NORTH AMERICAN DRÄGER CF 800 User manual

Technical Documentation

CF 800
for Continuous Flow CPAP Therarpy

Emergency Care • Perioperative Care • Critical Care • Perinatal Care • Home Care

Revision 2.0

5682

9036076

Because you care

Contents

General

1 Notes 3

1.1 Symbols and Definitions ......................................................................................................... 4

Function Description

1 General 7

2 Intended use 8

3 Monitoring 8

Annex

Parts catalog

Test List

All rights reserved. Copyright reserved.

K5682XXXbook.IVZ.fm 11.01.06

I

Contents

II

K5682XXXbook.IVZ.fm 11.01.06

All rights reserved. Copyright reserved.

General

1

2

CF 800 General

1Notes This Technical Documentation conforms to the IEC 60601-1 standard.

Read each step in every procedure thoroughly before beginning any test.
Always use the proper tools and specified test equipment. If you deviate from
the instructions and/or recommendations in this Technical Documentation,
the equipment may operate improperly or unsafely, or the equipment could
be damaged.

Use only original Dräger parts and supplies.

The maintenance procedures described in this Technical Documentation may
be performed by qualified service personnel only. These maintenance
procedures do not replace inspections and servicing by the manufacturer.

The information in this manual is confidential and may not be disclosed to
third parties without the prior written consent of the manufacturer.

Strictly follow the Instructions for Use manual / Operating
Instructions! This Technical Documentation does not replace the
Instructions for Use manual / Operating Instructions. Any use of the
product requires full understanding and strict observation of the
product-specific Instructions for Use manual/ Operating Instructions.

Reference is hereby made to the observance of the relevant safety
provisions, for example in Germany, the Medical Product Law (MPG), the
Medical Device Operator Ordinance (MPBetreibV), the Pressure Container
Ordinance (Druckbehälterverordnung), the Technical Rules for Pressurized
Gases (Technische Regeln Druckgase), or the Occupational Health and
Safety Provisions (Unfallverhütungsvorschriften).

Unless otherwise stated, reference is made to laws, regulations or
standards (as amended) applicable in the Federal Republic of Germany.

Follow the laws and regulations applicable in your country.

Observe protection mark DIN 34. Copyright reserved.

Version 2.0_ Released_Printed on_11.01.06_K5682XXX_XIEC_INT_General.fm

5682

3

General CF 800

1.1 Symbols and
Definitions

This symbol indicates a warning.

This symbol indicates tips and useful information.

This symbol is used to alert against unsafe practices when handling
electrostatic sensitive devices (ESD).

Definitions according to German standard DIN 31051:

Inspection = examination of actual condition

Maintenance = measures to maintain specified condition

Repair = measures to restore specified condition

Servicing = inspection, maintenance, and repair

4

5682

Version 2.0_ Released_Printed on_11.01.06_K5682XXX_XIEC_INT_General.fm

Observe protection mark DIN 34. Copyright reserved.

Function Description

5

6

CF 800 Functional Description

1 General Air and O2 passes via the filter 1 and 2 into the corresponding flowmeters

with metering valve 3 and 4. With the aid of the reference list the required O2
concentration is dajusted (with the proportion of the flow amount O2: air).
This flow fills the reservoir 5 and passes continuously via the non-return valve
6 to the inspiration output.The airway pressure is measured with the pressure
gauge 7. The relief valve 8 limits the airway pressure in the system to max. 30
mbar.The necessary breathing volume for the inspiration is provided prior
with the continuous flow. Inspiration flow for the patient comes from the reser­voir 5. The non-return valve 6 stops a rebreathing into the reservoir 5.In case
the medical compressed gas supply fails, ambient air is sucked in via the
bypass air valve 9. A self-locking coupling 10 supplies the medicaments neb­ulizer with compressed air.

