Mark II Manometric Perfusion Pump User Manual PDF download

MARK II Manometric Perfusion Pump Horizontal Deck

Dentsleeve International Ltd. Manufactured by Mui Scientific 145 Traders Blvd. East, Unit 33-34 Mississauga, Ontario, CANADA L4Z 3L3 Tel: (905) 712-8828 Fax: (905) 890-3523 Toll Free: 866 751-6345 Email: [email protected] Website: www.dentsleeve.com

Handbook November, 2004

In

Index

Section In

Index

Section A

Overview

A-1 A-2

Schematic of pump Major pump components

Section B

Precautions & Warnings

Section C

Normal Use

C-1 C-2

Assembly & filling of perfusate reservoir Check, connect & set air supply

C-3 C-4 C-5 C-6 C-7

Connection & flushing of water manifold Check flow values of each hydraulic resistor Turn on water perfusion to fill each transducer Transducer calibration (if required) Connect catheter to transducers

C-8 C-9 C - 10 C - 11

Water injection procedure - each channel Check flow value for air perfusion manometry Observation & refilling of perfusate reservoir Maintain correct perfusate reservoir pressure

C - 12

Prevention, recognition and correction of hydraulic resistor blockage

C - 13

Compressor

Section D D-1 D-2 D-3 Section E

Steps on completion of measurements Perfusate reservoir Water manifold Air supply Set Up Procedures & Connection of Components

E-1 E-2 E-3

Air supply/compressor Perfusate reservoir prior to first use Installation of pressure transducers

E-4

Water perfusion manifold – removal

E-5 E-6 E-7

Standard hydraulic resistors Compact resistors Air perfusion circuit

2

In

Index

Section F

Cleaning & Disinfection

F-1 F-2

Cleaning of plastic parts Sterilization of perfusate reservoir

F-3 F-4 F-5

Sterilization of manifolds Hydraulic resistors Cleaning of compressor

Section G

Regular Maintenance

G-1

Every 3 months (or as needed) : perfusate water filter

G-2

Every year (or as needed): gas filters

G-5 G-6

Service of control box by Dentsleeve Compressor dessicant

Section H

Problem Solving

H-1

Diagnosis of abnormal Air consumption

H-2

Abnormal Air consumption - perfusate reservoir leakage

Section I

○

Specifications, Support, Spart Parts & Accessories

I-1

Specifications

I-2

Support

I-3 I-4 I-5

Spare parts Parts List Regulatory information

○

Notes on the use of this manual • References within the manual are shown in brackets eg (C – 4.2) = section C, part 4, instruction 2 • Part numbers (#) given in the text are unique for Dentsleeve • The technical information and illustrations in this manual reflect specifications and operating procedures at the time of drafting. Some specifications and operating procedures differ from earlier manuals for Mark II perfusion pump models. Dentsleeve reserves the right to vary specifications and operating procedures as part of its continuous product improvement process.

3

May 2003

○

Overview

Schematic of pump

100 kpa or 15 psi

A A–1

Regulated Air Supply to perfusate reservoir

Water Perfusate

Air Supply

Pump control box Perfusate Manifold

Manifold Purge Clamp

Manifold side-arm pinch valves or pinch clamps

Hydraulic resistors

3 Way stop cocks Pressure transducers Catheter connector tubes

Catheter

Note: Schematic diagram of water perfusion circuit. Only critical components are shown.

May 2003

4

A

Overview

Major pump components

A–2

Perfusate reservoir Pump control box Reservoir pressurization line

Reservoir outflow control device

Air supply gauge Manifold cover Air inlet

Pinch valves

Compressor connection plug

Compressor on/off switch

Main deck

Pinch valve or pinch clamp deck

Pressure transducer rack

Manifold flush pinch clamp Standard hydraulic resistors Transducer rack slide

Note: Pump length, channel numbers and spacings vary according to individual specifications. Compact deck version shown. Transducer types vary.

5

May 2003

!

B

Precautions & Warnings

B–1

!

Only pressurise reservoir with this line (C – 3.1).

