NIRO-200NX Instruction Manual Ver 3.02E April 2014

NIRO-200NX INSTRUCTION MANUAL

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HAMAMATSU PHOTONICS K.K.

NIRO-200NX INSTRUCTION MANUAL

1.

Safety Precautions

1-1

Indication of the Symbols

The symbols shown below are used for this system

Power On/Off

Equipotentiality Danger: High Voltage

Start/Stop

(Labeled inside Display Unit) Ground

Battery Power Indicator

(Labeled inside Display Unit)

Battery Charging Indicator

Type B applied part

Alarm On

Type BF applied part

Alarm Off

Alternating Current

Menu

Attention

Output

Event Legal manufacturer for the

Input

1010

European Union

Input / Output

Year of manufacture

Digital Signal

Authorized representative for the European Union CE mark indicating conformity with EU Directive 93/42/EEC

Analog Signal

0120 – Notified Body No. “ON” for AMP Unit only Serial number “X1 X2 X3 X4 X5 X6”

9.6 V 30 min

Internal Battery X1: Complementary number indicating year of production (i.e.: for 2009, X1=1; for 2010, X1=0) X2: Month of production (1, 2, ……, 9, x, y, z) X3 X4 X5 X6: Serial number (0000 - 9999)

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NIRO-200NX INSTRUCTION MANUAL

1-2

Classification of Warning

We have classified the warnings symbols that appear in this instruction manual and on the system as follows for your convenience. Make sure that you fully understand them and obey the instructions they contain.

WARNING

Improper handling of the system without observing these warnings could lead to serious injury to the user and even death.

CAUTION

Improper handling of the system without observing these cautions could lead to personal injury to the user or damage to property.

Note

This symbol indicates a note to help you get the best performance from the system. Read the contents of the note carefully to ensure correct and safe use. Failure to observe one of these notes might impair the performance of the system. This symbol indicates a cautionary item that should be obeyed when handling the system. Read the contents carefully to ensure correct and safe use.

This symbol indicates an action that is forbidden. Read the contents carefully and be sure to obey them.

This symbol indicates a compulsory action or instruction. Read the contents carefully and be sure to obey them.

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NIRO-200NX INSTRUCTION MANUAL

1-3

Warnings and Cautions

WARNING Do not use the NIRO-200NX in flammable conditions or in an atmosphere of high oxygen concentration. Doing so may cause an explosion or a fire. When using an electric knife with the NIRO-200NX, be sure to attach the knife’s electrode plate properly and firmly to the patient. Attaching the electrode plate improperly may result in high-frequency current flowing into the probe, causing a burn. Strictly follow the detailed directions in the electric knife instruction manual. Before performing defibrillation, remove the probes from the patient. Touching the probe with the defibrillation paddle may cause a burn from the discharged energy. Furthermore, an electric shock may result if a person touches any metal part of the NIRO-200NX. Strictly follow the detailed directions in the defibrillator instruction manual. Do not attach the probe to skin in a sterile operating field. The probe must be attached only to normal skin surfaces. Patient diagnosis and treatment decisions should not be made exclusively with data from the NIRO-200NX, but rather in combination with other possible clinical signs and data. All equipment connected to the NIRO-200NX must comply with Clause 16 of IEC 60601-1:2005.

Power supply Use the system with the voltage indicated on the rating sticker. Using a different voltage can damage the system and lead to fire or electric shock. Do not insert the power supply cord into or remove it from a power outlet with wet hands. Do not touch the plug with wet hand. Doing so can lead to electric shock.

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NIRO-200NX INSTRUCTION MANUAL

Do not attempt to dismantle or modify the system. Doing so can also lead to damage and even injury, as some internal components become very hot or high voltage. Only touch parts as indicated in this manual.

If an abnormality occurs, such as the image suddenly disappearing or a strange noise, smell or see smoke coming from the system, immediately turn off the power switch and unplug the power supply cord and contact Hamamatsu subsidiary or local distributor. Never attempt to repair the system yourself.

1-3-1

Electricity

WARNING <Power Supply Cord and Power Outlets> Use only the power supply cord supplied with the NIRO-200NX. Connect it only to a grounded power outlet. <Protection against electric shock>

Do not open cover.

Hazardous voltage can shock.

