WM-NP3 MOBILE WORKSTATION Instructions for Use Sept 2020

Contents 1

Using this document... 5 1.1 User instructions... 5 1.2 Conventions throughout this document... 5 1.3 Safety-related information in this document... 6

2

Safety information... 7 2.1 Intended purpose... 7 2.2 Contact... 8 2.3 General safety notes... 9

3

Product description... 11 3.1 Standard sets... 11 3.2 Optional accessories... 12 3.3 Scope of delivery... 14 3.4 Labels and symbols... 15 3.5 Power cable... 20 3.6 Warranty... 21

4

Before use... 22 4.1 Handling pre-installed features... 22 4.2 Removing and attaching the rear panel... 30 4.3 Installing MAJ‑2159 Scope Pole Kit ... 32 4.4 Installing keyboards... 43 4.5 Installing medical electrical equipment ... 44

5

Maneuvering... 51 5.1 Specific safety notes for maneuvering... 51 5.2 Preparing for maneuvering... 51 5.3 Maneuvering the WM‑NP3 Mobile Workstation... 52

6

Use... 54 6.1 Specific safety notes for use... 54 6.2 Using the WM‑NP3 Mobile Workstation... 56

7

Reprocessing... 58 7.1 Safety notes for reporcessing... 58 7.2 Using reprocessing agents... 58 7.3 Cleaning and disinfection... 60

8

Maintenance... 63

9

Storage and disposal... 65 9.1 Storage... 65 9.2 Disposal... 65

10 Technical data... 66 10.1 Power cable... 66 10.2 Socket adaptor cable... 67 10.3 Protective earth terminal... 67 10.4 Winding... 68 10.5 Primary winding... 68 10.6 Secondary winding... 68 10.7 Potential equalization terminals... 69 10.8 Block diagram... 70 10.9 Safety standards for medical electric systems... 71 10.10 EMC Information... 73 10.11 Specifications... 76 11 Customer spare parts... 80 11.1 WM‑NP3 Mobile Workstation spares... 80 11.2 Scope pole kit spares... 92 11.3 Sliding keyboard tray spares... 95 11.4 Rear panel spares... 96 12 Troubleshooting... 99 13 End of life... 100 14 Glossary... 101 15 Index... 103

Using this document

1 Using this document This chapter provides general information on how to use these instructions for use.

1.1

User instructions Before use, thoroughly read these instructions for use and the instructions for use of all other items that will be used during the procedure. If the required instructions for use are missing, immediately contact an Olympus representative. Keep the instructions for use in a safe, accessible location.

1.2

Conventions throughout this document This is the safety alert symbol. It is used to alert the user to potential physical injury hazards. Observe all safety messages that follow this symbol to avoid possible injury. This symbol indicates additional helpful information. 1. 2. 3.

A numeration indicates a sequence of actions.

•

Bullet points indicate individual actions that do not have to performed in a specific order.

►

Arrows indicate the results of actions.

-

Dashes indicate the listing of data, options or objects.

1) 2) 3)

Numbers with right parenthesis name elements in illustrations

5

Using this document

1.3

Safety-related information in this document General safety notes General safety notes address risks that apply to the general use and handling of the product. Specific safety notes Specific safety notes address safety issues that are specific to the information and actions described in a chapter or section. Specific safety notes are located at the beginning of the corresponding chapter or section. Safety messages Safety messages focus on unexpected incidents that can occur during the intended purpose. Safety messages are placed in the context of such risks and actions. Safety messages are highlighted by the following signal words and symbols. WARNING Indicates a potentially hazardous situation which, if not avoided, can result in death or serious injury. CAUTION Indicates a potentially hazardous situation which, if not avoided, can result in minor or moderate injury. NOTICE Indicates a property damage message.

6

Safety information

2 Safety information This chapter provides general safety information for using the product. The safety information includes the following. – Intended purpose – Manufacturer information and contact details – General safety notes

2.1

Intended purpose

2.1.1

Intended use and indications The WM‑NP3 Mobile Workstation Narrow Platform 3 is intended to assist endoscopic procedures using Olympus medical devices and their accessories within medical facilities by providing a stable mains power supply and a platform for the efficient use and handling of the devices during endoscopic diagnostic and therapeutic procedures. The WM-NP3 workstation can also allow visualisation during the procedure when connected to a monitor. Do not use the device for any other purpose.