! Air perfusion channel. Only use for pharyngeal swallow monitoring.

!

Never drop. Do not use if visible damage.

!

Air Pressures never more than 300 kpa (45psi).

Water level never less than 2cm (C – 10).

May 2003

6

C

Normal Use

Assembly & filling of perfusate reservoir C – 1

Note: See E – 2 for Dentsleeve part #’s Fill with particle free, degassed, distilled H20

1

2

Add water, then place perfusion float barrier on top

Blow-off valve

Perfusate outlet hole

‘O’ ring

Reservoir outflow control device

! !

Always use diffusion float barrier

○

3

7 May 2003

○

Tighten firmly to seal

May 2003

○

C

Normal Use

For set-up and first use see E – 1 to E – 9

C–2

Check, connect & set air supply

1

Push together

Pull back to release

Click!

Air ○

○

2

Air Set to 100 kPa - 15 psi

3

At least 1000 kpa (150 psi) in high pressure Air supply cylinder

○

May 2003 8

Normal Use

Connection & flushing of water manifold

1

Push to seal onto reservoir

Part #: ZP1FIT/SW/B-QM2-B-200ZN

2

Connect to water manifold

Reservoir support posts

3

Air line from control box

Open outflow control

4

Open to vent bubbles

Manifold venting pinch clamp

9

May 2003

C C–3

C C–4

Normal Use

Check flow values of each hydraulic resistor

1

Flow ml/min

1

Standard resistor shown: flow is colour coded

Tube Colour

Screw Colour

Part #

0.01

Black

White

R01HRE/ST/1(2)

0.02

Black

R01HRE/ST/2(2)

0.04

Red

R01HRE/ST/4(2)

0.08

Red

White

R01HRE/ST/8(2)

0.15

Red

Black

R01HRE/ST/15(2)

0.3

Green

White

R01HRE/ST/30(2)

0.45

Green

Red

R01HRE/ST/45(2)

0.6

Green

Black

R01HRE/ST/60(2)

Alternative: Compact hydraulic resistor

Water flow on case

2

The flow value is...

• Correct, go to

C–5

• Changed, go to

E–5 or 6 May 2003

10

Normal Use

C

Turn on water perfusion to fill each transducer

1

Open pinch valve or clamp

2

Fill transducers

2

Fill transducers

Prefered position for 3 way stopcock - other than PVB DPT-6100 Note: PVB DPT-6100 Transducer shown

11 May 2003

Note: Abbott Transpac 42582-10 Transducer Shown

C–5

C

Normal Use

C–6

Transducer calibration (if required)

1

Turn perfusion off - (C – 5)

2

Set tranducer gain by applying standard external pressure

Shows AP1CMA/TR/2

Connect to transducers Note: Shows Dentsleeve calibration manifold; made according to channel numbers and spacings Part #’s AP1CMA/TR/1to5

Pressurise with syringe

C–7

Connect catheter to transducers

1

Select correct channel

2

Twist & push on firmly

Note: Catheter detail is for Dentsleeve product

May 2003

12

Normal Use

C

Water injection procedure - each channel

1

H2O - no bubbles

3

Inject 5ml of H2O

13 May 2003

2

Open side-port

C–8

C C–8

Normal Use

Water injection procedure - each channel (cont)

4

Close side-port then remove syringe

Note: Arrangement for PVB DPT-6100 transducer shown

May 2003 14

C

Normal Use

Check flow value for air perfusion manometry

1

C–9

Identify air perfusion channel

Red Band

! Only use air perfusion for detection of swallowing in pharynx

2

Ensure resistor for air perfusion channel is correct

!

Air flow rate through hydraulic resistor is x100 water flow rate.