Figure 1 Function diagram

Table 1 Legend Figure 1

Pos. Designation

1 Filter

2 Filter

3 Flowmeter with valve for air

4 Flowmeter with valve for oxygen

5 Reservoir (bellows)

6 Nor-return valve

7 Pressure gauge

8 Relief valve

9 Bypass air valve

10 Coupling for medicament nebulizer

Revision 2.0_ Released_Printed on_11.01.06_F5682000.fm

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5682

7

Functional Description CF 800

2 Intended use CF800 is a device for the application of respiratory therapeutical measures

with continuously positive airway pressure.The device schould only be
applied on patients with spontaneous breathing.The CPAP system CF 800 is
a compact unit consisting of:

– Aquapor for the heating and humidifiering of the breathing air

– AWT 01 or thermometer for the temperature measurement

– Oxydig for the inspiratory O2-measurement

– Pneumatic medicaments nebulizer for medicaments nebulizing

– PEEP valve to built up positive airway pressure (CPAP)

3 Monitoring The device has no integrated monitoring. By recognition of insufficient spon-

taneous breathing or malfunction of the device (disconnection, gas failure,
breaking of hoses) a regular visual check by authorized medical personnel is
necessary.With the Oxydig the inspiratory O2-concentration is monitored.
With the AWT 01 the inspiratory breathing air temperature is automatically
monitored.

Weight 3,0 kg

Measurements: Height = max. 550 mm

Width = 212 mm

Depth = 260 mm

8

Figure 2 CF 800

5682

Revision 2.0_ Released_Printed on_11.01.06_F5682000.fm

All rights reserved. Copyright reserved.

CF 800 Functional Description

Compliance of the reser-

400 mL/mbar

voir

Max. pressure variations

+/- 2 mbar
at flow > 1.5 x volume per
minute

Safety valve limits the airway pressure to max. 30 mbar

Emergency air valve opens at a low pressure of 0.4 mbar, makes it

possible to go on with spontaneous breathing if

the compresed air supply fails

Manometer for measuring

-10 to 30 mbar

the airway pressure

error in measuring 2,5% of final value

Operating values

Gas supply

O2-pressure 2,7 to 6 bar

Connection thread M12x1 innen

Air pressure 2,7 to 6 bar

Anschlussgewinde M20x1,5 außen

The gases must be dry, free of oir and dust

Gas consuption corresponds to the set total flow

Noise during operation

max. 45 dB (A)

sound pressure acc. to
DIN45635

Revision 2.0_ Released_Printed on_11.01.06_F5682000.fm

All rights reserved. Copyright reserved.

5682

9

Functional Description CF 800

10

5682

Revision 2.0_ Released_Printed on_11.01.06_F5682000.fm

All rights reserved. Copyright reserved.

Annex

Parts catalog

Test List

Parts catalog

CF 800

Emergency Care - Perioperative Care - Critical Care - Perinatal Care - Home Care

Revision: 2005-06-08 11:19:33

5682.000

Because you care

2

Products Concerned

3

Parts catalog

Item

Part No. Description Qty.

No.

8414300 CF 800 1.000 St

8409400 CF 800 (CPAP DEVICE)

8410130 CF 800 P (PAED. CPAP DEVICE)

1.000 St

1.000

Qty.
unit

St

Remark

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

5682.000

Revision: 2005-06-08 11:19:33

Accessories/Consumables

A

A

4

Parts catalog

Item

Part No. Description Qty.

No.

1 8409400 CF 800 (CPAP DEVICE) 1.000 St

2 8409645 ONE-WAY PATIENT CONNECTION

2.1 8407571 HOSE SET, DISPOSABLE

2.2.3 8290274

2.3.3 M25647 NOZZLE 22/22

2.4.3 8402041 CORRUGATED HOSE

2.5.3 8403685 SET 12 STAND. CONE A PLASTIC

3 8413146 HOSE SET E2 (BLUE)

