CAPD Katalog

RUJUKAN : QT 210000000024659

PEMBEKALAN INTEGRATED
DISCONNECT PERITONEAL
DIALYSIS SYSTEM (CAPD)MADEINMALAYSIA

UNTUK KEGUNAAN HOSPITAL-HOSPITAL KKM

TABLE OF CONTENT

CATALOGUE CONTENT Content Page

Technical Specifications 1

1. APPLICATION 5
1.1. The Disposable Integrated Disconnect
Peritoneal Dialysis PD System 6

2. TECHNICAL FEATURES 7
2.1 The Disposable System
8
3. PD BAGS 11
3.2. PD Bags 2.0L / 2.5L 12
13
4. CAPD SYSTEM CONSUMABLES 14
3.3 Transfer Set 15
3.4 Cap for Transfer Set 16
3.5 Disposable Dressing Set 17
3.6. Hand Sanitizer
3.7. Peritoneal Catheter Clamp 18
3.8. Face Mask 19
4.2. Locking Titanium Adaptor 20
4.4. PD Catheter

5. CAPD MONTHLY CONSUMABLE ITEMS

6. STARTER PACK

7. PACKAGING

CONTINUOUS AMBULATORY PERITONEAL TECHNICAL SPEC NPRA REGISTRATION
DIALYSIS (CAPD) SYSTEM

Disconnect Double Bag System with a Luer Lock Connector

Application
1.1 Continuous Ambulatory Peritoneal Dialysis (CAPD) is indicated for chronic kidney

disease patients (CKD) with end stage renal disease when dialysis is prescribed as a renal
replacement therapy by the healthcare professionals for adults and children as prescribed
by the nephrologists.

Features
2.1 The CAPD System is a disconnect double-bag system with a luer lock connector. The

disposable system is completely integrated and closed and consists of one pre-filled (solution
bag) and one empty bag. The integrated system can safely connect to a transfer set with a
‘Y’ connector technology for continuous ambulatory PD therapy.

Key features as follows:

• 2.2 Flush before fill technology.
• 2.3 Closed System.
• 2.4 Integrated inflow and outflow colour coded clamps.
• 2.5 Ex-vivo solution flow rate of minimum 7ml/sec.

Components of System

Dialysate Formulation • Compendial as per BP Standards.
• APIs qualified to BP Standards.
• APIs used in accordance with Islamic values.
• 3.2.5 Dextrose concentrations of 1.5%, 2.5% and 4.25%.
• 3.2.7 Calcium concentrations of 1.25mmol/L and 1.75mmol/L.

Dialysate Solution Bag • 3.2 Made of clear Polypropylene material.
(Environmentally Green & Non-PVC)
• 3.2.2 Variable volume content of 2.0 Litres and 2.5 Litres.
• 3.2.3 Separate sampling / injection port.

• 3.2.4 Provision for hanging bags during therapy.
• 3.2.6 Dialysate concentration identifiable by colour codes.

• Printed information on bag:
> 3.2.9 Name of product.
> 3.2.9 Formulation specifications.
> 3.2.9 Fill volume.
> 3.2.9 Manufacturing date.
> 3.2.9 Expiry date.
> 3.2.9 Lot Number.
> 3.2.9 Product registration number with local authority.
> 3.2.9 Manufacturer name and address.

The information contained within this catalogue and the functions offered are intended to provide general information of the
product. All reasonable efforts have been made to ensure the accuracy of the information. However, Peritone Health reserves the
right to make changes to the catalogue and its functions at any time without notice.

1

Disconnect Double Bag System with a Luer Lock Connector

TECHNICAL SPEC NPRA REGISTRATION Components of System

Drainage bag • Made of clear material to enable assessment of effuent.