Water flow ml/min

Part #

0.02

Black

R01HRE/ST/2(2)

0.04

Red

R01HRE/ST/4(2)

0.08

Red

White

R01HRE/ST/8(2)

Suitable compact resistors give airflow on case

! Must be installed between manifold and transducer to limit air flow into catheter to less than 10ml/min

15

May 2003

Air flow ml/min

Water Flow ml/min

Part #

2

0.02

R01HRE/CO/2

4

0.04

R01HRE/CO/4

8

0.0

R01HRE/CO/8 8

C

Normal Use

C – 10

Observation & refilling of perfusate reservoir

If perfusate exhausted, large volumes of gas may be perfused down catheter

1

Refill when at 2cm

2

Release pressure

Pull Back

3

Refill

Particle free, degassed, distilled H 20

4

Restart perfusion

Tighten

Repressurise

May 200316

Normal Use

C

Maintain correct perfusate reservoir pressure

C – 11

Monitor air pressure. Maintain at 100kPa/15psi.

1

150

100 15

20 25

10 50

0

2

200

30 35

5 psi kPa

250

Check if air pressure drops

3

Check that air supply is adequate

300 200

400 40 60 20

100

500 80

0

psi kPa

600

OR At least 130 kPa/ 20psi

At least 1000 kPa/ 150psi

17 May 2003

C C – 12

Normal Use

Prevention, recognition and correction of hydraulic resistor blockage

1

Prevention of blockages - Always use perfusate filter

2

Minimise perfusate particle load

Double-distilled or de-ionised water

No particles in reservoir (E-2) Perfusate filter Part # AP1FIL/WA/1

3

4

Replace water perfusate filter regularly - (G-1)

Check perfusate flow rates - assemble 1ml syringe barrel on transducer

1ml syringe

5

Start perfusion - (C-5)

6

Measure time to deliver water

Female/Female adapter Part # ZP1FIT/VP/FTLLC-9

Transducer on rack

Note: for resistor flow rates < 0.15ml/min use 0.25 - 0.50 ml syringe barrels

May 2003

18

C

Normal Use

Prevention, recognition & correction of hydraulic resistor blockage (cont.)

7

Flushing of blocked resistors - remove resistor from circuit

Transducer end

8

Backflush forcibly

9

Observe water flow

OR 11

Remove resistor from circuit

12

Insert flush support tool - (E – 6)

13

Same steps as C – 12.7 to 12.10 above

19 May 2003

10

Re-install - (E – 5)

C – 12

C

Normal Use

C – 13

Compressor

1

Always earth

2

Turn on power switch. Power is on when switch is illuminated

3 4

5

Connect compressor air outlet to pump control box

Plug in compressor to pump control

Press compressor on/off switch. Functioning normally when switch is illuminated

May 2003 20

Steps On Completion of Measurements

D

Perfusate reservoir

1

2

Depressurise

3

Remove lid

5

Remove float & air dry

Close and disconnect from manifold

4

Drain Reservoir

Lint & particle free surface

! Do not transfer particles to internal surfaces of reservoir

21 May 2003

D–1

D D–2

Steps On Completion of Measurements

Water manifold

1

D–3

Close

Air supply

1

Turn off compressor

OR 2

Close cylinder valves

May 2003

22

E

Set Up Procedures & Connection of Components

Air supply/Compressor

! ○

○

Installation only by an approved, qualified biomedical engineer ○

1

○

Use Air

Note: Air chosen as: 1. Air dissolution in perfusate prevented by perfusate float barrier. 2. More suitable for gas perfusion manometry than N2 . 3. Usually more available and cheaper than N 2 . 4. Available from wall supply and simple compressors.

2

23

E–1

May 2003

Set up for compressor, wall or air bottle supply

Compressor

E – 1.3

Wall

E – 1.4

Air bottle

E – 1.6 or 1.9

○

E E–1

3

Set Up Procedures & Connection of Components

Air supply/Compressor Install under pump deck

Air Compressor Unit

4

Identify air line

OR Black

Connects to pump Air/N2 inlet (C – 1.1)

5

Ensure air source is suitable: • 130 - 240 kPa or 20 - 35 psi no oil or moisture • filtered to 0.5 micron •

Short Air Link Lead – 65 cm

6

Make appropriate connection to supply

May 2003

24

E

Set Up Procedures & Connection of Components

Air supply/Compressor

7

E–1

Identify air line with Dentsleeve supplied regulator Factory set by Dentsleeve to deliver maximum 300 kPa or 45 psi

Part # ZP1REG/HP/1

Cylinder pressure gauge Black

Connect to pump air inlet (C – 1.1)

Air Bottle Regulator & Supply Lead Medical international air pin index (Size C cylinders only)

!

