CARE P&L

Global Service Engineering

Product Support Launch Plan
Engström Carestation

Rev: 1.51
Date: October 2004
Doc: PSLP Engström Carestation Rev 1.51
By: Paul Renner / CARE P&L

In order to ensure that local launches of Engström Carestation are properly

supported, at least one representative of each country service organization
must successfully complete technical training before shipments will be
authorized by the CARE P&L.

Product Support Launch Plan, Engström Carestation

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Table of Contents

1 Introduction

2 Product Information

2.1 Product Launch Schedule

2.2 Product Description
2.2.1 Product Features
2.3 Product Specifications
2.3.1 Technical Specifications
2.3.2 Safety Standards and Specifications
2.4 Warranty
2.4.1 Product Warranty
2.4.2 Spare Part Warranty

3 Service Support Policy

3.1 Technical Support

3.2 Technical Training
3.2.1 Technical Training Material
3.3 Installation and Configuration
3.4 Planned Maintenance
3.5 Field Repair Strategy
3.6 Factory Repair and Exchange Service
3.7 Traceability

4 Service Support Materials

4.1 Tools and Test Equipment

4.2 Documentation
4.3 Spare Parts
4.4 Exchange Parts

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1 Introduction
This document contains the service support launch plans for the Datex-
Ohmeda Engström Carestation and is intended to be used as a tool by
Datex-Ohmeda Subsidiaries and Distributors as a guide in preparing local
product launch and service business plans.

The information contained within this plan is valid as of the date shown on
the front cover, but is subject to change without further notice.

2 Product Information
2.1 Product Launch Schedule
CARE Marketing, in conjunction with the channel organizations, will
determine the launch schedule for each country.

Activity Estimated Date Market

User Preference Trials May – Sep 2004 Austria, Netherlands,
UK, Australia

Product Launch Oct 2004 Europe / Australia

Pending 510K USA

2.2 Product Description

The Engström Carestation is a flexible, adaptable, and intuitive critical care
ventilator. A wide selection of performance options gives the user full control
of the system configuration.

2.2.1 Product Features

• The ventilator is designed to be used with infant through adult patients
with a body weight of 5 kg or greater. The Engström Carestation is
designed to maintain lung ventilation in the absence of spontaneous
breathing effort as well as in support of the patient’s existing spontaneous
breathing effort. The Engström Carestation is not designed for use during
the transport of patients.
• The ventilator consists of three main components: a display, a ventilator
unit, and an optional module bay. The display allows the user to interface
with the system and control settings. The ventilator unit controls electrical
power, nebulization, and pneumatic gas flow to and from the patient. The
module bay allows the integration of various patient-monitoring modules
with the ventilator.
• Optional accessories include an air compressor, airway modules, module
bay, humidifier and water trap mounting brackets, and auxiliary electrical
outlets.

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2.3 Product Specifications
2.3.1 Technical Specifications
All specifications are approximate values and can change without notice.

Mechanical construction

EV with the cart EV without the cart

Height (display up) 144 cm Height (display up) 66 cm

Height (display down) 123 cm Height (display down) 46 cm

Width 53 cm Width 38 cm

Depth 78 cm Depth 36 cm

Weight 66 kg Weight 29 kg

Environmental specifications

Thermal Humidity Altitude

15 to 95% RH, -440 to 3565 m
Operating range 10 to 40 º C
non-condensing (800 to 500 mmHg)
15 to 95% RH, -440 to 5860 m
Storage range -20 to 50 º C
non-condensing (800 to 375 mmHg)

Pneumatic specifications

Supply gas Medical Air and Oxygen

Supply pressure 240 to 641 kPa / 35 to 94 psi

Supply gas flow - peak 160 l/min per gas supply

100 cmH2O
Maximum limited pressure
Range of inspiratory pressure 5 to 100 cmH2O ± 10%
Minimum limited pressure
-1.5 cmH2O
(subatmospheric)
Maximum working pressure range 12 to 100 cmH2O