Consumables • Transfer set *

> 3.3.1 Length between 25-30cm

• Cap for Transfer Set/Catheter Extension *

> 3.4.1 Pre-filled with povidone iodine

(Sterile and individually packed)

• Disposable dressing set *

> 3.5.1 3 compartments tray

> 3.5.2 3 forceps

> 3.5.3 Sterile and individually packed
> 3.5.4 1 dressing towel
> 3.2.5 1 waste disposal bag
> 3.5.6. 5 pcs of gauze
> 3.5.6 6 pcs of cotton


• Hand disinfection solution

> 3.6.1 Bottle of 500ml
> 3.6.2 Does not contain fragrances and dye
(Hypoallergenic)
> 3.6.3 Broad spectrum of activity: effective against
bacteria, fungi, and viruses

• 3.7 Catheter clamp
> Made of plastic
> Sterile and individually packed

• Face mask
> 3.8 2 ply non-woven material

• Starter kit

> 4.1 Peritonial Catheter Clamp
> 4.2 Locking Titanium Adapter
> 4.4 PD Catheter, curl, 2 cuff
> Transfer set
> Safety caps
> Dressing kits/Face mask/Tapes
> Hand sanitiser
> Disinfection solution
> PD solutions and others as per prescription

*Sterile & individually pack

The information contained within this catalogue and the functions offered are intended to provide general information of the
product. All reasonable efforts have been made to ensure the accuracy of the information. However, Peritone Health reserves the
right to make changes to the catalogue and its functions at any time without notice.

2

Disconnect Double Bag System with a Luer Lock Connector

Components of System TECHNICAL SPEC NPRA REGISTRATION

Packaging • 5.1 Non PVC Bags. Made of polypropylene materials
• 5.2.1.2 4 bags per carton in accordance with daily usage
to ensure clean storage of unused bags and
avoid mix-up.
• 5.2.1.4 Dialysate concentration is identifiable by

colour code.
• 5.2.1.5 Calcium Concerntrated of PD Solution
• 5.2.1.6 Volume of PD Bags

• User Leaflet in every carton.


Distribution • 5.4.3 In accordance with the GDP guidelines.
• 5.4.3 To hospitals or patient homes as per request.

Training and Support • 6.1.1 Professional technical training and support for patient.
• 6.1.2 Healthcare personnel training;
> Provided under the CPD program as per request
or at a minimum 6 monthly interval.
• 6.1.3 Caregiver training.
• 6.1.3 CAPD Home visits and training;

> Available on request by healthcare providers


Standards and Safety • 7.1 The PD solution is registered with the Malaysian
National Pharmaceutical Regulatory Authority
(NPRA) and other local Regulatory bodies.
• 7.2 PD solution is produced in GMP certified facility.


This is a Prescription (Rx) only System.
See your healthcare professional for suitability of renal replacement therapy.

The information contained within this catalogue and the functions offered are intended to provide general information of the
product. All reasonable efforts have been made to ensure the accuracy of the information. However, Peritone Health reserves the
right to make changes to the catalogue and its functions at any time without notice.

3

TECHNICAL SPEC NPRA REGISTRATION SOFT FLOW SC - Peritoneal Dialysis Solution

No. Products Fill Volume (L) Remarks

1 SOFT FLOW SC Low Calcium (2.5mEq/L) 2L CAPD
Peritoneal Dialysis Solution with Dextrose 1.5% w/v 2.5L CAPD / APD
MAL18116041AZ 5L
APD

2 SOFT FLOW SC Low Calcium (2.5mEq/L) 2L CAPD
Peritoneal Dialysis Solution with Dextrose 2.5% w/v 2.5L CAPD/APD
MAL18116042AZ 5L
APD

3 SOFT FLOW SC Low Calcium (2.5mEq/L) 2L CAPD
Peritoneal Dialysis Solution with Dextrose 4.25% w/v 2.5L CAPD/APD
MAL18116040AZ 5L
APD

4 SOFT FLOW SC Normal Calcium (3.5mEq/L) 2L CAPD
Peritoneal Dialysis Solution with Dextrose 1.5% w/v 2.5L CAPD/APD
MAL21026039AZ 5L
APD