2.1.2

Contraindications There are no known contraindications.

2.1.3

Patient target group Not dedicated to any patient population.

2.1.4

Intended user Medical use Only for use by a qualified physician or healthcare professional in a professional healthcare facility.

7

Safety information Reprocessing Reprocessing of reusable products may only be performed by qualified hygiene personnel. Repair Repair of the product may only be performed by trained qualified servicing personnel that has been authorized by Olympus. Otherwise, Olympus cannot be held responsible for the safety and performance of the product. 2.1.5

Clinical benefit The clinical benefit of the device lies in its functionality as described by its intended purpose.

2.2

Contact

2.2.1

Manufacturer KeyMed (Medical and Industrial Equipment) LTD KeyMed House, Stock Road, Southend-on-Sea, Essex SS2 5QH United Kingdom www.olympus.com

2.2.2

Incident reporting European Union If a serious incident occurs with the device, report it to the manufacturer and the relevant national authority. Eurasian Economic Union If an undesirable event occurs with the device, report it to the manufacturer or the authorized representative.

8

Safety information Other regions If a serious incident occurs with the device, report it to the manufacturer and/or the relevant national authority according to national legislation.

2.3

General safety notes The following safety information addresses points that apply to the general handling and use of the product. This information is to be supplemented by the information given in each chapter of this document. CAUTION Risk of Injury Exceeding the maximum load capacity can cause structural failure and instability, resulting in injury. Refer to the maximum load capacity as specified in “10.11 Specifications” on page 76. MAJ‑1661 LCD Arm - Adjustable The WM‑NP3 Mobile Workstation URO set has additional weight within its base for the use of the MAJ‑1661 LCD Arm Adjustable, as this accessory requires additional ballast weight. Refer to the MAJ‑1661 instructions for use for further information on product assembly and operation. The MAJ‑1661 LCD Arm Adjustable is only compatible with the URO set. Do not use the MAJ‑1661 LCD Arm - Adjustable with the Basic or GI Standard sets, as these are not fitted to carry the additional weight.

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Safety information NOTICE Risk of equipment damage Incorrect work practices when handling this product can result in equipment damage. Observe the following. – Only use the product in the environment specified in “Specifications” on page 76. – Only use products specified in “Standard sets” on page 11 and “Optional accessories” on page 12 with this product. – Do not exceed the maximum load capacity as specified in “10.11 Specifications” on page 76. Reprocessing of reusable products Reusable product must be reprocessed according to the applicable national and local standards and regulations.

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Product description

3 Product description This chapter provides information about the product and associated accessories.

3.1

Standard sets Contact Olympus if any parts are damaged or missing. The WM‑NP3 Mobile Workstation is available in 3 standard sets. Refer to the following table to check that all items in the set ordered are present. Standard sets GI Standard

Basic Set

URO Set

UK, Europe, USA, Japan, Rest of the World

UK, Europe, USA, Japan, Rest of the World

Europe, USA, Rest of the World

WM‑NP3 Mobile Workstation

1

1

1

Workstation fitting kit

1

1

1

Separation transformer (market specific)

1

1

1

MAJ‑2160 Irrigation Tube Holder

1

1

1

MAJ‑2146 Sliding Keyboard Tray

1

-

1

MAJ‑2159 Scope Pole Kit

1

-

-

Endoscope pole fitting kit

1

-

-

MAJ‑2216 LCD Monitor Arm

1

-

-

MAJ‑2211 Side Handles

1

-

1

IEC lead set

1

1

1

Socket adaptor cable (USA)

1

1

1

Socket adaptor cable (Japan)

1

1

-

Instructions for use

1

1

1

Product

11

Product description

3.2

Optional accessories The following products can be used as optional accessories. NOTICE Risk of equipment damage The fitment of some accessories may not be possible when other accessories are fitted and can result in equipment damage. For any questions, please contact the Endoscope Service Center, a service center designated by Olympus or an Olympus branch or sales office.

