Helmer IBX020 Manuel utilisateur

HELMER SCIENTIFIC

14400 Bergen Boulevard

Noblesville, IN 46060 USA

PH +1.317.773.9073

FAX +1.317.773.9082

USA and Canada 800.743.5637

ISO 13485 CERTIFIED

360203-1/B

Compartmental AccessRefrigerator - iBX020

Service & Maintenance Manual

360203-1/B i

Document History

Revision Date CO Supersession Revision Description

A 20 NOV 2015* 11330 n/a Initial release.

B 16 NOV 2022* 16980 B supersedesA Updated image and caption in Model and Input Power section.

Updated CE mark on cover and Compliance section.

* Date submitted for Change Order review. Actual release date may vary.

Notes and Disclaimers

Condential / Proprietary Notices

Use of any portion(s) of this document to copy, translate, disassemble or decompile, or create or attempt to create

by reverse engineering or otherwise the information from Helmer Scientic products is expressly prohibited.

Disclaimer

This manual is intended as a guide to provide the operator with necessary instructions on the proper use and

maintenance of certain Helmer Scientic products.

Any failure to follow the instructions as described could result in impaired product function, injury to the operator

or others, or void applicable product warranties. Helmer Scientic accepts no responsibility for liability resulting

from improper use or maintenance of its products.

The screenshots and component images appearing in this guide are provided for illustrative purposes only, and

may vary slightly from the actual software screens and/or product components.

Document Updates

The document is furnished for information use only, is subject to change without notice and should not be

construed as a commitment by Helmer Scientic. Helmer Scientic assumes no responsibility or liability for any

errors or inaccuracies that may appear in the informational content contained in this material. For the purpose of

clarity, Helmer Scientic considers only the most recent revision of this document to be valid.

