BCSI PH SAFE PH1000 Manual de usuario

pH SAFE

Reader

Model: BCSI pH1000

Operator Manual

Doc. No. 120001-09

Blood Cell Storage, Inc.

4203 23rd Ave W

Seattle, WA 98199 SA

MedEnvoy Global B.V.

Prinses Margrietplantsoen 33 - Suite 123

2595 AM The Hauge

The Netherlands

pH SAFE Reader Operator Manual - Doc. No. 120001-09

Table of Contents

1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

1.1 Intended Use ......................................................................... 1

1.2 Using this Manual ................................................................. 1

1.3 Warnings ............................................................................... 2

1.4 Precautions ........................................................................... 3

1.5 Informational Symbols ......................................................... 3

1.6 Limited Warranty .................................................................. 5

1.7 Trade Marks and Intellectual Property ................................ 6

2 System Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

2.1 Theory of Operation ............................................................. 7

2.2 Reader Components ............................................................ 8

2.3 Specifications ..................................................................... 10

3 Unpacking and Installation . . . . . . . . . . . . . . . . . . . . . . . 12

3.1 Unpacking ........................................................................... 12

3.2 Hardware Installation ......................................................... 12

3.2.1 Materials Required ...................................................................12

3.2.2 Procedure .................................................................................13

3.3 Software Setup ................................................................... 11

3.3.1 Configure pH SAFE Reader Options........................................11

4 Using the pH SAFE Reader Software. . . . . . . . . . . . . . . 14

4.1 Overview .............................................................................. 14

4.1.1 Power-On Self Check (SELF-CHK) ..........................................14

4.1.2 Run / Options Prompt ...............................................................15

4.1.3 Power Down .............................................................................15

4.2 Keypad Usage ..................................................................... 16

4.3 Bar Code Scanner Usage ................................................... 17

4.4 Software Security ............................................................... 17

4.4.1 Security Access to ‘Run Test’...................................................17

4.4.2 Security Access to ‘Options / System Settings’ ........................18

5 Run Test Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

5.1 Overview .............................................................................. 19

5.2 Security Access .................................................................. 19

5.2.1 Select/Enter User ID .................................................................19

5.2.2 Enter User PIN .........................................................................21

5.3 Enter Platelet Storage Bag ID ............................................ 22

5.4 Enter pHID ............................................................................ 23

5.5 Read pH ............................................................................... 24

5.6 Save/Print Test Results ...................................................... 25

5.6.1 Save pH................................................................................... 26

5.6.2 Print pH.....................................................................................27

5.6.3 Save & Print pH ........................................................................28

5.6.4 Discard Result ..........................................................................28

Table of Contents

pH SAFE Reader Operator Manual - Doc. No. 120001-09

5.7 Automatic Ethernet Results Upload ................................. 28

6 Using the Options Menu . . . . . . . . . . . . . . . . . . . . . . . . . 30

6.1 Overview .............................................................................. 30

6.2 Log Off User ........................................................................ 30

6.3 View Records ...................................................................... 31

6.3.1 pH Test Results List .................................................................31

6.3.2 Print Record?............................................................................32

6.3.3 Delete Record?.........................................................................33

6.4 Output Records .................................................................. 33

6.4.1 Select Records to Output .........................................................34

6.5 System Settings .................................................................. 37

6.5.1 System Menu............................................................................38

6.5.2 Supervisor PIN .........................................................................38

6.5.3 Set Clock ..................................................................................40

6.5.4 Enable User ID and PIN ...........................................................40

6.5.5 Edit User ID/PIN .......................................................................41

6.5.6 Erase Memory ..........................................................................42

6.5.7 Pack Memory............................................................................43

6.5.8 Ethernet Setup..........................................................................44

6.5.9 Read Ratio................................................................................46

6.5.10 Set QC Values........................................................................48

6.5.11 Set User Correction Values ....................................................49

6.5.12 Print Service Report ...............................................................49

6.5.13 Exit System Settings...............................................................50

6.6 Run QC Test......................................................................... 50

6.7 Exit Options ........................................................................ 50

7 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

7.1 Daily Fiber Optic Probe Tip Inspection ............................ 51

7.2 Quality Control Test ........................................................... 52

7.3 Routine Cleaning ................................................................ 54

7.4 Disposal Precautions .......................................................... 54

8 Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

8.1 BCSI Technical Support...................................................... 55

8.2 Error Messages ................................................................... 55

Appendix A Power-On Self Check (SELF-CHK) 57

A.1 pH SAFE Reader Calibration Self-Test.............................. 57

A.2 Real-Time Clock Test.......................................................... 57