5 SOFT FLOW SC Normal Calcium (3.5mEq/L) 2L CAPD
Peritoneal Dialysis Solution with Dextrose 2.5% w/v 2.5L CAPD/APD
MAL21026040AZ 5L
APD

6 SOFT FLOW SC Normal Calcium (3.5mEq/L) 2L CAPD
Peritoneal Dialysis Solution with Dextrose 4.25% w/v 2.5L CAPD/APD
MAL21026041AZ 5L
APD

The information contained within this catalogue and the functions offered are intended to provide general information of the
product. All reasonable efforts have been made to ensure the accuracy of the information. However, Peritone Health reserves the
right to make changes to the catalogue and its functions at any time without notice.

4

1.0 APPLICATION APPLICATION

1.1 The Disposable Integrated Disconnect CAPD System

• Used in end-stage renal disease patients
• Adults and children as prescibed by nephrologists
• Prescription () only
• Poison Group G (Pharmaceutical)

5

2.1 INTEGRATED DISPOSABLE SYSTEM (TWIN BAG)

2.1 One (1) Empty
Drain Bag

2.1 One Pre-filled
(solution bag)

TECHNICAL FEATURES 2.4 Integrated
Outflow Clamps

2.4 Integrated
Inflow Clamps
“Y” Connection
2.1 Technology

2.2 Flush Before Fill Technology

2.3 Closed System

2.5 Flow Rate of Minimum 7ml/sec

TECHNICAL INFORMATION/PACKAGING

PRODUCT BAG Polypropylene (Non-PVC) STERILITY Sterile
SHELF LIFE
COLOUR Transparent Low Calcium : 3 Years
BRAND Normal Calcium : 2 Years
CAPACITY 2.0 litres and 2.5 litres PACKAGING Soft Flow
DEXTROSE 1.5%, 2.5% and 4.25% COLOUR CODED
CALCIUM 1.25mmol/L and 1.75mmol/L FOR DEXTROSE Individual Pack (4 bag/carton)
CONCENTRATION 2.5mEq/L and 3.5mEq/L CONCENTRATION
Black (1.5%), Blue (2.5%) and Red (4.25%)

6

3.2 DIALYSIS SOLUTION BAG • Leak Proof
3.2.1 • Made of
3.2.4 Hole for Hanging
Variable Dextrose Clear Material

3.2.5 Concentration Calcium
1.5%, 2.5%, 4.25% Concentration of
3.2.7 1.25 mmol/L and
Manufacturer’s
3.2.9.4 Name and 1.75mmol/L DIALYSIS SOLUTION BAGS

Address Variable Volume
3.2.2 2L (2000ml) /

2.5L (2500ml)

3.2.3 Injection Port

3.2.9.3 Lot Number 3.2.9.1 Manufacturing 3.2.9.2 Expiry Date
Date

3.2.6 Color Coded

Dextrose 1.5% Dextrose 2.5% Dextrose 4.25%
(Black) (Blue) (Red)

7

3.3 TRANSFER SET (STERILE)

Connection Device : Transfer Set

CAPD SYSTEM CONSUMABLES

3.3.1 Length 26 cm
3.3.2 Sterile and Individually Packed

TECHNICAL INFORMATION/PACKAGING

LENGTH 26 cm STERILITY Sterile
SHELF LIFE 2 Years
REF 35500 BRAND Youwei

MDA # GA84078400417

PACKAGING Individual Pack (1 pcs/pack)

8

3.3 TRANSFER SET COMPATIBILITY TO CYCLERS CAPD SYSTEM COMPATIBILITY

Used in conjunction with CAPD Twin BAG System and
MiniCap with Povidone-Iodine

33

3.3.3 PERITONE CAPD SYSTEM IS COMPATIBLE TO
THE EXISTING PD CYCLERS IN MOH HOSPITALS

FEATURES:

1. Twist Lock Connection Design.

2. Completely sealed connection, decreases risk of contamination.

3. PD transfer set consists of female locking connector, twist
clamp, tubing, and male locking connector. This set is to be
used with locking titanium alloy adaptor for Peritoneal Dialysis.