<Devices connected to the NIRO-200NX> When connecting external devices to the NIRO-200NX, the entire system must comply with Clause 16 of IEC 60601-1:2005. In the case where the connected device is an information technology equipment such as a PC, the information technology equipment must comply with IEC60950-1. Particularly when the entire system is used in a patient environment and the connected information technology equipment does not comply with IEC60601-1, such a device as an isolation transformer must be used to ensure the combined system remains compliant with Clause 16 of IEC 60601-1:2005. <Accessible contacts of connectors> Do not to touch the accessible contacts of connectors and patient simultaneously.

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NIRO-200NX INSTRUCTION MANUAL

1-3-2

Probes

<Emission and detection probes>

WARNING The probes are not waterproof and contain sensitive electronics. Therefore, the permeation of any liquid may damage a probe. (If liquid permeates a probe and causes a short circuit inside, the safety circuit activates and prevents the probe from heating. In such an event, a warning message appears on the display screen; see “7 Messages”) Examine the probes carefully to see if there is any damage or dirt on the surface before attaching them to the patient. Removing the probes while the equipment is powered on may cause damage to the equipment. Turn the power off before removing the probes.

CAUTION Wipe the probe surface with a soft cloth dampened with disinfectant ethyl or isopropyl alcohol (70% concentration) before use. If there is dirt at the edge of the detection window, clean it carefully, using, for example, a cotton swab. <Attaching probes to patients>

WARNING Do not attach the probe to a sterile operating field. The probe must be attached only to normal skin surfaces.

CAUTION The long-time pressure of an attached probe may cause erythema or edema, so a probe should not remain continuously attached for more than 12 h. Do not sterilize the probes. (The efficacy of probe sterilization and the tolerance of the probes to sterilization have not been officially validated.) Disinfecting the probes using ethyl or isopropyl alcohol (70% concentration) is recommended. Avoid the use of the cable clips inside of incubators or patient beds in NICU/PICU applications. Loosened cable clips might be swallowed.

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NIRO-200NX INSTRUCTION MANUAL

Use the double-sided adhesive tape supplied with the NIRO-200NX to affix the probe to the patient’s skin. When removing the tape, peel it gently so as not to damage the skin. If the tape is difficult to remove, use a commercial adhesive solvent to loosen the probe and peel slowly to prevent damage to the skin. Do not re-use the double-sided adhesive tape and the disposable probes supplied with the NIRO-200NX.

2

1-3-3

Others

< Operating environment >

WARNING Do not use the NIRO-200NX in flammable conditions or in an atmosphere of high oxygen concentration. Doing so may cause an explosion or a fire. Avoid getting liquids into the NIRO-200NX. If liquid enters the system, it may cause a short circuit. When using an electric knife with the NIRO-200NX, be sure to attach the knife’s electrode plate properly and firmly to the patient. Attaching the electrode plate improperly may cause high-frequency current to flow into the probe, causing a burn. Strictly follow the detailed instructions in the electric knife manual. Before performing defibrillation, remove the probe from the patient. Touching the defibrillation paddle on the probe may cause a burn from the discharged energy, and an electric shock may result if a person touches any metal part of the NIRO-200NX. Strictly follow the detailed directions in the defibrillator instruction manual.

CAUTION

Note

The NIRO-200NX has been confirmed by official tests to comply with IEC 60601-1-2 (Electromagnetic Compatibility). However, strong electromagnetic interference may cause a malfunction. In particular, high-frequency noise from an electric knife may disable the NIRO-200NX’s measurement capabilities. Recommended electromagnetic environments for use of the NIRO-200NX are shown in Appendix B.

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NIRO-200NX INSTRUCTION MANUAL

<Usage>

WARNING Patient diagnosis and/or treatment decisions should not be made using only data from the NIRO-200NX, but rather in combination with other clinical signs and data. Do not insert the power supply cord into or remove it from a power outlet with wet hands. Do not touch the plug with wet hand. Doing so can lead to electric shock.

CAUTION Do not stop up ventilation opening. equipment. Do not open cover.

Heat will cause damage of

Hazardous voltage can shock.

Service must be performed only by supplier.

Note

Articles used in conjunction with NIRO-200NX measurements, such as probes, double-sided adhesive tape, batteries, etc., should be disposed of in accordance with hospital rules and other similar regulations to avoid risks such as infection and environmental pollution. The NIRO-200NX should not be used on a patient if there are contraindications.