8

Install C size cylinder under main deck

9

Install regulator on cylinder pin index

Maximum cylinder pressure 25,000 kPa or 3,700 psi.

Note: International pin-index is only available on C size medical air cylinders. (3 Litres volume on hydrostatic test). Index must be specified for air.

10

Identify air line if no high pressure regulator supplied

Black

Long Air Link Lead – 3 meters

!

11

Connect to suitable locally sourced high pressure regulator with lockable outlet pressure control

!

12

Adjust regulator to deliver outlet pressure no greater than 300 kPa or 45 psi

25 May 2003

E E–2

Set Up Procedures & Connection of Components

Perfusate reservoir prior to first use

1

Check correct assembly of perfusate reservoir

Blow-off valve Part # ZP1FIT/SW/SS-4CPA2-3

Closure Knob Part# AP1FAS/PR/1 Part # FAS/PR/1

‘O’ ring Part # ZP1SEA/OR/1

Reservoir outflow control device

Gasket under lid Part # ZP1SEA/GA/1

! Part # ZP1FIT/SW/SS-QM2-S-2PM

Always use water filter (C – 2.2) Part # AP1FIL/WA/1

! Always use diffusion float barrier Part # FLO/PR/1

Gasket in channel Part # ZP1SEA/GA/1

Outlet ‘O’ ring Part # ZP1SEA/OR/2

2

Flush reservoir with water to remove any particles

May 2003

26

Set Up Procedures & Connection of Components

Installation of pressure transducers

1 PVB DPT-6100

2

27

May 2003

Remove cable cover

Abbott Transpac 42582-01

E E–3

Set Up Procedures & Connection of Components

Installation of pressure transducers (continued)

3

Remove transducer rack

4

Attach transducers

May 2003

28

Set Up Procedures & Connection of Components

Installation of pressure transducers (continued)

29

5

Replace transducer rack

6

Replace cable cover

May 2003

E E–3

E

Set Up Procedures & Connection of Components

E–4

Water perfusion manifold removal

1

Unscrew manifold cover thumbscrews and slide off

2

Remove manifold luer clamps and pull plate off

Water perfusion manifold

!

Air perfusion (C – 9 and E – 7)

May 2003

30

Set Up Procedures & Connection of Components

Water perfusion manifold removal (continued)

3

Pinch valve

○

4

31

May 2003

E E–4

E

Set Up Procedures & Connection of Components

E–5

Standard hydraulic resistors

1

2

Identify standard resistor with correct flow value. (C – 4)

Prime resistor with water. Use 1 ml syringe for 0.6 - 0.15ml/min resistors 0.5ml syringe for lower flow rates

Particle-free water

3

Inject till water flows from other end

4

Fill resistor connector as syringe withdrawn

No bubbles trapped in luer

May 2003

32

Set Up Procedures & Connection of Components

Standard hydraulic resistors (continued)

5

Connect resistor to manifold side arm luer Ensure resistor connector remains water filled Manifold clamp

Part # ZP1FAS/RI/1

6

Push and rotate resistor firmly onto manifold luer

7

Open

33 May 2003

E E–5

Set Up Procedures & Connection of Components

Standard hydraulic resistors (continued)

8

Debubble downstream resistor luer Inject particle-free water into bottom of luer

9

Ensure no bubbles are trapped

10

Connect to pressure transducer Preferred position for 3 way stopcock

11

Use special high pressure stopcock

12 Abbott transpac 42582-01 shown

Push and rotate resistor firmly onto 3 way stopcock

Part # ZP1STO/HP/2

Water filled

Note PVB DPT-6100 transducer has integral stop-cock at transducer outlet

13

Final setup: Follow instructions from (C – 7.1)

