User Manual
53 Pages

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Page 1
MARK III Manometric Perfusion Pump Vertical 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 September, 2006
Index
Section In
Index
Section A
Overview
A-1
Schematic of pump
A-2
Major pump components
A-3
Air – Water System
Section B
Precautions & Warnings
Section C
Normal Use
C-1
Assembly & filling of perfusate reservoir
C-2
Check, connect & set air supply
C-3
Connection & flushing of water manifold
C-4
Check flow values of each hydraulic resistor
C-5
Turn on water perfusion to fill each transducer
C-6
Transducer calibration (if required)
C-7
Connect catheter to transducers
C-8
Water injection procedure - each channel
C-9
Check flow value for air perfusion manometry
C - 10
Observation & refilling of perfusate reservoir
C - 11
Maintain correct perfusate reservoir pressure
C - 12
Prevention, recognition and correction of hydraulic resistor blockage
C - 13
Compressor
Section D
Steps on completion of measurements
D-1
Perfusate reservoir
D-2
Water manifold
D-3
Air supply
Section E
In
Set Up Procedures & Connection of Components
E-1
Air supply
E-2
Perfusate reservoir prior to first use
E-3
Installation of pressure transducers
E-4
Water perfusion manifold – removal
E-5
Standard hydraulic resistors
E-6
Compact resistors
E-7
Air perfusion circuit
2
In
Index
Section F
Cleaning & Disinfection
F-1
Cleaning of plastic parts
F-2
Sterilization of perfusate reservoir
F-3
Sterilization of manifolds
F-4
Hydraulic resistors
F-5
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-3
Service of control box by Dentsleeve
G-4
Compressor dessicant
Section H
Problem Solving
H-1
Diagnosis of abnormal air consumption
H-2
Abnormal air consumption - perfusate reservoir leakage
Section I I-1 I-2 I-3 I-4
Specifications, Support, Spart Parts & Accessories Specifications Technical Support Spare parts 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 III perfusion pump models. Dentsleeve reserves the right to vary specifications and operating procedures as part of its continuous product improvement process.
3
A
Overview
Schematic of pump
A–1
Regulated air supply to perfusate reservoir
100 kpa or 15 psi
Air supply
Water perfusate
Pump control box Manifold purge clamp Manifold side-arm pinch valves
3 Way stop cocks Pressure transducers Catheter connector tubes Catheter
Note: Schematic diagram of water perfusion circuit. Only critical components are shown.
4
A A–2
Overview
Major pump components
Reservoir pressurization line
Pump control box Perfusate reservoir
Reservoir outflow control device
Air inlet Pressure transducer rack Air perfusion line Standard hydraulic resistors
Manifold flush valve
Calibration bowl
Main perfusate manifold
Pinch valves
Note: Pump length, channel numbers and spacings vary according to individual specifications. Standard deck version shown. Transducer types vary: Abbott Transpac 42582-10 transducers shown.
5
Overview
A–3
A
MKIII Pump Air – Water System #ZP1-GAU/TR/1
#ZP1FIT/SW/SS-4CPA-2-3
#ZP1-SEA/OR/5 Mini Female Quick Connect #ZP1FIT/SW/SS-QM2-B-200
6
B
!
Precautions & Warnings
B–1
!
!
! Never drop. Do not use if visible damage.
Only pressurise reservoir with this line (C – 3.1).
Water level never less than 2cm (C – 10).
!
!
7
Air perfusion channel. Only use for pharyngeal swallow monitoring (C – 9).
Air pressures never more than 300kpa / 45psi
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
Perfusate outlet hole
Blow-off valve
‘O’ ring
Reservoir outflow control device
!
!
Always use diffusion float barrier
Always use water filter Part #: AP1FIL/WA/1
3
May 2003
Tighten firmly to seal
8
C
Normal Use
For set-up and first use see E – 1 to E – 7
C – 2 Check, connect & set air supply
1
Click!