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NIRO-200NX INSTRUCTION MANUAL

Ｃｏｎｔｅｎｔｓ 1.

2.

3.

4.

SAFETY PRECAUTIONS ... 3 1-1

Indication of the Symbols ... 3

1-2

Classification of Warning ... 4

1-3

Warnings and Cautions ... 5

1-3-1

Electricity ... 6

1-3-2

Probes ... 7

1-3-3

Others ... 8

REGULATION ... 14 2-1

Electricity ... 14

2-2

Probes ... 14

CHECK THE CONTENTS OF PACKAGE... 15 3-1

Reusable Probe version ... 15

3-2

Disposable Probe version ... 16

3-3

Options... 16

INSTALLATION... 17 4-1

5.

6.

Power Supply Environments ... 18

4-1-1

Operation with AC power... 18

4-1-2

Battery Operation ... 18

OVER VIEW... 20 5-1

Function and Intended Use of the NIRO-200NX... 20

5-2

Measurement Items... 21

NAMES AND FUNCTIONS OF EACH PART... 22 6-1

Display Unit (DU)... 22

6-2

Control Panel ... 24

6-3

AMP Unit (for reusable probe) ... 26

6-4

Probes and Probe Holder (reusable probe)... 28

6-5

Labels ... 29

7.

MESSAGES... 31

8.

PREPARING TO TAKE MEASUREMENTS... 35 8-1

Connecting the cables... 35

8-1-1

Connecting the Display and AMP Units ... 35

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NIRO-200NX INSTRUCTION MANUAL

8-1-2

Connecting the Power Supply Cord ... 36

8-1-3

Connecting the Emission and Detection Probes ... 36

8-2 9.

Attaching the probes to the patient ... 37

OPERATING THE NIRO-200NX ... 38 9-1

Basic Measurement Operations ... 38

9-1-1

Turn the Power On ... 38

9-1-2

Display the Menu... 38

9-1-3

Start the Measurement ... 38

9-1-4

Input Event Marks... 39

9-1-5

Stop the Measurement ... 39

9-1-6

Turn the Power Off ... 40

9-2

Menus ... 41

9-3

Operating the Menus ... 43

9-3-1

Sample Time... 43

9-3-2

Zero Set ... 44

9-3-3

TOI Set ... 44

9-3-4

Time Scale... 45

9-3-5

Vertical Scale... 45

9-3-6

View Mode / Graph Screens... 46

9-3-7

Display Items Setting... 50

9-3-8

Scroll... 51

9-3-9

Data File Display ... 52

9-3-10

Save / Delete Data File... 53

9-3-11

Text-format (CSV) Saving ... 56

9-3-12

Data Capacity ... 58

9-3-13

List Display ... 58

9-3-14

ID Input ... 59

9-3-15

Ini.THI/Set TOI... 60

9-3-16

Alarm On/Off... 61

9-3-17

Help ... 61

9-3-18

Pathlength... 62

9-3-19

Date, Time ... 64

9-3-20

Alarm Setting ... 64

9-3-21

Analog Reference... 66

9-3-22

Analog Out Setting ... 67 11

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NIRO-200NX INSTRUCTION MANUAL

9-3-23

RS Setting... 68

9-3-24

Maintenance Display ... 69

9-4

Frequently Used Menus... 69

10. OPTIONAL PROBES AND ADAPTERS ... 70 10-1

Dual Fiber Adapter (DFA) option ... 70

10-1-1

Outline of the DFA ... 70

10-1-2

Details of the DFA ... 72

10-1-3

Names and Functions of DFA ... 73

10-1-4

Turn the Power On ... 77

10-1-5

DFA Fiber Check ... 78

10-1-6

Graph Screen for DFA measurement... 82

10-1-7

DFA Setting ... 83

10-1-8

Specifications of DFA Option... 84

10-2

Plus 2ch Adapter (P2A) ... 85

10-2-1

Outline of the P2A ... 85

10-2-2

Configuration ... 86

10-2-3

Names and Functions of the P2A... 86

10-2-4

Preparing to Take Measurements with the P2A... 88

10-2-5

Performing 4ch measurements with the P2A ... 91

10-2-6

View mode / Graph screens with P2A... 92

10-2-7

Others ... 95

10-2-8

P2A Specifications... 97

10-3

Disposable Probe Adaptor ... 98

10-3-1

Configuration ... 98

10-3-2

Names and Functions... 99

10-3-3

Labels ... 101

10-3-4

Outline of measurement ... 102

10-3-5

Connecting cables ... 103

10-3-6

Attaching the disposable probes to the patient ... 103

10-3-7

Function menus ... 103

10-3-8

Specification ... 104

11. MAINTENANCE ... 105 11-1

Maintenance... 105

12. WARRANTY ... 107 12-2

Repairs ... 107

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NIRO-200NX INSTRUCTION MANUAL