7 8409646 PEEP-VALVE WITH SUPPORT

8 8304411 Oxydig complete

9.1 8405791 SENSOR SLEEVE ADULTS

9.3 2M13259 THERMOMETER

10.1 M20650 Rail clamp

10.2 1335812

NGLE SOCKET ISO 1.000 St

LCALI-BATTERY,9 V 1.000 St

1.000 St part 2.1; 2.2.3; 2.3.3; 2.4.3 and 2.5.3

1.000

1.000 St

1.000

1.000 St

1.000 St

1.000 St

1.000

1.000 St

1.000 St

1.000

Qty.
unit

St

St

St

St

Remark

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

5682.000

Revision: 2005-06-08 11:19:33

Accessories/Consumables

A

5

Parts catalog

Item

Part No. Description Qty.

No.

10.3 8402868 BACTERIA FILTER 1.000 St

10.4 1190520 HOSE 4X1,5-SI 50 SH A NF

10.5 8400904 TAPER ADAPTER

11 8405000 MEDICAMENT NEBULIZER (PNEU)

12.1 8405029 PATIENT PART (AQUAPOR)

12.2 8403345 SET OF SPARE BRACKETS

12.4 8409450

13 8403201 TEST LUNG

14 8409609 HINGED ARM 240-DEGR.

14.1 8409746 SUPPORT FOR HINGED ARM A

14.2 8409841 HOSE CLAMP FOR HINGED ARM

QUAPOR SUPPORT FOR RAIL 1.000 St

1.000 m

1.000

1.000 St

1.000 St

1.000

1.000 St

1.000 St

1.000

1.000 St

Qty.
unit

St

St

St

Remark

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

5682.000

Revision: 2005-06-08 11:19:33

Concerned Devices

A

6

Parts catalog

Item

Part No. Description Qty.

No.

8414700

quapor EL, Humidifier 1.000 St

Qty.
unit

Remark

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

5682.000

Revision: 2005-06-08 11:19:33

Accessories Aquapor EL

A

7

Parts catalog

Item

Part No. Description Qty.

No.

1 8414699 Heating Top 1.000 St

1-5 8414700

2 8404739 TROUGH

2-5 8405029 PATIENT PART (AQUAPOR)

3 8404738 FLOAT

4 8404741 LIP SEAL

5 8406135 REP.SET COVER (AQUAPOR)

6 1190520 HOSE 4X1,5-SI 50 SH A NF

6-7 8405031 FILLING KIT FOR AQUAPOR

7 8405077 FUELLDORN,UGR.

8 M20650 Rail clamp

8-10 8403345 SET OF SPARE BRACKETS

9 1300849 SPLIT WASHER B5 DIN127-X12CRNI

10 1320440 SCREW AM5X16 DIN84

quapor EL, Humidifier 1.000 St

1.000

1.000 St

1.000 St

1.000

1.000 St

1.000 m

1.000 St

1.000

1.000 St

1.000 St

2.000

2.000 St

Qty.
unit

St

St

St

St

Remark

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

5682.000

Revision: 2005-06-08 11:19:33

Hose Set Adults

A

8

Parts catalog

Item

Part No. Description Qty.

No.

1 8414699 Heating Top 1.000 St

2-5 8405029 PATIENT PART (AQUAPOR)

8-10 8403345 SET OF SPARE BRACKETS

14 8405371 TEMPERATURE SENSOR

15 2165627 BREATHING HOSE E 60CM

15-26 8412092

16 8404985 Water trap

16A 8403976 POT

17 8403367

18 M25647 NOZZLE 22/22

19 M25649 MASKENKRUEMMER

20 8405435 Y-PIECE

21 M23840 STANDARD CONN.12,5 PLASTIC

22 8403566 TUBE CLAMPS

DULT HOSE SET, AQUAPOR

1.000 St

1.000

1.000 St

3.000 St

1.000

2.000 St

0.000 St

2.000 St

1.000

1.000 St

1.000 St

1.000

1.000 St

Qty.
unit

St

St

St

St

Remark

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

5682.000

Revision: 2005-06-08 11:19:33

Hose Set Adults

A

9

Parts catalog

Item

Part No. Description Qty.