360203-1/B ii

Notes and Disclaimers ...............................................i

Section I: General Information........................................5

1 About this Manual ..........................................................5

1.1 Intended Audience. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

1.2 Model References......................................................................5

1.3 Copyright and Trademark ................................................................5

2 Safety ....................................................................5

2.1 Safety Denitions ......................................................................5

2.2 Product Labels ........................................................................6

2.3 Avoiding Injury.........................................................................6

3 Compliance................................................................7

3.1 Regulatory Compliance..................................................................7

3.2 WEEE Compliance .....................................................................7

3.3 Electromagnetic Compliance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

3.4 Manufacturer..........................................................................7

4 Model and Input Power ......................................................8

Section II: Installation & Conguration ................................9

5 Location Requirements......................................................9

6 Install Components .........................................................9

6.1 Packing List...........................................................................9

6.2 Place Compartmental Access Refrigerator ...................................................9

6.3 Connect External Monitoring Devices .......................................................9

6.4 Connect AC Power Cord and Ethernet Cable for Kiosk ........................................10

6.5 Connect AC Power Cord for Compartmental Access Refrigerator ................................10

6.6 Connect Backup Power.................................................................11

7 Prepare For Monitoring ....................................................12

7.1 Temperature Probes ...................................................................12

7.1.1 Air Probe .....................................................................12

7.1.2 Primary Probe .................................................................12

7.1.3 Condenser Probe...............................................................12

7.1.4 Control Probe..................................................................12

7.1.5 Install Additional Probe Through Rear Chamber Access Panel............................13

7.2 Stand-Alone Chart Recorder (Optional) ....................................................13

Contents

360203-1/B iii

8 i.C³®Control System .......................................................13

8.1 Home Screen and HaemoBank™ Screensaver ..............................................13

8.1.1 Home Screen Functions..........................................................14

8.2 Alarm Reference ......................................................................14

8.3 Settings .............................................................................15

8.3.1 Temperature Settings............................................................15

8.4 Sensor Calibration.....................................................................16

8.4.1 View Sensor Calibration Values ....................................................16

8.4.2 Change Sensor Calibration O󰀨set Values ............................................16

8.5 Factory Default Settings ................................................................17

8.6 Restore Factory Default Settings .........................................................18

8.7 View System Information................................................................18

Section III: Maintenance & Service...................................19

9 Maintenance ..............................................................19

9.1 Alarm Tests ..........................................................................19

9.1.1 Automatic Chamber Temperature Alarm Test..........................................19

9.1.2 Manual Chamber Alarm Test ......................................................20

9.1.3 Power Failure Alarm Test .........................................................21

9.1.4 Door Open Alarm Test ...........................................................21

9.2 Upgrade System Firmware ..............................................................21

9.3 Test and Replace i.C3Monitoring System / Access Control Backup Battery.........................21

9.3.1 Replace the i.C3Monitoring System / Access Control Backup Battery ......................22

9.4 Check Probe Bottle ....................................................................22

9.5 Inspect and Secure Electrical Wiring and Terminals...........................................23

9.6 Clean the Compartmental Access Refrigerator...............................................24

9.6.1 Compartmental Access Refrigerator Condenser Grill ...................................24

9.6.2 Compartmental Access Refrigerator Exterior..........................................24

9.6.4 Compartmental Access Refrigerator Interior ..........................................24

9.6.5 Door and Panel Gaskets .........................................................25

9.6.6 Clean the Tray Assembly .........................................................25

9.6.7 Clean Probe Bottle and Rell Solution ...............................................25

9.6.8 i.C³®Touchscreen...............................................................25

9.7 Bypass System Check and Reset.........................................................26

10 Service ..................................................................26

10.1 Refrigerant Charge ....................................................................26

10.2 Replace Chamber LED Lamp Strip........................................................26

10.3 Maintaining Tray Assembly ..............................................................27

10.3.1 Remove and Install a Tray and Cover ...............................................27

10.3.2 Replace Tray Bumpers...........................................................28

360203-1/B iv

Section IV: Troubleshooting ........................................29

11 Troubleshooting...........................................................29

11.1 Compartment Access Circuit Boards and Sensors Diagnostic References .........................29

11.1.1 IRACS Horizontal Circuit Board LED Indicators........................................29

11.1.2 Check Circuit Board Status .......................................................29

11.1.3 Check Proximity Sensor Status ....................................................30

11.1.4 Check Solenoid Status...........................................................30

11.1.5 Check Voltage Conversion Status ..................................................31

11.1.6 IRACS Addresses...............................................................31

11.1.7 Power Distribution and Steering (PDAS) Circuit Status..................................32

11.2 Initiate Diagnostic Mode ................................................................33

11.3 Network Communications Reference Guide.................................................34

11.3.1 BloodTrack®Interface............................................................34

11.4 General Operation Problems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

11.5 Chamber Temperature Problems .........................................................35

11.6 i.C3Alarm Activation Problems ...........................................................38

11.7 Testing Problems......................................................................39

11.8 Condensation Problems ................................................................40

11.9 Access Control Lock Problems ...........................................................40

11.10 Compartment Assembly Problems ........................................................41

Section V: Parts & Schematics ......................................42

12 Parts ....................................................................42

12.1 Front ...............................................................................43

12.2 Front Interior .........................................................................44

12.3 Control System and Display .............................................................45

12.5 Compartmental Access Components ......................................................46

12.6 Rear Exterior .........................................................................47

12.7 Rear Interior .........................................................................48

12.8 Refrigeration Components ..............................................................49

12.9 Unit Cooler ..........................................................................49

13 Compartmental Access Refrigerator Schematics................................50

360203-1/B 5

General Information

Section I: General Information

1 About this Manual

1.1 Intended Audience

This manual is intended for use by end users of the iBX020 Compartmental Access Refrigerator. For information

on how to use the BloodTrack Courier®software which runs on the BloodTrack®Kiosk and provides blood product

management to the HaemoBank™, please refer to the BloodTrack Courier®User Guide (part number 113463-IE).

