)

3.2 Perform a 2pt calibration (#12)

3.3 Perform the Electrode millivolt test

3.3.1 Run 7.3 buffer (#311). Note the electrode output levels on the data sheet.

3.3.2 Run 6.8 buffer (#312). Note the differences between the 7.3 and 6.8 buffer
levels on the data sheet.

3.3.3 Run Cal Gas (#313). Note the electrode output levels on the data sheet.

3.3.4 Run Slope Gas (#314). Note the differences between the cal and slope gas
levels on the data sheet.

3.4 Perform system tests

3.4.1 Perform sample flow test (#32). Aspirate de-ionised water. Check each
detector reacts correctly.

3.4.2 Perform heater test (#33). Note the temperatures on the data sheet. The
system temperature should be typically around 6°C higher than ambient.

3.4.3 Perform electronics test (#34). Verify that all tests are OK.

3.4.5 Perform printer test (#35). Verify that correct test pattern is printed out.

3.5 Power off maintenance

3.5.1 Unplug the power cord. Remove reagents and waste bottle.

3.5.2 Remove the rear panel. Check the area around the fan for dust accumulation.
Remove with vacuum cleaner. Check all interconnecting plugs/sockets are
secure. Replace the rear panel.

3.5.3 Remove probe and tubing, probe protector, sample pump tube and reagent
pump tube. Remove bottle connecting tubing.

Refill all refillable electrodes. Replace reference cassette. Remove probe

housing, check for leaks and cracks. Replace if necessary. Check probe

DPBG-A05.831.01.02.02 3
 housing moves smoothly on its guide rod. Apply a small quantity of silicon
grease.

continued

Remove both rotors. Dispose of old end caps. Clean and grease rollers. Fit
new end caps and replace.

Replace probe and tubing kit, probe protector, sample and reagent pump tubes.
The 348 Reagent pump tube cassette should be used when reagents are left on
the instrument for 15-21 days. If the reagents are used within 14 days then the
248 cassette should be used.

Clean drip tray using disinfectant. Check both gas vent hole and waste exit
hole are clear. Check condition of manifold for leaks. Replace if necessary.

Replace bottle tubing.

Replace reagents. Empty waste bottle and replace.

3.6 Verify Performance

3.6.1 Reconnect power cord. Allow instrument to complete warming-up cycle.

When complete select the Maintenance menu and prime the hydraulics (#23).

3.6.2 Perform Deproteinize (#21) and Condition cycles (#22).

3.6.3 Allow instrument to calibrate. Once stable measure QC samples and record
the results on the data sheet.

4. Customer Review

4.1 Review the certification data sheet and control values with the customer.

4.2 Review any problems found and make recommendations to avoid future occurrences.

4.3 Review stocks of consumables and make any necessary recommendations.

4.4 Suggest or perform additional training as required.

DPBG-A05.831.01.02.02 4