No.

23 8402041 CORRUGATED HOSE 1.000 St

24 8403685 SET 12 STAND. CONE A PLASTIC

25 8403076

26 8402918 SET OF 5 CAPS (8401644)

DAPTER E

12.000 St different types from size 6 to 12

1.000

5.000 St

Qty.
unit

St

Remark

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

5682.000

Revision: 2005-06-08 11:19:33

Hose Set Children Aquapor

A

10

Parts catalog

Item

Part No. Description Qty.

No.

1 8414699 Heating Top 1.000 St

2-5 8405029 PATIENT PART (AQUAPOR)

8-10 8403345 SET OF SPARE BRACKETS

27 2165856 BREATHING HOSE K 22/10 0,4M

27-36 8412344 PAED HOSE SET, AQUAPOR

28 2165848 BREATHING HOSE K 10/10 0,6M

29 2165821 BREATHING HOSE K 22/10 0,6M

30 8405752 CONE 22A

31,16A 8409627 CONDENSATE TRAP EX.

32 8403075 Y-PIECE 90DEGREE

33 8401645 CAP (7 MM)

34 8403333 CORRUGATED HOSE 140 MM

35 8404760 STEAM TRAP

36 8403056

DAPTER FOR THERMOMETER 1.000 St

1.000 St

1.000

2.000 St

1.000 St

2.000

1.000 St

1.000 St

2.000 St

1.000

5.000 St

2.000 St

2.000

Qty.
unit

St

St

St

St

Remark

5682.000

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Revision: 2005-06-08 11:19:33

Flowmeter Air

11

Parts catalog

Item

Part No. Description Qty.

No.

1-11 8409452 FLOWMETER 30L/MIN, 5BAR 1.000 St

Qty.
unit

Remark

5682.000

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Revision: 2005-06-08 11:19:33

Flowmeter O2

12

Parts catalog

Item

Part No. Description Qty.

No.

1-5 8409445 O2 FLOWMETER 30L/MIN, 5BAR 1.000 St

Qty.
unit

Remark

5682.000

Items that are shown in the illustration but are not listed below the illustration are not available as spare parts

Revision: 2005-06-08 11:19:33

CF 800

13

Assembly Description Part No.

Parts catalog

Accessories Aquapor EL

Aquapor EL, Humidifier 8414700

FILLING KIT FOR AQUAPOR 8405031

FLOAT 8404738

FUELLDORN,UGR. 8405077

Heating Top 8414699

HOSE 4X1,5-SI 50 SH A NF 1190520

LIP SEAL 8404741

PATIENT PART (AQUAPOR) 8405029

Rail clamp M20650

REP.SET COVER (AQUAPOR) 8406135

SCREW AM5X16 DIN84 1320440

SET OF SPARE BRACKETS 8403345

SPLIT WASHER B5 DIN127-X12CRNI 1300849

TROUGH 8404739

Accessories/Consumables

ALCALI-BATTERY,9 V 1335812

ANGLE SOCKET ISO 8290274

AQUAPOR SUPPORT FOR RAIL 8409450

BACTERIA FILTER 8402868

CF 800 (CPAP DEVICE) 8409400

CORRUGATED HOSE 8402041

HINGED ARM 240-DEGR. 8409609

HOSE 4X1,5-SI 50 SH A NF 1190520

HOSE CLAMP FOR HINGED ARM 8409841

HOSE SET E2 (BLUE) 8413146

HOSE SET, DISPOSABLE 8407571

MEDICAMENT NEBULIZER (PNEU) 8405000

NOZZLE 22/22 M25647

ONE-WAY PATIENT CONNECTION 8409645

Oxydig complete 8304411

PATIENT PART (AQUAPOR) 8405029

PEEP-VALVE WITH SUPPORT 8409646

Rail clamp M20650

SENSOR SLEEVE ADULTS 8405791

SET 12 STAND. CONE A PLASTIC 8403685

SET OF SPARE BRACKETS 8403345

SUPPORT FOR HINGED ARM A 8409746

TAPER ADAPTER 8400904

TEST LUNG 8403201

THERMOMETER 2M13259

Basic Unit

5682.000

CF 800 (CPAP DEVICE) 8409400

Revision: 2005-06

CF 800

14

Assembly Description Part No.