A.3 Initialization of Ethernet Module 58

Appendix B Serial Port Results Upload 59

Appendix C Ethernet Setup 60

Chapter 1 Introduction

pH SAFE Reader Operator Manual - Doc. No. 120001-09 1

1 Introduction

1.1 Intended Use

The pH SAFE Reader (Sterile, Automated Fluoroscopic Evaluation) is an in

vitro diagnostic (IVD) medical device that provides a rapid, non-invasive method

to measure the pH of fluid contained in platelet storage bags. The pH SAFE

Reader (Model: BCSI pH1000) reports the pH at a temperature of 22°C.

Platelets collected in storage bags retain function over time. During storage of

platelets, the pH of the fluid in a platelet storage bag will change over time.

Regular pH monitoring of stored platelet units can be used to verify the quality

of platelet units before use in transfusion.

Current guidelines for acceptable pH range of stored platelets are established by

the Council of Europe, the International Society of Blood Transfusion (ISBT),

and the AABB. sers should refer to local protocols for additional guidance on

pH measurement.

The pH SAFE Reader is intended for use in hospital laboratories and blood

banks to monitor pH of platelet storage bags. Intended users are trained

laboratory and blood bank personnel; device is not intended for self-testing by

lay-users.

1.2 Using this Manual

Chapters in this manual provide comprehensive information describing the

technology and operation of the pH SAFE Reader:

Chapter 1 Introduction – (this chapter) contains introductory, safety, and

warranty information.

Chapter 2 System Description – contains a description about the principles of

the device technology, the components of the system, and the system

specifications.

Chapter 3 Unpacking and Installation – contains installation and setup

information.

Chapter 4 Using the pH SAFE Reader Software – contains a description of

the BCSI software application structure and detailed usage and configuration

information for all software features.

Chapter 5 Run Test Operation – contains instructions for performing the

specific tasks required for the typical daily use of the pH SAFE Reader.

Chapter 6 Using the Options Menu – contains procedures used to configure

and use functions available from the Options Menu.

Chapter 7 Maintenance – contains a description of the recommended

maintenance and quality control test procedures.

Chapter 8 Troubleshooting – contains BCSI Service and Technical Support

contact information and a list of possible error messages with a description of

the probable cause for each message and suggested resolution procedures.

1.3 Warnings

Chapter 1 Introduction

2 pH SAFE Reader Operator Manual - Doc. No. 120001-09

Appendix A Power-On Self Check (SELF-CHK)

Appendix B Serial Port Results Upload

Appendix C Ethernet Setup

1.3 Warnings

Conventions

Shock Potential when Power Improperly Applied

Ensure that the system is connected to a power receptacle that provides voltage

and current within the specified operating range. se of an incompatible power

source may produce electrical shock and fire hazards.

Shock Potential from Spilled Liquids

If liquid is spilled onto the instrument, fluid seepage into internal components

creates a potential shock hazard. If liquid is spilled onto the instrument,

disconnect power and clean/dry the instrument surfaces.

Do Not Remove Instrument Cover

The pH SAFE Reader contains no user-serviceable components. The

manufacturer warranty is voided if the instrument cover is removed.

Use only Supplied AC Power Adapter Cables for pH SAFE Reader and

Printer

A power adapter is supplied for specific use with the pH SAFE Reader. If the

optional Printer accessory will be used, an additional power adapter is also

supplied for specific use with the Printer.

DO NOT interchange the pH SAFE Reader and Printer AC power adapters.

Always ensure the proper supplied AC power adapter is used for each device.

Failure to do so may result in damage to the instrument and/or the Printer.

Ensure Instrument Power is OFF before connecting Bar Code Scanner

DO NOT connect the Bar Code Scanner to the pH SAFE Reader after the

instrument is turned ON. Doing so may result in damage to the Bar Code

Scanner.

This symbol indicates a potential hazard where misuse of the

system could result in damage to the equipment.

This symbol indicates a potential hazard where misuse of the

system could result in electric shock or fire.

1.4 Precautions

Chapter 1 Introduction

pH SAFE Reader Operator Manual - Doc. No. 120001-09 3

1.4 Precautions

Read the entire contents of this Operator Manual prior to using the pH SAFE

Reader.

Observe the following precautions when operating the pH SAFE Reader:

• nplug the instrument before cleaning.