May 2003

34

Set Up Procedures & Connection of Components

Compact resistors

1 ○

○

E E–6

Check flow values for each hydraulic resistor

○

2

○

Prime resistor with water - Use flush tool

Flush tool - Part # AP1FTO/CR/1

Flush tool holder on top of control box – Part# AP1FTO/CR/2

3

35

Place flush tool on silicone rubber connector

4

Use 1 ml syringe for 0.6 – 0.15 ml/min resistors 0.25 – 0.5 syringe for lower flow rates

5

Inject until water flows from other end

6

Fill resistor connector as syringe withdrawn

May 2003

7

Remove flush tool

E E–6

Set Up Procedures & Connection of Components

Compact resistor set-up (continued)

8

Connect as shown

To water manifold

Note: Connectors are self-debubbling. PVB DPT-6100 transducer shown.

May 2003 36

Set Up Procedures & Connection of Components

Compact resistors (continued)

9

Connect resistor to manifold sidearm

Manifold clamp

Part # ZP1FAS/RI/1

10

11 37

Open

Final set-up - follow from (C – 5.2).

E E–6

E

Set Up Procedures & Connection of Components

E–7

Air perfusion circuit N2 perfusion into pharynx may dilute inspired oxygen - use only Air for perfusate reservoir pressurisation in small children, as this gas also used for gas perfusion circuit

!

1

Identify circuit. To remove manifold cover see E - 4.1 to 4.2

red fitting red

Air manifold Part #’s Compact AP1MAN/AI/1 Wide AP1MAN/AI/2

Note: Shows Compact version 37mm channel spacings

3

2

Locate air manifold and check correctly connected

Resistor must always be installed Pinch valve

To transducer

Pinch clamp

red

May 2003

38

E

Set Up Procedures & Connection of Components

Air perfusion circuit (continued)

4

E–7

Select resistor that controls airflow to less than 10ml/min

Air flow Waterflow ml/min ml/min

!

5

Airflow is x100 waterflow

Part #

2

0.02

Black

R01HRE/ST/2(3)

4

0.04

Red

R01HRE/ST/4(3)

8

0.08

Red

White

R01HRE/ST/8(3)

Appropriate compact resistors show airflow on case

Air 2mL/min WATER 0.02mL/min

Air 4mL/min WATER 0.04mL/min

Air = 2ml/min

Air = 4ml/min

Air = 8ml/min

To manifold luer

6

Install air flow resistor between air manifold luer and transducer

No 3 way stopcock

7 ! 39

No water prime required

Air perfusion to be used only for pharyngeal manometry

Cleaning & Disinfection

Cleaning of plastic parts

1

Clean with cloth and mild detergent

2

F–1

Wipe with isopropyl alcohol

Sterilization of perfusate reservoir

1

F

F–2

Gas sterilize only

Sterilization of manifolds

F–3

Water manifold Air manifold

1

Autoclavable

Hydraulic resistors

!

1

Not autoclavable

2

Autoclavable

Cleaning of compressor

1

F–4

F–5

Wipe with a dry cloth

40

G G–1

1

Regular Maintenance

Every 3 months (or as needed): perfusate water filter

Replace

Part # AP1FIL/WA/1

41

G

Regular Maintenance

Every year (or as needed): gas filters !

G–2

To be done only by an approved, qualified biomedical engineer

1

Disconnect gas supply then open control box (G – 3.2)

2

Use correct filter

Part # AP1FIL/GA/1

Gas (Black)

3

Replace each filter in turn

!

Do not cross connections Air

4

= Black

Black

Check for air-tightness

Note: Gas filter life depends on quality of air – always use medical grade

G–3

Service of control box by Dentsleeve

1

Undo 4 screws under main deck that hold control box legs

2

Send control box to Dentsleeve

42 May 2003

Regular Maintenance

G

Compressor

1

G–4

Check dessicant is orange. When it becomes colourless, replace.