Parts catalog

Concerned Devices

Aquapor EL, Humidifier 8414700

Flowmeter Air

FLOWMETER 30L/MIN, 5BAR 8409452

Flowmeter O2

O2 FLOWMETER 30L/MIN, 5BAR 8409445

Heating Top

Heating Top 8414699

Hose Set Adults

ADAPTER E 8403076

ADULT HOSE SET, AQUAPOR 8412092

BREATHING HOSE E 60CM 2165627

CORRUGATED HOSE 8402041

Heating Top 8414699

MASKENKRUEMMER M25649

NOZZLE 22/22 M25647

PATIENT PART (AQUAPOR) 8405029

POT 8403976

SET 12 STAND. CONE A PLASTIC 8403685

SET OF 5 CAPS (8401644) 8402918

SET OF SPARE BRACKETS 8403345

STANDARD CONN.12,5 PLASTIC M23840

TEMPERATURE SENSOR 8405371

TUBE CLAMPS 8403566

Water trap 8404985

Y-PIECE 8405435

Hose Set Children Aquapor

ADAPTER FOR THERMOMETER 8403056

BREATHING HOSE K 10/10 0,6M 2165848

BREATHING HOSE K 22/10 0,4M 2165856

BREATHING HOSE K 22/10 0,6M 2165821

CAP (7 MM) 8401645

CONDENSATE TRAP EX. 8409627

CONE 22A 8405752

CORRUGATED HOSE 140 MM 8403333

Heating Top 8414699

PAED HOSE SET, AQUAPOR 8412344

PATIENT PART (AQUAPOR) 8405029

SET OF SPARE BRACKETS 8403345

STEAM TRAP 8404760

Y-PIECE 90DEGREE 8403075

5682.000

Revision: 2005-06

CF 800

15

Assembly Description Part No.

Parts catalog

Instructions For Use

GA-DISKONNEKTMONITOR D 9028681

User manual Aquapor EL me 9037476

User manual Aquapor EL me 9037567

Manuals/Techn.Documentation

IFU CF 800 DE/EN 9028679

IFU CF 800 FR/ES 9028680

IFU CF 800 IT/NL 9029214

IFU CF 800 SV 9029215

Patient Part

PATIENT PART (AQUAPOR) 8405029

Power Cord Aquapor EL

Power cable 10A, 3m, grey, USA/J 1841793

Power cable Australia 3m,10A,C13L 1844350

Power cable DK, 3 m, 10 A 1844342

Power cable Great Britian 3m black 1844369

POWERCORD CH 3M 1844377

SUPPLY MAIN, 3M 1824481

Products Concerned

CF 800 8414300

CF 800 (CPAP DEVICE) 8409400

CF 800 P (PAED. CPAP DEVICE) 8410130

5682.000

Revision: 2005-06

Test List

CF 800

Serial no.:

—————————

File no.:
5682

Installation site:

—————————

Edition:

05.00

K5682xxx_TL1.fm 19.01.06

Copyright reserved. Reproduction permitted for non-commercial purposes only.

This Test List does not replace inspection and servicing by the manufacturer.

5682 CF 800 Page 1

1 Test equipment required for the Test List

Flowmeter 10 to 120 L/min Class 1.6

Flowmeter 0.01 to 14 L/min Class 1.6

Manometer -30 to +120 mbar Class 1.6

Stopwatch

Thermometer

Test lung

2 Accessories

2.1 Peripheral equipment

• Check the peripheral equipment according to the relevant Test
List.