Air
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Air Set to 100 kPa / 15 psi
To gas supply
9
May 2003
Normal Use
Connection & flushing of water manifold
C C–3
1
2
Connect to water manifold Part # ZP1FIT/SW/SS-QM2-B-B-200
Air line from control box
Filter
3
Open
4 May 2003
Open, vent and close
10
C
Normal Use
C–4
Check flow values of each hydraulic resistor
1
Standard resistor shown : flow is colour coded
Flow ml/min
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1
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Tube Colour
Screw Colour
Part #
0.01
Black
White
R01HRE/ST/1(3)
0.02
Black
Black
R01HRE/ST/2(3)
0.04
Black
Red
R01HRE/ST/4(3)
0.08
Red
White
R01HRE/ST/8(3)
0.15
Red
Black
R01HRE/ST/15(3)
0.3
Green
White
R01HRE/ST/30(3)
0.45
Green
Red
R01HRE/ST/45(3)
0.6
Green
Black
R01HRE/ST/60(3)
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Alternative: Compact hydraulic resistor
Water flow on case
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2
11
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The flow value is... • Correct, go to
C–5
• Changed, go to
E–5 or 6 May 2003
Normal Use
C
Turn on water perfusion to fill each transducer
1
Open pinch valve or clamp
2
Fill transducers
2
C–5
Fill transducers
Prefered position for 3 way stopcock - other than PVB DPT-6100 Note: PVB DPT-6100 Transducer shown
Note: Abbott Transpac 42582-10 Transducer Shown
12
C C–6
Normal Use
Transducer calibration (if required)
1
Turn perfusion off - (C – 5)
2
Set tranducer gain by applying standard external pressure
3
or use gravity calibration
Shows AP1CMA/TR/2
68cm H 2O, 50mm Hg
Connect to transducers
Pressurise with syringe
Note: Shows Dentsleeve calibration manifold; made according to channel numbers and spacings Part #’s AP1CMA/TR/1to5
C–7
Connect catheter to transducers
1
Select correct channel
2
Twist & push on firmly
Note: Catheter detail is for Dentsleeve product
13
Note: Catheter must be attached to transducers – (C – 7)
Normal Use
C
Water injection procedure - each channel
1
2
H2O - no bubbles
3
C–8
Open side-port
Inject 5ml of H2O
14
C
Normal Use
C–8
Water injection procedure - each channel (continued)
4
Close side-port then remove syringe
Note: Arrangement for PVB DPT-6100 transducer shown
15
C
Normal Use
Check flow value for air perfusion manometry
1
C–9
Identify air perfusion channel pinch valve
! 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.
Air flow ml/min
Part #
2
Black
Black
R01HRE/ST/2(3)
4
Black
Red
R01HRE/ST/4(3)
8
Red
White
R01HRE/ST/8(3)
Suitable compact resistors give airflow on case
! Must be installed between manifold and transducer to limit air flow into manometric catheter to less than 10ml/min
May 2003
Air flow ml/min
Water Flow ml/min
Part #
2
0.02
R01HRE/CO/2
4
0.04
R01HRE/CO/4
8
0.08
R01HRE/CO/8
16
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 Tighten
Repressurise
17
Restart perfusion
C
Normal Use
Maintain correct perfusate reservoir pressure
1
C – 11
Monitor air pressure. Maintain at 100kPa/15psi.
100 51
150 200
kPa psi DENTSLEEVE INT’L Mfd. by Mui Scientific
2
Check if air pressure drops
3
Check that air supply is adequate
At least 130 kPa/ 20psi 200 100
300 400
kPa psi DENTSLEEVE INT’L Mfd. by Mui Scientific
OR
At least 1000 kPa/ 150psi open
18
C
Normal Use
C – 12
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 ○
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4
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Replace water perfusate filter regularly - (G-1) ○
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Check perfusate flow rates - assemble 1ml syringe barrel on transducer
1ml syringe
5
Start perfusion - (C -2)
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
19
Normal Use
Prevention, recognition and correction of hydraulic resistor blockage
7
C C – 12
Flushing of blocked resistors - remove resistor from circuit Transducer end
8 9
Backflush forcibly
Observe water flow
10
Re-install - (E – 5)
OR 11
Remove resistor from circuit
12
Insert flush support tool - (E – 6)
13
Same steps as C – 11.7 to 11.10 above
20
C
Normal Use
C – 13
Compressor
1
Always ground
2
Turn on power switch. Power is on when switch is illuminated
3
4
21
Connect compressor air outlet to pump
Plug in compressor to pump control
Steps On Completion of Measurements
Perfusate reservoir
1
2
4
Depressurise
3
Remove lid
5
Remove float & air dry
D D–1
Close and disconnect from manifold
Drain Reservoir
Lint & particle free surface
! Do not transfer particles to internal surfaces of reservoir
22
D
Steps On Completion of Measurements
Water manifold
D–2
1
D–3
Close
Air supply
1
OR
2
23
Close cylinder valve
Turn off compressor
E
Set Up Procedures & Connection of Components
Air supply
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1
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E–1
Installation only by an approved, qualified biomedical engineer ○
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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
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
24
E
Set Up Procedures & Connection of Components
E–1
Air supply (continued)
Install next to pump deck or place on bottom shelf of trolley
3
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Part # ZP1FIT/SW/SS-400-7-2
Connects to pump Air inlet (C – 1.1) Part # ZP1FIT/SW/B-QC4-B-400ZN
Ensure air source is suitable: • 130 - 240 kPa or 20 - 35 psi • no oil or moisture • filtered to 0.5 micron
25
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Identify air line
Black Part # ZP1TUB/NS/1
5
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6
Make appropriate connection to supply
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Set Up Procedures & Connection of Components
E
Air supply (continued)
7
E–1
Identify air line with Dentsleeve supplied regulator
Factory set by Dentsleeve to deliver 300 kPa / 45 psi
Part # ZP1REG/HP/1
Connect to pump air inlet (C – 1.1)
Cylinder pressure gauge
Medical international air pin index (Size C cylinders only)
8
Identify air line if no high pressure regulator supplied
Black
!