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Code

Description

K10036766

Socket adaptor cable (USA)

K10036760

Socket adaptor cable (Japan)

MAJ‑1635

EUS connector holder

MAJ‑1639

Single CO2 holder (up to Ø140 mm)

MAJ‑1642

IV Pole

MAJ‑1650

Single CO2 holder (Ø140 mm to Ø205 mm)

MAJ‑1653

Double CO2 holder

MAJ‑1654

Equipotential terminal strip

MAJ‑1657

Keyboard arm - side installed

MAJ‑1661

LCD Adjustable Arm (only compatible with the URO set)

MAJ‑1663

EUS Arm mount kit

MAJ‑1665

Camera head holder

MAJ‑1685

IV Bag Hanger

MAJ-1938

Holder for HC-RP / UPD-3

MAJ-1985

Cylinder Hose with Switch Over Valve (PIN) / UHI-4

MAJ-1986

Cylinder Hose with Switch Over Valve (DIN) / UHI-4

MAJ‑2145

ENT Scope Hanger

MAJ‑2146

Sliding Keyboard Tray

MAJ‑2149

Dual Monitor Arm

MAJ‑2154

Consumable Stowage Holder

MAJ‑2158

Suction Jar Holder

MAJ‑2159

Scope Pole Kit

MAJ‑2160

Irrigation Tube Holder

Product description Code

Description

MAJ‑2165

Drawer Unit

MAJ‑2166

Sterile Water Holder

MAJ‑2167

Nurses Control Arm

MAJ‑2173

Side Shelf

MAJ‑2211

Side Handles

MAJ‑2216

LCD Monitor Arm 6.5-12 kg

MAJ‑2217

LCD Monitor Arm 12-14 kg

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Product description

3.3

Scope of delivery The following section describes the scope of delivery of the GI standard set. Refer to the “Standard sets” on page 11 for details on other sets.

1) 2) 3) 4) 5) 14

MAJ‑2211 Side Handles (fitted) MAJ‑2159 Scope Pole Kit MAJ‑2216 LCD Monitor Arm MAJ‑2160 Irrigation Tube Holder (fitted) Socket adaptor cable (Japan)

Product description Socket adaptor cable (USA) 6) WM-NP3 Mobile Workstation instructions for use 7) IEC lead set, containing: – 3 x cable universal IEC 320 0.8 m – 5 x cable universal IEC 320 1.5 m – 1 x cable universal IEC 320 M-FEM 2.5 m (in separate bag) 8) Separation Transformer (fitted) 9) Fitting kit for WM-NP3 Mobile Workstation, containing: – 1 x 4 mm hex key – 1 x 6 mm hex key – 12 x cable ties Fitting kit for MAJ‑2159 Scope Pole Kit, containing: – 4 x M6 T-nuts – 2 x M6 button-head screws – 4 x M6 countersunk screws – 2 x M6 crinkle washer – 2 x M6 plain washer – 1 x 2.5 mm hex key – 1 x 4 mm hex key – 1 x 5 mm hex key 10) Water bottle bracket (fitted) 11) MAJ‑2146 Sliding Keyboard Tray (fitted)

3.4

Labels and symbols This section provides information on the labels and symbol on the product and on the packaging of the product.

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Product description 3.4.1

Unique Device Identification Unique Device Identification is a label required by some countries’ regulations regarding identification of medical device.

(01) 00000000000000 (11) 000000 (21) 00000000 The following information is coded in the 2-dimensional barcode (GS1 Data Matrix). – (01) 14-digit GS1 Global Trade Item number. – (11) 6-digit date of manufacture. – (21) 8-digit serial number.

The UDI can be found on the base panel at the front of the WM‑NP3 Mobile Workstation.