2.2 Hinged arm

• Check the following elements for proper functioning and condition:

− Rail clamp

− Adjustability of brackets

− Locking mechanism

− Hose holder

2.3 Patient tubes

• Check the following elements for proper functioning, tightness,
and condition:

− Water separator

− Y-piece

− Hoses (see Instructions for Use manual)

K5682xxx_TL1.fm 19.01.06

Copyright reserved. Reproduction permitted for non-commercial purposes only.

This Test List does not replace inspection and servicing by the manufacturer.

5682 CF 800 Page 2

2.4 Thermometer

• Perform a reference measurement using a thermometer.

Maximum deviation

±2 °C

2.5 Ambu PEEP valve

• Check the condition of the Ambu PEEP valve.

3 Compressed-gas supply

3.1 Pipeline supply connecting tubes

• Check the condition and the tightness of the pipeline supply
connecting tubes.

3.2 Flowmeters

• Perform a reference measurement using an external flowmeter.

• Unscrew the flowmeter and connect the port to an external
flowmeter.

• Check the readings at three different settings.

The permissible deviation for the lowest reading is
readings it is

O2 readings

AIR readings

Fit the flowmeters.

±10%.

3.3 Drug nebulizer supply

• Connect the drug nebulizer port to a flowmeter.

Reading 3.3 L/min

±0.3 L/min

±15%. For all other

K5682xxx_TL1.fm 19.01.06

Copyright reserved. Reproduction permitted for non-commercial purposes only.

This Test List does not replace inspection and servicing by the manufacturer.

5682 CF 800 Page 3

4 Functional test

4.1 Leak test

• Connect the outlet to a pressure gauge.

• Build up a pressure of 10 mbar.

• Close the flow-control valves.

The maximum permissible pressure drop within 1 minute is 1.5 mbar.

4.2 Pressure gauge

Test set-up as in 4.1.

• Adjust different pressures and compare the readings on the
internal and external pressure gauges.

The permissible tolerance between the pressure gauges is

±2.5% of

the upper-range value.

4.3 Safety valve

Test set-up as in 4.1.

• Adjust the flow to 20 L/min.

The bellows extend to its maximum length. The safety valve should
open at 22 + 4 mbar.

4.4 Emergency air valve

• Connect the outlet to the test lung.

• Close the flow-control valves.

• Generate a negative pressure using the test lung.

The emergency air valve should open at 0 to -0.5 mbar.

K5682xxx_TL1.fm 19.01.06

Copyright reserved. Reproduction permitted for non-commercial purposes only.

This Test List does not replace inspection and servicing by the manufacturer.

5682 CF 800 Page 4

4.5 Non-return valve

Test set-up as in 4.4.

• Generate a negative pressure using the test lung, and then
release the test lung.

The resulting reading may decrease by 5 mbar within 30 seconds.

4.6 PEEP valve

• Assemble the unit ready for use and connect the test lung.

• Adjust the flow to 20 L/min.

• Check the PEEP at the following settings:

PEEP = 0, reading 0 +1.5 mbar

PEEP = 10, reading 10 +1.5 mbar

4.7 Spontaneous breathing

Test set-up as in 4.6.

• Simulate breathing.

Pressure fluctuations at the pressure gauge are

±1.5 mbar.

5 Handover

• Place fully functional unit at the user’s/owner’s disposal.

Date: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Name: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

K5682xxx_TL1.fm 19.01.06

Copyright reserved. Reproduction permitted for non-commercial purposes only.

This Test List does not replace inspection and servicing by the manufacturer.

5682 CF 800 Page 5

Manufacturer:

Dräger Medical AG & Co. KG

Moislinger Allee 53 – 55

D-23542 Lübeck

Germany

Phone: (++49) (0) 1805-3723437

Fax: (++49) 451/882 - 3779

Subject to change without notice

Will not be replaced in the event of modifications.

© Copyright by Dräger Medical AG & Co. KG, Lübeck, Germany.

The warranty and liability conditions of the general terms and conditions for business transactions of
Dräger Medical AG & Co. KG are not extended by this Technical Documentation.