1.2 Model References

The Compartmental Access Refrigerator becomes a HaemoBank™ after the refrigerator is attached to a kiosk

running the BloodTrack Courier®software. References are used throughout this manual to denote the individual

components of the HaemoBank™. The iBX020 component is referenced as CompartmentalAccess Refrigerator.

1.3 Copyright and Trademark

Helmer®, i.Series®, i.C³®, and Rel.i™ are registered trademarks or trademarks of Helmer, Inc. in the United States

of Haemonetics Corporation in the United States and /or other countries. All other trademarks and registered

trademarks are the property of their respective owners.

Helmer, Inc., doing business as (DBA) Helmer Scientic and Helmer.

2 Safety

The operator or technician performing maintenance or service on Helmer Scientic products must (a) inspect the

product for abnormal wear and damage, (b) choose a repair procedure which will not endanger his/her safety,

the safety of others, the product, or the safe operation of the product, and (c) fully inspect and test the product to

ensure the maintenance or service has been performed properly.

2.1 Safety Denitions

The following general safety alerts appear with all safety statements within this manual. Read and abide by the

safety statement that accompanies the safety alert symbol.

WARNING The safety statement that follows this safety alert symbol indicates a hazardous situation which, if not avoided,

could result in serious injury.

CAUTION The safety statement that follows this safety alert symbol indicates a hazardous situation which, if not avoided,

could result in minor or moderate injury.

NOTICE The safety statement that follows this safety alert symbol indicates a situation which, if not avoided, could result

in damage to the product or stored inventory.

360203-1/B 6

General Information

2.2 Product Labels

Caution: Risk of damage to equipment

or danger to operator Caution: Unlock all casters

Caution: Hot surface Earth / ground terminal

Caution: Shock/electrical hazard Protective earth / ground terminal

Consult instructions for use

2.3 Avoiding Injury

► Review safety instructions before installing, using, or maintaining the equipment.

► Before moving unit, ensure door(s) is closed and casters (if installed) are unlocked and free of debris.

► Before moving unit, disconnect the AC power cord and secure the cord.

► Never physically restrict any moving component.

► Avoid removing electrical service panels and access panels unless so instructed.

► Keep hands away from pinch points when closing the door.

► Avoid sharp edges when working inside the electrical compartment and refrigeration compartment.

► Avoid staring into the tray illumination LEDs for extended periods of time as eye injury may occur.

► Ensure grill panel is installed above compartment assembly to prevent biological materials from being

improperly stored.

► Ensure biological materials are stored at recommended temperatures determined by standards, literature,

or good laboratory practices.

► Proceed with caution when adding and removing samples from the refrigerator.

► Use manufacturer supplied power cord only.

► Using the equipment in a manner not specied by Helmer Scientic may impair the protection provided by

the equipment.

► Decontaminate parts prior to sending for service or repair. Contact Haemonetics®Corporation

BloodTrack®Customer Support (877.996.7877) or your distributor for decontamination instructions and a

Return Authorization Number.

► Ensure biological materials are stored safely, in accordance with all applicable organizational, regulatory,

and legal requirements.

► The refrigerator is not considered to be a storage compartment for ammable or hazardous materials.

► Use caution when moving a stacked conguration.

360203-1/B 7

General Information

3 Compliance

3.1 Regulatory Compliance

Pollution degree: 2 (for use in USA and Canada only)

This product is certied to applicable UL and CSA standards by a NRTL.

This device complies with the requirements of directive 93/42/EEC concerning

Medical Devices, as amended by 2007/47/EC.

Sound level is less than 70 dB(A).

EC REP Emergo Europe

Prinsessegracht 20

2514 AP The Hague

The Netherlands

3.2 WEEE Compliance

The WEEE (waste electrical and electronic equipment) symbol (right) indicates compliance

with European Union Directive WEEE 2012/19/EU and applicable provisions. The directive

sets requirements for the labeling and disposal of certain products in a󰀨ected countries.