• Clean only external surfaces using 70% ethanol or a mild detergent or non-

organic laboratory disinfectant and a damp cloth. DO NOT SE STRONG

BLEACH (> 0.1% solution) OR ORGANIC SOLVENTS!

• se only BCSI supplied or approved platelet storage bags with the pH

SAFE Reader.

• If the instrument is used in a manner not specified by the installation/

operation procedures included in this manual the safety protections

provided by the equipment may be impaired.

1.5 Informational Symbols

The following informational symbols are displayed on the pH SAFE Reader

and the pH SAFE Reader Quick Reference Guide.

Symbol Location Meaning

Bottom

Instrument Panel

CA TION: Electric Shock Hazard. Refer servicing to

qualified personnel. Consult accompanying documents.

|Power Switch

(Right Side Panel) On (Power Supply)

0Power Switch

(Right Side Panel) Off (Power Supply)

Quick Reference

Guide Power Switch with | (On) and o (Off)

Quick Reference

Guide

Put the pH sensor all the way onto the probe until a

click sound or feeling.

Quick Reference

Guide Inspect the probe for scrapings (see Chapter 7.1)

1.5 Informational Symbols

Chapter 1 Introduction

4 pH SAFE Reader Operator Manual - Doc. No. 120001-09

Symbol Location Meaning

Quick Reference

Guide

Ensure pH SAFE Sensor is aligned with fiber optic

probe on pH SAFE Reader. Avoid scraping the sensor

on the probe.

Quick Reference

Guide

Check the information on the pH SAFE Reader Screen

and the barcoded information for correct barcode

scanning or keyboard entry.

Quick Reference

Guide Save the pH Record

Quick Reference

Guide Print the pH Record via the RS 232 Serial Port

Quick Reference

Guide Delete the pH Record

1.6 Limited Warranty

Chapter 1 Introduction

pH SAFE Reader Operator Manual - Doc. No. 120001-09 5

1.6 Limited Warranty

Blood Cell Storage, Inc. (BCSI) warrants that, at the time of shipment, the

instrumentation provided to the customer is free from defects in material and

workmanship.

This limited warranty is conditioned upon the customer giving BCSI notice of

any defect within one (1) year after shipment. This limited warranty will not

apply if the instrumentation (a) has not been installed, used, or maintained in

accordance with applicable instructions and manuals; (b) has been repaired or

altered by unauthorized persons or misused, abused, accidentally damaged or

subjected to operation for which it was not intended; or (c) has had its serial

number altered or removed. This limited warranty does not apply to consumable

items. Except as expressly stated herein, BCSI makes no other warranties,

express or implied, including warranties of merchantability or fitness for

particular purpose.

nder this limited warranty, BCSI at its option, will repair or replace any

defective instrumentation. This is the sole remedy for any breach of warranty.

Any instrumentation to be returned for repair or replacement must be properly

packaged and shipped via prepaid freight in accordance with BCSI instructions.

This limited warranty does not apply to the use of the instrument other than as

described herein.

This limited warranty contains BCSI's sole obligation and liability related to the

customer's use of the BCSI products. .BCSI shall not be liable to the customer

for any other remedies of damages, including special, indirect, incidental, and

consequential damages, including, but not limited to, lost profits, whether based

upon warranty, strict liability, tort, contract or otherwise. This limited warranty

may not be changed in any way without the express written permission of BCSI.

Each provision of this agreement that provides for a limitation of liability,

disclaimer of warranties, or exclusion of damages is to allocate the risks between

the parties. This allocation is reflected in the pricing offered by BCSI to the

customer and is an essential element of the basis of the bargain between the

parties. Each of these provisions is severable and independent of all other

provisions of this agreement. The limitations in this section will apply

notwithstanding the failure of essential purpose of any limited remedy in this

agreement.

1.7 Trade Marks and Intellectual Property

Chapter 1 Introduction

6 pH SAFE Reader Operator Manual - Doc. No. 120001-09

1.7 Trade Marks and Intellectual Property

pH SAFE® and BCSI "…it's in the bag"® are registered S, Canadian and/or

European trademarks. The pH SAFE technology is covered by multiple issued

and pending S and International equivalent Patents including but not limited

to: S Pat. No. 7,608,460, 7,968,346, 8,148,167, 8,183,052, 8,497,134, 9,040,307,

9,062,205, 9,217,170; A Pat. No. 2005277258; JP Pat. No. 5017113; CN Pat.

No. ZL200580033961.1; IN Pat. No. 257667

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