9

3.3 TRANSFER SET COMPATIBILITY TO EXISTING SYSTEM

CAPD SYSTEM COMPATIBILITY Peritone System

PERITONE CAPD SYSTEM Existing System
IS COMPATIBLE TO THE

EXISTING SYSTEM

10

3.4 CAP FOR TRANSFER SET (STERILE)

Sterile and Open CAPD SYSTEM CONSUMABLES
3.4.2 Individually

Packed

Close

3.4.1 Pre-Fillled with
Antiseptic Agent

*Enlarged image

MiniCap with Providone-Iodine is a plastic cap with safety
cover designed to isolate and disinfect the transfer set for

Peritoneal Dialysis.

TECHNICAL INFORMATION/PACKAGING

MATERIAL Polyethylene (PE) STERILITY Sterile
SHELF LIFE 2 Years
COLOUR White BRAND Youwei
PACKAGING Individual Pack
STANDARD ISO 9001:2015 ORDER CODE 35550

ISO 13485:2016

MDA # GA47734209017

11

3.5 DISPOSABLE DRESSING SET (STERILE)

Dressing Set is sterile, used to clean and promote wound
healing and prevent infection or further harm.

CAPD SYSTEM CONSUMABLES 3.5.1 Tray with Three 3.5.2 Three (3) 3.5.4 Two (2)
(3) Compartment Disposable Forceps Dressing Towel

3.5.5 One (1) Waste 3.5.6 Five (5) Pieces 3.5.6 Six (6) Pieces
Disposal Bag of Gauze of Cotton

3.5.3 Individually Packed One (1) One (1)
Patient Drape Sterile Field

TECHNICAL INFORMATION/PACKAGING

BRAND Connecx STERILITY Sterile
SHELF LIFE 5 Years
PACKAGING Individual Pack

MDA # GA6924221-60692

12

3.6 HYGIENIC AND SURGICAL HAND
DISINFECTION SOLUTION

An alcohol-based hand sanitizer that is Virucidal, CAPD SYSTEM CONSUMABLES
Bactericidal and Germicidal. It is suitable for use in any
environment that practices hand hygiene and cleanliness to

prevent cross contamination.

Broad Antiseptic
Spectrum of
3.6.3 Activity: Effective
Against Bacteria,
Fungi and Viruses

WHO
Recommended

Formulation
Fragrance
Free

3.6.2 Hypo-
Allergenic

3.6.1 500 ml NOT Number

MADE IN MALAYSIA

TECHNICAL INFORMATION/PACKAGING

ACTIVE 75% Isopropyl Alcohol GENERAL For external use on hands only. For
INGREDIENT INFORMATION safe handling information on this
STORAGE product, consult the Material Safety
COLOUR Clear Data Sheet (MSDS).
Cool and dry condition
CAPACITY 500 ml

DISPENSER TYPE Press

13

3.7 PERITONEAL CATHETER CLAMP (STERILE)

Designed to clamp the Peritoneal Catheter when required.

CAPD SYSTEM CONSUMABLES Individually Packed 3.7.1 Peritoneal Catheter Clamp

*Enlarged image

TECHNICAL INFORMATION/PACKAGING

MATERIAL Polypropylene (PP) STERILITY Ethylene Oxide
SHELF LIFE 3 Years
COLOUR Transparent BRAND KIMAL
PACKAGING Individual Pack (1 pcs/pack)
STANDARD CE 0088

ORDER CODE 35556 (K41/10)

14

3.8 FACE MASK 3-PLY CAPD SYSTEM CONSUMABLES

Disposable 3-Ply Face Mask

TECHNICAL INFORMATION/PACKAGING STERILITY
TYPE SHELF LIFE
COLOUR BRAND
SIZE PACKAGING
STANDARD MDA #

15

3.9 MONTHLY HOME DELIVERY PRESCRIPTION

MONTHLY DELIVERY SOFT FLOW SC CAPD 3.9.2 MINICAP 3.9.3 DRESSING SET
3.9.1 (2L & 2.5L)