When disposing of this product in countries a󰀨ected by this directive:

► Do not dispose of this product as unsorted municipal waste

► Collect this product separately

► Use the collection and return systems available locally

For more information on the return, recovery, or recycling of this product, contact your local distributor

3.3 Electromagnetic Compliance

This device is suitable for use in a specic electromagnetic environment. The end user of this device is

responsible for ensuring the device is used in compliance with the following European Union directives and

standards regarding EMC (electromagnetic compliance):

EMC Directive 2004/108/EC

► EN 55011:2015 ► EN 61000-3-3:2013

► EN 61000-3-2:2014 ► EN 61326-1:2013

3.4 Manufacturer

Helmer Scientic is the manufacturer as dened in 93/42/MDD of the iBX020 and for which the CE mark on the

cover of this manual applies.

Haemonetics Corporation is the manufacturer as dened in 93/42/MDD of the BloodTrack Courier®software and

maintains sole responsibility for placing the HaemoBank™ in its nal conguration on the market.

360203-1/B 8

General Information

4 Model and Input Power

Model Voltage Frequency Power Current Draw

iBX020 100 - 230V 50 Hz/60 Hz 0.26 kW 5 A

7 A (w/ Kiosk)

The iBX020 information is displayed on the product specication label located on the left side of the Compartmental

Access Refrigerator toward the lower rear of the unit. The model information is also displayed on a label in the

chamber on the upper right side wall.

Sample Product Specication Label

(For illustration only: regulatory information and other content shown here may dier from that on the equipment label)

Label Description

A Model (REF)

B Serial number

C Version

D Power Requirements

360203-1/B 9

Installation & Conguration

Section II: Installation & Conguration

5 Location Requirements

► Has a grounded outlet meeting the electrical requirements stated on the product specication label.

► Meets the limits specied for ambient temperature (15 °C to 32 °C) and relative humidity (80% for

temperatures up to 31 °C, decreasing linearly to 50% at 40 °C).

► Is clear of direct sunlight, high temperature sources, heating vents, and air conditioning vents.

► For counter top installation, must have a minimum 30” (763 mm) depth and ability to safely support a

minimum 550 pounds (249 kg).

► For undercounter installation, must have a clearance of (w x h) 30.25” x 34.25” (768 x 870 mm).

6 Install Components

To prevent tipping:

► ensure doors are closed before moving the refrigerator and casters (if installed) are unlocked.

► do not sit, lean, push or place heavy objects on upper door ledge.

► do not use open door as leverage to assist in standing.

6.1 Packing List

Included on skid with refrigerator:

• Spare parts kit (optional)

• Chart recorder (optional; box will include chart recorder paper)

• Wall mount kit (optional)

• Stacking kit (optional)

6.2 Place Compartmental Access Refrigerator

NOTE Pliers may be useful when unlocking and locking casters if installed on the Compartmental Access Refrigerator.

1 Remove the Compartmental Access Refrigerator from the shipping carton.

2 Remove and discard the interior packing material.

3 Remove the accessory package from above the Compartmental Access Refrigerator.

4 Remove all materials from the accessory package and le them in a secure location.

5 Ensure doors are closed and casters (if installed) are unlocked

6 Position refrigerator in place and lock casters (if installed).

7 Ensure refrigerator is level.

8 Ensure trays are locked in place inside compartments.

6.3 Connect External Monitoring Devices

► The interface on the remote alarm monitoring system is intended for connection to the end user’s central alarm system(s)

using normally-open or normally-closed dry contacts.

► If an external power supply exceeding 30 V (RMS) or 60 V (DC) is connected to the remote alarm monitoring system’s

circuit, the remote alarm will not function properly; may be damaged; or may result in injury to the user.

Required tools:

► #2 Phillips screwdriver

► Cable tie

The remote alarm interface is a relay switch with three terminals:

► Common (COM)

► Normally Open (NO)

► Normally Closed (NC)

The terminals on the remote alarm interface have the following maximum load capacity:

► 0.5 A at 30 V (RMS); 1.0 A at 60 V (DC)

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