9
!
10
Connect to suitable locally sourced high pressure regulator with lockable outlet pressure control
Adjust regulator to deliver outlet pressure of 300 kPa / 45 psi
26
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 # FAS/PR/1
Reservoir outflow control device
‘O’ ring Part # ZP1SEA/OR/1
Gasket under lid Part # ZP1SEA/GA/1
! Always use water filter (C – 2.2) Part # AP1FIL/WA/1
Part # ZP1FIT/SW/SS-QM2-S-2PM
! Always use diffusion float barrier Part # FLO/PR/1
Gasket in channel Part # ZP1SEA/GA/1
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Outlet ‘O’ ring Part # ZP1SEA/OR/2
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Flush reservoir with water to remove any particles
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Set Up Procedures & Connection of Components
Installation of pressure transducers
E E–3
1 PVB DPT-6100
2
Abbott Transpac 42582-01
Mount bar removable
28
E
Set Up Procedures & Connection of Components
E–3
Installation of pressure transducers (continued)
3
4
29
Set Up Procedures & Connection of Components
Installation of pressure transducers (continued)
E E–3
5
30
E
Set Up Procedures & Connection of Components
E–4
Water perfusion manifold – removal
1
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Water perfusion manifold
! 31
Air perfusion (C – 9 and E – 7)
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E
Set Up Procedures & Connection of Components
Water perfusion manifold – removal (continued)
E–4
2
Pinch valve ○
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3
32
E
Set Up Procedures & Connection of Components
E–5
Standard hydraulic resistors
1 ○
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Identify standard resistor with correct flow value. (C – 4)
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Prime resistor with water. Use 1 ml syringe for 0.6 - 0.15ml/min resistors 0.5ml syringe for lower flow rates
2
Particle-free water
3 ○
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Inject till water flows from other end
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Fill resistor connector as syringe withdrawn
No bubbles trapped in luer
33
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E
Set Up Procedures & Connection of Components
Standard hydraulic resistors (continued)
5
E–5
Connect resistor to manifold side arm luer Ensure resistor connector remains water filled
Manifold clamp
Part # ZP1FAS/RI/1
6 ○
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7
Push and rotate resistor firmly onto manifold luer
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Open
34
E
Set Up Procedures & Connection of Components
E–5
Standard hydraulic resistors (continued)
8
Debubble downstream resistor luer Inject particle-free water into bottom of luer
9
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Ensure no bubbles are trapped
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Connect to pressure transducer Preferred position for 3 way stopcock
11
Use special high pressure stopcock
Push and rotate resistor firmly onto 3 way stopcock
12 Abbott transpac 42582-01 shown
Part # ZP1STO/HP/2
Water filled
Note PVB DPT-6100 transducer has integral stop-cock at transducer outlet ○
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13 35
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Final setup: Follow instructions from (C – 7.2)
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E
Set Up Procedures & Connection of Components
Compact resistors
1 ○
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Check flow values for each hydraulic resistor
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2
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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
6
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Prime resistor with water - Use flush tool
3
5
E–6
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Inject until water flows from other end
Fill resistor connector as syringe withdrawn
7
Remove flush tool
36
E E–6
Set Up Procedures & Connection of Components
Compact resistors (continued)
8
Connect as shown
DENTSLEEVE
0.60mL/min Water Only #HRE/CO/60
To water manifold
Note: Connectors are self-debubbling. PVB DPT-6100 transducer shown.