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 Electrical requirements

85 to 132 VAC, 47 / 63 Hz
Supply voltage (switchable)
187 to 264 VAC, 47 / 63 HZ

Electrical power consumption < 200 W

Internal batteries
The Engström Carestation is not designed for use during the transport of patients
between facilities. Two internal 12 VDC sealed lead-acid batteries supply battery
backup. Batteries are used as backup power in case of a power failure. The battery
is in a float charge state as long as the system is connected to a primary electrical
source.
• Capacity to operate for > 30 minutes minimum, 120 minutes typical, battery fully
charged
• Ampere-hour rating: 4 A-h
• Voltage requirement: 12 VDC
• Current requirement: 7.5 A
• Shelf life: 9 months following last charge.
• Recharge time: full discharge to full charge in 8 hours.
• Estimated life: four to six years; 250 100% discharge cycles.
• The System Status menu shows the status of the internal battery.

2.3.2 Safety Standards and Specifications

• Reference Section 11 of the Engström Carestation User Reference

Manual. P/N 1505-1000-000

2.4 Warranty
2.4.1 Product Warranty
The warranty period for the Datex-Ohmeda Engström Carestation is 12
months from the date of original delivery to Buyer or to Buyer’s order, but in
no event for a period of more than two years from the date of original
delivery by Datex-Ohmeda to a Datex-Ohmeda Authorized Dealer.
(Reference warranty statement in the User Reference Manual)

Disposable accessories and supplies are intended for single use, therefore
the warranty is limited to ninety (90) days from the date of shipment or when
used, whichever occurs first.

2.4.2 Spare Part Warranty

Delivered spare parts have 3 months warranty from the date of original
shipment from the manufacturing site.

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3 Service Support Policy
3.1 Technical Support
Technical support for the Engström Carestation will be provided by trained
personnel through the existing service channels currently utilized for support
of other CARE P&L systems.

Contact information for CARE P&L Global Technical Support –

(4th level Technical Support)

• E-mail (preferred method of contact):

advent.tech.support@datex-ohmeda.com

• Telephone Support (Monday – Friday):

From Europe (UTC/GMT + 1 hour) 08:00 - 24:00 CET
08:00 - 17:00 Phone: +46 - 8 - 555 22 222
15:00 - 24:00 Phone: +1 - 608 - 221 6505

• From America (UTC/GMT - 6 hours) 01:00 - 17:00 CST

01:00 - 10:00 Phone: +46 - 8 - 555 22 222
08:00 - 17:00 Phone: +1 - 608 - 221 6505

• From Asia/Pacific (UTC/GMT + 8 hours) 15:00 - 07:00

15:00 - 24:00 Phone: +46 - 8 - 555 22 222
22:00 - 07:00 Phone: +1 - 608 - 221 6505

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3.2 Technical Training
In order to ensure that local launches of Engström Carestation are
properly supported, at least one representative of each country service
organization must successfully complete technical training before
shipments will be authorized by the CARE P&L.

Technical training for the Engström Carestation will be provided to local

country service organizations by the CARE P&L Global Support Technical
Training Team per the following guidelines:

• The Technical Training Team will determine the best method and media
to use to deliver training to local country service organizations based on
the individual requirements of each territory.
• The development of the technical training materials required for class
presentations will be managed by the Technical Training Team.

The CARE P&L Global Support Technical Training Coordinator should be

contacted for additional details regarding class schedules and availability.
Class schedules are also post on the Datex-Ohmeda Extr@Net.

Global Technical Education – CARE P&L

Kit-San Spång – Technical Training Coordinator
Email: kit-san.spang@med.ge.com
Telephone: +46 8555 22140

3.2.1 Technical Training Material

The following material will be provided to each student attending technical

training for the Engström Carestation.
• Technical Reference Manual (TRM)
• User Reference Manual (URM)
• Training PowerPoint Presentations
• Windows based EV Service Application: P/N 1505-8001-000

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3.3 Installations and Configuration
The Datex-Ohmeda Service Representative should perform the following
system setup, calibration, and preoperative tests during the installation of
the Engström Carestation:

Unpack and setup the Engström Carestation per Section 3 “Setup and
Connections” of the User’s Reference Manual.