1.5% / 2.5% / 4.25%

3.9.4 HAND SANTIZER 3.9.5 3-PLY DISPOSABLE
FACE MASK

3.9.6 4 bags per day
4 pieces per day
Soft Flow SC CAPD (2L & 2.5L), DEXTROSE 1.5%/ 2.5%/ 4.25% 1 bottle per month
MiniCap with Povidone Iodine
Hand Sanitizer, 500ml 1 set daily
Dressing Set 4 pieces daily
2 Ply Disposable Face Mask (62 pcs/box) As required
CAPD Record Book

16

4.0 STARTER PACK

4.1 PD CATHETER 4.2 LOCKING TITANIUM
CLAMP ADAPTER

STARTER PACK

4.4 PERITONEAL
DIALYSIS CATHETER

4.4.1

STARTER PACK CONTENT
PD Catheter Clamp 1 Piece
Locking Titanium Adapter 1 Piece
Peritoneal Dialysis Catheter (Length 47-62cm) 1 Piece

17

4.1 PERITONEAL CATHETER CLAMP

4.1.1 Peritoneal Catheter Clamp

CAPD SYSTEM CONSUMABLES 4.2 LOCKING TITANIUM ADAPTOR

4.2.1 Locking Titanium Adaptor

3

Individually Packed FEATURES:

• Used to connect the PD Catheter to
Transfer Set

• Material Titanium Alloy
Lightweight, durable, resistant to

rust, Non-Magnetic.

• Smooth, Glossy, No Spaces
Decreases the possibility of damage

to the pipeline and deceases the
chances of peritoneum infection.

• Locking Design
Fine sealed connection, decreases

possibility of contaminations.

TECHNICAL INFORMATION/PACKAGING

MATERIAL Titanium alloy STERILITY Sterile
SHELF LIFE 2 Years
COLOUR silver BRAND Youwei
PACKAGING Individual Pack (1 unit/pack)
MDA # GMD356771026419A

ORDER CODE 35507

18

4.4 PD CATHETER CAPD SYSTEM CONSUMABLES

4.4 PD Catheter
4.4.2 Made of Silicone
4.4.1 Lengths 62 cm
4.4.4 Double Cuffed

4.4.3 Coiled

TECHNICAL INFORMATION/PACKAGING

MATERIAL Polytetrafluoroethylene (PTFE) STERILITY Sterile
SHELF LIFE 5 Year
LENGTH 47-62 cm BRAND Argyle
PACKAGING Individual Pack
ORDER CODE 35548

MDA # GC37789808118

19

5.2 PACKAGING FOR PD SOLUTION

5.2.1.3 Names of the 5.2.1.4 PD Solution Strength
Product with Color Coding

PACKAGING 5.2.1.6 Volume Per Bag 5.2.1.8 Expiry Date
2000 mL / 2500 mL 5.2.1.7 Manufacturing Date
5.2.1.9 Batch/Lot Number
5.2.1.5 Calcium Concentration 5.2.1.2 4 PD Bags
of PD Solution

20

5.2 PACKAGING FOR PD SOLUTION

5.2.1.11 Kementerian Kesihatan
Malaysia (KKM)

5.2.1.12 Sealing Tape
Easy Peel

5.2.1.10 Manufacturer’s PACKAGING
Name and Address

5.2.1.4 PD Solution Strength
with Color Coding

NAME OF THE PRODUCT YES
PD Solution strength with colour coding Yes
Volume per bag Yes
Manufacturing date Yes
Expiry date Yes
Batch / Lot Number Yes
Manufacturer’s name & address Yes
Kementerian Kesihatan Malaysia (KKM) label Yes
Sealing tape easy peel Yes

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Lot 12, Industrial Zone Phase 4, Kulim Hitech Park,
09000 Kulim Kedah Darul Aman

(60)19 470 9008 / (60)16 494 9108
www. Peritone-health.com

MADE IN MALAYSIA