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Product description 3.4.2

Symbols on the workstation

Symbol

Description

Source

Refer to instructions for use

ISO 7010-M002

Mains power ON / OFF switch

IEC 60417-5010

MDR EU regulatory requirement (Class I)

Manufacturer

Do not push the workstation when the brakes are applied

ISO 7010-P017

Max laden weight

Manufacturer

Unit complies with China RoHS 2 requirements

China RoHS 2 – Management methods for the Restriction of the Use of Hazardous Substances in Electrical and Electronic Products, January 2016

Stability warning

Manufacturer

Unit complies with METI-PSE regulations – only applicable for Japan

METI-PSE regulations (Electrical Appliances and Materials Safety Act) Japan

Compliance to the Korean Radio Waves Act (Clause 3, Article 58-2)

Korean Radio Waves Act (Clause 3, Article 58-2)

CE marking indicating that the device is in conformity with the applicable requirements set out in applicable European Union harmonization legislation.

MDR (EU) 2017/745

Medical Device

311 kg 686 lbs

17

Product description 3.4.3

Packaging symbols

Symbol

Description

Source

Consult instructions for use

ISO 15223-1

eIfU - Instructions for use available online

ISO 15223-1

Catalogue number

ISO 15223-1

Keep dry

ISO 15223-1

Manufacturer

ISO 15223-1

Keep away from sunlight

ISO 15223-1

Stacking limit by number

ISO 7000

Fragile, handle with care

ISO 15223-1

This way up

ISO 7000

Lot number

ISO 15223-1

Temperature limitations

ISO 15223-1

Serial number

ISO 15223-1

Humidity limitation

ISO 15223-1

Atmospheric pressure limitation

ISO 15223-1

MDR EU regulatory requirement (Class I)

Manufacturer

olympus-europa.com

Medical Device

18

Product description

3.4.4 Symbol

Unit complies with China RoHS 2 requirements

China RoHS 2 – Management methods for the Restriction of the Use of Hazardous Substances in Electrical and Electronic Products, January 2016

Translation

ISO 15223-1

Authorized representative in the European Community / European Union

ISO 15223-1

Symbols on the separation transformer Description

Source

Refer to instructions for use

ISO 7010-M002

Warning to observe rules regarding the use of multiple socket outlets

ISO 7010-W001

Equipotentiality terminal

IEC 60417-5021

Input

IEC 60417-5034

Output

IEC 60417-5035

Alternating current

IEC 60417-5032

Weight

ISO 7000-430

Remote switch

Manufacturer

Non-inherently short circuit proof separation transformer

IEC 60417-5220

According to European Directive 2012/19/EU on Waste Electrical and Electronic Equipment, this symbol indicates that the product must not be disposed off as unsorted municipal waste, but should be collected separately.

EN 50419

19

Product description Symbol

3.5

Description

Source

Indicates the unit has been independently assessed for compliance with UL and CSA standards as a Recognized Component of The WM‑NP3 Mobile Workstation (MAJ‑2156 only).

EN 60601

Unit complies with METI-PSE regulations – only applicable for Japan

METI-PSE regulations (Electrical Appliances and Materials Safety Act) Japan

Power cable The WM‑NP3 Mobile Workstation includes a power cable appropriate to the model of separation transformer fitted and the intended market area, as listed in “Technical data” on page 66. – MAJ-2155 (Japan): Always use the supplied power cable, IEC, and Socket Adapter cable. Use of any other cables may cause a malfunction of the instrument or burns on the cables. Additionally, the supplied cables are for exclusive use with this instrument and must not be used with other devices. – MAJ‑2156/ MAJ-2156-15A (USA): The power cable on this unit is fitted with a ‘hospital grade’ plug. Grounding reliability is achieved when this equipment is connected to an equivalent receptacle marked ‘hospital grade’. – MAJ‑2157 (Rest of the World): The power cable on this unit is terminated in flying leads, for a suitable plug to be fitted according to the area of intended use. Only suitably qualified personnel should fit the power plug to this cable. The cores of the power cable are colored according to the following code. – Brown: live (‘hot’) – Blue: neutral (‘cold’) – Green/yellow: earth (‘ground’) WARNING Risk of electric shock Connecting the power cable to a mains electricity without protective earth can result in electric shock.

20

Product description Always connect the power cable to a mains electricity with protective earth.

3.6

Warranty Any warranty claims towards Olympus are forfeited if the user or unauthorized persons attempt repair or modification of the product. No warranty is provided for any damage due to misuse of the product.

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