Turn system on per Section 4, Page 4-2 of the User’s Reference Manual.

Access the Installation and Service menus per Section 4.1 of the
Technical Reference Manual.

Access the Service menu per Section 4.4 of the Technical Reference
Manual and perform:
Configuration: Set language, altitude and units.
(Note: Copy Configuration Menu can be used to save a configuration to a
PCMCIA card and then copy the configuration to additional machines)
Service Log: Review and reset error and alarm log entries.

Access the Install/Service menu per Section 4.2 of the Technical

Reference Manual and set the following as required:
Colors – Set Colors
Units – Set Units
Show Alarm Limits – Yes/No
Time and Date – Set clock and calendar
Defaults – Set or change defaults
Calibration – Calibrate airway gas and test backlights

Perform the Pre-use Checkout per Section 4, Page 4-2 of the User’s
Reference Manual.

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3.4 Planned Maintenance
The recommended service level PM interval for the Engström Carestation
is every 12 months. Reference Section 6 of the Technical Reference
Manual for PM requirements.

3.4.1 PM Parts

Part Number Description Replacement

Frequency
1505-3027-000 Vent Engine Fan Filter As Required
897010 Display Unit Fan Filter As Required
1504-3708-000 Gas Inlet Filters As Required
1009-5682-000 Battery, Sealed Lead 48 Months *
(2 required) Acid 12V

*Battery replacement may be extended to a maximum of 72 months (6years)

by performing the battery capacity test in Section 6.2 of the Technical
Reference Manual during the 48-month inspection.

3.4.2 Estimated PM Times

12 Month PM 2.0 hours

48 Month PM 3.0 hours *

The Engström Carestation will typically be repaired at the customer’s site

utilizing a sub-assembly or component level parts replacement strategy. The
system has been designed to allow easy access to all electrical and
pneumatic components and sub-assemblies. Troubleshooting, repair and
part replacement procedures are covered in the Technical Reference
Manual. Once a defective part has been identified and a replacement part
obtained, the time required to replace it should typically be less than twenty
minutes.

Note: Datex-Ohmeda does not support repair or replacement of individual

components beyond the level specified in the Technical Reference Manual.

3.5.1 Checks Required After Field Repair

Perform the Checkout Procedure per Section 3 in the Technical Reference

Manual after any repair or service.

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3.6 Factory Repair and Exchange Service
Does not apply. The CARE P&L does not offer a factory repair service for
the Engström Carestation.

3.7 Traceability
Country Sales Leader shall maintain serial and/or lot number and date of
shipment records for each Product so that, if necessary for corrective action
purposes, the Product can be identified and traced. In addition, each Party
shall maintain the same or similar records with respect to its components
that are incorporated within the Product so that, if necessary for corrective
action purposes, the manufacturing and delivery lot for such products can be
identified and traced.

4. Service Support Materials

4.1 Tools and Test Equipment
4.1.1 Test Equipment

Description Minimum Stock Number

Specification
Leakage Current Test Approved test Local Purchase
Device (reference TRM device (e.g. UL,
Section 3.5) CSA, or AAMI)
Low Pressure Test Device 0-150cmH20, ±2% Local Purchase
(digital manometer or test of reading
gauge)

4.1.2 Special Tools

Description Stock Number

Manual shut off valve, O2 1505-8578-000
Manual shut off valve, Air 1505-8579-000
Cable, Display Unit (to be used when 1505-5600-000
removing engine from main enclosure)
Handle f/OF302-1.5SDA complete 5370055
(Service Handles for Jun-Air
Compressor)
Tool, Nebulizer connector removal 1505-8506-000

4.1.3 Software Tools

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 Description Stock Number
Windows based EV Service Application 1505-8001-000
RS-422 to USB Adapter w/PC cable 1505-8586-000
System Software / Service Diagnostic &
Troubleshooting Software (compact
flash) 1505-8000-000