37
E
Set Up Procedures & Connection of Components
E–6
Compact resistors (continued)
9
Connect resistor to manifold sidearm DENTSLEEVE
0.60mL/min Water Only #HRE/CO/60
Manifold clamp
Part # ZP1FAS/RI/1
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Open
Final set-up - follow from (C – 5.2).
38
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 is also used for gas perfusion circuit
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1
Identify circuit
2
Locate air manifold and check correctly connected
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3
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Resistor must always be installed
To transducer
39
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
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5
Airflow is x100 waterflow
Part #
2
0.02
Black
Black
R01HRE/ST/2(3)
4
0.04
Black
Red
R01HRE/ST/4(3)
8
0.08
Red
White
R01HRE/ST/8(3)
Appropriate compact resistors show airflow on case
DENTSLEEVE Air
DENTSLEEVE Air 4mL/min
WATER
0.02mL/min
0.04mL/min
0.04mL/min
HRE/CO/2
HRE/CO/4
HRE/CO/4
4mL/min
WATER
Air = 2ml/min ○
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6
DENTSLEEVE Air
2mL/min
WATER
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Air = 4ml/min ○
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Air = 8ml/min ○
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Install air flow resistor between air manifold luer and transducer No 3 way stopcock
7 !
No water prime required
Air perfusion to be used only for pharyngeal manometry To manifold luer
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F
Cleaning & Disinfection
Cleaning of plastic parts
1
F–1
Clean with cloth and mild detergent
Sterilization of perfusate reservoir
1
F–2
Gas sterilize only
Sterilization of manifolds
F–3
Water manifold Air manifold
1
Autoclavable
Hydraulic resistors
F–4
DENTSLEEVE Air 4mL/min WATER 0.04mL/min
HRE/CO/4
!
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Not autoclavable
2
Autoclavable
Cleaning of compressor
1 41
Wipe with a dry cloth
F–5
Regular Maintenance
G–1
1
G
Every 3 months (or as needed): perfusate water filter
Replace
Part # AP1FIL/WA/1
42
G
Regular Maintenance
Every year or as needed: gas filters G – 2
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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)
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3
Replace filter
4
Check for air-tightness
Note: Gas filter life depends on quality of air – always use medical grade
43
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Regular Maintenance
G–3
G
Service of control box by Dentsleeve
1 2
Undo screw that holds control box
Send control box to Dentsleeve
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G
Regular Maintenance
Compressor Dessicant G – 4
1
Check dessicant is orange. When it becomes green, replace.
Orange
✓ GREEN
8
OR • Spread granules evenly onto tray, one granule deep. • Heat granules for approximately 5 hours. (or until it turns back to its original orange color) at 125oC (250oF) in a conventional oven. • Cool dessicant before replacing back into canister.
45
H
Problem Solving
Diagnosis of abnormal air consumption
1
H–1
Check compressor connection
For compressor malfunction, please contact Dentsleeve
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Check regulator/cylinder connection
Air Tighten Not connected ○
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Pressurise air circuit - Turn on
Air
100 50
3
150
Adjust air pressure
200
kPa psi DENTSLEEVE INT’L Mfd. by Mui Scientific
Air
4
Turn off
46
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
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Drop more than 33 kPa/5psi
Significant leak
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47
Follow (H-1.9) below
H
Problem Solving
Diagnosis of abnormal air consumption (continued)
9
H–1
Check for leakage outside control box
100 50
150 200
kPa psi If there are bubbles, replace fitting Part # ZP1FIT/SW/SS-QM2-B-200
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DENTSLEEVE INT’L Mfd. by Mui Scientific
Consult approved, qualified biomedical engineer to do check (H-1.12 to H-1.17) below ○
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Air
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Leakage?
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Open pump control box.
Remove control box lid/back
48
H H–1
Diagnosis of abnormal air consumption (continued)
15
16
49
H
Problem Solving
Check rest of air circuit
Filter leakage - tighten or replace
H
H
Problem Solving
Abnormal air consumption - perfusate reservoir leakage H – 2
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First exclude air circuit leakage - (H – 1)
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Set pressure
100 50
150 200
kPa psi DENTSLEEVE INT’L Mfd. by Mui Scientific
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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
50