Orange

✓ White

8

500

OR • Spread granules evenly onto tray, one granule deep. • Heat granules for approximately 15 mins. (or until it turns back to its original orange color) at 100oC (200oF) in a conventional oven. • Cool dessicant before replacing back into canister. 43

H

Problem Solving

Diagnosis of abnormal air consumption

1

H–1

Check compressor connection

For compressor malfunction, please contact Dentsleeve

○

OR ○

○

Check regulator/cylinder connection

Air Tighten ○

○

2

○

Pressurise air circuit - Turn on

Not connected

150

100 15

25

10 50

200

30 35

5 0

Air

20

psi kPa

Air

250

3

4

Adjust air pressure

Turn off

44

H H–1

Problem Solving

Diagnosis of abnormal air consumption (continued)

5

Recognise leakage - Wait 1 hour

either

or

6

Drop less than 33 kPa/5psi

No significant leak

7

Drop more than 33 kPa/5psi

Significant leak

8

45

Follow (H-1.9) below

H

Problem Solving

Diagnosis of abnormal air consumption (continued)

9

Check for leakage outside control box

150

100 20

15

Water

25

10 50

11

! ○

○

250

Consult approved, qualified biomedical engineer to do check (H-1.12 to H-1.17) below ○

○

12

Air

○

psi kPa

0

If there are bubbles, replace fitting Part # ZP1FIT/SW/B-QM2-B-200ZN

200

30 35

5

10

H–1

○

Leakage?

○

13

Open pump control box. Remove 2 screws on both sides

14

Remove control box lid/back

46

H H–1

Diagnosis of abnormal air consumption (continued)

15 16

47

H

Problem Solving

Check rest of air circuit

? Filter leakage - tighten or replace

H

Problem Solving

Abnormal air consumption - perfusate reservoir leakage

1 ○

○

First exclude air circuit leakage - (H – 1)

○

2

○

Set pressure

○

psi kPa

○

200

30 35

0

○

25

5

○

20

50

○

150 15

○

100

10

○

H–2

○

250

○

Tighten

3

Set up reservoir. Remove blow-off valve cap

4

No water

5

Pressurise

6

Locate site of leakage - observe underwater

Still pressurised

7

Locate site of bubbling

48

H

Problem Solving

Abnormal Air consumption - perfusate reservoir leakage (cont.)

H–2

ZP1FIT/SW/B-QM2-B-200ZN

8 ○

○

If leak elsewhere, dismantle reservoir

○

9

○

11

○

Underside

Flip

49

○

Gasket clean and intact?

Identify cause of leakage at top

Check ‘O’ ring Part # ZP1SEA/OR/1

○

Identify cause of leakage at base

10 ○

○

Gasket underneath clean and intact? Part # ZP1SEA/GA/1

○

Specifications, Support & Spare Parts

Specifications Air

Medical grade only

High pressure regulators Recommended first stage regulators (*if supplied)

CONCOA Medical Air (Air pin index)

Inlet pressure Pump inlet pressure (from gas supply first stage regulator)

Air 167 - 300kPa (25 - 45 psi) Compressor 130 - 240kpa (20 - 35 psi)

Supply lines (from gas bottles) Air (black) line

I I–1

Supplied with Swagelok female quick connects Air Male Inlet Swagelok Code

ZP1FIT/SW/B-QC4-DI-400KI Dentsleeve part #

Air female connector to perfusate reservoir Swagelok Code

ZP1FIT/SW/B-QM2-B-200ZN Dentsleeve part #

Air supply on pump Driving air supply (pump) Air flow rate ± 20%

Adjustable 0 -250 kPa (0 - 36psi) Flow restricted to 30ml/min at 100kPa (15psi)

Pressure relief valves Perfusate reservoir relief valve Control box inlet overpressure relief valve

Preset to 200 kPa (29psi) Preset to 300 kPa (45psi)

Filtration Air

0.5 micron male/female luer connection disposable disc filter

Technical Support

1

Contact Dentsleeve for advice

2

See contact details on front cover

I–2

50