13. TROUBLE SHOOTING CHECK LIST ... 108 14. SPECIFICATIONS... 112 14-1

Specifications ... 112

15. DIMENSIONAL OUTLINES ... 120 16. APPENDIX... 121 APPENDIX A

MEASUREMENT PRINCIPLE ... 121

APPENDIX B

RECOMMENDED ELECTROMAGNETIC ENVIRONMENTS ... 125

17. CONTACT INFORMATION... 128

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NIRO-200NX INSTRUCTION MANUAL

2.

Regulation

2-1

Electricity Protection against electric shock Class Ι / Internally Powered (IEC 60601-1:1988) Battery Main battery

Eight nickel-metal hydride (NiMH) batteries (HR-4/3FAUPC, SANYO) are used in the main battery. (Batteries must be replaced by the distributor.)

CPU battery

There is a lithium battery (ER6V C4, TOSHIBA) on the CPU board inside the main body. If this battery runs down, the date and time must be reset, but there are no other interruptions to normal measurement functions. (The battery must be replaced by the supplier.)

Electromagnetic Compatibility (EMC) The NIRO-200NX complies with IEC 60601-1-2.

2-2

Probes LED light irradiation to patients

Class 1

The LED radiation intensity to the patient does not exceed the Class 1 level (IEC 60825-1).

< applied part > Emission Probe / Detection Probe

Type B applied part

Dual Fiber Probe

Type BF applied part

NIRO Disposable Probe

Type BF applied part

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NIRO-200NX INSTRUCTION MANUAL

3.

Check the Contents of Package

When you open the package, check that the following items are included before use. If the contents are incorrect, insufficient, or damaged in any way, contact Hamamatsu subsidiary or local distributor without attempting to operate the system. Use only the devices and parts listed below.

2

3-1

Do not re-use the double-sided adhesive tape supplied with the NIRO-200NX.

Reusable Probe version

(1) Standard Configuration Display Unit (DU) AMP Unit (AU)

1 cable 4m

1

Emission probe (A10959) 2.5 m

2

Detection probe (A10962) 2.5 m

2

Probe holder S type (A10963)

2

Probe holder L type (A10965)

2

Double-sided adhesive tape for S type (A10967) *

1 bag

Double-sided adhesive tape for L type (A10968) *

1 bag

Cable clip (A11047)

1 bag

Power supply cord

2.5 m

NIRO-200NX Instruction Manual (this book)

1 1

(2) Options and Consumables Consumables: Emission probe (A10959)

1

Detection probe (A10962)

1

Probe holder S type (A10963)

1

Probe holder L type (A10965)

1

Double-sided adhesive tape for S type (A10967) *

1 bag

Double-sided adhesive tape for L type (A10968) *

1 bag

Cable clip (A11047)

1 bag

* Material: 3M #1522 15

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NIRO-200NX INSTRUCTION MANUAL

(3) Option Probes and Adapters

3-2

Dual Fiber Adapter Option

See “10-1-2 Details of the DFA”

Plus 2CH Adapter Option

See “10-2-1 Outline of the P2A”

Disposable Probe version

<2ch> Display Unit (DU)

1

Disposable Probe Adaptor (C12115)

1

DPA AMP Unit(C12116)

1

Probe Cable (A12453)

2

Power supply cord

2.5 m

1

NIRO-200NX Instruction Manual (this book)

1

Display Unit (DU)

1

Disposable Probe Adaptor (C12115)

1

DPA AMP Unit(C12116)

2

Probe Cable (A12453)

4

<4ch>

Power supply cord

2.5 m

NIRO-200NX Instruction Manual (this book)

1 1

(2) Option and Consumables Disposable Probe L (A12325) Disposable Probe S (A12326)

3-3

Options Options: Analog cable(A11486)

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NIRO-200NX INSTRUCTION MANUAL

4.