Cable, USB Converter to Engström

1505-8587-000
Ventilator
PCMCIA Adapter for Compact Flash 1009-5874-000

4.1.4 Leak Test Devices

Description Stock Number

* EV Leak Test Device Kit 1505-8590-000
* Includes the following parts:
SYRINGE, 60ML LUER-LOK 1505-3061-000
Clamp, tubing 7000-0000-097
Tee, 1/8 inch barb 7000-0000-186
Negative low pressure leak test device 0309-1319-800
Tee, sensing
0212-0763-100
22 mm to 15 mm
Connector, Endo tube 0219-5060-530
Plug, 4 mm 1006-3530-000
Plug, stopper (2 ea) 2900-0001-000
Silicone tubing 3/16 inch ID
1006-3666-000
(length = 24 inches)
Tubing, clear 1/8 inch ID
0994-6370-010
(length = 2 inches)

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4.2 Documentation
User and Technical Reference Manuals for the Engström Carestation are
available through the normal Datex-Ohmeda distribution channels.

Technical Reference Manuals:

Part Number Description Scheduled Availability
1505-1018-000 Engström Carestation, English October 2004
6189655 EVair03 Air Compressor Available

User Reference Manuals:

Part Number Description Scheduled Availability
1505-1000-000 Engström Carestation, English Available
1505-1002-000 Engström Carestation, German Available
1505-1004-000 Engström Carestation, Dutch Available
1505-1006-000 Engström Carestation, French Available
1505-1008-000 Engström Carestation, Swedish Available
1505-1010-000 Engström Carestation, Italian Available
1505-1012-000 Engström Carestation, Spanish Available
1505-1014-000 Engström Carestation, Portuguese Available
1505-1016-000 Engström Carestation, Japanese Available

Check the Datex-Ohmeda Extr@Net for latest revisions

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 4.3 Spare Parts
The Engström Carestation Technical Reference Manual identifies all sub-
assemblies and components that are available as repair or maintenance
parts. Following is a list of spare parts that the CARE P&L recommends be
stocked by local country service organizations to ensure proper support of
the Engström Carestation.

Tools & Spare Parts X = Part Also Used

Minimum Stocking Recommendations QTY on Avance

Stock Number Part Description

Service Tools Required per Rep

1505-8578-000 Manual shut-off valve — O2 1
1505-8579-000 Manual shut-off valve — AIR 1
1505-8590-000 EV Leak Test Devices Kit 1
755581 Airway Module Calibration Gas 1
755583 Airway Module Calibration Gas 1 X
755534 Calibration Gas Regulator 1 X
1505-8586-000 RS-422 to USB Adapter w/PC cable 1
1505-8587-000 Cable, USB Converter to Engström Ventilator 1
1505-8001-000 Windows Based EV Service Application 1
1505-8000-000 System Software / Service Diagnostic & 1
Troubleshooting Software (compact flash)
1009-5874-000 PCMCIA Adapter for Compact Flash 1 X
1505-8506-000 Tool, Nebulizer connector removal 1
1505-5600-000 Cable, Display Unit (to be used when 1
removing engine from main enclosure)
5370055 Handle f/OF302-1.5SDA complete 2
(Service Handles for Jun-Air Compressor)

Lubricants and Adhesives

1001-3854-000 Lubricant, Krytox GPL 205, 2 oz 1
0220-5017-300 Thread Lock, Loctite No 24221 (medium 1
strength), 10 ml
0220-5021-300 Thread Lock, Loctite No 271 (high strength), 1
10 cc

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Tools & Spare Parts X = Part Also Used
Minimum Stocking Recommendations QTY on Avance

Stock Number Part Description

Display Module
1009-8243-000 Backlight Kit 1 X
1009-8289-000 CPU Board, Display unit (with PCMCIA 1
Frame)
1503-3012-000 Encoder Assembly 1 X
898794 Knob, Com Wheel 2 X
1009-5505-000 Membrane Switches, Right Side 1 X
1009-5507-000 Membrane Switches, Lower 1 X
1009-5506-000 Membrane Switches, left 1
Language Specific (see TRM) Keypad Set 1
1009-5938-000 Display, LCD 12-inch Color (includes 1
backlights)
897010 Filter, Fan 5 X
1009-5679-000 Door, PCMCIA 1 X