Installation Do not stop up ventilation opening. Heat will cause damage of equipment. To prevent overheating in the system’s interior, do not wrap the unit in cloth or other material, or in any way allow the power supply unit’s ventilation ports to become blocked.

Avoid using or storing this system in the following places. When the ambient temperature might fall below -10 °C or rise above 45 °C. (Storage) When the ambient temperature might fall below +10 °C or rise above +35 °C. (Operation) Where the temperature varies extremely. In direct sunlight or near a heater. Where the humidity is below 10 % or above 85 % or where there is dripping water. (Storage) Where the humidity is below 30 % or above 80 % or where there is dripping water. (Operation) Close to a strong source of magnetism or radio waves. Where there is vibration. Where it might come into contact with corrosive gases (such as chlorine or fluorine). Where there is a lot of dust. Where there is dripping water.

For an emergency, keep enough space around the NIRO-200NX to pull out the power supply cord from the AC power connector at the back panel. When the NIRO-200NX is placed from where it might drop, fix the device firmly. Place the NIRO-200NX on a horizontal plane (plane inclined an angle of under 10° from the horizontal plane).

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NIRO-200NX INSTRUCTION MANUAL

4-1

Power Supply Environments

NIRO-200NX is operated with AC power or an internal battery. < Isolation from the supply main > In case of an emergency, pull out the power supply cord from the AC power connector at the back panel. < Potential-Equalization > To prevent micro-shock to the patient, perform potential-equalization using the equipotentiality terminal as follows: Note

If the NIRO-200NX is used under such an environment where electrodes or catheters are used directly or nearby to the heart of patient, it is required to connect and ground among equipments (including NIRO-200NX) nearby the patient with the potential equalization conductor.

4-1-1

Operation with AC power

Use only the power supply cord (with grounded pin) supplied with the NIRO-200NX to avoid electric shock.

4-1-2

Battery Operation

The battery operation time is about 30 minutes after being fully charged.

Battery power

should be considered supplementary means and used only in such cases as when an instantaneous power failure occurs or the patient is moved to another room. 1) Battery Power Lamp Remaining battery power is indicated by the Battery Power Lamp as follows.

BAT.

Battery Power Lamp

Color of the Lamp

Remaining Battery Power

Green

High

Orange

Middle

Red

Low

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NIRO-200NX INSTRUCTION MANUAL

2) Battery Charge Lamp Charging of the battery starts when the AC power supply cord is connected. When the battery is charging, the Battery Charge Lamp light turns on. When the charging has been completed, the light turns off.

CHARGE

Battery Charge Lamp

Note

Lamp

Status

ON

Charging

OFF

Completed

Charging of the battery may pause for safety if the battery temperature exceeds the proper range.

Note

• Disconnect the AC power supply cord when the NIRO-200NX is not used for a period

longer than two or three days. • Frequent connection and disconnection of the AC power supply cord may increase the

battery temperature and the error message “(303) Battery Failure” would appear. See “7 Messages”.

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NIRO-200NX INSTRUCTION MANUAL

5.

Over View

5-1

Function and Intended Use of the NIRO-200NX

The NIRO-200NX (C10448) is designed to non-invasively monitor changes in concentration of oxygenated and deoxygenated hemoglobin and the degree of oxygenation of human tissues using optical methods. The intended use of the system is to monitor the above parameters in patients when monitoring of tissue oxygenation is necessary or desirable. Features z

Non-Invasive bedside monitor

z

Data Storage ( 50 000 sampling data for a measurement; 10 times measurement)

z

Data Save to USB memory device

z

Battery Operation ( 30 min available with fully charged battery)

z

Touch-panel operation

z

2ch measurement (standard configuration)

z

VueLink (Phillips monitor) connection

z

Measurement of Tissue Oxygenation Index (TOI), change of TOI (ΔTOI), Normalized Tissue Hemoglobin Index (nTHI), change of oxygenated hemoglobin (ΔO2Hb), change of deoxygenated hemoglobin (ΔHHb), and, change of hemoglobin(ΔcHb)

Note

Intended operator: medical doctors, nurses and medical engineers The patient is normally lying on the bed and the device is placed and operated near the patient within the distance of the cable length.

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