Main Enclosure (external)

1505-3027-000 FILTER Fan 80 MM 2
1503-3073-000 Fuse, 2A 250V 5X20 mm Delayed Time 2
1605-3043-000 Switch, On/Standby DPST 1
1505-5600-000 Cable, Display Unit 1
1505-3411-000 Cover Display Arm 1
1505-3416-000 Cover Display Unit Pivot Mount 2

Main Enclosure (internal)

1505-5000-000 Power Supply Module 1
1505-5502-000 Power Management Board (PMB) 2
1505-5501-000 Vent Monitor Board (VMB) 1
1505-5500-000 Vent Control Board (VCB) 1
1009-5682-000 Battery (Internal) 2 X

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Tools & Spare Parts X = Part Also Used
Minimum Stocking Recommendations QTY on Avance

Stock Number Part Description

Vent Engine
1505-3256-000 Regulator w/screws 1
1505-3218-000 Restrictor, Pneumatic 2
1505-3220-000 Gasket, Pneumatic restrictor 1
1505-3208-000 Transducer Flow 0-160 LPM 2
1505-3209-000 Valve Flow Control 160 LPM 2
1505-3215-000 Transducer O2 Conc 2
1006-3616-000 O-ring, EPR, 2-016 5
1505-3262-000 Gasket Inspiratory Manifold 2
1503-3204-000 Valve Seat Free Breathing 1
0211-1454-100 Valve Flapper (Free Breathing) 5
1503-3208-000 O-ring, EPR, 2-126 5
1505-5706-000 Harness (vent engine to VCB/VMB) 1
1505-3267-000 Valve Umbrella Check 5
1505-8502-000 Manifold Inspiratory Valve Assy 1
1505-8503-000 Pressure Sensor Assembly 1
1505-3059-000 O-Ring, VITON, BS 4518 0717-16 2

Outlet manifold
1505-3227-000 Actuator Voice Coil 1
1505-8568-000 Exhalation Valve Housing Assy 2
1505-3224-000 Diaphragm 5
1505-3225-000 Seal Rolling Shaft 1
1505-3236-000 Pull Exh Housing Latch 1
1505-3251-000 PCA Ultrasonic Neb Control 1
1505-5508-000 PCA Exh Flow Interface Brd 1
1505-5507-000 PCA Exh Flow Snsr Brd 1

Inlet manifold
1006-3430-000 Check Valve 4
1504-3708-000 Filter Disc, Wire Mech 2 Micron 5
1504-3612-000 O-ring, EPR 2-122 70 duro 5

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Tools & Spare Parts X = Part Also Used
Minimum Stocking Recommendations QTY on Avance

Stock Number Part Description

1011-3413-000 Transducer, Pressure 827 kPa 1

Exhalation valve assembly

1505-8568-000 Exhalation valve assembly 2
(without flow transducer)
1505-3224-000 Diaphragm 5
1505-3223-000 Seal 5
1505-3257-000 Seal 5
1505-3039-000 Retaining ring 5
1505-3231-000 Flow transducer 2
(Includes check valve and screen)
1505-3244-000 Water Trap 2
1505-3009-000 O-Ring 2

AC Power Cords
1505-3041-000 Retainer, Outlet Power Cord Jumper 2
1505-3033-000 Retainer, Inlet Power Cord 2
0140-6219-130 Screw, M3X8 PAN HD Sems 10

Cart
21947-029 Caster Swivel 5” without Lock 2
21947-028 Caster Swivel 5” with Lock 2

Module Rack
1505-5601-000 Cable, Patient Module Rack 1

Air Compressor
6985795 Air inlet filter 5
5471001 Filter kit f/OF302-1.5SDA 1
1006-3614-000 O-Ring –019 70 EPDM 2

4.4 Exchange Parts

No exchange parts have been identified for this product

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